ng INCIVEK combination treatment. Follow dose modifications for ribavirin; discontinue INCIVEK if required. (5.4)
ADVERSE REACTIONS
The most common adverse drug reactions to INCIVEK (incidence at least 5% higher with INCIVEK than in controls) were rash, pruritus, anemia, nausea, hemorrhoids, diarrhea, anorectal discomfort, dysgeusia, fatigue, vomiting, and anal pruritus. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 877-824-4281 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Co-administration of INCIVEK combination treatment with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of telaprevir. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions. (4, 7, 12.3)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: Safety and efficacy have not been established in patients with Child-Pugh score greater than or equal to 7 (class B and C). (5.8, 8.6)
Co-infection: Safety and efficacy have not been established in HCV/HIV and HCV/HBV co-infected patients. (8.8)
Pediatrics: Safety and efficacy have not been established in pediatric patients. (8.4)
Solid Organ Transplant: Safety and efficacy have not been established in patients undergoing solid organ transplants. (8.9)
Ribavirin Pregnancy Registry available (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide
Revised: 05/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1Chronic Hepatitis C
2 DOSAGE AND ADMINISTRATION
2.1INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
2.2Dose Reduction
2.3Discontinuation of Dosing
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1Pregnancy: Use with Ribavirin and Peginterferon Alfa
5.2Serious Skin Reactions
5.3 Rash
5.4Anemia
5.5Drug Interactions
5.6Laboratory Tests
5.7General
5.8Hepatic Impairment
6 ADVERSE REACTIONS
6.1Clinical Trials Experience
7 DRUG INTERACTIONS
7.1Potential for INCIVEK to Affect Other Drugs
7.2Potential for Other Drugs to Affect INCIVEK
7.3Established and Other Potentially Significant Drug Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
8.8 Co-infection
8.9 Solid Organ Transplantation
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4Microbiology
12.5 Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Description of Adult Clinical Studies
14.2 Treatment-Naïve Adults
14.3 Previously Treated Adults
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1Pregnancy
17.2Serious Skin Reactions/Rash
17.3Hepatitis C Virus Transmission
17.4Administration
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