Tenofovir alafenamide

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach discomfort
• bloody urine
• dark urine
• decreased appetite
• decreased frequency or amount of urine
• diarrhea
• fast, shallow breathing
• general feeling of discomfort
• increased blood pressure
• increased thirst
• light-colored stools
• loss of appetite
• lower back or side pain
• muscle pain or cramping
• nausea and vomiting
• right upper abdominal or stomach pain and fullness
• sleepiness
• swelling of the face, fingers, or lower legs
• troubled breathing
• unusual tiredness or weakness
• weight gain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cough
• headache

• Back pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You will need to have an HIV test as you were told by your doctor. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Bone problems like bone pain, soft bones, and thin bones have happened with tenofovir alafenamide. This may lead to broken bones. You may need to have a test to check your bones. Talk with your doctor.
• Take calcium and vitamin D as you were told by your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• This medicine may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use tenofovir alafenamide as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine with food.
• It is important that you do not miss or skip a dose of tenofovir alafenamide during treatment.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with food.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Vemlidy: 25 mg

• Antihepadnaviral, Reverse Transcriptase Inhibitor, Nucleotide (Anti-HBV)

Tenofovir alafenamide, an analog of adenosine 5'-monophosphate, is converted intracellularly by hydrolysis to tenofovir and subsequently phosphorylated to the active tenofovir diphosphate. The active moiety inhibits replication of HBV by inhibiting HBV polymerase.

Metabolism

Tenofovir alafenamide (TAF) is converted intracellularly by hydrolysis to tenofovir, then phosphorylated to the active tenofovir diphosphate.

Excretion

Feces (31.7%) and urine (<1%)

Time to Peak

Serum: 0.48 hours

Half-Life Elimination

Serum: 0.51 hours

Protein Binding

80% to plasma proteins

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to tenofovir alafenamide or any component of the formulation

Store below 30°C (86°F). Dispense in original container.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, abdominal pain, loss of strength and energy, cough, nausea, or back pain. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of lactic acidosis (fast breathing, tachycardia, abnormal heartbeat, vomiting, fatigue, shortness of breath, severe loss of strength and energy, severe dizziness, feeling cold, or muscle pain or cramps), bone pain, muscle pain, muscle weakness, or pain in the extremities (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.