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Uses
Moderiba (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
The following points should be considered when initiating Moderiba combination therapy with peginterferon alfa-2a:
- This indication is based on clinical trials of combination therapy in patients with CHC and compensated liver disease, some of whom had histological evidence of cirrhosis (Child-Pugh class A), and in adult patients with clinically stable HIV disease and CD4 count greater than 100 cells/mm3.
- This indication is based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks, based on HCV genotype, and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose.
- Safety and efficacy data are not available for treatment longer than 48 weeks.
- The safety and efficacy of ribavirin and peginterferon alfa-2a therapy have not been established in liver or other organ transplant recipients, patients with decompensated liver disease, or previous non-responders to interferon therapy.
- The safety and efficacy of ribavirin therapy for the treatment of adenovirus, RSV, parainfluenza or influenza infections have not been established. Moderiba should not be used for these indications. Ribavirin for inhalation has a separate package insert, which should be consulted if ribavirin inhalation therapy is being considered.
History
There is currently no drug history available for this drug.
Other Information
Moderiba (ribavirin, USP) is a nucleoside analogue with antiviral activity. The chemical name of ribavirin is 1-β-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula:
![ribavirin-structure](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7046ff4c-8a75-5fd4-d40f-ff0cc84eed5f&type=img&name=img%2D0448.jpg)
The molecular formula of ribavirin is C8H12N4O5 and the molecular weight is 244.2. Ribavirin is a white to off-white powder. It is freely soluble in water and slightly soluble in anhydrous alcohol.
Moderiba is available as a blue-colored (shade depending on strength), capsule-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg, 400 mg, or 600 mg of ribavirin and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and purified water. The coating of the 200 mg tablet contains partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, FD&C blue #2 [indigo carmine aluminum lake], and carnauba wax. The coating of the 400 mg and 600 mg tablet contains partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, FD&C blue #1 [brilliant blue FCF aluminum lake], and carnauba wax.
Moderiba complies with Organic Impurities: Procedure 1 of the current USP Monograph for Ribavirin Tablets.
Sources
Moderiba Manufacturers
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Abbvie Inc.
Moderiba | Abbvie Inc.
Moderiba (ribavirin, USP) should be taken with food. Moderiba should be given in combination with peginterferon alfa-2a; it is important to note that Moderiba 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 MonoinfectionAdult Patients
The recommended dose of Moderiba 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 Moderiba 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 Moderiba Dosing Recommendations Hepatitis C Virus (HCV)
Genotype Peginterferon
alfa-2a Dose*
(once weekly) Moderiba Dose
(daily) Duration 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 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.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.
Moderiba should be given in combination with peginterferon alfa-2a. Moderiba is available as a 200 mg, 400 mg and 600 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for Moderiba 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 Moderiba Dosing Recommendations for Pediatric Patients Body Weight in kilograms (kg) Moderiba Daily Dose* Moderiba 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.*** *approximately 15 mg/kg/day
**or 1 x 400 mg tablet
***or 1 x 600 mg tablet 2.2 Chronic Hepatitis C with HIV CoinfectionAdult 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 Moderiba 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.
2.3 Dose ModificationsAdult and Pediatric Patients
If severe adverse reactions or laboratory abnormalities develop during combination Moderiba/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, Moderiba/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.
Moderiba 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 Moderiba Dose Modification Guidelines in Adults and Pediatrics Body weight in kilograms (kg) Laboratory Values 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 or
1 x 400 mg tablet P.M. Discontinue Moderiba Pediatric Patients 5 to 18 years of age 23 – 33 kg 1 x 200 mg tablet A.M. Discontinue Moderiba 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. 60 – 74 kg 1 x 200 mg tablet A.M. 2 x 200 mg tablets P.M. or
1 x 400 mg tablet P.M. ≥75 kg 1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M. or
1 x 400 mg tablet P.M.The guidelines for Moderiba dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.
Adult Patients
Once Moderiba has been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart Moderiba at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that Moderiba 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 Moderiba dose to the original dose may be attempted depending upon the physician’s judgment. If Moderiba has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart Moderiba at one-half the full dose.
2.4 Renal ImpairmentThe total daily dose of Moderiba 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-2a Package Insert].
Table 4 Dosage Modification for Renal Impairment Creatinine Clearance Peginterferon alfa-2a Dose
(once weekly) Moderiba 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 dailyThe dose of Moderiba should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, Moderiba should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting Moderiba, Moderiba/peginterferon alfa-2a therapy should be discontinued.
No data are available for pediatric subjects with renal impairment.
2.5 Discontinuation of DosingDiscontinuation of peginterferon alfa-2a/Moderiba 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/Moderiba therapy should be discontinued in patients who develop hepatic decompensation during treatment [see Warnings and Precautions (5.3)].
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