Nexataf - Tablet Tenofovir Alafenamide - 25mg 30 Tablet(s) / Box Everest Pharmaceuticals Ltd. Introduction: Nexataf is used in the treatment of HIV infection and chronic hepatitis B virus (HBV) infection. It prevents the multiplication of virus in human cells. This stops the virus from producing new viruses and clears up your infection. Nexataf should be used in the dose and duration as advised by your doctor. Do not skip any doses and finish the full course of treatment even if you feel better. Take it with food, as this increases the absorption of the medicine into the body. It is important to keep taking them until your doctor tells you it is safe to... Uses of Nexataf: HIV infectionChronic hepatitis B virus (HBV) infection Side effects of Nexataf: Headache How to use Nexataf: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Nexataf is to be taken empty stomach. How Nexataf works: Nexataf is an antiviral medication. It prevents the multiplication of virus in human cells. This stops the virus from producing new viruses and clears up your infection. What if you forget to take Nexataf?: If you miss a dose of Nexataf, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Chronic Hepatitis B Infection Administration: Take with food Adult Dose: Chronic Hepatitis B Infection Indicated for treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease 25 mg PO qDay with food Hepatic impairment Mild (Child-Pugh A): No dosage adjustment required Decompensated (Child-Pugh B or C) hepatic impairment: Use not recommended Renal Dose: Renal impairment Mild, moderate, or severe: No dosage adjustment required ESRD (CrCl <15 mL/min): Use not recommended Contraindication: Hypersensitivity Mode of Action: Tenofovir alafenamide (AF) is a nucleotide reverse transcriptase inhibitor (NRTI) and a phosphonamidate prodrug of tenofovir Compared with tenofovir disoproxil fumarate (tenofovir DF, Viread), tenofovir AF is a more targeted form of tenofovir that has demonstrated high antiviral efficacy at a dose that is 10 times lower than tenofovir DF, as well as an improved renal and bone safety profile Tenofovir AF as a lipophilic cell-permeant compound enters primary hepatocytes by passive diffusion and by the hepatic uptake transporters OATP1B1 and OATP1B3 and is converted to tenofovir diphosphate Tenofovir diphosphate inhibits HBV replication through incorporation into viral DNA by the... Precaution: Lactic acidosis and severe hepatomegaly with steatosis, including fatalities, reported with nucleoside analogs, including tenofovir disoproxil fumarate in combination with other antiretrovirals; most were reported in women; obesity and prolonged nucleoside exposure may be risks factors Discontinuation of antihepatitis B drugs may result in severe acute exacerbations of hepatitis B Owing to the risk of development of HIV-1 resistance, tenofovir AF alone is not recommended for the treatment of HIV-1 infection; test for HIV-1 before initiating treatment Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for... Side Effect: 1-10% Headache (9%) ALT >5 x ULN (8%) Abdominal pain (7%) Fatigue (6%) Cough (6%) Glycosuria >3+ (5%) Nausea (5%) Back pain (5%) Pregnancy Category Note: There are no human data on use in pregnant women to inform a drug-associated risks of adverse fetal developmental outcome In animal studies, no adverse developmental effects were observed when tenofovir alafenamide was administered during the period of organogenesis at exposure equal to or 51 times (rats and rabbits, respectively) the tenofovir alafenamide exposure at the recommended daily dose Interaction: Drugs that induce P-gp result in decreased tenofovir AF absorption and plasma concentrations, which may lead to loss of therapeutic effect (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St John’s wort) Drugs that inhibit P-gp and BCRP may increase tenofovir AF absorption and plasma concentration. Coadministration of tenofovir AF with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs, and this may increase the risk of adverse reactions Some examples include acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or long-term NSAD use