Vidaza

Vidaza Manufacturers

• Celgene Corporation
  

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  Vidaza | Aurobindo Pharma Limited

  

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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. 

  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 capsules 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/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 capsules 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 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 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 capsules 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 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%.
  * 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.
  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 to <1.5 x 109/L
  <1 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
  
  

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

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