- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: tenofovir AF
Brand Name: Vemledy
Drug Class: Hepatitis B, NRTIs
What is tenofovir AF, and what is it used for?
Tenofovir alafenamide (AF) is a medication used in the treatment of chronic hepatitis B virus (HBV) infection in patients 12 years of age or older with compensated liver disease. HBV is spread by body fluids and causes serious liver infection that can lead to liver failure, cirrhosis or cancer. Tenofovir AF is one of the drugs used in antiretroviral treatment (ART) combinations to manage human immunodeficiency virus (HIV) infection that affects the immune system. Neither HBV nor HIV infection can be cured and must be prevented with vaccination and controlled with lifelong medication.
Tenofovir belongs to a class of medications known as nucleoside reverse transcriptase inhibitors (NRTIs), that work by preventing viral replication. Tenofovir AF is a prodrug that enters the liver cells, is converted into tenofovir, and then metabolized into its active form tenofovir diphosphate. Tenofovir diphosphate gets incorporated into the HBV DNA by the HBV reverse transcriptase, the viral enzyme that is essential for replication of the viral DNA, which results in DNA chain termination.
Tenofovir AF is a more recent formulation and different from tenofovir disoproxil fumarate (DF), an earlier formulation. Tenofovir DF is rapidly converted to tenofovir in the blood, while tenofovir AF is more stable in the blood and is converted to tenofovir and its active form only inside the infected liver cells. This property of tenofovir AF makes it possible to maximize tenofovir’s efficacy with lower dosages, improve its safety profile, and reduce the risk of adverse effects on the kidneys and bone mineral density from tenofovir carried in the bloodstream.
- Discontinuation of anti-hepatitis B treatment, including tenofovir AF can result in severe acute exacerbation of hepatitis B. Monitor patients for several months with medical checkups and lab tests after discontinuation of treatment, and resume treatment if required.
- Tenofovir AF is not approved for use as a single agent in the treatment of HIV-1 due to the risk of development of HIV-1 resistance, and its safety and efficacy have not been established in the treatment of patients who are infected with both HBV and HIV-1. Screen HBV patients for HIV-1 infection, and if positive, use an approved combination antiretroviral treatment regimen.
- Tenofovir AF can affect the kidneys, and the risk is higher in patients with impaired kidney function or those taking other drugs that are toxic to the kidneys. Evaluate the patient's kidney function before starting treatment and monitor at regular intervals during treatment. Discontinue tenofovir AF if the patient develops signs and symptoms of kidney damage including decrease in renal function or evidence of Fanconi syndrome.
- Tenofovir AF therapy can lead to lactic acid buildup (lactic acidosis), and enlarged and fatty liver (hepatomegaly with steatosis). Suspend tenofovir AF treatment in patients who develop signs and symptoms of lactic acidosis or significant hepatotoxicity.
What are the side effects of tenofovir AF?
Common side effects of tenofovir AF include:
- Abdominal pain
- Indigestion (dyspepsia)
- Gas (flatulence)
- Reduced bone mineral density
- Back pain
- Joint pain (arthralgia)
- Increase in liver enzymes ALT and AST
- Increase in low-density lipoprotein (LDL) cholesterol
- Excretion of sugar in urine (glycosuria)
- Increase in creatine kinase
- Inflammation of pancreas (pancreatitis)
- Increase in levels of pancreatic enzymes amylase and lipase in blood
- New onset or worsening of kidney function impairment
- Acute exacerbation of hepatitis B with discontinuation of the drug
- Excessive lactic acid buildup in the body (lactic acidosis)
- Liver enlargement with fatty liver (hepatomegaly with steatosis)
Less common side effects of tenofovir AF include:
- Hives (urticaria)
- Swelling beneath the skin and mucous membranes (angioedema)
- Kidney damage including:
- Acute kidney failure
- Death of kidney cells (acute tubular necrosis)
- Proximal renal tubulopathy
- Fanconi syndrome
Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:
- Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
- Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
- Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
- Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
What are the dosages of tenofovir AF?
- 25 mg
Adult and Pediatric:
Chronic Hepatitis B Infection
Indicated for treatment of chronic hepatitis B virus (HBV) infection in patients aged 12 years or above with compensated liver disease
- Children below 12 years: Safety and efficacy not established
- Adults and children 12 years or above: 25 mg orally once daily with food
- Mild, moderate, or severe: No dosage adjustment required
- ESRD (creatinine clearance [CrCl] below 15 mL/minute: Not recommended in patients who are not receiving hemodialysis; in patients receiving chronic hemodialysis, administer drug after completion of hemodialysis
- Mild (Child-Pugh A): No dosage adjustment required
- Decompensated (Child-Pugh B or C): Not recommended
- Test for HIV-1 infection before initiating; do not use tenofovir alone in patients coinfected with HIV infection
- Assess serum creatinine, phosphorous, estimated CrCl, urine glucose, and urine protein before initiating and periodically throughout treatment
High doses of tenofovir AF can reduce bone mineral density and affect the kidneys. Tenofovir AF overdose may be treated with symptomatic and supportive care, including monitoring of the patient's clinical condition and vital signs.
What drugs interact with tenofovir AF?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation. Tenofovir AF may be removed by hemodialysis efficiently.
- Severe interactions of tenofovir AF include:
- Severe interactions of tenofovir AF include:
- Tenofovir AF has moderate interactions with at least 25 different drugs.
- Tenofovir AF has no known mild interactions with other drugs.
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
Subscribe to MedicineNet's General Health Newsletter
Pregnancy and breastfeeding
- Animal studies and available data from use of tenofovir AF in pregnant women do not show evidence of fetal harm if administered during pregnancy.
- There is no information on the presence of tenofovir AF or its metabolites in breastmilk, or its effects on milk production and the breastfed infant. Decision to breastfeed should be based on the nursing mother’s clinical need for tenofovir AF, health and developmental benefits of breastfeeding, and the risks to the breastfed infant from exposure to the drug or the mother’s underlying condition.
- There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VEMLIDY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258 4263.
What else should I know about tenofovir AF?
- Take tenofovir AF with food exactly as instructed and do not miss your doses, it can result in the development of viral resistance to the medication.
- Do not discontinue tenofovir AF without checking with your physician, it can cause acute, severe exacerbation of hepatitis B.
- If you are co-infected with HIV-1, it must be treated effectively with an approved combination regimen, taking tenofovir alone can increase the risk of development of resistance to HIV medication.
- Report to your physician immediately if you develop new onset or worsening of kidney-related symptoms such as urinary problems, blood in urine or fluid retention.
- Inform your physician if you develop signs and symptoms of liver injury and lactic acidosis such as, dark urine, jaundice, exhaustion, fatigue, exhaustion, nausea, vomiting, muscle cramps or body aches.
- Store tenofovir AF safely out of reach of children.
- In case of overdose, contact your treating physician or Poison Control.
Tenofovir alafenamide (AF) is a medication used in the treatment of chronic hepatitis B virus (HBV) infection in patients 12 years or older with compensated liver disease. Common side effects of tenofovir AF include headache, abdominal pain, nausea, diarrhea, indigestion (dyspepsia), vomiting, gas (flatulence), cough, reduced bone mineral density, fatigue, back pain, joint pain (arthralgia), rash, increase in liver enzymes ALT and AST, and others. Consult your doctor if pregnant or breastfeeding.
Multimedia: Slideshows, Images & Quizzes
Hepatitis C, Hep B, Hep A: Symptoms, Causes, Treatment
Hepatitis C, B, and A are viruses that cause liver inflammation. Hepatitis B vaccines and hepatitis A vaccines are available....
Liver Health: 14 Best and Worst Foods for Your Liver
Get some simple diet tips to keep your liver healthy, including the best veggies to keep disease away and some snacks you'll want...
What Is Viral Hepatitis? How You Catch Hepatitis A, B, and C
Hepatitis C virus and hepatitis B can make an infected person very sick and they are risk factors for liver cancer, liver...
Hepatitis C (Hep C): Symptoms, Treatments, Antivirals
What is hepatitis C (Hep C, HVC)? Learn about hepatitis C symptoms, how you get Hep C, contagiousness, and treatment for...
Hepatitis A Quiz: Test Your Medical IQ
How many types of hepatitis are there, and what is different about hepatitis A? Take this quiz to find out!
Hepatitis C Quiz: What is Hepatitis C?
How many Americans have hepatitis C? Take this quiz to learn the facts about this chronic disease.
Picture of Hepatitis B
Inflammation of the liver due to the hepatitis B virus (HBV), once thought to be passed only through blood products. See a...
Related Disease Conditions
Hepatitis (Viral Hepatitis A, B, C, D, E, G)
Hepatitis is most often viral, due to infection with one of the hepatitis viruses (A, B, C, D, E, F (not confirmed), and G) or another virus (such as those that cause infectious mononucleosis, cytomegalovirus disease). The main nonviral causes of hepatitis are alcohol and drugs. Many patients infected with hepatitis A, B, and C have few or no symptoms of illness. For those who do develop symptoms of viral hepatitis, the most common are flu-like symptoms including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, and aching in the abdomen. Treatment of viral hepatitis is dependent on the type of hepatitis.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Is Hepatitis B Contagious?
Hepatitis B is a type of liver infection. Hepatitis B is spread through person-to-person contact or through personal items like razors, toothbrushes, etc. Symptoms of hepatitis B include fever, yellowish skin (jaundice), dark urine, fatigue, nausea, and vomiting. There is no drug to cure hepatitis B; however, there is a hepatitis B vaccine available.
How Long Can a Person Live After Being Diagnosed With Hepatitis C (Hep C)?
Hepatitis C is a virus that causes inflammation of the liver. The impact of hepatitis C on lifespan is dependent on how the disease progresses and the effectiveness of timely treatment.
Hepatitis B (HBV, Hep B)
The hepatitis B virus (HBV, hep B) is a unique, coated DNA virus belonging to the Hepadnaviridae family of viruses. The course of the virus is determined primarily by the age at which the infection is acquired and the interaction between the virus and the body's immune system. Successful treatment is associated with a reduction in liver injury and fibrosis (scarring), a decreased likelihood of developing cirrhosis and its complications, including liver cancer, and a prolonged survival.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by people sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
Hepatitis A and B Vaccinations
Hepatitis A and hepatitis B are the two most commnon viruses that infect the liver. Hepatitis A and Hepatitis B can be prevented and treated with immunizations (vaccinations) such as Havrix, Vaqta, Twinrix, Comvax, Pediarix, and hepatitis b immune globulin (HBIG).
Hepatitis Vaccines for Hepatitis B and C
Hepatitis is a family of viruses that infect the liver. There are vaccines for hepatitis A and B infections, but not for hepatitis C.
Can Alcoholic Hepatitis Be Cured?
Liver damage from mild alcoholic hepatitis can usually be cured by complete abstinence from alcohol and lifestyle changes. Learn about symptoms, treatment, and survival rates.
Is Hepatitis A Contagious?
Hepatitis means inflammation of the liver. Hepatitis A is one type of hepatitis. Hepatitis is transmitted through person to person contact, contaminated ice, vegetables, fruits, and untreated water. Hepatitis A can be prevented by the hepatitis A vaccine. Symptoms of hepatitis A may include nausea and/or vomiting, fever, loss of appetite, abdominal pain, dark urine, clay-colored stools, jaundice (yellowish color to skin and/or eyes, or joint pain.
Can Alcoholic Hepatitis Be Reversed?
While mild alcoholic hepatitis may be reversed, once it reaches the stage of liver cirrhosis, it is irreversible. After diagnosis, abstaining from alcohol can improve your lifespan.
What Causes Hepatitis?
Hepatitis is inflammation of the liver. It can occur due to a variety of factors, but the most common cause is a virus infection. The types of hepatitis are hepatitis A, B, C, D, and E. Hepatitis can be acute (short-term) or chronic (long-term) and can have fatal complications. Early diagnosis, treatment and lifestyle modification can slow or inhibit the progression of the disease and reduce complications.
Hepatitis E Viral Infection
Hepatitis E (hep E) is a type of hepatitis viral infection that includes hepatitis A, B, C, D, F, which is caused by the hepatitis E virus. Usually, you get (transmitted) hepatitis E from eating or drinking dirty or contaminated water. Hepatitis E can be very serious, especially if a woman is pregnant. Up to ¼ of women who are pregnant with the hep E virus can die from the infection. The signs and symptoms of hepatitis E infection are nausea and vomiting, brown or dark urine, stool changes jaundice (yellow eyes and skin), pain in the right side of the abdomen, dark or brown urine, and light-colored stool. Some people with hep E don’t have any symptoms so they don’t know that they are contagious. It takes about 6 weeks to recover from hep E. A person who has any type of hepatitis, including hepatitis E, should not drink any alcohol. Hep E complications are rare, but when they do occur they include severe (“fulminant”) hepatitis, liver failure, and death. Currently, no specific drugs or treatments are available for hepatitis E. Moreover, the only hepatitis E vaccine currently is available in China. Avoid alcohol, keep hydrated, and getting rest are home remedies for hepatitis E. Talk to your doctor before taking any over-the-counter (medications), especially those containing acetaminophen (Tylenol and others). Usually, the prognosis and life expectancy for hepatitis E after recovery is good. Most people do not have long term liver problems from the infection.
What Is HCV Positive? Symptoms and Causes
HCV positive (reactive) is an interpretation of the results of the HCV antibody test that may mean the following.
Is HBV the Same as Hepatitis B?
Hepatitis B is caused by HBV, or the hepatitis B virus. Learn about transmission, diagnosis, phases of infection, and treatment options.
Treatment & Diagnosis
- Hepatitis C FAQs
- Hepatitis A FAQs
- Hepatitis C News Release
- Chronic Viral Hepatitis, Alcoholism, Cirrhosis Linked to Liver Cancer
- Hepatitis A at Jam Band Concerts Alert
- Hepatitis C: Nightmare in Vegas
- IBS, GERD, Hepatitis C: Doctors Dialogue
- How common is Hepatitis C?
- How is diagnosis of Hepatitis C made?
- Hepatitis C : Can it be sexually transmitted?
- Hepatitis C: What blood tests?
- Hepatitis C genotypes
- Hepatitis C Treatments
- Hepatitis C: Most effective treatment
- Hepatitis C: Reasons for treating
- Hepatitis C: Interferon/ribavarin side effects
- Hepatitis C: Good candidates for treatment
- Do you treat hepatitis C patients with normal liver tests?
- Hepatitis C: Not Good Candidates for Treatment?
- Hepatitis C: Diet and Vitamins
- Hepatitis C: Should patients receive immunizations
- Hepatitis C treatment relapse
- What to do for relapsers after hepatitis C treatment?
- Hepatitis C: What is unique about hepatitis C?
- Can You Be Allergic to Ceclor for Hepatitis B?
- Can You Treat Hepatitis B With Aids Drug Lamivudine?
- Does Hepatitis B Cause Liver Cancer?
- What Kind of Doctor Do I See for Hepatitis C?
- Can The Hepatitis C Virus Survive Outside the Body?
Medications & Supplements
- hepatitis A and hepatitis B (recombinant) vaccine (Twinrix)
- hepatitis B vaccine
- hepatitis A vaccine (Havrix, Vaqta)
- hepatitis b vaccine (Recombivax HB)
- Twinrix (hepatitis A/B vaccine)
- Side Effects of Havrix, Vaqta (Hepatitis A vaccine)
- Side Effects of Recombivax HB (hepatitis B vaccine)
- haemophilus b/hepatitis b vaccine - injection, Comvax
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.