Avonza

HIV-1 infection in patients weighing ≥35 kg w/ virologic suppression to HIV-1 RNA levels of <50 copies/mL on their current combination antiretroviral therapy for >3 mth & must not have experienced virological failure on any prior antiretroviral therapy.

1 tab once daily at bedtime. Coadministration w/ rifampicin Consider additional 200 mg efavirenz daily.

Should be taken on an empty stomach: Swallow whole w/ water.

Hypersensitivity. Concomitant use w/ herbal prep containing St. John's wort (Hypericum perforatum); voriconazole; elbasvir & grazoprevir.

Discontinue treatment if hepatoxicity is symptomatic or transaminase levels are >10x ULN. Discontinue immediately if severe rash or erythema including SJS; clinical signs, symptoms or lab abnormalities suggestive of pancreatitis occur. Not recommended to discontinue treatment in patients w/ advanced liver disease or cirrhosis due to hepatic decompensation; for screening for hyperlactataemia in asymptomatic patients on therapy. Interrupt treatment in patients whose CrCl falls <50 mL/min or serum phosphate decreases <1 mg/dL (0.32 mmol/L). Increased transaminase levels particularly in patients w/ HBV- &/or HCV co-infection. Increased risk of severe & potentially fatal hepatic adverse reactions in patients w/ chronic hepatitis B or C. Severe depression, psychosis or suicidal ideation. Renal failure, elevated creatinine, hypophosphataemia & proximal tubulopathy (including Fanconi syndrome). Decreases in bone mineral density of spine & changes in bone biomarkers from baseline. Lactic acidosis. Higher risk of lipodystrophy eg, older age, longer duration of antiretroviral therapy & related metabolic disturbances. May continue to develop opportunistic infections & other complications of HIV infection. Osteonecrosis; joint aches & pain, joint stiffness or difficulty in movement. Patients w/ history of seizures or other risk factors; hyperlactataemia; pre-existing severe immune deficiency. Use appropriate precautions to prevent HIV transmission. Monitor liver enzyme in patients w/o pre-existing hepatic dysfunction; renal function wkly if concomitant use w/ nephrotoxic agents is unavoidable. Closely monitor clinical & lab follow-up for at least 4 mth after stopping treatment in patients co-infected w/ HIV & HBV. Calculate CrCl prior to & during therapy. Perform routine monitoring of calculated CrCl & serum phosphate in patients at risk for renal impairment; clinical exam including evaluation of physical signs of fat redistribution. Re-evaluate renal function w/in 1 wk including measurements of blood glucose & K, & urine glucose conc, if serum phosphate is <1.5 mg/dL (0.48 mmol/L) or CrCl decreases <50 mL/min. Consider measurement of fasting serum lipids & blood glucose, & appropriate management of lipid disorders. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be administered concomitantly w/ other cytidine analogues eg, emtricitabine. Not recommended in concomitant use w/ didanosine. Additive effect w/ alcohol & other psychoactive drugs. Avoid concurrent use w/ nephrotoxic medicinal product (eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). May impair ability to drive & use machine. Severe liver disease. Not recommended in moderate or severe renal impairment (CrCl <50 mL/min). Women of childbearing potential should undergo pregnancy testing before treatment initiation. Cases of neural tube defects in infants born to women w/ 1st trimester exposure. Not to be used during 1st trimester of pregnancy. Mitochondrial dysfunction in HIV -ve infants exposed in utero &/or postnatally to nucleoside analogues. Adolescents <18 yr. Not recommended in childn <35 kg. Elderly (decreased renal function).

Increased fasting triglycerides, total cholesterol, HDL-C & LDL-C, hypophosphataemia; dizziness; rash; diarrhoea, nausea, vomiting. Cough, nasal symptoms; abnormal dreams, disturbance in attention, headache, insomnia, somnolence; anxiety, depression; elevation of liver enzymes; pruritus, hair loss; arthralgia, myalgia; abdominal pain, flatulence; fatigue, malaise, fever. Erythema multiforme, SJS.

Additive effect w/ abacavir. Not recommended in concomitant use w/ didanosine; nevirapine, etravirine; indinavir; adefovir dipivoxil. Avoid concomitant use w/ fosamprenavir/ritonavir; ritonavir; tipranavir/ritonavir; posaconazole; amodiaquine/artesunate; carbamazepine. Concomitant use w/ indinavir/ritonavir; ketoconazole; itraconazole. Increased/decreased AUC & C_min w/ nelfinavir. Substantial decrease of lopinavir exposure. Decreased AUC & C_max of maraviroc. Tenofovir: Increased serum conc w/ medicinal products that reduce renal function or compete for active tubular secretion via transport proteins hOAT1, hOAT3 or MRP4 (eg, cidofovir). Avoid concurrent use w/ nephrotoxic medicinal product eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2. Concomitant use w/ tacrolimus. Increased exposure w/ atazanavir/ritonavir. Lamivudine: Increased AUC w/ trimethoprim/sulfamethoxazole. Concomitant use w/ emtricitabine. Efavirenz: Altered plasma conc w/ agents altering CYP2B6 or CYP3A activity. Decreased systemic exposure of CYP3A substrates; quinine; lumefantrine, halofantrine; artemisinin & its derivatives; verapamil, felodipine, nifedipine, nicardipine; etonogestrel; tacrolimus, cyclosporine, sirolimus; warfarin. Altered plasma conc of terfenadine, astemizole, cisapride, pimozide, bepridil or ergot derivatives. Increased AUC of & w/ ritonavir; of lorazepam. Not to be coadministered w/ voriconazole. Concomitant use w/ rifampicin; rifabutin. Increased clearance w/ & of phenytoin. Decreased AUC of diltiazem; atorvastatin, pravastatin, simvastatin; levonorgestrel, norelgestromin; methadone; buprenorphine, norbuprenorphine. Decreased levels w/ St. John's wort (Hypericum perforatum).

Antivirals

J05AR11 - lamivudine, tenofovir disoproxil and efavirenz ; Belongs to the class of antivirals for treatment of HIV infections, combinations.

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