Short Prescribing Information DELSTRIGO® (doravirine, lamivudine, tenofovir disoproxil)

DELSTRIGO^®: C: Doravirine, lamivudine, tenofovir disoproxil (as tenofovir disoproxil fumarate). I: 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, lamivudine or tenofovir 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: One tablet once daily. 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. Test patients with HIV-1 for HBV before initiating therapy; monitor patients with HIV and HBV/HCV co‑infection for hepatic adverse effects before and after treatment for several months. Caution in patients with severe liver disease or at risk of renal dysfunction (incl. patients with renal ADRs receiving adefovir dipivoxil). Avoid administration if a nephrotoxic agent (e.g. high-dose or multiple NSAIDs) is in concomitant use or has recently been used. Monitor renal function regularly in all patients before and during treatment. Not recommended for patients with an estimated creatinine clearance of < 50 mL/min. Caution when combined with trimethoprim in patients with renal impairment. In patients receiving combination antiretroviral therapy, immune reactivation syndrome (incl. autoimmune disorders) may occur. Contains lactose. Do not take concomitantly with other medicinal products that contain tenofovir alafenamide, adefovir dipivoxil or the same active substances as DELSTRIGO^®. Continue to monitor patients for opportunistic infections and other complications of HIV infection. Caution in adult patients with a known history of pathological fractures or other risk factors for osteoporosis or bone loss. If bone anomalies are detected or suspected in pediatric patients, consult an endocrinologist and/or nephrologist. 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. If there are signs of pancreatitis, discontinue therapy. Caution in patients aged ≥ 65 years. DDI: Medicinal products that affect renal function. 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, cough, nasal symptoms, nausea, diarrhoea, flatulence, abdominal pain, vomiting, rash, alopecia, muscle disorders, fatigue, fever, alanine aminotransferase increased. P: 30 film-coated tablets containing 100 mg doravirine, 300 mg lamivudine and 245 mg tenofovir disoproxil. DC: A. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne, Switzerland; (V3.0); CH-DOR-00012.

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