Tenofovir alafenamide is used to treat chronic hepatitis B infection, a viral infection of the liver. It works by stopping or slowing the growth of the virus. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer.

It is not known if tenofovir alafenamide can cure hepatitis B or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

Before starting treatment with this medication, your doctor should test you for HIV infection. If you have HIV infection along with hepatitis B infection, tenofovir alafenamide should not be used alone since this may make it harder to treat your HIV infection. Combination drug treatment should always be used to treat HIV infection.

Read the Patient Information Leaflet if available from your pharmacist before you start taking tenofovir alafenamide, and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually once daily.

If you are on dialysis, on your dialysis days, take your daily dose of this medication following dialysis.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

If you vomit within 1 hour after taking a dose, take another dose of this medication. If vomiting occurs more than 1 hour after taking your dose, do not take another dose. Take your next dose at the regular time.

Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may make the infection worse or harder to treat (resistant), or worsen side effects.

Headache, nausea, tiredness, or cough may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression, anxiety, confusion)
• signs of kidney problems (such as a change in the amount of urine)
• unusual thirst

Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine) or lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting, unusual weakness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking tenofovir alafenamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems
• HIV infection
• other liver problems (such as hepatitis C, cirrhosis)
• bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones)
• disease of the pancreas (pancreatitis)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• adefovir
• orlistat
• other drugs that may harm the kidneys (including aminoglycosides such as amikacin/gentamicin)

Do not take this medication with other products that contain tenofovir.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, urine glucose/protein, hepatitis B virus levels, blood mineral levels, bone density tests) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is more than 18 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.