ted subjects had cirrhosis at baseline. SVR rates among cirrhotic subjects who received INCIVEK combination treatment compared to Pbo/PR48 were: 87% (48/55) compared to 13% (2/15) for prior relapsers, 34% (11/32) compared to 20% (1/5) for prior partial responders, and 14% (7/50) compared to 10% (1/10) for prior null responders.
Four percent (19/530) of treatment experienced subjects who received INCIVEK combination treatment were Black/African Americans; the SVR rate for these subjects was 63% (12/19) compared to 65% (328/503) for Caucasians.
16 HOW SUPPLIED/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
Bottle containing 168 tablets NDC 51167-100-02
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Once the bottle is opened use within 28 days. Keep bottle tightly closed.
17 PATIENT COUNSELING INFORMATION
[See FDA-Approved Patient Labeling (Medication Guide).]
17.1 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. Because INCIVEK must be used in combination with ribavirin and peginterferon alfa, the contraindications and warnings applicable to those drugs are applicable to combination treatment. INCIVEK combination treatment is contraindicated in women who are pregnant and in men whose female partners are pregnant (see also the prescribing information for ribavirin).
Patients must be advised of the teratogenic/embryocidal risks of ribavirin and should be advised that extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients—both during treatment and for 6 months after the completion of all treatment. Women of childbearing potential must be counseled about use of effective contraception (two methods) prior to initiating treatment. Patients (both male and female) should be advised to notify their health care provider immediately in the event of a pregnancy [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1) ].
Patients should also be advised that hormonal contraceptives may not be reliable during INCIVEK dosing and for up to two weeks following cessation of INCIVEK [see Drug Interactions (7) ]. During this time, female patients of childbearing potential should use 2 non-hormonal methods of effective birth control. Examples of non-hormonal methods of contraception include a male condom with spermicidal jelly OR female condom with spermicidal jelly (a combination of a male condom and a female condom is not suitable), a diaphragm with spermicidal jelly, a cervical cap with spermicidal jelly, or an intrauterine device (IUD).
17.2 Serious Skin Reactions/Rash
Patients should be informed that INCIVEK combination treatment may cause rash. The rash can be severe and may be accompanied by fever and skin breakdown. Patients should promptly report any skin changes or itching to their healthcare provider. Patients should not stop INCIVEK due to rash unless |
