Incivek (telaprevir)
INCIVEK (telaprevir) – a hepatitis C virus (HCV) NS3/4A protease inhibitor commonly used, in combination with peginterferon alfa and ribavirin, to treat type hepatitis C. Telaprevir exerts its effects by acting directly against the hepatitis C virus.
FDA approved uses: Incivek is indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.
Available dosage forms: Tablets – 375 mg.
Usual dosage: Initiate INCIVEK at 750 mg taken 3 times a day (7-9 hours apart) with food (not low fat). INCIVEK must be administered with both peginterferon alfa and ribavirin for all patients for 12 weeks, followed by a response-guided regimen of either 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on viral response and prior response status.
Contraindications: Pregnant women and men whose female partners are pregnant; Co-administration with drugs that: are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events; strongly induce CYP3A which may lead to lower exposure and loss of efficacy of INCIVEK.
Special warnings: SERIOUS SKIN REACTIONS – Fatal and non-fatal serious skin reactions, including Stevens Johnson Syndrome (SJS), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with INCIVEK combination treatment [see Warnings and Precautions. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK combination treatment after a serious skin reaction was identified. For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK, peginterferon alfa, and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should be considered. Patients should be promptly referred for urgent medical care.
Adverse reactions (side effects) of these medications: The most common side effects of Incivek seen in clinical trials include rash, pruritus, anemia, nausea, hemorrhoids, diarrhea, anorectal discomfort, dysgeusia, fatigue, vomiting, and anal pruritus. Other adverse events reported abnormal white blood cell counts, abnormal platelet values, abnormal bilirubin findings, and elevated uric acid levels.
Common drug interactions: INCIVEK is a strong inhibitor of CYP3A. Co-administration of INCIVEK with drugs that are primarily metabolized by CYP3A may result in increased plasma concentrations of such drugs, which could increase adverse reactions. INCIVEK is a substrate of CYP3A and P-gp; therefore, drugs that induce CYP3A and/or P-gp may decrease INCIVEK plasma concentrations and reduce the therapeutic effect of INCIVEK. The following is a listing of some, but not all, of the established and potential drug interactions with INCIVEK: lidocaine, amiodarone, bepridil, flecainide, propafenone, quinidine, digoxin, clarythromycin, erythromycin, telirthromycin, warfarin, phnytoin, phenobarbital, carbamazepine, escitalopram, trazodone, “azole” antifungals, colchicine, rifabutin, benzodiazepines, calcium channel blockers, corticosteroids, bosentan, HIV drugs, “statins”, hormonal contraceptives, and immunosuppresant drugs.
Special instructions for patients: Take this medication exactly as directed by physician. Read the official Medication Guide before starting Incivek and when you receive new refills. Skin rash and serious skin conditions may occur. Call your doctor right away if you have any of the following: skin rash, with or without itching, blisters or skin lesions, mouth sores or ulcers, red or inflammed eyes, fever, or swelling of your face. Never stop taking INCIVEK combination treatment without talking with your healthcare provider first.
Full prescribing information may be found at the manufacturer‘s official website Incivek.com or at the U.S. Food and Drug Administration’s website at Incivek Info at Drugs@FDA
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