Vemlidy is a tablet containing tenofovir alafenamide for oral administration, which is designed to act as a hepatitis B virus nucleoside analog reverse transcriptase inhibitor. Each tablet contains 25 mg of tenofovir alafenamide, which is equivalent to 28 mg of tenofovir alafenamide fumarate. The tablets include inactive ingredients like croscarmellose sodium, lactose monohydrate, and magnesium stearate, and are film-coated with materials such as iron oxide yellow and talc. Vemlidy is thus intended to be used in the treatment of hepatitis B.

How should I use this medication?

Take this medication by mouth with 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 medications. 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 6 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.

Where should I keep my medication?

Keep out of the reach of children and pets. Store below 30 degrees C (86 degrees F). Get rid of any unused medication after the expiration date. To get rid of medications that are no longer needed or have expired: -Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location. -If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome): -Back pain -Cough -Diarrhea -Fatigue -Headache -Nausea -Stomach pain

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.

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 -Frequently drink alcohol -Kidney disease -Liver disease -An unusual or allergic reaction to tenofovir, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breast-feeding

What may interact with this medication?

-Certain antibiotics, such as rifabutin, rifampin, rifapentine, aminoglycosides -Certain medications for seizures, such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin -Medications for viral infections, such as cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir -Non-steroidal antiinflammatory medications (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 care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Discuss any new symptoms with your care team. You may need blood work while taking this medication. If you have hepatitis B, talk to your care team if you plan to stop taking this medication. The symptoms of hepatitis B may get worse if you stop this medication. Hepatitis B is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of hepatitis B. Tell your care team if you also have HIV. You need to be on additional medications to treat your HIV infection while you are taking this medication.

What are the most serious risks of this medication?

Do not stop taking this medication without first talking to your care team. The symptoms of hepatitis B may worsen when you stop taking this medication. Your care team will check your liver and general health after treatment is stopped. You may need to take other medications if your hepatitis flares or returns.