Videx

Videx Manufacturers

• Bristol-myers Squibb Company
  

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  Videx | Bristol-myers Squibb Company

  

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  VIDEX should be administered on an empty stomach, at least 30 minutes before or 2 hours after eating.

  2.1 Recommended Dosage (Adult and Pediatric Patients)

  The preferred dosing frequency of VIDEX is twice daily because there is more evidence to support the effectiveness of this dosing regimen. Once-daily dosing should be considered only for patients whose management requires once-daily dosing of VIDEX [see Clinical Studies (14)]. The recommended adult total daily dose is based on body weight (kg) (see Table 1).

  Table 1:      Recommended Dosage (Adult) at least 60 kg less than 60 kg

  Preferred dosing

  200 mg twice daily

  125 mg twice daily

  Dosing for patients whose management requires once-daily frequency

  400 mg once daily

  250 mg once daily

  Pediatric Patients (2 weeks old to 18 years old): The recommended dose of VIDEX (didanosine) in pediatric patients between 2 weeks old and 8 months old is 100 mg per m2 twice daily, and the recommended VIDEX dose for pediatric patients greater than 8 months old is 120 mg per m2 twice daily but not to exceed the adult dosing recommendation.

  Dosing recommendations in patients less than 2 weeks of age cannot be made because the pharmacokinetics of didanosine in these children are too variable to determine an appropriate dose. There are no data on once-daily dosing of VIDEX in pediatric patients.

  2.2 Renal Impairment Adult Patients

  In adult patients with impaired renal function, the dose of VIDEX should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of VIDEX in adult patients with renal insufficiency are presented in Table 2.

  Table 2:       Recommended Dosage in Patients with Renal Impairment a  400 mg once daily (at least 60 kg) or 250 mg once daily (less than 60 kg) for patients whose management requires once-daily frequency of administration.

  Creatinine Clearance
  (mL/min)

  Recommended VIDEX Dose by Patient Weight

  at least 60 kg

  less than 60 kg

  at least 60

  200 mg twice dailya

  125 mg twice dailya

  30-59

  200 mg once daily
  or 100 mg twice daily

  150 mg once daily
  or 75 mg twice daily

  10-29

  150 mg once daily

  100 mg once daily

  less than 10

  100 mg once daily

  75 mg once daily

  Pediatric Patients

  Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of VIDEX in this patient population, a reduction in the dose should be considered (see Table 2).

  Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

  For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL per min, shown in Table 2. It is not necessary to administer a supplemental dose of VIDEX following hemodialysis.

  2.3 Dosage Adjustment Concomitant Therapy with Tenofovir Disoproxil Fumarate

  In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of VIDEX to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL per min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL per min) once daily is recommended. VIDEX and tenofovir disoproxil fumarate may be taken together in the fasted state. Alternatively, if tenofovir disoproxil fumarate is taken with food, VIDEX should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food). The appropriate dose of VIDEX coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL per min has not been established. ([See Drug Interactions (7) and Clinical Pharmacology (12.3)]; see the complete prescribing information for VIDEX EC (enteric-coated formulation of didanosine) for results of drug interaction studies of tenofovir disoproxil fumarate with reduced doses of the enteric-coated formulation of didanosine.)

  Hepatic Impairment

  No dose adjustment is required in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

  2.4 Instructions for Reconstitution

  Prior to dispensing, the pharmacist must reconstitute dry powder with Purified Water, USP, to an initial concentration of 20 mg per mL and immediately mix the resulting solution with antacid to a final concentration of 10 mg per mL as follows:

  20 mg per mL Initial Solution

  Reconstitute the product to 20 mg per mL by adding 100 mL or 200 mL of Purified Water, USP, to the 2 g or 4 g of VIDEX powder, respectively, in the product bottle.

  10 mg per mL Final Admixture 1. Immediately mix one part of the 20 mg per mL initial solution with one part of any commercially available antacid that contains as active ingredients aluminum hydroxide (400 mg per 5 mL), magnesium hydroxide (400 mg per 5 mL), and simethicone (40 mg per 5 mL) for a final dispensing concentration of 10 mg VIDEX per mL. For patient home use, the admixture should be dispensed in appropriately sized, flint-glass or plastic (HDPE, PET, or PETG) bottles with child-resistant closures. 2. Instruct the patient to shake the admixture thoroughly prior to use and to store the tightly closed container in the refrigerator.

  The bottles of powder should be stored at 59° F to 86° F (15° C to 30° C). The VIDEX admixture may be stored up to 30 days in a refrigerator, 36° F to 46° F (2° C to 8° C). Discard any unused portion after 30 days.

  2.1 Recommended Dosage (Adult and Pediatric Patients)

  The preferred dosing frequency of VIDEX is twice daily because there is more evidence to support the effectiveness of this dosing regimen. Once-daily dosing should be considered only for patients whose management requires once-daily dosing of VIDEX [see Clinical Studies (14)]. The recommended adult total daily dose is based on body weight (kg) (see Table 1).

  Table 1:      Recommended Dosage (Adult) at least 60 kg less than 60 kg

  Preferred dosing

  200 mg twice daily

  125 mg twice daily

  Dosing for patients whose management requires once-daily frequency

  400 mg once daily

  250 mg once daily

  Pediatric Patients (2 weeks old to 18 years old): The recommended dose of VIDEX (didanosine) in pediatric patients between 2 weeks old and 8 months old is 100 mg per m2 twice daily, and the recommended VIDEX dose for pediatric patients greater than 8 months old is 120 mg per m2 twice daily but not to exceed the adult dosing recommendation.

  Dosing recommendations in patients less than 2 weeks of age cannot be made because the pharmacokinetics of didanosine in these children are too variable to determine an appropriate dose. There are no data on once-daily dosing of VIDEX in pediatric patients.

  2.2 Renal Impairment Adult Patients

  In adult patients with impaired renal function, the dose of VIDEX should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of VIDEX in adult patients with renal insufficiency are presented in Table 2.

  Table 2:       Recommended Dosage in Patients with Renal Impairment a  400 mg once daily (at least 60 kg) or 250 mg once daily (less than 60 kg) for patients whose management requires once-daily frequency of administration.

  Creatinine Clearance
  (mL/min)

  Recommended VIDEX Dose by Patient Weight

  at least 60 kg

  less than 60 kg

  at least 60

  200 mg twice dailya

  125 mg twice dailya

  30-59

  200 mg once daily
  or 100 mg twice daily

  150 mg once daily
  or 75 mg twice daily

  10-29

  150 mg once daily

  100 mg once daily

  less than 10

  100 mg once daily

  75 mg once daily

  Pediatric Patients

  Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of VIDEX in this patient population, a reduction in the dose should be considered (see Table 2).

  Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

  For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL per min, shown in Table 2. It is not necessary to administer a supplemental dose of VIDEX following hemodialysis.

  Adult Patients

  In adult patients with impaired renal function, the dose of VIDEX should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of VIDEX in adult patients with renal insufficiency are presented in Table 2.

  Table 2:       Recommended Dosage in Patients with Renal Impairment a  400 mg once daily (at least 60 kg) or 250 mg once daily (less than 60 kg) for patients whose management requires once-daily frequency of administration.

  Creatinine Clearance
  (mL/min)

  Recommended VIDEX Dose by Patient Weight

  at least 60 kg

  less than 60 kg

  at least 60

  200 mg twice dailya

  125 mg twice dailya

  30-59

  200 mg once daily
  or 100 mg twice daily

  150 mg once daily
  or 75 mg twice daily

  10-29

  150 mg once daily

  100 mg once daily

  less than 10

  100 mg once daily

  75 mg once daily

  Pediatric Patients

  Urinary excretion is also a major route of elimination of didanosine in pediatric patients, therefore the clearance of didanosine may be altered in pediatric patients with renal impairment. Although there are insufficient data to recommend a specific dose adjustment of VIDEX in this patient population, a reduction in the dose should be considered (see Table 2).

  Patients Requiring Continuous Ambulatory Peritoneal Dialysis (CAPD) or Hemodialysis

  For patients requiring CAPD or hemodialysis, follow dosing recommendations for patients with creatinine clearance of less than 10 mL per min, shown in Table 2. It is not necessary to administer a supplemental dose of VIDEX following hemodialysis.

  2.3 Dosage Adjustment Concomitant Therapy with Tenofovir Disoproxil Fumarate

  In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of VIDEX to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL per min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL per min) once daily is recommended. VIDEX and tenofovir disoproxil fumarate may be taken together in the fasted state. Alternatively, if tenofovir disoproxil fumarate is taken with food, VIDEX should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food). The appropriate dose of VIDEX coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL per min has not been established. ([See Drug Interactions (7) and Clinical Pharmacology (12.3)]; see the complete prescribing information for VIDEX EC (enteric-coated formulation of didanosine) for results of drug interaction studies of tenofovir disoproxil fumarate with reduced doses of the enteric-coated formulation of didanosine.)

  Hepatic Impairment

  No dose adjustment is required in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

  Concomitant Therapy with Tenofovir Disoproxil Fumarate

  In patients who are also taking tenofovir disoproxil fumarate, a dose reduction of VIDEX to 250 mg (adults weighing at least 60 kg with creatinine clearance of at least 60 mL per min) or 200 mg (adults weighing less than 60 kg with creatinine clearance of at least 60 mL per min) once daily is recommended. VIDEX and tenofovir disoproxil fumarate may be taken together in the fasted state. Alternatively, if tenofovir disoproxil fumarate is taken with food, VIDEX should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food). The appropriate dose of VIDEX coadministered with tenofovir disoproxil fumarate in patients with creatinine clearance of less than 60 mL per min has not been established. ([See Drug Interactions (7) and Clinical Pharmacology (12.3)]; see the complete prescribing information for VIDEX EC (enteric-coated formulation of didanosine) for results of drug interaction studies of tenofovir disoproxil fumarate with reduced doses of the enteric-coated formulation of didanosine.)

  Hepatic Impairment

  No dose adjustment is required in patients with hepatic impairment [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

  2.4 Instructions for Reconstitution

  Prior to dispensing, the pharmacist must reconstitute dry powder with Purified Water, USP, to an initial concentration of 20 mg per mL and immediately mix the resulting solution with antacid to a final concentration of 10 mg per mL as follows:

  20 mg per mL Initial Solution

  Reconstitute the product to 20 mg per mL by adding 100 mL or 200 mL of Purified Water, USP, to the 2 g or 4 g of VIDEX powder, respectively, in the product bottle.

  10 mg per mL Final Admixture 1. Immediately mix one part of the 20 mg per mL initial solution with one part of any commercially available antacid that contains as active ingredients aluminum hydroxide (400 mg per 5 mL), magnesium hydroxide (400 mg per 5 mL), and simethicone (40 mg per 5 mL) for a final dispensing concentration of 10 mg VIDEX per mL. For patient home use, the admixture should be dispensed in appropriately sized, flint-glass or plastic (HDPE, PET, or PETG) bottles with child-resistant closures. 2. Instruct the patient to shake the admixture thoroughly prior to use and to store the tightly closed container in the refrigerator.

  The bottles of powder should be stored at 59° F to 86° F (15° C to 30° C). The VIDEX admixture may be stored up to 30 days in a refrigerator, 36° F to 46° F (2° C to 8° C). Discard any unused portion after 30 days.

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