Emtricitabine and Tenofovir alafenamide Atlanta Medicare

Emtricitabine and Tenofovir alafenamide Atlanta Medicare

tenofovir + emtricitabine

Manufacturer:

Mylan

Distributor:

Atlanta Medicare
Concise Prescribing Info
Contents
Emtricitabine 200 mg, tenofovir alafenamide 25 mg
Indications/Uses
In combination w/ other antiretroviral agents for HIV-1 in adults & adolescents ≥12 yr weighing at least 35 kg.
Dosage/Direction for Use
Adult & adolescent ≥12 yr weighing at least 35 kg 1 tab once daily w/ 3rd agent in HIV treatment regimen (dolutegravir, efavirenz, maraviroc, nevirapine, rilpivirine, raltegravir).
Administration
May be taken with or without food: Do not chew/crush/split.
Special Precautions
Consider interruption or discontinuation of treatment if there is evidence of worsening liver disease. Avoid use in antiretroviral-experienced patients w/ HIV-1 harbouring K65R mutation. Discontinue treatment in patients w/ estimated CrCl that declines <30 mL/min during treatment. Residual risk of sexual transmission. Increased wt, & blood lipid & glucose levels. Mitochondrial dysfunction following exposure in utero. Haematological (anaemia, neutropenia), metabolic (hyperlactatemia, hyperlipasemia) & neurological (hypertonia, convulsion, abnormal behaviour) disorders. Cytomegalovirus retinitis, generalized &/or focal mycobacterial infections, & Pneumocystis jirovecii pneumonia; Graves' disease. May continue to develop opportunistic infections & other complications of HIV infection. Cases of osteonecrosis. Potential risk of nephrotoxicity resulting from chronic exposure. Patients co-infected w/ HIV & HBV or HCV; w/ pre-existing liver dysfunction including chronic active hepatitis. Closely monitor w/ both clinical & lab follow-up for at least several mth after discontinuation in patients co-infected w/ HIV & HBV. Monitor blood lipids & glucose. Concomitant use w/ 3rd nucleoside analogue. Not recommended in concomitant use w/ anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin), antimycobacterials (eg, rifampicin, rifabutin, rifapentine), boceprevir, telaprevir, St. John's wort, HIV PIs other than atazanavir, lopinavir, darunavir; medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil. May affect ability to drive & use machines. Liver disease. ESRD (estimated CrCl <15 mL/min) on chronic haemodialysis. Pregnancy. Not to be used during lactation. Childn <12 yr weighing <35 kg.
Adverse Reactions
Nausea. Abnormal dreams; headache, dizziness; diarrhoea, vomiting, abdominal pain, flatulence; rash; fatigue.
Drug Interactions
Concomitant use w/ medicinal products containing tenofovir alafenamide, tenofovir disoproxil, emtricitabine, lamivudine or adefovir dipivoxil. Emtricitabine: Increased conc w/ medicinal products that are eliminated by active tubular secretion & decrease renal function. Tenofovir alafenamide: Decreased plasma conc w/ P-gp inducers eg, rifampicin, rifabutin, rifapentine carbamazepine, phenobarb, oxcarbazepine, phenytoin, St. John's wort (Hypericum perforatum). Increased absorption & plasma conc w/ P-gp & BCRP inhibitors eg, cobicistat, ritonavir, ciclosporin. Increased plasma conc w/ ketoconazole, itraconazole, fluconazole or isavuconazole. Increased AUC & Cmax w/ atazanavir/cobicistat. Decreased exposure w/ tipranavir/ritonavir. Decreased AUC & Cmax w/ efavirenz. Increased AUC & Cmax of sertraline.
MIMS Class
Antivirals
ATC Classification
J05AR17 - emtricitabine and tenofovir alafenamide ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Emtricitabine and Tenofovir alafenamide Atlanta Medicare FC tab
Packing/Price
30's
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