Tenofovir Alafenamide (ten-OF-oh-vir al-a-FEN-a-mide)

Treats chronic hepatitis B infection in patients with compensated liver failure.

Brand Name(s):

Vemlidy

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the bottle tightly closed. Keep the medicine in the original bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how tenofovir alafenamide works. Tell your doctor if you are using any of the following:
  • Acyclovir, carbamazepine, cidofovir, ganciclovir, gentamicin, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, St John's wort, valacyclovir, valganciclovir
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, ibuprofen, naproxen)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or liver disease.
• This medicine may cause the following problems:
  • Lactic acidosis (too much acid in the blood)
  • Severe liver problems
  • Worsening of hepatitis B infection (if the medicine is stopped)
  • Kidney problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, cloudy urine
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Trouble breathing, lightheadedness, severe weakness, tiredness, confusion

If you notice these less serious side effects, talk with your doctor:

• Cough
• Headache
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088