Incivek
FDA Warns of Fatal Rash From Hep C Drug Incivek »
"Dec. 19, 2012 -- The FDA warned people taking the hepatitis C drug Incivek (telaprevir) that it has received reports of a serious skin rash from the medication, which has led to several deaths.
The deaths occurred in people taking Inc"...
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Incivek
INDICATIONS
Chronic Hepatitis C
INCIVEK4 (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based treatment, including prior null responders, partial responders, and relapsers [see Clinical Studies, including definitions of these terms].
The following points should be considered when initiating treatment with INCIVEK:
- INCIVEK must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin [see WARNINGS AND PRECAUTIONS].
- A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with INCIVEK combination treatment [see Microbiology and Clinical Studies].
- INCIVEK efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes INCIVEK or other HCV NS3/4A protease inhibitors [see Microbiology].
DOSAGE AND ADMINISTRATION
INCIVEK/Peginterferon Alfa/Ribavirin Combination Treatment
The recommended dose of INCIVEK tablets is 750 mg (two 375-mg tablets) taken orally 3 times a day (7-9 hours apart) with food (not low fat) [see CLINICAL PHARMACOLOGY and PATIENT INFORMATION]. For specific dosage instructions for peginterferon alfa and ribavirin, refer to their respective prescribing information.
Duration of Treatment
The recommended duration of treatment with INCIVEK is 12 weeks in combination with peginterferon alfa and ribavirin. HCV RNA levels should be monitored at weeks 4 and 12 to determine combination treatment duration and assess for treatment futility (Tables 1 and 2).
Table 1: Recommended Treatment Duration (See also
Table 2 for Treatment Futility Rules)
| Treatment-Naive and Prior Relapse Patients | |||
| HCV RNAa | Triple Therapy INCIVEK, peginterferon alfa and ribavirin | Dual Therapy peginterferon alfa and ribavirin | Total Treatment Duration |
| Undetectable (Target Not Detected) at Weeks 4 and 12 | First 12 weeks | Additional 12 weeks | 24 weeks |
| Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 | First 12 weeks | Additional 36 weeks | 48 weeks |
| Prior Partial and Null Responder Patients | |||
| Triple Therapy INCIVEK, peginterferon alfa and ribavirin | Dual Therapy peginterferon alfa and ribavirin | Total Treatment Duration | |
| All Patients | First 12 weeks | Additional 36 weeks | 48 weeks |
| a In clinical trials, HCV RNA in plasma was measured using a COBAS® TaqMan® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL. See Laboratory Tests for a description of HCV RNA assay recommendations. | |||
For the purpose of assessing response-guided therapy eligibility at weeks 4 and 12 (see Table 1), an “undetectable” HCV RNA (Target Not Detected) result is required; a confirmed “detectable but below limit of quantification” HCV RNA result should not be considered equivalent to an “undetectable” HCV RNA (Target Not Detected) result [see Laboratory Tests].
Treatment-naïve patients with cirrhosis who have undetectable HCV RNA (Target Not Detected) at weeks 4 and 12 of INCIVEK combination treatment may benefit from an additional 36 weeks of peginterferon alfa and ribavirin (48 weeks total) [see Clinical Studies].
Dose Reduction
To prevent treatment failure, the dose of INCIVEK must not be reduced or interrupted. Refer to the respective prescribing information for dose modification of peginterferon alfa and ribavirin [see WARNINGS AND PRECAUTIONS].
Discontinuation of Dosing
Patients with inadequate viral response are unlikely to achieve SVR, and may develop treatment-emergent resistance substitutions [see Microbiology]. Discontinuation of therapy is recommended in all patients with (1) HCV RNA levels of greater than 1000 IU/mL at Treatment Week 4 or 12; or (2) confirmed detectable HCV RNA levels at Treatment Week 24 (see Table 2).
Table 2: Treatment Futility Rules: All Patients
| HCV RNA | Action |
| Week 4 or Week 12: Greater than 1000 IU/mL | Discontinue INCIVEK and peginterferon alfa and ribavirin (INCIVEK treatment complete at 12 weeks) |
| Week 24: Detectable | Discontinue peginterferon alfa and ribavirin |
If peginterferon alfa or ribavirin is discontinued for any reason, INCIVEK must also be discontinued.
HOW SUPPLIED
Dosage Forms And Strengths
Each tablet contains 375 mg of telaprevir. Tablets are available as purple, film-coated, capsule-shaped tablets debossed with the characters “V 375” on one side.
Storage And Handling
INCIVEK™ (telaprevir) is supplied as purple film-coated capsule-shaped tablets containing 375 mg of telaprevir. Each tablet is debossed with the characters “V 375” on one side and is packaged as follows:
28-day packer contains 4 weekly cartons of 7 blister strips each (6 tablets per blister strip) NDC 51167-100-01
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Manufactured for Vertex Pharmaceuticals Incorporated Cambridge, MA 02139. Revised: Apr 2013
Last reviewed on RxList: 5/9/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Incivek Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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