Company: Janssen-Cilag Ltd.
Legal category: Prescription. Hospital. Sport permitted.
Active ingredient: Simeprevir 150mg.
Description: White gelatin hard capsule marked TMC435 150.
Presentation: Price available on request.
Indication: In combination with other medicinal products for the treatment of adults with genotype 1 or 4 chronic hepatitis C. Do not use as monotherapy.
Pharmacology: Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease.
Dosage: Adult: 150mg once daily. Take with food and swallow whole. Treatment-naive and relapsers: Olysio 12 weeks, peginterferon α and ribavirin 24 weeks (including patients with cirrhosis or co-infected with HIV-1). Partial and null responders: Olysio 12 weeks, peginterferon α and ribavirin 48 weeks (including patients with cirrhosis and co-infected with HIV-1). Interferon intolerant, ineligible and urgent to treat: Olysio 12 weeks, sofosbuvir 12 weeks. May be used for up to 24 weeks (with or without ribavirin). HCV RNA ≥25 IU/ml at week 4; discontinue all therapy. Elderly: Over 65 years, limited data. Over 75 years, safety and efficacy not established. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (only if benefit outweighs risk), lactation. Female patients and female partners of male patients must use effective contraception (see SPC for ribavirin).
Special precautions: Consider alternative therapy for patients with HCV genotype 1a who test positive for Q80K polymorphism. Do not use in patients with HCV genotypes 2, 3, 5 or 6. Do not reduce dosage or re-initiate treatment if interrupted. Caution: Severe renal impairment, moderate or severe hepatic impairment. Re-treatment of patients who failed an HCV NS3-4A protease inhibitor-based therapy (no data). Avoid excess exposure to sun and tanning devices during treatment; if photosensitivity reactions occur, discontinuation should be considered. Discontinue therapy if severe rash occurs. East Asian patients (assess risk/benefit). Co-infection with HBV or organ transplant patients (safety and efficacy not established). See SPCs of medicinal products used in combination with Olysio. Contains lactose.
Drug interactions: Not recommended: Telaprevir, boceprevir, moderate or strong CYP3A4 inducers or inhibitors (some anticonvulsants, antihistamines, antibiotics, antifungals, antimycobacterials, herbal products, antiretrovirals, dexamethasone, cisapride). Caution: Oral midazolam, some antiarrhythmics, calcium channel blockers, oral triazolam. OATP1B1 inhibitors (such as eltrombopag or gemfibrozil), CYP3A4/OATP1B1/P-gp substrates, digoxin, rosuvastatin, atorvastatin, simvastatin.
Adverse drug reactions: Dyspnoea, gastrointestinal upset, increased blood bilirubin, rash, pruritus, photosensitivity reaction.
Full prescribing information and references available from Janssen-Cilag Ltd. Telephone: (01) 620 2300.
MIMS Ireland Copyright ®