Adult Dosing
Chronic hepatitis C
Combination therapy with peginterferon and ribavirin: Previously untreated patients and previous partial responders or relapsers
- Begin therapy with peginterferon and ribavirin x 4 wks; add boceprevir 800 mg PO tid to peginterferon alfa and ribavirin after 4 wks of treatment
Notes:- Duration of therapy may vary based on the patient's HCV-RNA levels at treatment week (TW) 8, 12, and 24
- Discontinue the combination therapy if HCV-RNA levels
100 IU/mL at TW 12 or if the patient has confirmed, detectable HCV-RNA levels at TW24 - Take the medicine with food
Cirrhosis patients
Combination therapy with peginterferon and ribavirin
- Initiate therapy with peginterferon and ribavirin x 4 wks; add boceprevir 800 mg PO tid to peginterferon alfa and ribavirin regimen after 4 wks of treatment x 44 wks
Notes:- Dose reduction of boceprevir is not recommended; if there is a serious adverse reaction associated with peginterferon and/or ribavirin, the dose of peginterferon alfa and/or ribavirin should be reduced or discontinued
- Discontinue therapy if HCV-RNA levels 100 IU/mL at TW12 or if the patient has confirmed, detectable HCV-RNA levels at TW24
- Take the medicine with food
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Boceprevir must not be used as a monotherapy
- Use is contraindicated in pregnant women and their male partners. During combination therapy, ribavirin may cause birth defects and fetal death. Therefore, avoid pregnancy in female patients and female partners of male patients. Prior to initiating ribavirin therapy, patients must have a negative pregnancy test. Perform monthly pregnancy tests during treatment and for 6 months after therapy and use at least 2 effective methods of contraception during this period
- Anemia has been associated with peginterferon alfa and ribavirin therapy; additional decreases in hemoglobin levels have been reported on addition of boceprevir to peginterferon alfa and ribavirin
- Monitor CBC before initiating therapy and at TW 4, 8, 12, and at other time points as needed
- Consider decreasing ribavirin dosage or discontinuing therapy if hemoglobin is <10 g/dL; discontinue ribavirin if hemoglobin level is <8.5 g/dL
- Thromboembolic events have been reported with the use of peginterferon alfa in hepatitis C patients
- Severe, life-threatening infections associated with neutropenia have been reported with boceprevir use in combination with peginterferon alfa and ribavirin. Dose reduction or discontinuation of peginterferon alfa and ribavirin may be recommended if decreases in neutrophils are observed
- Monitor HCV-RNA levels at TW 4, 8, 12, and 24, at the end of treatment, during treatment follow-up, and for other time points as needed
- During therapy, use a sensitive real-time reverse-transcription polymerase chain reaction (RT-PCR) assay for monitoring HCV-RNA levels
- The assay should have a lower limit of HCV-RNA quantification of =<25 IU/mL or less, and a limit of HCV-RNA detection of approximately 10 to 15 IU/mL
- Serious acute hypersensitivity reactions such as urticaria, angioedema have been reported during combination therapy with boceprevir, peginterferon alfa and ribavirin. Discontinue the therapy if such acute reaction occurs and initiate appropriate medical therapy
Cautions: Use cautiously in
- HIV co-infection
- Hepatitis B virus co-infection
- Organ transplant
Pregnancy Category:B (boceprevir alone); X (boceprevir in combination with peginterferon alfa and ribavirin)
Breastfeeding: Safety unknown. As per manufacturer's data, due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Victrelis 200 MG CAPS [Bottle] (SCHERING)
12 mg = $183.99
36 mg = $521.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
