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What is tenofovir used for: Tenofovir disoproxil fumarate/Tenofovir alafenamide: MedlinePlus Drug Information

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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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  • Why is this medication prescribed?
  • How should this medicine be used?
  • Other uses for this medicine
  • What special precautions should I follow?
  • What special dietary instructions should I follow?
  • What should I do if I forget a dose?
  • What side effects can this medication cause?
  • What should I know about storage and disposal of this medication?
  • In case of emergency/overdose
  • What other information should I know?
  • Brand names

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 Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking tenofovir. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop tenofovir. Tell your doctor right away if you develop symptoms of worsening liver problems.

Warnings:

If you have hepatitis B infection, your hepatitis symptoms may get worse or become very serious if you stop taking tenofovir. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop tenofovir. Tell your doctor right away if you develop symptoms of worsening liver problems.

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Uses

Tenofovir is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Tenofovir belongs to a class of drugs known as nucleotide reverse transcriptase inhibitors (NRTIs). Tenofovir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.Tenofovir is also used to treat a certain type of liver infection called chronic hepatitis B infection. It helps to decrease the amount of hepatitis B virus in your body by interfering with virus growth.

How to use tenofovir disoproxil fumarate oral

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

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

The dosage is based on your medical condition, kidney function, and response to treatment. For children, the dosage is also based on weight.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

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

Side Effects

Dizziness, diarrhea, headache, or trouble sleeping 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.

As your immune system gets stronger with HIV treatment, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

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).

Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones.

Tenofovir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

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.

Precautions

Before taking tenofovir, 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, liver problems (such as hepatitis C, cirrhosis), bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), disease of the pancreas (pancreatitis), alcohol use.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Also limit alcohol because it may increase your risk of liver problems and 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. If you have HIV infection, treatment can lower the risk of passing HIV infection to your baby, and tenofovir may be part of that treatment.

This medication passes into breast milk. Consult your doctor before breast-feeding. If you have HIV infection, do not breast-feed because breast milk can transmit HIV.

Interactions

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 include: 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.

Some other drugs to treat HIV infection (including atazanavir) may also interact with tenofovir. Tenofovir can decrease the effectiveness of atazanavir (by decreasing blood levels). If you are taking atazanavir with this product, you may need to also take another medication (ritonavir). Consult your doctor or pharmacist for more details. Your doctor will adjust your medications and monitor your treatment to reduce the risk of side effects.

Does tenofovir disoproxil fumarate oral interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/liver function, urine glucose/protein, viral load, T-cell counts, 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 near the time of the next 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.

Images

tenofovir disoproxil fumarate 300 mg tablet

Color: blueShape: almondImprint: 32

This medicine is a blue, almond, film-coated, tablet imprinted with “32”.

tenofovir disoproxil fumarate 300 mg tablet

Color: blueShape: ovalImprint: CL 77

This medicine is a blue, almond, film-coated, tablet imprinted with “32”.

tenofovir disoproxil fumarate 300 mg tablet

Color: whiteShape: almondImprint: H 123

This medicine is a blue, almond, film-coated, tablet imprinted with “32”.

tenofovir disoproxil fumarate 300 mg tablet

Color: light blueShape: oblongImprint: C533

This medicine is a blue, almond, film-coated, tablet imprinted with “32”.

tenofovir disoproxil fumarate 300 mg tablet

Color: whiteShape: ovalImprint: I 36

This medicine is a blue, almond, film-coated, tablet imprinted with “32”.

tenofovir disoproxil fumarate 300 mg tablet

Color: blueShape: ovalImprint: LA16

This medicine is a blue, almond, film-coated, tablet imprinted with “32”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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

  • 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.

HIV and hepatitis B. Role of tenofovir in the treatment of co-infection

HIV and hepatitis B. Role of tenofovir in the treatment of co-infection

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  • HIV and hepatitis B. The role of tenofovir in the treatment of co-infection

Viral hepatitis B (HBV) and HIV infection share a common mode of transmission, but HBV is about 100 times more contagious. In some countries, markers of current or past HBV infection are found in 2/3 of HIV-infected people. Among men who have sex with men (MSM), the frequency of HBV/HIV co-infection is higher than among injecting drug users (IDUs) and heterosexual people.

Impact of HIV infection on the progression of hepatitis B

According to WHO, HBV infection is more common in HIV-infected people and is accompanied by more severe liver damage. In patients with HBV/HIV co-infection, the activity of the inflammatory process in the liver is generally less pronounced, but higher replication of the hepatitis B virus leads to more severe liver fibrosis, an increased (4.2 times) risk of cirrhosis, and more rapid development of the terminal stage of the lesion. liver.

Also, patients with HBV/HIV co-infection, with severe immunodeficiency, have an increased risk of death from hepatitis and related diseases. It is important to remember that HIV infection is a risk factor for hepatitis B reactivation in patients with anti-HBsAg antibodies, especially those with severe immunodeficiency.

Effect of HBV on the progression of HIV infection

Most clinical studies that have examined the effect of HBV on the course of HIV infection and considered HBsAg as a marker of chronic hepatitis B have failed to establish any effect of HBV on the progression of HIV infection. But it is important to note that patients receiving ART have an increased risk of hepatotoxicity, as well as the risk of reactivation of the inflammatory process in the liver upon discontinuation of antiviral therapy for HBV and HIV infection.

HBV/HIV co-infection treatment

Among antiretroviral drugs for HIV, there are four nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs):

● tenofovir alafenamide (TAF),

● tenofovir disoproxil fumarate (TDF),

● emtricitabine,

● lamivudine.

These drugs also have antiviral activity against HBV. Although emtricitabine and lamivudine can be used interchangeably, they should not be used together in the same ART regimen.

According to the recommendations of the European AIDS Clinical Society (EACS European AIDS Clinical Society), in the treatment of persons with co-infection with HBV and HIV, it is recommended to use an antiretroviral regimen that includes drugs from the NRTI group, namely:

● tenofovir alafenamide (TAF) + emtricitabine,

● tenofovir disoproxil fumarate (TDF) + emtricitabine,

● tenofovir (TDF) + lamivudine.

Tenofovir (TDF) has proven itself quite well as a drug capable of suppressing both viruses together.

Although the use of tenofovir (TDF) is associated with an increased risk of nephrotoxicity, it can be given to patients with impaired renal function by adjusting the dose:

● with creatinine clearance ≥50 ml / min, the dose is 300 mg 1 time per day;

● with a creatinine clearance of 30-49 ml/min, the dose is 300 mg every 48 hours;

● with creatinine clearance ≥10-29 ml / min, the dose is 300 mg every 72-96 hours.

● with creatinine clearance <10 ml/min, the dose is 300 mg every 7 days unless there is no alternative;

● with hemodialysis – 300 mg every 7 days.

There are also less extensive data on the efficacy of HBV treatment with tenofovir alafenamide (TAF), which has been shown to be safer in terms of effects on kidney and skeletal function in individuals co-infected with HIV+ HBV.

Another clinical study in individuals with HBV monoinfection showed that switching from tenofovir (TDF) to tenofovir alafenamide (TAF) did not reduce the effectiveness of HBV treatment.

Both drugs have a high genetic barrier to the development of HBV drug resistance.

How long does HIV/HBV co-infection last?

Unfortunately, the optimal duration of HBV treatment has not yet been determined, so experts recommend lifelong therapy.

In case of forced replacement of ART (namely drugs from the NRTI group), anti-HBV therapy can be cautiously discontinued only after a confirmed cure for HBV.

In people living with HIV infection who have already developed cirrhosis, discontinuation of effective HBV treatment is not recommended in order to avoid liver decompensation.

Monitoring during HIV/HBV treatment

● During treatment, blood chemistry (most importantly ALT, AST) should be taken every 3 months during the first year of treatment and every 6 to 12 months thereafter.

● HBV DNA by PCR should be determined every 3–6 months during the first year of treatment and every 12 months thereafter.

● HBsAg should be checked every 12 months until this marker disappears.

Purpose of HIV/HBV treatment

The long-term goals of treating HBV/HIV co-infection are to reduce the progression of fibrosis, reduce the risk of opportunistic infections, reduce the risk of liver decompensation, prevent the development of hepatocellular carcinoma, and increase life expectancy and quality of life.

And remember that adherence to therapy is one of the most important points in treatment.

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  • SavchenkoMikhail Andreevich

    Infectionist,
    Hepatologist,
    Doctor of the first category,
    Candidate of Medical Sciences