Revised SPC: Stribild (50mg elvitegravir/150mg cobicistat/200mg emtricitabine/245 mg tenofovir disoproxil fumarate [TDF]) film-coated tablets -

Revised SPC: Stribild (50mg elvitegravir/150mg cobicistat/200mg emtricitabine/245 mg tenofovir disoproxil fumarate [TDF]) film-coated tablets
Information type: Drug prescribing
Source: electronic Medicines compendium
Specialities: Infection and infectious diseases | Mental health and illness | Paediatric and neonatal medicine
Summary
SPC has been revised with extension of indication to include treatment of adolescents aged 12 to < 18 years weighing ≥ 35 kg with HIV-1 without known mutations linked to resistance to any of 3 agents in Stribild and who have experienced ADRs which preclude use of non-TDF regimens
UKMi comment
Data from Study GS-US-292-1316 have been added to SPC highlighting no clinically significant drug interactions have been either observed or are expected between the components of Stribild and sertraline.
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