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Victrelis (Boceprevir) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
7 DRUG INTERACTIONS
7.3 Established and Other Potential Significant Drug Interactions
- See Table 5 ............ interactions with raltegravir, rilpivirine and sirolimus added
WARNINGS AND PRECAUTIONS
Pregnancy (Use with Ribavirin and Peginterferon Alfa)
- One of these forms of contraception can be a combined oral contraceptive product containing at least 1 mg of norethindrone. Oral contraceptives containing lower doses of norethindrone and other forms of hormonal contraception have not been studied or are contraindicated. Routine monthly pregnancy tests must be performed during this time.
- If ribavirin is permanently discontinued for management of anemia, then peginterferon alfa and Victrelis must also be discontinued
- In clinical trials, the median time to onset of hemoglobin less than 10 g per dL from the initiation of therapy was similar among subjects treated with the combination of...
- A randomized, parallel-arm, open-label clinical trial was conducted in previously untreated CHC subjects with genotype 1 infection to compare use of an ESA versus ribavirin dose reduction for initial management of anemia during therapy...
- If peginterferon alfa and ribavirin are permanently discontinued, then Victrelis must also be discontinued.
- Complete blood count (with white blood cell differential counts) must be conducted in all patients prior to initiating Victrelis/peginterferon alfa/ribavirin combination therapy.
- Patients with a history of a hypersensitivity reaction to boceprevir
WARNINGS AND PRECAUTIONS
- Serious acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with VICTRELIS, peginterferon alfa and ribavirin. If such an acute reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
- Skin and Subcutaneous Tissue Disorders: angioedema, urticaria
PATIENT COUNSELING INFORMATION
- Patients should be informed that serious acute hypersensitivity reactions have been observed during combination therapy with VICTRELIS, peginterferon alfa, and ribavirin therapy
- Dose adjustments of cyclosporine should be anticipated when administered with VICTRELIS and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.
- Concomitant administration of VICTRELIS with tacrolimus requires significant dose reduction and prolongation of the dosing interval for tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects
- Exposure to atorvastatin was increased when administered with VICTRELIS. Use the lowest effective dose of atorvastatin, but do not exceed a daily dose of 40 mg when coadministered with VICTRELIS.
Concomitant administration of pravastatin with VICTRELIS increased exposure to pravastatin. Treatment with pravastatin can be initiated at the recommended dose when coadministered with VICTRELIS. Close clinical monitoring is warranted.
- Exposure of escitalopram was slightly decreased when coadministered with VICTRELIS. Selective serotonin reuptake inhibitors such as escitalopram have a wide therapeutic index, but doses may need to be adjusted when combined with VICTRELIS.
USE IN SPECIFIC POPULATIONS
- For data regarding drug-drug interactions with antiretroviral agents in healthy subjects…
- Victrelis is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C genotype 1 infection in adults with stable (compensated) liver disease who have not been treated before or who have failed previous treatment
- Victrelis and other medicines may affect each other, causing serious and/or life-threatening side effects or affecting the way VICTRELIS and your other medicines work. Do not start taking a new medicine without telling your healthcare provider or pharmacist.
Tell your healthcare provider if you are taking or starting to take any of these medications:
- Atazanavir (Reyataz)
- Darunavir (Prezista)
- Lopinavir (Kaletra)