Not for monotherapy treatment of chronic hepatitis C virus infection. Primary toxicity is hemolytic anemia. Anemia associated w/ therapy may result in worsening of cardiac disease and lead to fatal and nonfatal MIs. Avoid w/ history of significant/unstable cardiac disease. Contraindicated in women who are pregnant and in male partners of pregnant women. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking therapy. Use at least 2 reliable forms of effective contraception during treatment and for 6 months after discontinuation.
View FDA-Approved Full Prescribing Information for Rebetol
In combination w/ interferon alfa-2b (pegylated and nonpegylated) for treatment of chronic hepatitis C in patients ≥3 yrs of age w/ compensated liver disease.
Chronic Hepatitis C with Compensated Liver Disease
Combination Therapy w/ PegIntron:
Treat w/ PegIntron 1.5mcg/kg/week SQ
<66kg: 400mg qam and 400mg qpm
66-80kg: 400mg qam and 600mg qpm
81-105kg: 600mg qam and 600mg qpm
>105kg: 600mg qam and 800mg qpm
Genotype 1: Treat for 48 weeks
Genotype 2 and 3: Treat for 24 weeks
Treat for 48 weeks, regardless of hepatitis C virus genotype
Combination Therapy w/ Intron A:
Treat w/ Intron A 3 million IU 3X weekly SQ
≤75kg: 400mg qam and 600mg qpm
>75kg: 600mg qam and 600mg qpm
Treat for 24-48 weeks
Treat for 24 weeks
Chronic Hepatitis C with Compensated Liver Disease
Combination Therapy w/ PegIntron/Intron A:
<47kg: 15mg/kg/day divided into two doses; may use sol regardless of body weight
47-59kg: 400mg qam and 400mg qpm
60-73kg: 400mg qam and 600mg qpm
>73kg: 600mg qam and 600mg qpm
Treat w/ Intron A 3 million IU/m2 3X weekly SQ for 25-61kg (refer to adult dosing for >61kg) or PegIntron 60mcg/m2/week SQ
Genotype 1: Treat for 48 weeks
Genotype 2 or 3: Treat for 24 weeks
Remain on pediatric dosing while receiving therapy in combination w/ PegIntron when 18th birthday is reached
CrCl <50mL/min: Not recommended
Start at lower end of dosing range
Refer to PI for dose modification/discontinuation based on lab parameters in adults and pediatric patients
D/C therapy if at least a 2 log10 drop or loss of hepatitis C virus (HCV)-RNA at 12 weeks of therapy is not achieved
D/C therapy if HCV-RNA levels remain detectable after 24 weeks of therapy
Previously Treated Patients:
Consider discontinuation if fail to achieve undetectable HCV-RNA at Week 12 of therapy, or if HCV-RNA remains detectable after 24 weeks of therapy
Pediatric Patients (3-17 Years):
All Genotypes (Excluding Genotype 2 and 3):
D/C therapy at 12 weeks if treatment Week 12 HCV-RNA drops <2 log10 compared to pretreatment
D/C therapy at 24 weeks if HCV-RNA is detectable at treatment Week 24
Take w/ food
Refer to PegIntron or Intron A PIs for further information on dosing, dosing modifications, and administration for these drugs
Do not open, crush, or break
Cap: 200mg; Sol: 40mg/mL [100mL]
Women who are or may become pregnant, men whose female partners are pregnant, autoimmune hepatitis, hemoglobinopathies (eg, thalassemia major, sickle cell anemia), CrCl <50mL/min, coadministration w/ didanosine.
Do not start therapy unless a negative pregnancy test has been obtained immediately prior to therapy. Suspend therapy in patients w/ signs and symptoms of pancreatitis; d/c therapy w/ confirmed pancreatitis. Pulmonary symptoms (eg, dyspnea, pulmonary infiltrates, pneumonitis) reported; closely monitor if pulmonary infiltrates or pulmonary function impairment develops and if appropriate, d/c therapy. Alfa interferons may induce or aggravate ophthalmologic disorders (eg, decrease or loss of vision, retinopathy); perform eye exam in all patients prior to therapy, periodically w/ preexisting ophthalmologic disorders (eg, diabetic or hypertensive retinopathy), and if ocular symptoms develop during therapy. D/C if new or worsening ophthalmologic disorders develop. Severe decreases in neutrophil and platelet counts, and hematologic, endocrine (eg, TSH), and hepatic abnormalities may occur in combination w/ PegIntron; perform hematology and blood chemistry testing prior to therapy and periodically thereafter. Dental/periodontal disorders reported in patients receiving ribavirin and interferon or peginterferon combination therapy. Weight changes and growth inhibition (including long-term growth inhibition) reported in pediatric patients during combination therapy w/ PegIntron or Intron A. Use w/ PegIntron or Intron A is associated w/ significant adverse reactions (eg, severe depression and suicidal or homicidal ideation, suppression of bone marrow function, autoimmune and infectious disorders). Caution w/ preexisting cardiac disease; d/c if cardiovascular (CV) status deteriorates.
Hemolytic anemia, inj-site reactions, headache, fatigue, rigors, fever, N/V, anorexia, myalgia, arthralgia, insomnia, irritability, depression, neutropenia, alopecia.
See Contraindications. Closely monitor for toxicities, especially hepatic decompensation and anemia when receiving interferon w/ribavirin and nucleoside reverse transcriptase inhibitors (NRTIs); consider dose reduction or discontinuation of interferon, ribavirin, or both, or discontinuation of NRTI if medically appropriate. May antagonize the cell culture antiviral activity of stavudine and zidovudine against HIV; caution w/ concomitant use of ribavirin with either of these drugs. Severe pancytopenia and bone marrow suppression reported w/ concomitant administration of pegylated interferon/ribavirin and azathioprine; d/c pegylated interferon/ribavirin and azathioprine if pancytopenia develops and do not reintroduce pegylated interferon/ribavirin w/ concomitant azathioprine.
PREGNANCY AND LACTATION
Category X, not for use in nursing.
MECHANISM OF ACTION
Nucleoside analogue; has not been established. Has direct antiviral activity in tissue culture against many RNA viruses; increases mutation frequency in the genomes of several viruses and ribavirin triphosphate inhibits HCV polymerase in a biochemical reaction.
Absorption: Rapid and extensive. Absolute bioavailability (64%). Multiple Dose: (Cap) (Adults) Cmax=3680ng/mL, Tmax=3 hrs, AUC=228,000ng•hr/mL. (Pediatrics) Cmax=3275ng/mL, Tmax=1.9 hrs, AUC=29,774ng•hr/mL. Distribution: (Adults) (Cap) Single Dose: Vd=2825L. Metabolism: Nucleated cells (phosphorylation); deribosylation and amide hydrolysis. Elimination: Urine (61%), feces (12%). (Adults) (Cap) Multiple Dose: T1/2=298 hrs.
Assess for autoimmune hepatitis, hemoglobinopathies, depression, preexisting ophthalmologic disorders, history of or preexisting cardiac disease, hypersensitivity, and possible drug interactions. Assess nursing status and hepatic/renal/pulmonary function. Conduct pregnancy test (including female partners of male patients), standard hematologic tests, blood chemistries, ECG in patients w/ preexisting cardiac disease, and eye examination.
Monitor for anemia, worsening of cardiac disease, pancreatitis, renal/hepatic dysfunction, CV deterioration, pulmonary function impairment, new/worsening ophthalmologic disorders, and other adverse reactions. Monitor height and weight in pediatric patients. Perform standard hematologic tests, blood chemistries (eg, TSH), ECG, and HCV-RNA periodically. Obtain Hct and Hgb (Week 2 and 4 of therapy, and as clinically appropriate). Perform pregnancy test monthly during therapy and for 6 months after discontinuation of therapy (including female partners of male patients). Schedule regular dental exams.
Counsel on risk/benefits associated w/ treatment. Inform that anemia may develop. Advise that lab evaluations are required prior to starting therapy and periodically thereafter. Advise to be well-hydrated, especially during the initial stages of treatment. Inform of pregnancy risks. Instruct to use at least 2 forms of contraception and perform a monthly pregnancy test during therapy and for 6 months post-therapy (including female partners of male patients); advise to notify physician in the event of a pregnancy. Inform that appropriate precautions to prevent HCV transmission should be taken. Instruct to brush teeth bid and have regular dental exams; if vomiting occurs, advise to rinse out mouth afterwards.
(Cap) 25°C (77°F); excursions permitted to 15-30°C (59-86°F). (Sol) 2-8°C (36-46°F) or at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
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