Tenofovir alafenamide oral tablets

What is this medication?

TENOFOVIR ALAFENAMIDE (te NOE fo veer) is an antiviral medicine used to treat hepatitis B virus infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Vemlidy

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bone problems
• drink alcohol-containing drinks
• kidney disease
• liver disease
• an unusual or allergic reaction to tenofovir, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the virus resistant to this and other medicines. Keep taking this therapy unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• certain antibiotics like rifabutin, rifampin, rifapentine, aminoglycosides
• certain medicines for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• medicines for viral infections like cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir
• non-steroidal antiinflammatory drugs (NSAIDs)
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

Your hepatitis infection may get worse after you stop taking this medicine. Do not stop taking this medicine unless your doctor tells you to.

Hepatitis B is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of hepatitis B.

Tell your doctor if you also have HIV. You need to be on additional medicines to treat your HIV infection while you are taking this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bone pain
• breathing problems
• dizziness
• fast, irregular heartbeat
• muscle pain
• nausea, vomiting, unusual upset stomach or stomach pain
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs of infection - fever or chills, cough, sore throat, pain or trouble passing urine

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• headache
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.