Forvic 300

Tenofovir disoproxil fumarate

In combination w/ other antiretrovirals for HIV-1 infection in adults. HIV-1 infection in adolescents 12 to <18 yr & weighing >35 kg w/ NRTI resistance or toxicities precluding use of 1st line agents. Chronic hepatitis B in adults w/ compensated liver disease, evidence of active viral replication, persistently elevated serum ALT levels & histological evidence of active inflammation &/or fibrosis; evidence of lamivudine-resistant HBV; decompensated liver disease.

300 mg once daily.

Should be taken with food.

Hypersensitivity.

Test HIV Ab in all HBV-infected patients before initiating therapy. Residual risk of HIV-1 transmission cannot be excluded. Has not been proven to prevent risk of HBV transmission. Reports of renal failure, renal impairment, elevated creatinine, hypophosphatemia & proximal tubulopathy (including Fanconi syndrome). Calculate CrCl in all patients prior to initiating therapy & monitor renal function (CrCl & serum phosphate). Risk of bone abnormalities eg, osteomalacia; reduction in bone mineral density. Limited safety & efficacy data in liver transplant patients; in HBV-infected patients w/ decompensated liver disease & w/ Child-Pugh-Turcotte score >9. Hepatitis exacerbations while on & after discontinuing treatment. Co-infection w/ hepatitis C or D; HIV-1 & hepatitis B. Increase in wt & in levels of blood lipids & glucose may occur during therapy. Mitochondrial dysfunction in HIV -ve infants exposed in utero &/or postnatally to nucleoside analogues. Immune reactivation syndrome. Reports of osteonecrosis, particularly in patients w/ advanced HIV disease &/or long-term exposure to CART. Reports of acute renal failure after initiation of high-dose or multiple NSAIDs in patients treated w/ tenofovir disoproxil fumarate & w/ risk factors for renal dysfunction. Higher risk of renal impairment in patients receiving tenofovir disoproxil fumarate in combination w/ a ritonavir- or cobicistat-boosted PI. Triple therapy w/ nucleosides/nucleotides. Co-administration w/ other medicinal products containing tenofovir disoproxil fumarate or tenofovir alafenamide; adefovir dipivoxil; didanosine; nephrotoxic medicinal products; ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir; stavudine; zidovudine. May impair ability to drive or operate machinery. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Not recommended in patients w/ severe renal impairment (CrCl <30 mL/min) & those requiring hemodialysis. Pregnancy. HIV-infected women should not breastfeed. Safety & efficacy in childn <2 yr have not been established. Elderly.

Hypophosphatemia; dizziness; diarrhea, vomiting, nausea; rash; asthenia. Headache; abdominal pain/distension, flatulence; increased transaminases; fatigue.

Not recommended w/ other medicinal products containing tenofovir disoproxil fumarate or tenofovir alafenamide; adefovir dipivoxil; didanosine; renally eliminated medicinal products (eg, cidofovir); nephrotoxic medicinal products (eg, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir, interleukin-2); tacrolimus. Potentiated tenofovir-associated adverse reactions w/ PIs & HCV antivirals.

Antivirals

J05AF07 - tenofovir disoproxil ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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