Boceprevir Dosage

Applies to the following strengths: 200 mg

Usual Adult Dose for:

Chronic Hepatitis C

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Chronic Hepatitis C

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

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 [TWs] 8, 12, and 24 to determine duration of therapy and assess for treatment futility):
Previously untreated patients:

HCV-RNA not detected at TWs 8 and 24: Complete 3-drug regimen (boceprevir, peginterferon alfa, ribavirin) at TW 28.
HCV-RNA detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 36, and then use peginterferon alfa and ribavirin and finish through TW 48.
Poorly interferon responsive at TW 4: Consider using 3-drug regimen for 44 weeks (to maximize rates of sustained virologic response [SVR]).

Previous partial responders or relapsers:

HCV-RNA not detected at TWs 8 and 24: Complete 3-drug regimen at TW 36.
HCV-RNA detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 36, and then use peginterferon alfa and ribavirin and finish through TW 48.

Previous null responders:

HCV-RNA detected or not detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 48.

In Patients with Compensated Cirrhosis:

The 3-drug regimen should be used for 44 weeks.

TREATMENT FUTILITY:

Therapy discontinuation is recommended in all patients with (a) HCV-RNA levels at least 1000 international units/mL at TW 8, or (b) HCV-RNA levels at least 100 international units/mL at TW 12, or (c) confirmed detectable HCV-RNA levels at TW 24.

COMMENTS:

Therapy should be initiated with peginterferon alfa and ribavirin for 4 weeks; boceprevir should be added to the regimen after the initial 4 weeks of therapy.
Duration of therapy is based on viral response, prior response status, and presence of cirrhosis.
Poorly interferon responsive patients using this regimen are less likely to achieve SVR, and have a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
The risks/benefits of this regimen should be carefully considered before starting therapy in patients with compensated cirrhosis who have platelet count less than 100,000/mm3 and serum albumin less than 3.5 g/dL at baseline.

USE: 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.

Comments:

The manufacturer product information for peginterferon alfa should be consulted regarding use in patients with hepatic decompensation.

Dose Adjustments

The dose of this drug should not be reduced.

The manufacturer product information for peginterferon alfa and/or ribavirin should be consulted for appropriate dose reduction and/or discontinuation due to side effects. If peginterferon alfa or ribavirin is stopped for any reason, this drug must also be discontinued.

Precautions

CONTRAINDICATIONS:
In Combination with Peginterferon alfa and Ribavirin:

Pregnant women
Men whose female partners are pregnant
History of hypersensitivity reaction to the active component
Contraindications to peginterferon alfa and ribavirin
Coadministration with drugs highly dependent on CYP450 3A4/5 for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events
Coadministration with potent CYP450 3A4/5 inducers where significantly reduced boceprevir plasma levels may be associated with reduced efficacy
Coadministration with alfuzosin, doxazosin, silodosin, tamsulosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), cisapride, St. John's wort, lovastatin, simvastatin, drospirenone, triazolam, oral midazolam, sildenafil or tadalafil for treatment of pulmonary arterial hypertension

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:

Use in combination with peginterferon alfa and ribavirin; administer peginterferon alfa and ribavirin for 4 weeks before adding boceprevir to the regimen. Do not use as monotherapy.
Take with food (a meal or light snack).
If peginterferon alfa or ribavirin is stopped for any reason, discontinue this drug.
Consult the manufacturer product information regarding missed doses.

Storage requirements:

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; container should be kept tightly closed.

General:

The manufacturer product information for peginterferon alfa and ribavirin should be consulted for additional information.
Efficacy not established in patients who previously failed therapy with a regimen that included this or other HCV NS3/4A protease inhibitors.

Monitoring:

General: HCV-RNA levels (at TWs 4, 8, 12, and 24, at the end of treatment, during treatment follow-up, and as clinically indicated)
Hematologic: Complete blood count with white blood cell differential counts (prior to and at TWs 2, 4, 8, and 12, and as clinically appropriate)
Hepatic: For worsening liver function in patients with compensated cirrhosis
Infections/Infestations: For infections in patients with compensated cirrhosis
The manufacturer product information for peginterferon alfa and ribavirin should be consulted for laboratory testing recommendations including hematology, biochemistry (including liver function tests), and pregnancy testing (baseline, on-treatment, and posttreatment).

Patient advice:

Read the US FDA-approved patient labeling (Medication Guide).
Notify health care provider immediately if pregnancy occurs.
Seek medical advice at once if symptoms of acute hypersensitivity reactions (e.g., itching, hives, swelling of the face/eyes/lips/tongue/throat, trouble breathing/swallowing) occur.