Vemlidy

Vemlidy

tenofovir alafenamide

Manufacturer:

Gilead Sciences

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Tenofovir alafenamide
Indications/Uses
Chronic HBV infection in adults w/ compensated liver disease.
Dosage/Direction for Use
Administration
Should be taken with food.
Special Precautions
Discontinuation may result in severe acute exacerbations of hepatitis B; closely monitor patients w/ both clinical & lab follow-up for at least several mth after stopping treatment. Risk of development of HIV-1 resistance in patients co-infected w/ HBV & HIV-1. Not recommended as monotherapy for treatment of HIV-1 infection. Test for HIV-1 infection prior to initiation. Assess serum creatinine, estimated CrCl, urine glucose, & urine protein in all patients before initiating & during therapy as clinically appropriate. Assess serum P in patients w/ CKD. Discontinue in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Suspend treatment in any patient who develops clinical or lab findings suggestive of lactic acidosis or pronounced hepatotoxicity. Administer after completion of hemodialysis treatment on hemodialysis days in patients receiving chronic hemodialysis. Not recommended in patients w/ ESRD who are not receiving chronic hemodialysis. Not recommended in patients w/ decompensated (Child-Pugh B or C) hepatic impairment. Pregnancy & lactation. Safety & effectiveness have not been established in ped patient <18 yr.
Adverse Reactions
Headache, abdominal pain, cough, back pain, fatigue, nausea, arthralgia, diarrhea, dyspepsia; lab parameter abnormalities (ALT, LDL-C, glycosuria, AST, creatine kinase, serum amylase); lipid abnormalities (total cholesterol, HDL-C, LDL-C, triglycerides, total cholesterol to HDL ratio).
Drug Interactions
Decreased plasma conc w/ P-gp inducers (eg, carbamazepine, oxcarbazepine, phenobarb, phenytoin, rifabutin, rifampin, rifapentine, St. John's wort). Increased plasma conc w/ P-gp & BCRP inhibitors. Drugs that reduce renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (eg, gentamicin), & high-dose or multiple NSAIDs) may increase conc of tenofovir & other renally eliminated drugs.
MIMS Class
Antivirals
ATC Classification
J05AF13 - tenofovir alafenamide ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Vemlidy FC tab 25 mg
Packing/Price
30's
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