Ribavirin (Page 2 of 9)

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.

3 DOSAGE FORMS AND STRENGTHS

Ribavirin capsules 200 mg

4 CONTRAINDICATIONS

Ribavirin capsule combination therapy is contraindicated in:

women who are pregnant. Ribavirin capsules may cause fetal harm when administered to a pregnant woman. Ribavirin capsules are contraindicated in women who are or may become pregnant. If ribavirin capsules are used during pregnancy, or if the patient becomes pregnant while taking ribavirin capsules, the patient should be apprised of the potential hazard to her fetus [see Warnings and Precautions (5.1), Use in Specific Populations (8.1), and Patient Counseling Information (17)].
men whose female partners are pregnant
patients with known hypersensitivity reactions such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product
patients with autoimmune hepatitis
patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia)
patients with creatinine clearance less than 50 mL/min. [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.3)]
Coadministration of ribavirin capsules and didanosine is contraindicated because exposure to the active metabolite of didanosine (dideoxyadenosine 5’-triphosphate) is increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving didanosine in combination with ribavirin [see Drug Interactions (7.1) ].

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