Incivek™ (telaprevir) and Hepatitis C

Are there any other warnings one should know regarding Incivek™ combination therapy?

UPDATE: As of August 2014 Vertex announced it will discontinue selling Incivek.

• Pregnancy – Ribavirin may cause birth defects and/or death of the unborn baby. Pregnancy must be avoided in female patients as well as female partners of male patients. It is recommended that at least two forms of contraception be used during treatment and for at least 6 months after the completion of treatment since systemic hormonal contraceptives (birth control pills, vaginal rings, implants, or injections) may not be as effective for women taking Incivek™. Recommended alternative contraception options include intrauterine devices (IUD) and barrier methods. If the female patient or female partner of the male patient should get pregnant during treatment or within 6 months of completing treatment, she should contact her healthcare provider right away.
• Skin reactions – During Incivek™ combination treatment one should call their healthcare provider immediately if rash (with or without itching), blisters or skin lesions, mouth sores or ulcerts, red or inflamed eyes, facial swelling or fever are present.
• Anemia – while anemia has been reported with peginterferon alfa and ribavirin therapy, adding Incivek™ is associated with an additional decrease in hemoglobin concentrations.
• Drug Interactions – see “When is Incivek™ contraindicated?” for more information.
• Laboratory Tests – HCV-RNA levels should be monitored at weeks 4 and 12 of treatment, and in some cases at 24 weeks.Additionally, it is recommended that a complete blood count be conducted prior to initiating Incivek™ combination therapy. Vertex recommends that hemoglobin should be monitored prior to treatment with Incivek™ and at least every 4 weeks during Incivek ™ combination therapy.

  Due to the risk of birth defects and/or fetal death, the report of a negative pregnancy test should be obtained immediately before the start of therapy and performed routinely every month during treatment until at least 6 months after treatment has concluded.

• Breastfeeding – It is not known whether Incivek™ is excreted into human breast milk. Due to the potential for adverse reactions from the drug in breastfeeding infants, a decision must be made whether one should discontinue breastfeeding or discontinue Incivek™ combination treatment.

Last Updated: July 2014