Ribavirin

Ribavirin Manufacturers

• State Of Florida Doh Central Pharmacy
  

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  CHC Monoinfection

  The recommended dose of ribavirin tablet is provided in Table 5. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

  The daily dose of ribavirin tablet is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 5).

  In the pivotal clinical trials, patients were instructed to take ribavirin tablets with food; therefore, patients are advised to take ribavirin tablets with food.

  Table 5 Peginterferon alfa-2a and Ribavirin Tablets Dosing Recommendations

  Genotype

  Peginterferon alfa-2a Dose

  Ribavirin Tablets Dose

  Duration

  Genotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.

  Genotype 1, 4 180 mcg <75 kg = 1000 mg 
  ≥75 kg = 1200 mg 48 weeks 
  48 weeks Genotype 2, 3 180 mcg 800 mg 24 weeks CHC with HIV Coinfection

  The recommended dose for hepatitis C in HCV/HIV coinfected patients is peginterferon alfa-2a 180 mcg sc once weekly and ribavirin tablets 800 mg po daily for a total of 48 weeks, regardless of genotype.

  Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued.

  Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease (see Table 6). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see WARNINGS).

  Table 6 Ribavirin Tablets Dosage Modification Guidelines

  Laboratory Values

  Reduce Only Ribavirin 
  Tablets Dose to 600 mg/day* 
  if:

  Discontinue Ribavirin 
  Tablets if:

  * One 200 mg tablet in the morning and two 200 mg tablets in the evening. Hemoglobin in patients with 
  no cardiac disease <10 g/dL <8.5 g/dL Hemoglobin in patients with 
  history of stable cardiac 
  disease ≥2 g/dL decrease in
   hemoglobin during any 4
   week period treatment <12 g/dL despite 4 weeks at 
  reduced dose

  Once ribavirin tablet has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that ribavirin tablets be increased to its original assigned dose (1000 mg to 1200 mg).

  Renal Impairment

  Ribavirin tablets should not be used in patients with creatinine clearance <50 mL/min (see WARNINGS and CLINICAL PHARMACOLOGY: Special Populations).

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  (See CLINICAL PHARMACOLOGY: Special Populations; see WARNINGS.)

  Ribavirin/INTRON A Combination Therapy Adults

  The recommended dose of ribavirin capsules in patients 18 years of age and older depends on the patient’s body weight. The recommended dose of ribavirin is provided in TABLE 6.

  The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen. (See Description of Clinical Studies and ADVERSE REACTIONS). After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

  In patients who relapse following non-pegylated interferon mono-therapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient population.

  
  TABLE 6. Recommended Dosing for Patients 18 years of age and older Body Weight Ribavirin Capsules

  ≤75 kg

  2 x 200 mg capsules AM,

  3 x 200 mg capsules PM

  daily p.o.

  >75 kg

  3 x 200 mg capsules AM,

  3 x 200 mg capsules PM

  daily p.o.

  Ribavirin may be administered without regard to food, but should be administered in a consistent manner with respect to food intake. (See CLINICAL PHARMACOLOGY).

  Dose Modifications

  (See TABLE 7.)

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/INTRON A therapy the dose should be modified, or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin/INTRON A therapy should be discontinued.

  Ribavirin should not be used in patients with creatinine clearance <50 mL/min. Subjects with impaired renal function and/or those over the age of 50 should be carefully monitored with respect to development of anemia. (See WARNINGSand CLINICAL PHARMACOLOGY: Special Populations).

  Ribavirin should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped. (See WARNINGS).

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by ≥2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains <12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination ribavirin/INTRON A therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin dose reduced to 600 mg daily (1 x 200 mg capsule AM, 2 x 200 mg capsules PM) for adults. A patient whose hemoglobin level falls below 8.5 g/dL should be permanently discontinued from ribavirin therapy. (See WARNINGS).

  
  TABLE 7. Guidelines for Dose Modifications and Discontinuation for Anemia

  Dose Reduction

  Ribavirin –

  600 mg daily adults

  Permanent

  Discontinuation of

  Ribavirin Treatment Hemoglobin No Cardiac History <10 g/dL <8.5 g/dL

  Cardiac History Patients

  ≥2 g/dL decrease

  during any 4-week

  period during treatment

  <12 g/dL after

  4 weeks dose

  reduction

  INTRON A Injection should be administered subcutaneously and ribavirin capsules should be administered orally. Ribavirin capsules may be administered without regard to food, but should be administered in a consistent manner. (See CLINICAL PHARMACOLOGY.)

  Adults

  The recommended dose of ribavirin capsules in patients 18 years of age and older depends on the patient’s body weight. The recommended doses of ribavirin capsules and INTRON A for adults are given in TABLE 6.

  The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen (see Description of Clinical Studies and ADVERSE REACTIONS). After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

  In patients who relapse following interferon therapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient population.

  TABLE 6. Recommended Adult Dosing Body Weight Ribavirin Capsules INTRON A Injection

  ≤75 kg

  2 x 200 mg capsules AM,

  3 x 200 mg capsules PM

  daily p.o.

  3 million

  IU 3 times weekly s.c.

  >75 kg

  3 x 200 mg capsules AM,

  3 x 200 mg capsules PM

  daily p.o.

  3 million

  IU 3 times weekly s.c.

  Under no circumstances should ribavirin capsules be opened, crushed or broken (see CONTRAINDICATIONS and WARNINGS).

  Dose Modifications

  (See TABLE 7.)

  In clinical trials, approximately 26% of patients required modification of their dose of ribavirin capsules, INTRON A Injection, or both agents. If severe adverse reactions or laboratory abnormalities develop during combination ribavirin capsules/INTRON A therapy the dose should be modified, or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin capsules/INTRON A therapy should be discontinued.

  Ribavirin capsules/INTRON A therapy should be administered with caution to patients with preexisting cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped. (See WARNINGS.)

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by ≥2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains <12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination ribavirin capsules/INTRON A therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin capsules dose reduced to 600 mg daily (1 x 200 mg capsule AM, 2 x 200 mg capsules PM). A patient whose hemoglobin level falls below 8.5 g/dL should be permanently discontinued from ribavirin capsules/INTRON A therapy. (See WARNINGS.)

  It is recommended that a patient who experiences moderate depression (persistent low mood, loss of interest, poor self image, and/or hopelessness) have his/her INTRON A dose temporarily reduced and/or be considered for medical therapy. A patient experiencing severe depression or suicidal ideation/attempt should be discontinued from ribavirin capsules/INTRON A therapy and followed closely with appropriate medical management. (See WARNINGS.)

  
  TABLE 7. Guidelines for Dose Modifications * Study medication to be dose reduced is shown in parenthesis.

  Dose Reduction*

  Ribavirin capsules –

  Adults 600 mg daily

  INTRON A – Adults

  1.5 million IU TIW

  Permanent

  Discontinuation

  of Treatment

  Ribavirin capsules

  and INTRON A

  Hemoglobin

  <10 g/dL

  (Ribavirin capsules)

  <8.5 g/dL

  Cardiac History

  Patients Only

  ≥2 g/dL decrease

  during any 4-week

  period during treatment

  (Ribavirin capsules/

  INTRON A)

  <12 g/dL after

  4 weeks of dose

  reduction

  White blood count <1.5 x 109/L (INTRON A) <1.0 X 109/L Neutrophil count <0.75 x 109/L (INTRON A) <0.5 X 109/L

  Platelet count

  Adults: <50 x 109/L

  (INTRON A)

  Adults: <25 x 109/L

  Administration of INTRON A Injection

  At the discretion of the physician, the patient may self-administer the INTRON A. [See illustrated Appendix to Medication Guide on ribavirin capsules for instructions.]

  The Intron A Injection is supplied as a clear and colorless solution. The appropriate INTRON A dose should be withdrawn from the vial or set on the multidose pen and injected subcutaneously. The INTRON A Injection supplied with the B-D Safety Lok™ syringes contain a plastic sleeve to be pulled over the needle after use. The syringe locks with an audible click when the green stripe on the safety sleeve covers the red stripe on the needle. After administration of INTRON A Injection, it is essential to follow the procedure for proper disposal of syringes and needles. [See Appendix to Medication Guide on ribavirin capsules for detailed instructions.]

  * This is a multidose vial which contains a total of 22.8 million IU of interferon alfa-2b, recombinant per 3.8 mL in order to provide the delivery of six 0.5-mL doses, each containing 3 million IU of interferon alfa-2b, recombinant (for a label strength of 18 million IU). † This is a multidose pen which contains a total of 22.5 million IU of interferon alfa-2b, recombinant per 1.5 mL in order to provide the delivery of six 0.2-mL doses, each containing 3 million IU of interferon alfa-2b, recombinant (for a label strength of 18 million IU). Vial/Pen Label Strength Fill Volume Concentration 3 million IU vial 0.5 mL 3 million IU/0.5 mL 18 million IU multidose vial* 3.8 mL 3 million IU/0.5 mL 18 million IU multidose pen† 1.5 mL 3 million IU/0.2 mL

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. INTRON A Injection may be administered using either sterilized glass or plastic disposable syringes.

  Stability

  INTRON A Injection provided in vials is stable at 35°C (95°F) for up to 7 days and at 30°C (86°F) for up to 14 days. INTRON A Injection provided in a multidose pen is stable at 30°C (86°F) for up to 2 days. The solution is clear and colorless.

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  Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin capsules should not be used in patients with creatinine clearance < 50 mL/min.

  2.2 Ribavirin capsules /INTRON A Combination Therapy

  Adults

  Duration of Treatment – Interferon Alpha-naïve Patients

  The recommended dose of INTRON A is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin capsules depends on the patient’s body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1), and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

  Duration of Treatment – Retreatment with INTRON A/ribavirin capsules in Relapse Patients

  In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks.

  Table 3Recommended Dosing Body weight 
  Ribavirin Capsules  
  ≤ 75 kg 
  2 x 200 mg capsules AM
  3 x 200 mg capsules PM
  daily orally
  > 75 kg 
  3 x 200 mg capsules AM
  3 x 200 mg capsules PM
  daily orally
  

  Pediatrics

  The recommended dose of ribavirin is 15 mg/kg per day orally (divided dose AM and PM). INTRON A for Injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

  2.3 Laboratory Tests

  The following laboratory tests are recommended for all patients treated with ribavirin capsules, prior to beginning treatment and then periodically thereafter.

  Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7)], complete and differential white blood cell counts, and platelet count. Blood chemistries - liver function tests and TSH. Pregnancy - including monthly monitoring for women of childbearing potential. ECG [see Warnings and Precautions (5.2)]. 2.4 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin capsules/INTRON A therapy, modified, or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued.

  Ribavirin capsules should not be used in patients with creatinine clearance <   50 mL/min. Subjects with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use In Specific Populations (8.5), and Clinical Pharmacology (12.3)].

  Ribavirin capsules should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by ≥ 2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains < 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin capsules dose modified or discontinued per Table 5 [see Warnings and Precautions (5.2)].

  Table 5Guidelines for Dose Modification and Discontinuation of INTRON A or Ribavirin Capsules Based on Laboratory Parameters in Adults and Pediatrics

  *For adult patients with a history of stable cardiac disease receiving INTRON A in combination with ribavirin, the INTRON A dose should be reduced by half and the ribavirin capsules dose by 200 mg/day if a > 2 g/dL decrease in hemoglobin is observed during any 4-week period. Both INTRON A and ribavirin capsules should be permanently discontinued if patients have hemoglobin levels < 12 g/dL after this ribavirin capsules dose reduction.
  

  Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease ≥ 2 g/dL during any 4 week period during treatment should have weekly evaluations and hematology testing.
  

  †1stdose reduction of ribavirin capsules is by 200 mg/day, except in patients receiving the 1400 mg dose it is by 400 mg/day; 2nddose reduction of ribavirin capsules (if needed) is by an additional 200 mg/day.
  

  For patients on ribavirin capsules/INTRON A combination therapy, reduce INTRON A dose by 50%.
  

  Laboratory Values
  Adults
  Pediatrics
  Adults
  Pediatrics
  
  INTRON A 
  INTRON A
  Ribavirin capsules 
  
  Hgb < 10g/dL 
  For patients with cardiac disease, reduce by 50%*
  See footnote* Adjust
  Dose†
  1st reduction to 12 mg/kg/day 2nd reduction to 8 mg/kg/day
  WBC           < 1.5 x 109/L Neutrophils    < 0.75 x 109/L Platelets 
  < 50 x 109/L (Adults) 
  < 70 x 109/L (Pediatrics)
  Adjust Dose
  Reduce by 50%
  No Dose Change
  No Dose Change
  Hgb       < 8.5g/dL
  WBC   < 1 x 109/L Neutrophils 
           < 0.5 x 109/L 
  Creatinine
           > 2 mg/dL                                                                (Pediatrics)    
          
  Platelets 
  < 25 x 109/L (Adults)
  < 50 x 109/L (Pediatrics)
   
  Permanently Discontinue
  Permanently Discontinue
  Permanently Discontinue
  Permanently Discontinue
  

  Refer to the INTRON A Package Insert Package Insert for additional information about how to reduce an INTRON A dose.

  2.5 Discontinuation of Dosing

  Adults

  Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

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  2.1 Chronic Hepatitis C Monoinfection

  The recommended dose of ribavirin tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

  The daily dose of ribavirin is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1).

  Ribavirin should be taken with food.

  Table 1Peginterferon alfa-2a and Ribavirin Dosing Recommendations Hepatitis C Virus (HCV) Genotype 
  Peginterferon Alfa-2a Dose*
  Ribavirin Dose
  Duration
  

  Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 6).

  Data on genotypes 5 and 6 are insufficient for dosing recommendations.
  

  *See Peginterferon alfa-2a Package Insert for further details on peginterferon alfa-2a dosing and administration.
  

  Genotypes 1, 4 
  180 mcg
  < 75 kg = 1000 mg 
  ≥ 75 kg = 1200 mg
  48 weeks
  48 weeks
  Genotypes 2, 3 
  180 mcg
  800 mg
  24 weeks
  2.2 Chronic Hepatitis C with HIV Coinfection

  The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is peginterferon alfa-2a 180 mcg subcutaneous once weekly and ribavirin 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

  Ribavirin should be taken with food.

  2.3 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, ribavirin/peginterferon alfa-2a therapy should be discontinued. Table 2 provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status.

  Ribavirin should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see WARNINGS AND PRECAUTIONS (5.2)].

  Table 2Ribavirin Dosage Modification Guidelines Laboratory Values 
  Reduce Only Ribavirin Dose to 600 mg/day* if:
  Discontinue Ribavirin if:
  

  * One 200 mg tablet in the morning and two 200 mg tablets in the evening.
  

  Hemoglobin in patients with no cardiac disease 
  < 10 g/dL
  < 8.5 g/dL
  Hemoglobin in patients with history of stable cardiac disease 
  ≥ 2 g/dL decrease in hemoglobin during any 4 week period treatment
  < 12 g/dL despite 4 weeks at reduced dose
  

  Once ribavirin has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin be increased to the original assigned dose (1000 mg to 1200 mg).

  See peginterferon alfa-2a full prescribing information for recommendations on peginterferon alfa-2a dose modification.

  2.4 Discontinuation of Dosing

  Discontinuation of peginterferon alfa-2a/ ribavirin therapy should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.

  Peginterferon alfa-2a/ ribavirin therapy should be discontinued in patients who develop hepatic decompensation during treatment [see WARNINGS AND PRECAUTIONS (5.3)].

  2.5 Renal Impairment

  Ribavirin should not be used in patients with creatinine clearance < 50 mL/min [see USE IN SPECIFIC POPULATIONS (8.7)].

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  CHC Monoinfection

  The recommended dose of ribavirin tablet is provided in Table 5. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

  The daily dose of ribavirin tablet is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 5).

  In the pivotal clinical trials, patients were instructed to take ribavirin tablets with food; therefore, patients are advised to take ribavirin tablets with food.

  Table 5 Peginterferon alfa-2a and Ribavirin Tablets Dosing Recommendations Genotype 
  Peginterferon alfa-
  2a Dose
  Ribavirin Tablets Dose
  Duration
  

  Genotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.
  

  Genotype 1, 4
  180 mcg
  <75 kg = 1000 mg
  ≥75 kg = 1200 mg
  48 weeks
  48 weeks
  Genotype 2, 3
  180 mcg
  800 mg
  24 weeks
  CHC with HIV Coinfection

  The recommended dose for hepatitis C in HCV/HIV coinfected patients is peginterferon alfa-2a 180 mcg sc once weekly and ribavirin tablets 800 mg po daily for a total of 48 weeks, regardless of genotype.

  Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued.

  Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease (see Table 6). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see WARNINGS).

  Table 6 Ribavirin Tablets Dosage Modification Guidelines Laboratory Values 
  Reduce Only Ribavirin
  Tablets Dose to 600 mg/day*
  if: 
  Discontinue Ribavirin
  Tablets if: 
  * One 200 mg tablet in the morning and two 200 mg tablets in the evening. Hemoglobin in patients with
  no cardiac disease 
  <10 g/dL 
  <8.5 g/dL 
  Hemoglobin in patients with
  history of stable cardiac
  disease 
  ≥2 g/dL decrease in
  hemoglobin during any 4
  week period treatment 
  <12 g/dL despite 4 weeks at
  reduced dose 
  

  Once ribavirin tablet has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that ribavirin tablets be increased to its original assigned dose (1000 mg to 1200 mg).

  Renal Impairment

  Ribavirin tablets should not be used in patients with creatinine clearance <50 mL/min (see WARNINGS and CLINICAL PHARMACOLOGY: Special Populations).

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  do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pains or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor 

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  Ribavirin | Baxter Healthcare Corporation

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  2.1 Depressive Episodes Associated with Bipolar I Disorder

  Adults

  Olanzapine and fluoxetine capsules should be administered once daily in the evening, generally beginning with the 6 mg/25 mg (mg equivalent olanzapine/mg equivalent fluoxetine) capsule. While food has no appreciable effect on the absorption of olanzapine and fluoxetine given individually, the effect of food on the absorption of olanzapine and fluoxetine capsules has not been studied. Make dosage adjustments, if indicated, according to efficacy and tolerability. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine capsules in a dose range of olanzapine 6 mg to 12 mg and fluoxetine 25 mg to 50 mg [see CLINICAL STUDIES (14.1)]. The safety of doses above 18 mg of olanzapine and 75 mg of fluoxetine has not been evaluated in adult clinical studies. Periodically reexamine the need for continued pharmacotherapy.

  Children and Adolescents (10 to 17 years of age)

  Information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine and fluoxetine hydrochloride capsules. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with the pediatric information.

  2.3 Specific Populations

  Start olanzapine and fluoxetine capsules at 3 mg/25 mg or 6 mg/25 mg in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine and fluoxetine capsules (female gender, geriatric age, nonsmoking status) or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. Olanzapine and fluoxetine capsules has not been systematically studied in patients >65 years of age or in patients <10 years of age [see WARNINGS AND PRECAUTIONS (5.19), USE IN SPECIFIC POPULATIONS (8.5), and CLINICAL PHARMACOLOGY (12.3, 12.4)].

  Treatment of Pregnant Women

  When treating pregnant women with fluoxetine, a component of olanzapine and fluoxetine capsules the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding [see USE IN SPECIFIC POPULATIONS (8.1)].

  2.4 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with olanzapine and fluoxetine capsules. Conversely, at least 5 weeks should be allowed after stopping olanzapine and fluoxetine capsules before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS (4.1)].

  2.5 Use of Olanzapine and Fluoxetine Capsules with Other MAOIs such as Linezolid or Methylene Blue

  Do not start olanzapine and fluoxetine capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS (4.1)].

  In some cases, a patient already receiving olanzapine and fluoxetine capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, olanzapine and fluoxetine capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for five weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with olanzapine and fluoxetine capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS (5.5)].

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with olanzapine and fluoxetine capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS (5.5)].

  2.6 Discontinuation of Treatment with Olanzapine and Fluoxetine Capsules

  Symptoms associated with discontinuation of fluoxetine, a component of olanzapine and fluoxetine capsules, SNRIs, and SSRIs, have been reported [see WARNINGS AND PRECAUTIONS (5.23)].

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  2.1 Chronic Hepatitis C Monoinfection

  The recommended dose of ribavirin tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

  The daily dose of ribavirin tablets is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1).

  Ribavirin tablets should be taken with food.

  Table 1. Peginterferon alfa-2a and Ribavirin Tablet Dosing Recommendations * See peginterferon alfa-2a Package Insert for further details on peginterferon alfa-2a dosing and administration. Hepatitis C Virus (HCV) Genotype Peginterferon alfa-2a Dose* Ribavirin Tablet Dose Duration Genotypes 1, 4 180 mcg < 75 kg = 1000 mg 48 weeks ≥ 75 kg = 1200 mg 48 weeks Genotypes 2, 3 180 mcg 800 mg 24 weeks

   Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 6).
  Data on genotypes 5 and 6 are insufficient for dosing recommendations.

  2.2 Chronic Hepatitis C With HIV Coinfection

  The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is peginterferon alfa-2a 180 mcg subcutaneous once weekly and ribavirin tablets, 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

  Ribavirin tablets should be taken with food.

  2.3 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablet/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, ribavirin tablet/peginterferon alfa-2a therapy should be discontinued. Table 2 provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status.

  Ribavirin tablets should be administered with caution to patients with preexisting cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  Table 2. Ribavirin Tablet Dosage Modification Guidelines * One 200 mg tablet in the morning and two 200 mg tablets in the evening. Laboratory Values Reduce Only Ribavirin Tablet Dose to 600 mg/day* if: Discontinue Ribavirin Tablets if: Hemoglobin in patients with no cardiac disease < 10 g/dL < 8.5 g/dL Hemoglobin in patients with history of stable cardiac disease ≥ 2 g/dL decrease in hemoglobin during any 4 week period treatment < 12 g/dL despite 4 weeks at reduced dose

  Once ribavirin tablets have been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin tablets be increased to the original assigned dose (1000 mg to 1200 mg).

  See peginterferon alfa-2a full prescribing information for recommendations on peginterferon alfa-2a dose modification.

  2.4 Discontinuation of Dosing

  Discontinuation of peginterferon alfa-2a/ribavirin tablet therapy should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.

  Peginterferon alfa-2a/ribavirin tablet therapy should be discontinued in patients who develop hepatic decompensation during treatment [see Warnings and Precautions (5.3)].

  2.5 Renal Impairment

  Ribavirin tablets should not be used in patients with creatinine clearance < 50 mL/min [see Use in Specific Populations (8.7)].

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  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area • using more or more often will not improve results • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

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  For Control of Hypertension: The adult initial dose of hydrochlorothiazide is one capsule given once daily whether given alone or in combination with other antihypertensives. Total daily doses greater than 50 mg are not recommended.

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  Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin capsules should not be used in patients with creatinine clearance < 50 mL/min.

  2.2 Ribavirin/INTRON A Combination Therapy

  Adults

  Duration of Treatment – Interferon Alpha-naïve Patients

  The recommended dose of INTRON A is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin capsules depends on the patient’s body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1) and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

    Duration of Treatment – Re-treatment with INTRON A/Ribavirin in Relapse Patients   In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks. Table 3: Recommended Dosing Body Weight Ribavirin Capsules ≤ 75 kg

  2 x 200 mg capsules AM

  3 x 200 mg capsules PM daily orally > 75 kg

  3 x 200 mg capsules AM

  3 x 200 mg capsules PM daily orally

  Pediatrics

  The recommended dose of ribavirin is 15 mg/kg per day orally (divided dose AM and PM). Refer to Table 5 for Pediatric Dosing of ribavirin in combination with INTRON A. INTRON A for injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. Refer to adult dosing table for > 61 kg body weight.

  The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

  2.3 Laboratory Tests

  The following laboratory tests are recommended for all patients treated with ribavirin, prior to beginning treatment and then periodically thereafter.

  Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7)], complete and differential white blood cell counts, and platelet count. Blood chemistries - liver function tests and TSH. Pregnancy - including monthly monitoring for women of childbearing potential. ECG [see Warnings and Precautions (5.2)]. 2.4 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/INTRON A therapy, modify or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued.

  Ribavirin should not be used in patients with creatinine clearance < 50 mL/min. Subjects with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)].

  Ribavirin should be administered with caution to patients with preexisting cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by ≥ 2 g/dL during any 4 week period. In addition, for these cardiac history patients, if the hemoglobin remains < 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin dose modified or discontinued per Table 5 [see Warnings and Precautions (5.2)].

  Table 5: Guidelines for Dose Modification and Discontinuation of INTRON A/Ribavirin Based on Laboratory Parameters in Adults and Pediatrics * For adult patients with a history of stable cardiac disease receiving INTRON A in combination with ribavirin, the INTRON A dose should be reduced by half and the ribavirin dose by 200 mg/day if a > 2 g/dL decrease in hemoglobin is observed during any 4 week period. INTRON A and ribavirin should be permanently discontinued if patients have hemoglobin levels < 12 g/dL after this ribavirin dose reduction. Pediatric patients who have preexisting cardiac conditions and experience a hemoglobin decrease ≥ 2 g/dL during any 4 week period during treatment should have weekly evaluations and hematology testing. † 1 st dose reduction of ribavirin is by 200 mg/day, except in patients receiving the 1400 mg dose it is by 400 mg/day; 2 nd dose reduction of ribavirin (if needed) is by an additional 200 mg/day. ‡ For patients on ribavirin/INTRON A combination therapy, reduce INTRON A dose by 50%. Laboratory Values Adults Pediatrics Adults Pediatrics INTRON A Ribavirin Hgb < 10 g/dL For patients with cardiac disease, reduce by 50%* See footnote* Adjust Dose†

  1st reduction to 12 mg/kg/day

  2nd reduction to 8 mg/kg/day

  WBC < 1.5 x 109/L Adjust Dose‡ Reduce by 50% No Dose Change No Dose Change Neutrophils < 0.75 x 109/L Platelets < 50 x 109/L (Adults) < 70 x 109/L (Pediatrics) Hgb < 8.5 g/dL Permanently Discontinue Permanently Discontinue Permanently Discontinue Permanently Discontinue WBC < 1 x 109/L Neutrophils < 0.5 x 109/L Creatinine > 2 mg/dL (Pediatrics) Platelets < 25 x 109/L (Adults) < 50 x 109/L (Pediatrics)

  Refer to the INTRON A Package Insert for additional information about how to reduce an INTRON A dose.

  2.5 Discontinuation of Dosing

  Adults

  Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

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  Comb the hair to remove scaly debris and after suitably parting, apply Calcipotriene Topical Solution, 0.005% (Scalp Solution), twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Calcipotriene Topical Solution, 0.005% (Scalp Solution), have been demonstrated in patients treated for eight weeks.

  Keep Calcipotriene Topical Solution, 0.005% (Scalp Solution), well away from the eyes. Avoid application of the solution to uninvolved scalp margins.

  Always wash hands thoroughly after use.

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  Ribavirin should be taken with food. Ribavirin should be given in combination with peginterferon alfa-2a; it is important to note that ribavirin should never be given as monotherapy. See peginterferon alfa-2a package insert for all instructions regarding peginterferon alfa-2a dosing and administration.

  2.1 Chronic Hepatitis C Monoinfection

  Adult Patients

  The recommended dose of ribavirin tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

  The daily dose of ribavirin tablets is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1).

  Table 1. Peginterferon alfa-2a and Ribavirin Tablets Dosing Recommendations Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10).
  Data on genotypes 5 and 6 are insufficient for dosing recommendations. * See peginterferon alfa-2a package insert for further details on peginterferon alfa-2a dosing and administration, including dose modification in patients with renal impairment.

  
  Hepatitis C
  Virus (HCV)
  Genotype

  Peginterferon
  alfa-2a
  Dose*
  (once weekly)

  Ribavirin
  Tablets
  Dose
  (daily)

  
  
  
  Duration

  Genotypes 1,4

  180 mcg

  <75 kg =
  1000 mg

  48 weeks

  ≥75 kg =
  1200 mg

  48 weeks

  Genotypes 2, 3

  180 mcg

  800 mg

  24 weeks

  Pediatric Patients

  Peginterferon alfa-2a is administered as 180 mcg/1.73m2 x BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks.

  Ribavirin should be given in combination with peginterferon alfa-2a. Ribavirin is available only as a 200 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for ribavirin are provided in Table 2. Patients who initiate treatment prior to their 18th birthday should maintain pediatric dosing through the completion of therapy.

  Table 2. Ribavirin Dosing Recommendations for Pediatric Patients * approximately 15 mg/kg/day

  Body Weight in
  kilograms (kg)

  Ribavirin
  Daily Dose*

  Ribavirin Number
  of Tablets

  23 – 33

  400 mg/day

  1 x 200 mg tablet A.M.
  1 x 200 mg tablet P.M.

  34 – 46

  600 mg/day

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M.

  47 – 59

  800 mg/day

  2 x 200 mg tablets A.M.
  2 x 200 mg tablets P.M.

  60 – 74

  1000 mg/day

  2 x 200 mg tablets A.M.
  3 x 200 mg tablets P.M.

  ≥75

  1200 mg/day

  3 x 200 mg tablets A.M.
  3 x 200 mg tablets P.M.

  2.2 Chronic Hepatitis C with HIV Coinfection

  Adult Patients

  The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is peginterferon alfa-2a 180 mcg subcutaneous once weekly and ribavirin tablets 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

  2.3 Dose Modifications

  Adult and Pediatric Patients

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status.

  Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  Table 3. Ribavirin Dose Modification Guidelines in Adults and Pediatrics

  Laboratory Values

  Body weight in
  kilograms (kg)

  Hemoglobin <10 g/dL in patients with no cardiac disease, or
  Decrease in hemoglobin of ≥2 g/dL during any 4 week period in patients with history of stable cardiac disease

  Hemoglobin <8.5 g/dL in patients with no cardiac disease, or
  Hemoglobin <12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease

  Adult Patients older than 18 years of age

  Any weight

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M.

  Discontinue Ribavirin

  Pediatric Patients 5 to 18 years of age

  23 – 33 kg

  1 x 200 mg tablet A.M.

  34 – 46 kg

  1 x 200 mg tablet A.M.
  1 x 200 mg tablet P.M.

  47 – 59 kg

  1 x 200 mg tablet A.M.
  1 x 200 mg tablet P.M.

  Discontinue Ribavirin

  60 – 74 kg

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M.

  ≥75 kg

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M.

  The guidelines for ribavirin dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.

  Adult Patients

  Once ribavirin tablets have been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin tablets be increased to the original assigned dose (1000 mg to 1200 mg).

  Pediatric Patients

  Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in ribavirin dose to the original dose may be attempted depending upon the physician's judgment. If ribavirin has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin at one-half the full dose.

  2.4 Renal Impairment

  The total daily dose of ribavirin tablets should be reduced for patients with creatinine clearance less than or equal to 50 mL/min; and the weekly dose of peginterferon alfa-2a should be reduced for creatinine clearance less than 30 mL/min as follows in Table 4[see Use in Specific Populations (8.7), Pharmacokinetics (12.3), and peginterferon alfa-2aPackage Insert].

  Table 4 Dosage Modification for Renal Impairment

  Creatinine

  Clearance

  Peginterferon alfa-2a Dose

  (once weekly)

  Ribavirin Tablets Dose

  (daily)

  30 to 50 mL/min

  180 mcg

  Alternating doses, 200 mg and
  400 mg every other day

  Less than 30 mL/min

  135 mcg

  200 mg daily

  Hemodialysis

  135 mcg

  200 mg daily

  The dose of ribavirin tablets should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, ribavirin tablets should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting ribavirin tablets, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued.

  No data are available for pediatric subjects with renal impairment.

  2.5 Discontinuation of Dosing

  Discontinuation of peginterferon alfa-2a/ribavirin tablets therapy should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.

  Peginterferon alfa-2a/ribavirin tablets therapy should be discontinued in patients who develop hepatic decompensation during treatment [see Warnings and Precautions (5.3)].

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  Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin should not be used in patients with creatinine clearance less than 50 mL/min.

  2.2 Ribavirin/INTRON A Combination Therapy Adults Duration of Treatment – Interferon Alpha-naïve Patients

  The recommended dose of INTRON A is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin capsules depends on the patient’s body weight (refer to Table 1). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1), and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

  Duration of Treatment – Retreatment with INTRON A/Ribavirin in Relapse Patients

  In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks.

  Table 1. Recommended Dosing

  Body Weight

  Ribavirin Capsules

  ≤75 kg

  2 x 200 mg capsules AM
  3 x 200 mg capsules PM
  daily orally

  >75 kg

  3 x 200 mg capsules AM
  3 x 200 mg capsules PM
  daily orally

  Pediatrics

  The recommended dose of ribavirin is 15 mg/kg per day orally (divided dose AM and PM). INTRON A for Injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously.

  The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

  2.3 Laboratory Tests

  The following laboratory tests are recommended for all patients treated with ribavirin, prior to beginning treatment and then periodically thereafter.

  • Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7)]), complete and differential white blood cell counts, and platelet count. • Blood chemistries - liver function tests and TSH. • Pregnancy - including monthly monitoring for women of childbearing potential. • ECG [see Warnings and Precautions (5.2)]. 2.4 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/INTRON A therapy modify, or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued.

  Ribavirin should not be used in patients with creatinine clearance less than 50 mL/min. Patients with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)].

  Ribavirin should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by greater than or equal to 2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains less than 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin dose modified or discontinued per Table 2[see Warnings and Precautions (5.2)].

  Table 2. Guidelines for Dose Modification and Discontinuation of INTRON A Based on Laboratory Parameters in Adults and Pediatrics * Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease greater than or equal to 2 g/dL during any 4-week period during treatment should have weekly evaluations and hematology testing. † These guidelines are for patients with stable cardiac disease [see Warnings and Precautions (5.2)].

  
  
  Laboratory
  Parameters

  Reduce
  Ribavirin
  Daily Dose
  (see note 1) if:

  Reduce
  INTRON A
  Dose
  (see note 2) if:

  
  
  Discontinue
  Therapy if:

  WBC

  N/A

  1.0 to <1.5 x 109/L

  <1.0 x 109/L

  Neutrophils

  N/A

  0.5 to <0.75 x 109/L

  <0.5 x 109/L

  Platelets

  N/A

  25 to < 50 x 109/L
  (adults)

  <25 x 109/L
  (adults)

  N/A

  50 to <70 x 109/L
  (pediatrics)

  <50 x 109/L
  (pediatrics)

  Creatinine

  N/A

  N/A

  >2 mg/dL
  (pediatrics)

  Hemoglobin in patients without history of cardiac disease

  8.5 to <10 g/dL

  N/A

  <8.5 g/dL

  Reduce Ribavirin Dose by
  200 mg/day and
  INTRON A Dose by Half if:

  Hemoglobin in patients with history of stable cardiac disease*,†

  ≥2 g/dL decrease in hemoglobin during any four week period during treatment

  <8.5 g/dL or <12 g/dL after four weeks of dose reduction

  Note 1: Adult patients: 1st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of ribavirin is by an additional 200 mg/day. Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening. Pediatric patients: 1st dose reduction of ribavirin is to 12 mg/kg/day, 2nd dose reduction of ribavirin is to 8 mg/kg/day.

  Note 2: For patients on ribavirin/INTRON A combination therapy: reduce INTRON A dose by 50%.

  Refer to labeling for INTRON A for additional information about how to reduce an INTRON A dose.

  2.5 Discontinuation of Dosing Adults

  Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

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  2.1 Recommended Dosing and Dose Modification Guidelines
  

  Dosage of temozolomide must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For temozolomide dosage calculations based on body surface area (BSA) see Table 5. For suggested capsule combinations on a daily dose see Table 6.
  
  Patients with Newly Diagnosed High Grade Glioma:
  Concomitant Phase:
  Temozolomide capsules are administered at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by maintenance temozolomide for 6 cycles. Focal RT includes the tumor bed or resection site with a 2- to 3-cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The temozolomide dose should be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 × 109/L, platelet count greater than or equal to 100 × 109/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, and vomiting). During treatment a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 1. Pneumocystis pneumonia (PCP)prophylaxis is required during the concomitant administration of temozolomide and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC Grade less than or equal to 1).

  
  TABLE 1: Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide * Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 × 109/L; platelet count greater than or equal to 100 × 109/L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting). TMZ=temozolomide; CTC=Common Toxicity Criteria. Toxicity
  TMZ Interruption*
  TMZ Discontinuation
  Absolute Neutrophil Count
  greater than or equal to 0.5 and less than 1.5 × 109/L
  less than 0.5 × 109/L
  Platelet Count
  greater than or equal to 10 and less than 100 × 109/L
  less than 10 × 109/L
  CTC Nonhematological Toxicity
  (except for alopecia, nausea, vomiting)
  CTC Grade 2
  CTC Grade 3 or 4
  
  

  Maintenance Phase:
  Cycle 1:
  Four weeks after completing the temozolomide + RT phase, temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.
  
  Cycles 2 to 6:
  At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the CTC nonhematologic toxicity for Cycle 1 is Grade less than or equal to 2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 × 109 /L, and the platelet count is greater than or equal to 100 × 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
  
  Dose Reduction or Discontinuation During Maintenance:
  
  Dose reductions during the maintenance phase should be applied according to Tables 2 and 3.
  
  During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of temozolomide) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1,500/µL) and the platelet count exceeds 100 × 109/L (100,000/µL). The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 2 and 3.

  
  TABLE 2: Temozolomide Dose Levels for Maintenance Treatment Dose Level
  Dose (mg/m2/day)
  Remarks
  -1
  100
  Reduction for prior toxicity
  0
  150
  Dose during Cycle 1
  1
  200
  Dose during Cycles 2 to 6 in absence of toxicity
  
  TABLE 3: Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment * TMZ dose levels are listed in Table 2. † TMZ is to be discontinued if dose reduction to less than 100 mg/m2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. Toxicity
  Reduce TMZ by 1 Dose Level*
  Discontinue TMZ
  Absolute Neutrophil Count
  less than 1 × 109/L
  See footnote†
  Platelet Count
  less than 50 × 109/L
  See footnote†
  CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting)
  CTC Grade 3
  CTC Grade 4†
  

  TMZ=temozolomide; CTC=Common Toxicity Criteria.
  
  Patients with Refractory Anaplastic Astrocytoma:
  
  For adults the initial dose is 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) ANC are greater than or equal to 1.5 × 109/L (1,500/µL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 × 109/L (100,000/µL), the temozolomide dose may be increased to 200 mg/m2/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1,500/µL) and the platelet count exceeds 100 × 109/L (100,000/µL). The next cycle of temozolomide should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1 × 109/L (1,000/µL) or the platelet count is less than 50 × 109/L (50,000/µL) during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2, the lowest recommended dose (see Table 4). Temozolomide therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known.

  
  
  
  
  
  
  TABLE 5: Daily Dose Calculations by Body Surface Area (BSA) Total BSA (m2)
  75 mg/m2 (mg daily)
  150 mg/m2 (mg daily)
  200 mg/m2 (mg daily)
  1
  75
  150
  200
  1.1
  82.5
  165
  220
  1.2
  90
  180
  240
  1.3
  97.5
  195
  260
  1.4
  105
  210
  280
  1.5
  112.5
  225
  300
  1.6
  120
  240
  320
  1.7
  127.5
  255
  340
  1.8
  135
  270
  360
  1.9
  142.5
  285
  380
  2
  150
  300
  400
  2.1
  157.5
  315
  420
  2.2
  165
  330
  440
  2.3
  172.5
  345
  460
  2.4
  180
  360
  480
  2.5
  187.5
  375
  500
  
  TABLE 6: Suggested Capsule Combinations Based on Daily Dose in Adults Number of Daily Capsules by Strength (mg)
  Total Daily Dose (mg)
  250 mg
  180 mg
  140 mg
  100 mg
  20 mg
  5 mg
  75
  0
  0
  0
  0
  3
  3
  82.5
  0
  0
  0
  0
  4
  0
  90
  0
  0
  0
  0
  4
  2
  97.5
  0
  0
  0
  1
  0
  0
  105
  0
  0
  0
  1
  0
  1
  112.5
  0
  0
  0
  1
  0
  2
  120
  0
  0
  0
  1
  1
  0
  127.5
  0
  0
  0
  1
  1
  1
  135
  0
  0
  0
  1
  1
  3
  142.5
  0
  0
  1
  0
  0
  0
  150
  0
  0
  1
  0
  0
  2
  157.5
  0
  0
  1
  0
  1
  0
  165
  0
  0
  1
  0
  1
  1
  172.5
  0
  0
  1
  0
  1
  2
  180
  0
  1
  0
  0
  0
  0
  187.5
  0
  1
  0
  0
  0
  1
  195
  0
  1
  0
  0
  0
  3
  200
  0
  1
  0
  0
  1
  0
  210
  0
  0
  0
  2
  0
  2
  220
  0
  0
  0
  2
  1
  0
  225
  0
  0
  0
  2
  1
  1
  240
  0
  0
  1
  1
  0
  0
  255
  1
  0
  0
  0
  0
  1
  260
  1
  0
  0
  0
  0
  2
  270
  1
  0
  0
  0
  1
  0
  280
  0
  0
  2
  0
  0
  0
  285
  0
  0
  2
  0
  0
  1
  300
  0
  0
  0
  3
  0
  0
  315
  0
  0
  0
  3
  0
  3
  320
  0
  1
  1
  0
  0
  0
  330
  0
  1
  1
  0
  0
  2
  340
  0
  1
  1
  0
  1
  0
  345
  0
  1
  1
  0
  1
  1
  360
  0
  2
  0
  0
  0
  0
  375
  0
  2
  0
  0
  0
  3
  380
  0
  1
  0
  2
  0
  0
  400
  0
  0
  0
  4
  0
  0
  420
  0
  0
  3
  0
  0
  0
  440
  0
  0
  3
  0
  1
  0
  460
  0
  2
  0
  1
  0
  0
  480
  0
  1
  0
  3
  0
  0
  500
  2
  0
  0
  0
  0
  0
  2.2 Preparation and Administration
  

  In clinical trials, temozolomide capsules were administered under both fasting and nonfasting conditions; however, absorption is affected by food [see Clinical Pharmacology (12.3)], and consistency of administration with respect to food is recommended. There are no dietary restrictions with temozolomide capsules. To reduce nausea and vomiting, temozolomide capsules should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administration of temozolomide capsules.
   
  Temozolomide capsules should not be opened or chewed. They should be swallowed whole with a glass of water.
  
  If capsules are accidentally opened or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes [see How Supplied/Storage and Handling (16.1)].

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  Ribavirin | Teva Pharmaceuticals Usa Inc

  

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  Under no circumstances should ribavirin capsules be opened, crushed, or broken. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3)]. Ribavirin capsules should not be used in patients with creatinine clearance less than 50 mL/min.

  Table 2: Recommended Ribavirin Dosing in Combination Therapy (Pediatrics) * Ribavirin Oral Solution may be used for any patient regardless of body weight.

  Body Weight kg (lbs)

  Ribavirin

  Daily Dose

  Ribavirin Number of Capsules

  < 47

  15 mg/kg/day

  Use Ribavirin Oral Solution*

  (< 103)

  47 to 59

  800 mg/day

  2 x 200 mg capsules A.M.

  (103 to 131)

  2 x 200 mg capsules P.M.

  60 to 73

  1000 mg/day

  2 x 200 mg capsules A.M.

  (132 to 162)

  3 x 200 mg capsules P.M.

  > 73

  1200 mg/day

  3 x 200 mg capsules A.M.

  (> 162)

  3 x 200 mg capsules P.M.

  2.2 Ribavirin/INTRON A Combination Therapy

  Adults

  Duration of Treatment – Interferon Alpha-naïve Patients

  The recommended dose of INTRON A is 3 million IU three times weekly subcutaneously. The recommended dose of ribavirin capsules depends on the patient’s body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1) and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

    Duration of Treatment – Re-treatment with INTRON A/Ribavirin in Relapse Patients   In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks. Table 3: Recommended Dosing

  Body Weight

  Ribavirin Capsules

  ≤ 75 kg

  2 x 200 mg capsules AM

  3 x 200 mg capsules PM daily orally

  > 75 kg

  3 x 200 mg capsules AM

  3 x 200 mg capsules PM daily orally

  Pediatrics

  The recommended dose of ribavirin is 15 mg/kg per day orally (divided dose AM and PM). Refer to Table 2 for Pediatric Dosing of ribavirin in combination with INTRON A. INTRON A for injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. Refer to adult dosing table for greater than 61 kg body weight.

  The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

  2.3 Laboratory Tests

  The following laboratory tests are recommended for all patients treated with ribavirin, prior to beginning treatment and then periodically thereafter.

  • Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [ see Warnings and Precautions (5.2, 5.7)], complete and differential white blood cell counts, and platelet count. • Blood chemistries - liver function tests and TSH. • Pregnancy - including monthly monitoring for women of childbearing potential. • ECG [ see Warnings and Precautions (5.2)]. 2.4 Dose Modifications

  If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/INTRON A therapy, modify or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued.

  Ribavirin should not be used in patients with creatinine clearance less than 50 mL/min. Patients with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)].

  Ribavirin should be administered with caution to patients with preexisting cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by greater than or equal to 2 g/dL during any 4 week period. In addition, for these cardiac history patients, if the hemoglobin remains less than 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

  It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her ribavirin dose modified or discontinued per Table 4 [see Warnings and Precautions (5.2)].

  Table 4: Guidelines for Dose Modification and Discontinuation of Ribavirin in combination with INTRON A Based on Laboratory Parameters in Adults and Pediatrics * Pediatric patients who have preexisting cardiac conditions and experience a hemoglobin decrease greater than or equal to 2 g/dL during any 4 week period during treatment should have weekly evaluations and hematology testing. † These guidelines are for patients with stable cardiac disease [ see Warnings and Precautions (5.2)].

  Laboratory Parameters

  Reduce Ribavirin Daily Dose

  (see note 1) if:

  Reduce INTRON A

  Dose (see note 2) if:

  Discontinue Therapy if:

  WBC

  N/A

  1.0 to < 1.5 x 109/L

  < 1.0 x 109/L

  Neutrophils

  N/A

  0.5 to < 0.75 x 109/L

  < 0.5 x 109/L

  Platelets

  N/A

  25 to < 50 x 109/L (adults)

  < 25 x 109/L (adults)

  N/A

  50 to < 70 x 109/L (pediatrics)

  < 50 x 109/L (pediatrics)

  Creatinine

  N/A

  N/A

  > 2 mg/dL (pediatrics)

  Hemoglobin in patients without history of cardiac disease

  8.5 to < 10 g/dL

  N/A

  < 8.5 g/dL

  Reduce Ribavirin Dose by 200 mg/day and INTRON

  A Dose by Half if:

  Hemoglobin in patients with history of stable cardiac disease*†

  ≥ 2 g/dL decrease in hemoglobin during any

  four week period during treatment

  < 8.5 g/dL or

  < 12 g/dL after four weeks of

  dose reduction

  Note 1: Adult patients: 1st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of ribavirin is by an additional 200 mg/day. Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.

  Pediatric patients: 1st dose reduction of ribavirin is to 12 mg/kg/day, 2nd dose reduction of ribavirin is to 8 mg/kg/day.

  Note 2: For patients on Ribavirin/INTRON A combination therapy: reduce INTRON A dose by 50%.

  Refer to labeling for INTRON A for additional information about how to reduce an INTRON A dose.

  2.5 Discontinuation of Dosing

  Adults

  Regardless of genotype, previously treated patients who have detectable HCV-RNA at week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

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