Drug Interaction:
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by CYP3A4/5.
The potential for drug-drug interactions must be considered prior to and during
therapy.
Indication:
VICTRELIS. (boceprevir) Capsules
Initial U.S. Approval: 2011
Drug Name- Victrelis
Active Ingredient - Boceprevir
To treat certain adults with Chronic Hepatitis C
Indication-
To treat certain adults with Chronic Hepatitis C
Approved by FDA on 13-5-2011 (Ref- FDA approved List- 2011)
Adverse Reaction:
The most commonly reported adverse reactions (greater than 35% of subjects) in
clinical trials in adult subjects receiving the combination of VICTRELIS with
PegIntron and REBETOL were fatigue, anemia, nausea, headache and dysgeusia.
Contra-Indications:
CONTRAINDICATIONS
.
All contraindications to peginterferon alfa and ribavirin also apply since VICTRELIS
must be administered with peginterferon alfa and ribavirin.
.
Because ribavirin may cause birth defects and fetal death, boceprevir in combination
with peginterferon alfa and ribavirin is contraindicated in pregnant women and in men
whose female partners are pregnant.
.
Coadministration with drugs that are highly dependent on CYP3A4/5 for clearance,
and for which elevated plasma concentrations are associated with serious
and/or life-threatening events.
.
WARNINGS AND PRECAUTIONS
Use of VICTRELIS with Ribavirin and Peginterferon alfa:
Ribavirin may cause birth defects and fetal death; avoid pregnancy in female patients
and female partners of male patients. Patients must have a negative pregnancy
test prior to therapy; use two or more forms of contraception, and have monthly
pregnancy tests.
Anemia - The addition of VICTRELIS to peginterferon alfa and ribavirin is associated
with an additional decrease in hemoglobin concentrations compared with peginterferon
alfa and ribavirin alone.
Neutropenia - The addition of VICTRELIS to peginterferon alfa and ribavirin may
result in worsening of neutropenia associated with peginterferon alfa and
ribavirin therapy alone.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the
treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with
peginterferon alfa and ribavirin, in adult patients (.18 years of age) with
compensated liver disease, including cirrhosis, who are previously untreated or
who have failed previous interferon and ribavirin therapy.
VICTRELIS must not be used as a monotherapy.
DOSAGE AND ADMINISTRATION
.
800 mg administered orally three times daily (every 7 - 9 hours) with food
(a meal or light snack).
.
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin.
.
Refer to peginterferon alfa and ribavirin Package Inserts for specific dosing instructions.
DOSAGE FORMS AND STRENGTHS
Capsules: 200 mg
Patient Information:
PATIENT COUNSELING INFORMATION
1. Pregnancy
Ribavirin must not be used by women who are pregnant or by men whose female partners
are pregnant. Ribavirin therapy should not be initiated until a report of a negative
pregnancy test has been obtained immediately before starting therapy.
Female patients of childbearing potential and male patients with female partners
of childbearing potential must be advised of the teratogenic/embryocidal risks
of ribavirin and must be instructed to practice effective contraception during therapy
and for 6 months post-therapy.
Patients should be advised to notify the healthcare provider immediately in the event
of a pregnancy
2. Anemia
Patients should be informed that anemia may be increased when VICTRELIS is
administered with peginterferon alfa and ribavirin
Patients should be advised that laboratory evaluations are required prior to
starting therapy and periodically thereafter
3. Neutropenia
Patients should be informed that neutropenia may be increased when VICTRELIS
is administered with peginterferon alfa and ribavirin
Patients should be advised that laboratory evaluations are required prior to
starting therapy and periodically thereafter
4. Usage Safeguards
Patients should be advised that VICTRELIS must not be used alone due to the high
probability of resistance without combination anti-HCV therapies
See peginterferon alfa and ribavirin Package Inserts for additional patient
counseling information on the use of these drugs in combination with VICTRELIS
Pharmacology/ Pharmacokinetics:
1. Mechanism of Action
VICTRELIS is a direct acting antiviral drug against the hepatitis C virus
2. Pharmacokinetics
VICTRELIS capsules contain a 1:1 mixture of two diastereomers, SCH534128
and SCH534129. In plasma the diastereomer ratio changes to 2:1, favoring the
active diastereomer, SCH534128.
Plasma concentrations of boceprevir described below consist of both diastereomers
SCH534128 and SCH534129, unless otherwise specified.
In healthy subjects who received 800 mg three times daily alone, boceprevir drug
exposure was characterized by AUC(ò) of 5408 ng.hr/mL (n=71), Cmax of 1723 ng/mL (n=71), and Cmin of 88 ng/mL (n=71).
Pharmacokinetic results were similar between healthy subjects and HCV-infected subjects.
Absorption
Boceprevir was absorbed following oral administration with a median Tmax of 2 hours.
Steady state
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
VICTRELIS must be administered in combination with peginterferon alfa and ribavirin
Pregnancy Category X: Use with Ribavirin and Peginterferon Alfa
Significant teratogenic and/or embryocidal effects have been demonstrated
in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated
in women who are pregnant and in the male partners of women who are pregnant
Extreme caution must be taken to avoid pregnancy in female patients and female
partners of male patients while taking this combination.
2. Nursing Mothers
Because of the potential for adverse reactions from the drug in nursing infants,
a decision must be made whether to discontinue nursing or discontinue treatment
with VICTRELIS, taking into account the importance of the therapy to the mother.
3. Pediatric Use
The safety, efficacy, and pharmacokinetic profile of VICTRELIS in pediatric patients
have not been studied.
4. Geriatric Use
Clinical studies of VICTRELIS did not include sufficient numbers of subjects aged
65 and over to determine whether they respond differently from younger subjects.
In general, caution should be exercised in the administration and monitoring
of VICTRELIS in geriatric patients due to the greater frequency of decreased
hepatic function, concomitant diseases and other drug therapy
Manufacturer Details