GENERIC VEMLIDY

Generic Vemlidy is an antiviral medicine and as well as antiretroviral activity and is a prodrug of Tenofovir that prevents the hepatitis B virus multiplying in the body. Generic Vemlidy containing active ingredient Tenofovir Alafenamide and each tablet contains 25mg of Tenofovir Alafenamide which is a nucleotide reverse transcriptase inhibitor Generic Vemlidy developed by Gilead sciences for use to treat the HIV infection and Chronic hepatitis B.

CLINICAL DATA


Brand Name: Tafnat, Tafero,Hepbest
IUPAC Name: Isopropyl (2S)-2-[[[(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methyl-phenoxy-phosphoryl]amino]propanoate
Molecular Formula : C21H29N6O5P
Pregnancy category: B
Route of administration: mouth



In patient with decompensated cirrhosis using Generic Vemlidy drug, the safety and efficacy is not established and treatment of HBV infection in such patients is not recommended. Generic Vemlidy is indicated for the treatment of chronic hepatitis B virus infection and HIV infection in adult and for pediatric patient the safety and efficacy is not established.

The Generic Vemlidy is a fixed dose combination of Tenofovir Alafenamide and recommended dose in adult is 25mg which is administrated orally, once daily taken with food. Generic Vemlidy is then converted to tenofovir disproxil Fumarate via loss of water primarily by carboxylesterase 1 (CES1) in primary hepatocytes. Tenofovir Intracellularily , finally phosphorylated by cellular kinases for the formation the pharmacologically active metabolite tenofovir diphosphate.It interfere with the Hepatitis B virus proliferation via fusing into viral DNA by the HBV reverse transcriptase, which causes in DNA chain-termination.

Based on pharmacokinetic activity the action of Generic Vemlidy as follows:



ABSORPTION


Generic vemlidy is a phosphonamide prodrug of Tenofovir, peak plasma concentration is approx 0.5hrs after the dose.Food effect: Drug with a high fat meal increase AUC compared with administration in fasted state.


DISTRIBUTION


Plasma protein binding is 80%


METABOLISM


Only minimal metabolized by CYP3A


ELIMINATION


Excreted by kidneys , 32% of dose in feces and<1% excreted in urine. Half life is 0.5hrs. Major side effects are increased ALT, pruritus, arthralgia, dizziness, fatigue, vomiting, abdominal pain, nausea, flatulence.





Risk of Kidney impairment


Generic Vemlidy used in patient for the treatment with mild moderate, severe renal impairment has no dose adjustment and the drug is not recommended in patients with end stage renal disease. Consult with your doctor for further details.


Risk of liver impairment


Patient with decompensated hepatic impairment is not recommended with Generic Vemlidy treatment, because safety and efficacy is not been established. No adjustment is required. Consult with your doctor


Pregnancy category B


While Generic vemlidy during pregnancy ,no malformation, fetotoxicity or neonatal toxicity, Hepbest referred for only limited number of pregnant women. In animal reproduction studies have shown negative risk to the fetus and there no sufficient and well – tolerated studies in pregnant women. This drug harms the unborn baby. Alcohol usage on treatment with Generic Vemlidy drinking alcoholic beverages is not safe or not depends upon number of factors involves the patient receiving drugs. Alcohol may inhibits some action of hepatitis drugs work. So patient should discuss with doctor about any adverse reaction of drinking during treatment.


(If you missed any dose, as soon as you remember take the missed dose. If time for next dose then skips the missed dose and follow the routine scheduled. Do not take more than one tablet per day. Please consult your doctor for changes in dose or new schedule for replace of missed dose.)

GENERIC VEMLIDY (Tenofovir Alafenamide 25 mg)



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