Short Prescribing Information PIFELTRO^® (doravirine)

PIFELTRO^®: C: Doravirine. I: In combination with other antiretroviral medicinal products, for the treatment of infection with the human immunodeficiency virus type 1 (HIV-1) in adults, who are therapy naïve or for the replacement of the current antiretroviral therapy in patients in whom no HIV-1 mutations associated with resistances against doravirine were found, and who did not have a virological therapy failure in the past, and who are virologically suppressed since at least 6 months with a stable antiretroviral therapy (HIV-1 RNA <50 copies/ml). D: 1x 100 mg tablet daily in combination with other antiretroviral medicinal products. For further indications and the corresponding dosages for adults and pediatric patients, please refer to the prescribing information. CI: Hypersensitivity to active substances/excipients. Combination with medicinal products that are strong CYP3A enzyme inducers such as enzalutamide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine, mitotane, lumacaftor, St. John’s wort. Pr: The risk of sexual transmission of HIV cannot be excluded if prescribed ART is not taken regularly and/or viral suppression is not achieved and maintained. Severe skin reactions (incl. Stevens-Johnson syndrome/toxic epidermal necrolysis) reported. In patients receiving combination antiretroviral therapy, immune reactivation syndrome (incl. autoimmune disorders) may occur. Contains lactose. Test patients with HIV-1 for HBV before initiating therapy; monitor patients with HIV and HBV/HCV co‑infection for hepatic adverse effects. Continue to monitor patients for opportunistic infections and other complications of HIV infection. Due to the risk of osteonecrosis, patients should be advised to consult their physician if they experience joint pain and discomfort, joint stiffness or difficulty moving. DDI: CYP3A enzyme inducers & inhibitors. If concomitant prescription with moderate CYP3A inducers is unavoidable, increase the dose. Caution when combining doravirine with medicinal products that are sensitive CYP3A substrates with a narrow therapeutic window. P/L: Not recommended. UDE: Common: abnormal dreams, insomnia, headache, dizziness, somnolence, nausea, diarrhoea, flatulence, abdominal pain, vomiting, rash, fatigue, alanine aminotransferase increased. P: 30x 100 mg film-coated tablets. DC: A. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne, Switzerland; (V3.0); CH-DOV-00009.

Before prescribing please consult the full prescribing information published on the homepage of Swissmedic (www.swissmedicinfo.ch).