Revised SPC: Tenofovir disoproxil fumarate – all products

SPCs for products with tenofovir disoproxil fumarate (TDF) caution the use of ledipasvir/sofosbuvir (LDV/SOF), and LDV and SOF as single agents with TDF due to an interaction that may raise TDF plasma concentrations, thereby increasing ADRs, such as renal disorders.

The updated SPCs are:
• Truvada film-coated tablets (200 mg emtricitabine / 245 mg of tenofovir disoproxil)

• Eviplera 200 mg/25 mg/245 mg film coated tablets (200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil [as fumarate].)

• Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets (150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil)

• Atripla 600 mg/200 mg/245 mg film coated tablets (600 mg of efavirenz, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil [as fumarate].)