Tenofovir disoproxil fumarate/Tenofovir alafenamide: MedlinePlus Drug Information

pronounced as (ten of’ oh vir dye” soe prox’ il fue’ ma rate)

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If you have hepatitis B virus infection (HBV; an ongoing liver infection) and you take tenofovir, your condition may suddenly worsen when you stop taking this medication. Be careful not to miss doses or run out of tenofovir. Tell your doctor if you have or have ever had liver disease other than hepatitis B or cirrhosis (scarring of the liver). If you experience any of the following symptoms after you stop taking tenofovir, call your doctor immediately: extreme tiredness, weakness, nausea, vomiting, loss of appetite, yellowing of the skin or eyes, dark-colored urine, light-colored bowel movements, and muscle or joint pain. If you are taking tenofovir to treat human immunodeficiency virus (HIV) infection, tell your doctor if you have or have ever had HBV. Your doctor may test you to see if you have HBV before you begin your treatment with tenofovir. Your doctor will examine you and order lab tests regularly for several months after you stop taking this medication to see if your HBV has worsened. Tell your doctor if you experience any new or unusual symptoms after you stop taking tenofovir.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body’s response to tenofovir.

Talk to your doctor about the risks of taking tenofovir.

Tenofovir disoproxil fumarate (DF) (Viread) is used along with other medications to treat HIV infection in adults and children 2 years of age and older weighing 22 pounds (10 kilograms) or more. Tenofovir DF is also used to treat chronic (long term) HBV in adults and children 2 years of age and older weighing 22 pounds (10 kilograms) or more. Tenofovir alafenamide (AF) (Vemlidy) is used to treat chronic (long term) HBV in adults and children 12 years of age and older who have stable liver disease. Tenofovir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV and HBV in the blood. Although tenofovir will not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people. Tenofovir will not cure hepatitis B and may not prevent complications of chronic hepatitis B such as cirrhosis of the liver or liver cancer. Tenofovir may not prevent the spread of hepatitis B to other people.

Tenofovir DF comes as a tablet and as an oral powder to take by mouth. The tablet is usually taken with or without food once daily. The powder is usually taken with food once daily. Tenofovir AF comes as a tablet to take by mouth. It is usually taken with food once daily. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Tenofovir DF oral powder must be added to 2 to 4 ounces of soft food such as applesauce, baby food, or yogurt. Stir the mixture with a spoon until well mixed. Consume the mixture right away to avoid a bitter taste. Do not mix tenofovir DF oral powder with liquid.

Continue to take tenofovir even if you feel well. Do not stop taking tenofovir without talking to your doctor. If you stop taking tenofovir even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tenofovir,

• tell your doctor and pharmacist if you are allergic to tenofovir DF, tenofovir AF, any other medications, or any of the ingredients in tenofovir DF tablets or oral powder or tenofovir AF tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures, or liver or kidney disease.
• tell your doctor if you have or ever had HIV. If you have HIV that is not being treated with medications and you take tenofovir, your HIV infection may become more difficult to treat. Your doctor may test you for HIV before you begin your treatment.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tenofovir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking tenofovir.
• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms during your treatment with tenofovir, be sure to tell your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tenofovir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• depression
• rash
• itching
• fever
• difficulty falling asleep or staying asleep
• gas, heartburn, or indigestion
• weight loss

Some side effects can be serious. If you experience any of those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately.

• decreased urination
• swelling of feet and ankles
• ongoing or worsening bone pain
• pain in the arms, hands, feet, or legs
• pain in upper right part of your stomach,
• dizziness or lightheadedness
• fast or irregular heartbeat
• shortness of breath or fast breathing
• cold or blue-colored hands and feet

Tenofovir DF and tenofovir AF may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

• Viread^®
• Vemlidy^®

Last Revised – 01/15/2023

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Tenofovir Disoproxil Fumarate – Patient

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Pronounce:

Tenofovir Disoproxil Fumarate

Brand Name

Viread

Other Names

TDF, tenofovir DF

Drug Class

Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

Drug Image(s): (Click to enlarge)

What are the most important things to know about tenofovir disoproxil fumarate? What are the most important things to know about tenofovir disoproxil fumarate?

What are the most important things to know about tenofovir disoproxil fumarate?

Tenofovir disoproxil fumarate (tenofovir DF) can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, and new or worsening kidney problems, including kidney failure.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

• Weakness or tiredness
• Unusual muscle pain
• Shortness of breath or fast breathing
• Stomach pain with nausea or vomiting
• Cold or blue hands or feet
• Dizziness or lightheadedness
• Fast or abnormal heartbeat

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

• Yellowing of your skin or the whites of your eyes (jaundice)
• Dark-colored urine
• Light-colored bowel movements
• Loss of appetite for several days or longer
• Nausea or vomiting
• Pain, aching, or tenderness on the right side of your stomach/abdominal area
• Itching

If you have hepatitis B virus infection (HBV) and take tenofovir DF, your HBV infection may get much worse (flare up) if you stop taking tenofovir DF. Do not stop taking tenofovir DF without first talking to your health care provider.

Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called Fanconi Syndrome), which may be related to tenofovir-containing drugs:

• Bone pain that does not go away or gets worse
• Pain in your arms, hands, legs, or feet
• Broken bones
• Muscle pain or weakness

While taking tenofovir DF, it is important to keep all of your appointments with your health care provider.

What is tenofovir disoproxil fumarate?What is tenofovir disoproxil fumarate?

What is tenofovir disoproxil fumarate?

Tenofovir DF (brand name: Viread) is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age and older who weigh at least 22 lb (10 kg). Tenofovir DF is always used in combination with other HIV medicines.

For more information on the use of tenofovir DF in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.

HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.

Tenofovir DF is also approved by FDA for the treatment of chronic hepatitis B virus infection (HBV) in adults and children 2 years of age and older who weigh at least 22 lb (10 kg). Tenofovir DF may be included as part of an antiretroviral therapy (ART) regimen to treat both HIV and HBV infection in people with HIV/HBV coinfection. In addition to tenofovir DF, the ART regimen should include another drug that is active against both HIV and HBV. For more information on the HBV-related use of tenofovir DF, please refer to the HBV section of the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV.

What should I tell my health care provider before taking tenofovir disoproxil fumarate?What should I tell my health care provider before taking tenofovir disoproxil fumarate?

What should I tell my health care provider before taking tenofovir disoproxil fumarate?

Before taking tenofovir DF, tell your health care provider:

• If you are allergic to tenofovir DF or any other medicines.
• If you have liver problems, including hepatitis B virus infection (HBV).
• If you have kidney problems or receive kidney dialysis treatment.
• If you have bone problems.
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking tenofovir DF during pregnancy. For more information on the use of tenofovir DF during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
• If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
• If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tenofovir DF may affect the way other medicines or products work, and other medicines or products may affect how tenofovir DF works. Taking tenofovir DF together with certain medicines or products may cause serious side effects.

How should I take tenofovir disoproxil fumarate?How should I take tenofovir disoproxil fumarate?

How should I take tenofovir disoproxil fumarate?

Tenofovir DF comes in the following forms and strengths:

• 150-mg, 200-mg, 250-mg, and 300-mg tablets
• Oral powder (40 mg of tenofovir DF per 1 g of powder)

Take tenofovir DF according to your health care provider’s instructions. Do not miss a dose of tenofovir DF, and do not change your dose or stop taking tenofovir DF without first talking with your health care provider.

Tenofovir DF tablets should be swallowed whole and can be taken with or without food.

People who are unable to swallow the tablets whole may take the oral powder. Use the provided dosing scoop to measure the oral powder. Mix the oral powder with soft foods that can be swallowed without chewing, such as applesauce, baby food, or yogurt. Do not mix the oral powder with liquid, as the powder may float to the top even after stirring. Take the dose of oral powder right after mixing it. Read the “Instructions for Use” that comes with tenofovir DF oral powder for information about the right way to prepare and take a dose.

Always take tenofovir DF in combination with other HIV medicines.

If you have taken too much tenofovir DF, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take tenofovir DF, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of tenofovir DF, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can tenofovir disoproxil fumarate cause?What side effects can tenofovir disoproxil fumarate cause?

What side effects can tenofovir disoproxil fumarate cause?

Tenofovir DF may cause side effects. Some side effects of tenofovir DF can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of tenofovir DF include:

• Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
• Bone problems, including bone pain, or softening or thinning of the bones (osteopenia), which may lead to fractures.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of tenofovir DF. To learn more about possible side effects of tenofovir DF, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should tenofovir disoproxil fumarate be stored?How should tenofovir disoproxil fumarate be stored?

How should tenofovir disoproxil fumarate be stored?

• Store tenofovir DF tablets and oral powder at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep tenofovir DF in the container that it came in and keep the container tightly closed.
• Do not use tenofovir DF if the original seal over the container opening is broken or missing.
• Throw away tenofovir DF that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
• Keep tenofovir DF and all medicines out of reach of children.

Where can I find more information about tenofovir disoproxil fumarate?Where can I find more information about tenofovir disoproxil fumarate?

Where can I find more information about tenofovir disoproxil fumarate?

• For more information on the use of tenofovir DF in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
• Recommendations on the use of tenofovir DF in people with HIV and HBV, from the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV and the Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV.
• This Patient Version drug summary is based on the following FDA label(s): Powder, tablet (coated). The Patient Package Insert and Instructions For Use include information for people taking tenofovir DF.
• The American Hospital Formulary Service (AHFS) Patient Medication Information for tenofovir disoproxil fumarate available from MedlinePlus.
• Tenofovir DF-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
• A list of FDA-approved HIV medicines, from HIVinfo.

Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

Last Reviewed: April 12, 2023

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Active substance TENOFOVIR (TENOFOVIRUM) | Compendium – drug reference book

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• Pharmacological properties
• Indications TENOFOVIR
• Application of TENOFOVIR
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

Medicinal products containing the active substance TENOPHOVIR

Viread

film-coated tablets 300 mg bottle, No. 30

Gilead Sciences

Prices in pharmacies

Tenochop

film-coated tablets 300 mg bottle, No. 30

Macleods Pharmaceuticals Ltd

Pharmacy prices

tenofovir disoproxil fumarate is a salt of fumaric acid and a bis-isopropoxycarbonyloxymethyl ester, a derivative of tenofovir. In vivo tenofovir disoproxil fumarate is converted to tenofovir, a non-cyclic phosphonate nucleoside (nucleotide) analogue of 5΄-AMP. Tenofovir has an inhibitory effect on HIV-1 reverse transcriptase.

Tenofovir disoproxil fumarate needs prior diester hydrolysis and further phosphorylation by cellular enzymes to form tenofovir diphosphate to be converted to tenofovir. Tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase, competing with the natural substrate deoxyadenosine-5΄-triphosphate, and after fusion with DNA breaks its chain. Tenofovir diphosphate is a weak inhibitor of mammalian α-, β-DNA polymerase and mitochondrial γ-DNA polymerase.

The antiviral activity of tenofovir against laboratory and donor strains of HIV-1 was evaluated on colonies of lymphoblastoid cells, monocyte/macrophage precursor cells and peripheral blood lymphocytes. 50% effective concentration (EC ₅₀ ) of tenofovir is in the range of 0.04–8.5 µmol. In combined studies of Tenofovir preparations with nucleoside inhibitors of reverse transcriptase (Abakavir, Didanosine, Lamivudin, Stavudin, Zalcitabin, Zidovudin), non -coaloside inhibitors of reverse transcription (Delavirdin, Efavirenz, Nevvirapin) and AMPR inhibitors (AMPR Enavir, Indinavir, Nelfinavir, Ritonavir, Sakvinaavir) was observed additional synergistic effect. Tenofovir showed antiviral activity against cell culture against HIV-1 subtypes A, B, C, D, E, F, G, O (EC ₅ 0 within 0.5–2.2 µmol) and had selective activity on HIV-2 strains (EC ₅ 0 within 1.6–4.9 µmol). Resistance: HIV-1 strains with reduced sensitivity to tenofovir have been isolated from cell culture. These viruses showed a K65R mutation to reverse transcriptase and a 4-fold decrease in sensitivity to tenofovir.

Some nucleoside reverse transcriptase inhibitors have shown cross-resistance. The K65R mutation has been selected for tenofovir and has also been selected in some HIV-infected patients treated with abacavir, didanosine, or zalcitabine. HIV strains with this mutation also showed reduced sensitivity to emtricitabine and lamivudine. So, cross-resistance among these drugs is possible in patients infected with viruses with the K65R mutation. Isolated from patients (n=20) infected with HIV-1, which revealed on average three zidovudine-associated reverse transcriptase amino acid mutations (M41L, D67N, K70R, L210W, T215Y/F or K219Q/E/N), HIV-1 strains showed a 3. 1-fold decrease in susceptibility to tenofovir. Multinucleoside resistance of HIV-1 with a double insertion of T69S in reverse transcriptase showed reduced sensitivity to tenofovir.

Clinical studies conducted in previously treated patients evaluated the antiviral activity of tenofovir against strains of HIV-1 resistant to nucleoside inhibitors. The virological response to tenofovir was not reduced in HIV-1 patients who developed resistance to abacavir/emtricitabine/lamivudine associated with the M184V mutation. Patients using tenofovir who had ≥3 zidovudine resistance-associated mutations in HIV-1, which included M41L or L210W reverse transcriptase mutations, showed a reduced response to tenofovir therapy.

Pharmacokinetics. The pharmacokinetic properties of tenofovir were evaluated in healthy volunteers and HIV-infected patients. The pharmacokinetics of tenofovir were similar in these groups.

Absorption. When administered orally on an empty stomach, the bioavailability of tenofovir is approximately 25%. After oral administration on an empty stomach of a single dose of 300 mg in HIV-1 infected patients, C _{max in the blood was reached after 1.0 ± 0.4 hours. The value of C max and AUC were 296±90 ng/ml and 2287±685 ng/h/ml, respectively.}

The pharmacokinetics of tenofovir is dose-dependent within doses of 75–600 mg, and multiple doses do not affect the pharmacokinetics.

Effect of food on oral absorption. The use of tenofovir after a high fat meal (≈700 to 1000 kcal, contains 40-50% fat) increases oral bioavailability with a concomitant increase in tenofovir AUC _0-∞ by ≈40% and C _{max – by ≈14%. However, administration with a low-calorie meal does not significantly affect the pharmacokinetics of tenofovir compared with fasting. Food delays reaching C max tenofovir by approximately 1 hour. C max and AUC of tenofovir is 326 ± 119 ng / ml and 3324 ± 370 ng / h / ml after multiple doses of tenofovir 300 mg 1 time per day after food when food content was not controlled.}

Distribution. In vitro binding of tenofovir to plasma or plasma proteins was <0.7% and 7.2%, respectively, within tenofovir concentrations of 0.01–25 mg/mL. The volume of distribution at steady state is 1.3 (0.6 L/kg body weight) and 1.2 (0.4 L/kg) after intravenous administration of tenofovir 1.0 mg/kg and 3.0 mg/kg.

Metabolism and excretion. After intravenous administration of tenofovir, about 70-80% of its dose is determined in the urine unchanged within 72 hours after application. After a single oral dose of the drug T _½ tenofovir is approximately 17 hours. After multiple doses of 300 mg 1 time per day (after meals), 10% of the dose taken is determined in the urine for 24 hours.

Tenofovir is eliminated by glomerular filtration and active tubular secretion. There may be competition for excretion with other substances that are also excreted by the kidneys.

Special groups. Insufficient data to adequately assess potential pharmacokinetic differences between races.

Tenofovir pharmacokinetics are similar for women and men.

Pharmacokinetic studies have not been conducted in children (<18 years) and the elderly (>65 years).

The pharmacokinetics of tenofovir following a single 300 mg dose has been studied in non-HIV-infected patients with moderate to severe hepatic impairment. There are no significant changes in the pharmacokinetics of tenofovir in patients with hepatic impairment compared to those without such impairment. Patients with impaired liver function do not need dose adjustment.

Tenofovir pharmacokinetics are altered in individuals with impaired renal function. In patients with creatinine clearance <50 ml / min or with end-stage renal disease (ESRD) requiring dialysis, tenofovir C _{max and AUC 0-∞ increase. It is recommended to adjust the dosing interval for patients with creatinine clearance <50 ml / min or with end-stage renal disease who require dialysis.}

treatment of HIV-1 infection in combination with other antiretroviral drugs.

adults : The recommended dose is 300 mg orally once daily, with or without food.

Elderly Patients: should be carefully dosed in elderly patients, given the higher incidence of hepatic, renal, or cardiac dysfunction, comorbidities, or other drug use.

Renal failure . When using tenofovir in patients with moderate or severe renal insufficiency, the effect of the drug increased. Therefore, the interval between doses of tenofovir should be adjusted for patients with creatinine clearance <50 ml/min.

There is no need for dose adjustment for patients with mild renal insufficiency (creatinine clearance – 50-80 ml / min.). For these patients, constant monitoring of the level of creatinine clearance and the level of phosphate in the blood plasma is necessary.

The pharmacokinetics of tenofovir have not been evaluated in patients who are not on hemodialysis with creatinine clearance <10 ml/min, so there are no dosing recommendations for such patients.

hypersensitivity to any of the components of the drug. Tenofovir should not be taken in combination with products containing tenofovir disoproxil fumarate. Patients aged <18 years.

CNS disorders: dizziness.

From the immune system: allergic reactions.

Metabolism and digestive disorders: hypophosphatemia, lactic acidosis.

On the part of the respiratory system: shortness of breath.

From the digestive system: diarrhea, nausea, vomiting, flatulence, pain in the lower abdomen, increased amylase levels, pancreatitis.

From the side of the hepatobiliary system: increased levels of liver enzymes, hepatitis.

Skin side: rash.

From the musculoskeletal system: myopathy and osteomalacia (associated with pathology of the proximal tubules).

From the side of the kidneys and urinary system: renal disorders, renal failure, acute renal failure, Fanconi syndrome, proximal tubular pathology, proteinuria, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, polyuria, interstitial nephritis (including acute cases).

General disorders: asthenia.

tenofovir should not be used in combination with preparations containing tenofovir disoproxil fumarate, as it is a component of these preparations.

Lactic acidosis/severe liver enlargement with steatosis. When using nucleoside analogs alone or in combination with other antiretroviral drugs, there have been reports of lactic acidosis, severe liver enlargement with steatosis, including death. Most of these cases were observed in women. Obesity and the use of long-acting nucleosides may be risk factors. Particular caution should be exercised when using nucleoside analogues in patients with known risk factors for liver disease, but such cases have been reported in patients without known risk factors. Treatment with tenofovir in a person who develops clinical or laboratory evidence of lactic acidosis or overt hepatotoxicity (which may include liver enlargement and steatosis even in the absence of a marked increase in transaminase levels) should be discontinued.

Patients co-infected with HIV and hepatitis B virus. It is recommended that all HIV-infected patients be tested for chronic hepatitis B before starting antiretroviral therapy. Tenofovir is not approved for the treatment of chronic hepatitis B virus infections. The safety and efficacy of tenofovir have not been established in patients co-infected with hepatitis B and HIV. There have been reports of severe acute exacerbation of hepatitis B in patients co-infected with HIV and hepatitis B who stopped taking tenofovir. In patients co-infected with HIV and hepatitis B who have stopped taking tenofovir, clinical and laboratory monitoring of liver function is required for at least several months.

Renal disorders. Tenofovir is primarily excreted by the kidneys. With the use of tenofovir, renal disorders have been identified, including acute renal failure and Fanconi syndrome (renal tubular damage with severe hypophosphatemia).

It is recommended that all patients have their creatinine clearance determined before starting treatment and during therapy. In patients with the threat of renal failure, constant monitoring of the level of clearance of creatinine and phosphorus in the blood plasma is necessary.

Tenofovir dose interval adjustment and close monitoring of renal function are recommended for all patients with creatinine clearance <50 ml/min.

No information is available regarding the safety and efficacy of tenofovir in patients with renal insufficiency who followed dosing recommendations. Therefore, the potential benefit of tenofovir must be weighed against the potential risk of renal toxicity.

Tenofovir should be avoided concomitantly or after recent use of nephrotoxic active ingredients.

Effects on bone tissue during treatment with tenofovir. In a clinical study, a decrease in baseline bone mineral density in the bones of the lumbar and femur was observed during treatment with tenofovir or in the active control group. Most cases of bone mineral density decrease were observed during the first 24–48 weeks and persisted during the 144 weeks of the study.

In HIV-infected patients with a history of pathological bone fractures and the risk of developing osteopenia, the condition of the bones should be monitored. If a bone abnormality is suspected, appropriate consultation should be undertaken.

Cases of osteomalacia (associated with pathology of the proximal renal tubules) have been reported and have been associated with the use of tenofovir.

Distribution in adipose tissue. Redistribution/accumulation of body fat was observed in patients treated with antiretroviral therapy, including abdominal obesity, dorsocervical fat deposition (buffalo hump), limb fat loss, facial fat loss, breast enlargement, and a Cushing-like appearance. The mechanism and duration of the effects of these cases are unknown. A causal relationship has not been established.

Immune recovery syndrome. Immune recovery syndrome has been reported in patients receiving combination antiretroviral therapy, including tenofovir. During the initial phase of combination antiretroviral treatment, patients whose immune system responds to treatment may develop an inflammatory response to delayed or residual opportunistic infections ( Mycobacterium avium infections, cytomegalovirus infection, pneumonia caused by Pneumocystis jirovecii , or tuberculosis), which may require further evaluation and treatment.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Studies on the effect of the drug on the ability to drive vehicles or operate other mechanisms have not been conducted. Patients should be informed of the possibility of dizziness during treatment with tenofovir.

Use during pregnancy or lactation. No controlled studies have been conducted in pregnant women. Because animal reproductive studies do not always predict a human response, tenofovir may be used during pregnancy for health reasons when the benefit outweighs the potential risk to the fetus.

Women who are breastfeeding: HIV-infected mothers are advised not to breastfeed their infants to prevent the risk of postnatal transmission of HIV. The penetration of tenofovir into human breast milk is unknown. Due to the risk of HIV transmission and the potential for severe adverse reactions in an infant, a woman should not breastfeed during tenofovir therapy.

Children. Safety and efficacy in patients <18 years of age have not been established and therefore should not be used in pediatric practice.

The combined use of tenofovir and didanosine at a dose of 400 mg / day leads to an increase in the systemic effect of didanosine. Strict monitoring of the health status of patients who simultaneously use tenofovir and didanosine is necessary due to the manifestation of side effects associated with didanosine (pancreatitis, lactic acidosis). Suppression of the number of CD4 lymphocytes was observed in patients who received tenofovir with didanosine at a dose of 400 mg / day.

In adults weighing >60 kg, the dose of didanosine should be reduced to 250 mg if given concomitantly with tenofovir. No information is available regarding recommendations for dose adjustment of didanosine in patients weighing <60 kg.

Atazanavir and lopinavir/ritonavir have been shown to increase tenofovir concentrations. The mechanism of this interaction is unknown. Patients receiving atazanavir and lopinavir/ritonavir and tenofovir should be closely monitored due to the potential for tenofovir-associated adverse events. Individuals who experience side effects from taking tenofovir should discontinue its use.

Tenofovir reduces C _max of atazanavir. When co-administered with tenofovir, it is recommended to take atazanavir 300 mg in combination with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with tenofovir.

Tenofovir is primarily excreted by the kidneys by glomerular filtration and active tubular secretion. Co-administration of tenofovir with drugs that impair renal function or compete for active tubular secretion may increase plasma concentrations of tenofovir and other drugs that are excreted by the kidneys due to competition for this route of excretion. Examples are acyclovir, valaciclovir, ganciclovir.

Increasing the concentration of tenofovir contributes to the occurrence of adverse events associated with tenofovir, including renal disorders.

in case of overdose, symptomatic therapy.

Tenofovir is effectively eliminated by hemodialysis, with an extraction ratio of about 54%.

at a temperature not exceeding 25 °C.

Tenofovir alafenamide and integrase inhibitors promote weight gain

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Tenofovir alafenamide and integrase inhibitors promote weight gain