Short prescribing information ISENTRESS® (Raltegravir)

ISENTRESS® (Raltegravir): C: Raltegravir; I: For treatment of human immunodeficiency virus (HIV-1) infection, in combination with antiretroviral medications; D: Adults: 600 mg: 1x daily 1200 mg (2×600 mg) in treatment-naïve patients or treatment-experienced patients, stable on 400 mg 2x daily, without prior virologic treatment failure, and virologically suppressed for at least 6 Mt on 400 mg 2x daily as part of initial HIV treatment. 400 mg: 2x daily in treatment-naive or -experienced patients. Formulations are not bioequivalent, so do not substitute 400 mg tablet for 600 mg. Children/Adolescents: 400 mg: 2x daily if bw ≥ 25 kg. Impaired renal function: no dose adjustment. Mildly to moderately impaired hepatic function: no dose adjustment; CI: Hypersensitivity to ingredients; Pr: 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. HIV and hepatitis B virus (HBV) or hepatitis C virus (HCV) coinfection: Limited data available. Osteonecrosis: cases reported; in case of joint aches and pain, joint stiffness or difficulty in movement consult physician. Serious skin reactions and hypersensitivity reactions: Serious, potentially life-threatening and fatal skin reactions possible with concomitant use with drugs associated with such reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) – immediate discontinuation and adequate treatment may be required.; DDI: 400 mg: caution with strong UGT1A1 inducers. 600 mg: coadministration with UGT1A1 inhibitors and strong UGT1A1 inducers not recommended. Antacids (Al- and/or Mg-containing; and CaCO3-containing at 600 mg): coadministration not recommended.; P/L 400 mg 2x daily: Can be used during pregnancy if clinically necessary; 600 mg: Limited data available. Breastfeeding is not recommended.; UDE: 400 mg and 600 mg: comparable incidence of serious clinical UDE. Pretreated patients: Drug-related ≥ 2%: diarrhea, headache. Treatment-naive patients: Drug-related ≥ 2%: diarrhea, nausea, fatigue, dizziness, headache, insomnia, rash, maculopapular rash; P: Bottles of 60 pieces: film-coated tablets: 400 mg and 600 mg. DC: A. MHA: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne, Switzerland. (V3.0); CH-MFA-00004.

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