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Vemlidy 25mg Tablet
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Indications & Clinical Uses
- Vemlidy 25 mg tablets contain tenofovir alafenamide (as the fumarate), an antiviral medicine for chronic hepatitis B virus (HBV) infection.
- It is approved in adults and in children aged 6 years and older who weigh at least 25 kg, who have compensated liver disease.
- The dose is one 25 mg tablet taken by mouth once daily with food.
- Vemlidy treats hepatitis B only; it is not a treatment for HIV-1 infection and should not be used alone in people who also have HIV, because HIV can develop resistance.
- It is a prescription medicine started and monitored by a healthcare provider experienced in treating hepatitis B.
Side Effects
- The most common side effects (5% or more) are headache (12%), abdominal pain (9%), cough (8%), back pain (6%), fatigue (6%), nausea (6%), diarrhoea (5%) and indigestion (5%).
- BOXED WARNING: stopping anti-hepatitis B therapy, including Vemlidy, may cause a severe acute worsening (flare) of hepatitis B.
- Watch for tiredness, yellow skin or eyes, dark urine, pale stools and stomach pain after stopping, and contact your provider at once.
- Rare but serious effects include kidney problems (acute kidney failure and Fanconi syndrome), and lactic acidosis with an enlarged liver (severe hepatomegaly).
- Get urgent help for unusual muscle pain, fast breathing, severe weakness or severe stomach pain.
Precautions & Warnings
- BOXED WARNING: severe acute exacerbations of hepatitis B can occur after stopping Vemlidy, so liver function must be closely monitored, clinically and with laboratory tests, for several months after treatment ends; resuming hepatitis B therapy may be necessary.
- Do not stop Vemlidy without medical advice.
- Kidney function is checked before and during treatment.
- Stop and seek help if lactic acidosis or severe hepatotoxicity is suspected.
- Vemlidy alone is not recommended for HIV-1 infection.
- Registry data on pregnancy show birth-defect rates (3.9% to 4.8%) comparable to background, and animal studies showed no developmental harm.
- Take with food, once daily.
- Store below 30 degrees C in the original bottle with the desiccant, tightly closed.
Avoid Interactions
- Medicines that reduce effectiveness: strong P-gp and BCRP inducers lower tenofovir alafenamide levels, including carbamazepine, rifampin (rifampicin) and St. John's wort.
- Co-administration with carbamazepine needs a dose increase to two Vemlidy tablets daily; the other inducers are not recommended.
- Because Vemlidy can affect the kidneys, tell your provider about any other medicines that affect kidney function so that kidney monitoring can be planned.
- The label sections reviewed did not name specific medicines that raise Vemlidy levels.
- Tell your healthcare provider about all prescription medicines, over-the-counter products, herbal remedies and supplements.
References
Frequently Asked Questions
Vemlidy (tenofovir alafenamide) treats chronic hepatitis B virus infection in adults and children aged 6 and over weighing at least 25 kg, who have compensated liver disease. It does not cure hepatitis B and is not a treatment for HIV.
Take one Vemlidy (tenofovir alafenamide) 25 mg tablet by mouth once a day with food. Keep taking it exactly as prescribed. Do not stop Vemlidy unless your healthcare provider tells you to, because stopping can make hepatitis B flare severely.
Vemlidy side effects include headache, stomach pain, cough, back pain, tiredness, nausea, diarrhoea and indigestion. Rarer serious effects are kidney problems and lactic acidosis. Boxed warning: hepatitis B can flare severely if you stop Vemlidy. Report yellow skin, dark urine or severe tiredness.
Avoid strong P-gp inducers such as rifampin and St. John's wort, which lower Vemlidy levels. Carbamazepine requires two Vemlidy tablets daily under medical direction. Do not stop Vemlidy (tenofovir alafenamide) on your own, and do not use it alone for HIV-1 infection.
Your provider checks liver tests and kidney function on Vemlidy (tenofovir alafenamide). After stopping, liver function must be monitored closely for several months because of the boxed warning on severe hepatitis B flares. Restarting hepatitis B treatment may be needed.
Registry data on Vemlidy (tenofovir alafenamide) show birth-defect rates of 3.9% to 4.8%, similar to background rates, and animal studies showed no harm. Talk to your healthcare provider before starting or continuing it in pregnancy, and do not stop it without medical advice.
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