Regulatory Information
GILEAD SCIENCES SINGAPORE PTE. LTD.
GILEAD SCIENCES SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _Adults and paediatric patients aged 6 years and older, weighing at least 25 kg_ One tablet to be taken once daily with food. If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Genvoya by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 1 hour of taking Genvoya another tablet should be taken. _Elderly_ No dose adjustment of Genvoya is required in elderly patients (see sections 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Renal impairment_ No dose adjustment of Genvoya is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min. Genvoya should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available to make dose recommendations in children aged less than 12 years with renal impairment. Genvoya should not be initiated in patients with estimated CrCl < 30 mL/min as there are limited data available regarding the use of Genvoya in this population (see sections 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Hepatic impairment_ No dose adjustment of Genvoya is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Genvoya has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Genvoya is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Genvoya in children younger than 6 years of age, or weighing < 25 kg, have not yet been established. No data are available. Method of administration Genvoya should be taken orally, once daily with food (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Due to the bitter taste, it is recommended that the film-coated tablet not be chewed or crushed. For patients who are unable to swallow the tablet whole, the tablet may be split in half and both halves taken one after the other, ensuring that the full dose is taken.
ORAL
Medical Information
**4.1 Therapeutic indications** Genvoya is indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows: - In adults and adolescents aged from 12 years and with body weight at least 35 kg - In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities. See sections 4.2, 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
**4.3 Contraindications** Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Co-administration with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious or life-threatening adverse reactions. Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_): - alpha 1-adrenoreceptor antagonists: alfuzosin - antiarrhythmics: amiodarone, quinidine - ergot derivatives: dihydroergotamine, ergometrine, ergotamine - gastrointestinal motility agents: cisapride - HMG Co-A reductase inhibitors: lovastatin, simvastatin - lipid-modifying agent: lomitapide - neuroleptics/antipsychotics: pimozide, lurasidone - PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension - sedatives/hypnotics: orally administered midazolam, triazolam Co-administration with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Genvoya. Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_): - anticonvulsants: carbamazepine, phenobarbital, phenytoin - antimycobacterials: rifampicin - herbal products: St. John’s wort ( _Hypericum perforatum_) Co-administration with dabigatran etexilate, a P-glycoprotein (P-gp) substrate (see section 4.5 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
J05AR18
emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat
Manufacturer Information
GILEAD SCIENCES SINGAPORE PTE. LTD.
Patheon Inc.
Active Ingredients
Tenofovir Alafenamide Fumarate 11.2mg eqv Tenofovir Alafenamide Fumarate free base
10.0mg
Documents
Package Inserts
Genvoya PI.pdf
Approved: June 13, 2022