Concise Prescribing Info
Contents
Elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg
Indications/Uses
HIV-1 infection in adults & adolescents ≥12 yr weighing at least 35 kg.
Dosage/Direction for Use
Administration
Should be taken with food: Swallow whole, do not chew/crush/split.
Contraindications
Special Precautions
Patients co-infected w/ HIV, HBV or HCV; lactose intolerance or intolerance to other sugars. Discontinuation of therapy is not recommended in patients w/ advanced liver disease or cirrhosis. Signs of inflammation or infection, joint pain, stiffness or bone problems may occur. Increase in wt & blood lipids & glucose during therapy. Autoimmune disorders. Osteonecrosis may occur. Do not drive & use tools or machines. Pregnancy & lactation. Childn ≤11 yr or weighing <35 kg. Do not take antacids or multivit at the same time w/ Genvoya.
Adverse Reactions
Hypersensitivity, nausea. Abnormal dreams, headache, dizziness, diarrhoea, vomiting, stomach pain, flatulence, rash, fatigue.
Drug Interactions
Do not administer concomitantly w/ medicinal products containing tenofovir disoproxil fumarate, lamivudine or adefovir dipivoxil used for the treatment of HBV infection; alfuzosin; amiodarone, quinidine; carbamazepine, phenobarb, phenytoin; rifampicin; dihydroergotamine, ergometrine, ergotamine; cisapride; St. John's wort; lovastatin, simvastatin; pimozide; sildenafil; midazolam, triazolam. Antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole); antibiotics (rifabutin, clarithromycin, telithromycin); antihepatitis C virus (telaprevir, boceprevir); antidepressants (trazodone or escitalopram), sedatives & hypnotics (buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem & lorazepam), immunosuppressants (ciclosporin, sirolimus, tacrolimus), inhaled steroids (fluticasone), oral antidiabetics (metformin), OCs, erectile dysfunction medicines (sildenafil, tadalafil, vardenafil), antiarrhythmics (digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone); antihypertensives (metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil); pulmonary arterial HTN (bosentan); anticoagulants (warfarin, dabigatran); bronchodilators (salmeterol); cholesterol-lowering agents (atorvastatin, pitavastatin); anti-gout (colchicine).
MIMS Class
ATC Classification
J05AR18 - emtricitabine, tenofovir alafenamide, elvitegravir and cobicistat ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Genvoya FC tab
Packing/Price
30's
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