Boceprevir Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Chronic Hepatitis C

800 mg orally 3 times a day (7 to 9 hours apart) with food

Comments:
-Start therapy with peginterferon alfa and ribavirin for 4 weeks, and then add boceprevir to the regimen.
-Duration of therapy is based on viral response, prior response status, and presence of cirrhosis.

Duration of therapy:
In Patients without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy (HCV-RNA levels should be monitored at treatment weeks 8, 12, and 24 to determine duration of therapy and assess for treatment futility):
Previously untreated patients:
-HCV-RNA not detected at treatment weeks 8 and 24: Complete boceprevir, peginterferon alfa, and ribavirin at treatment week 28.
-HCV-RNA detected at treatment week 8 and not detected at treatment week 24: Continue boceprevir, peginterferon alfa, and ribavirin and finish through treatment week 36, and then use peginterferon alfa and ribavirin and finish through treatment week 48.
-Poorly interferon responsive at treatment week 4: Consider using boceprevir, peginterferon alfa, and ribavirin for 44 weeks (to maximize rates of sustained virologic response).

Previous partial responders or relapsers:
-HCV-RNA not detected at treatment weeks 8 and 24: Complete boceprevir, peginterferon alfa, and ribavirin at treatment week 36.
-HCV-RNA detected at treatment week 8 and not detected at treatment week 24: Continue boceprevir, peginterferon alfa, and ribavirin and finish through treatment week 36, and then use peginterferon alfa and ribavirin and finish through treatment week 48.

Previous null responders:
-HCV-RNA detected or not detected at treatment week 8 and not detected at treatment week 24: Continue boceprevir, peginterferon alfa, and ribavirin and finish through treatment week 48.

In Patients with Compensated Cirrhosis:
-Boceprevir, peginterferon alfa, and ribavirin should be continued for 44 weeks.

Treatment Futility:
-Therapy discontinuation is recommended in all patients with (a) HCV-RNA levels of 1000 international units/mL or greater at treatment week 8, or (b) HCV-RNA levels of 100 international units/mL or greater at treatment week 12, or (c) confirmed detectable HCV-RNA levels at treatment week 24.

Approved indication: For the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Dosage reduction of boceprevir is not recommended. The prescribing information for peginterferon alfa and/or ribavirin should be consulted for appropriate dose adjustments. If peginterferon alfa or ribavirin is stopped for any reason, boceprevir must also be discontinued.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:
-Boceprevir must be used in combination with peginterferon alfa and ribavirin; initiate therapy with peginterferon alfa and ribavirin for 4 weeks, and then start boceprevir.
-Take boceprevir with food (a meal or light snack).
-If a patient misses a dose, the missed dose should be skipped if it is less than 2 hours before the next dose is due. If it is at least 2 hours before the next dose is due, the patient should take the missed dose with food and then resume the usual dosing schedule.

Storage requirements:
-Boceprevir capsules should be refrigerated at 2C to 8C (36F to 46F) until dispensed; excessive heat should be avoided.
-For patient use: Refrigerated capsules can be stable until labeled expiration date; capsules can be stored at room temperature up to 25C (77F) for 3 months.

General:
-The prescribing information for peginterferon alfa and ribavirin should be consulted for additional information.

Monitoring:
-General: HCV-RNA levels (at treatment weeks 4, 8, 12, and 24, at the end of treatment, during treatment follow-up, and as clinically indicated); monthly pregnancy tests (immediately prior to, during, and for at least 6 months after stopping ribavirin).
-Hematologic: Complete blood count with white blood cell differential counts (prior to and at treatment weeks 2, 4, 8, and 12, and as clinically appropriate).

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