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INCIVEK
Viral infections
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Drug Name:

INCIVEK Rx

Generic Name and Formulations:
Telaprevir 375mg; tabs.

Company:
Vertex Pharmaceuticals

e-Prescribe this drug via Surescripts


Therapeutic Use:

Indications for INCIVEK:

Chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have previously been treated with interferon-based therapy, including prior null responders, partial responders, and relapsers. Not for use as monotherapy.

Adult Dose for INCIVEK:

Take with food (not low fat). 750mg three times daily. Treat for 12 weeks (with peginterferon + ribavirin), then continue peginterferon + ribavirin according to HCV-RNA response at Weeks 4 and 12. Do not reduce dose or interrupt therapy. Discontinue if futile (see full labeling).

Children's Dose for INCIVEK:

≤18yrs: not established.

Pharmacological Class:

Hepatitis C virus NS3/4A protease inhibitor.

Contraindications:

Concomitant strong CYP3A inducers (eg, rifampin, St. John’s wort), or narrow therapeutic index CYP3A substrates (eg, alfuzosin, cisapride, ergots, lovastatin, pimozide, simvastatin, sildenafil/tadalafil for PAH, triazolam, oral midazolam). Pregnant women, or partners. Review peginterferon and ribavirin contraindications.

Warnings/Precautions:

Must have (–) pregnancy test before therapy, use 2 effective forms of contraception, and undergo monthly pregnancy test during treatment and for 6 months after. Risk of serious skin reactions (eg, Stevens-Johnson syndrome, DRESS, TEN); monitor. Moderate/severe hepatic impairment, decompensated liver disease: not recommended. Coinfection with HBV or HIV. Organ transplant recipients. Monitor hemoglobin and CBC with differential prior to and at weeks 2, 4, 8 and 12 during treatment. Monitor HCV-RNA at weeks 4 and 12, and clinical chemistry frequently. Elderly. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid concomitant atorvastatin. Concomitant colchicine w/renal or hepatic impairment, voriconazole; lopinavir, fosamprenavir, darunavir (all w/ritonavir): not recommended. May be potentiated by macrolides, azole antifungals. May be antagonized by anticonvulsants, rifabutin, dexamethasone, HIV protease inhibitors, efavirenz. May potentiate antiarrhythmics, digoxin, macrolides, carbamazepine, trazodone, azole antifungals, colchicine, rifabutin, alprazolam, midazolam, calcium channel blockers, corticosteroids, bosentan, atazanavir, tenofovir, immunosuppressants, salmeterol, PDE5 inhibitors for ED (reduce dose). May antagonize escitalopram, zolpidem, efavirenz, ethinyl estradiol, methadone. Monitor warfarin.

Adverse Reactions:

Rash (if serious; discontinue therapy and treat, do not restart), pruritus, anemia, GI upset, anorectal effects, dysgeusia, fatigue, hyperbilirubinemia, hyperuricemia.

Metabolism:

Hepatic (CYP3A4).

Elimination:

Fecal, renal.

Generic Availability:

NO

How Supplied:

Tabs—168 (7 blister strips x 6 tabs/ blister strip x 4 weekly cartons)

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