Ribavirin

RIBAVIRIN- ribavirin capsule
Teva Pharmaceuticals USA Inc

WARNING: RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS

Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication [see Warnings and Precautions ( 5.10)].
The primary toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin [see Dosage and Administration ( 2.4), and Warnings and Precautions ( 5.2)].
Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple-dose half-life of 12 days, and so it may persist in nonplasma compartments for as long as 6 months. Therefore, ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6 month post-treatment follow-up period [see Contraindications ( 4), Warnings and Precautions ( 5.1), Use in Specific Populations ( 8.1), Nonclinical Toxicology ( 13.1), and Patient Counseling Information (17) ].

1 INDICATIONS AND USAGE

1.1 Chronic Hepatitis C (CHC)

Ribavirin capsules in combination with interferon alfa-2b (nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease [see Warnings and Precautions (5.9, 5.10), and Use in Specific Populations (8.4)].

The following points should be considered when initiating ribavirin capsule combination therapy with INTRON A:

These indications are based on achieving undetectable HCV-RNA after treatment for 24 or 48 weeks and maintaining a Sustained Virologic Response (SVR) 24 weeks after the last dose.
Patients with the following characteristics are less likely to benefit from re-treatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see Clinical Studies (14) ].
No safety and efficacy data are available for treatment of longer than one year.

2 DOSAGE AND ADMINISTRATION

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.

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