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Tenofovir Alafenamide: Brands, Price & Uses in Bangladesh
Tenofovir Alafenamide is a nucleotide analog reverse transcriptase inhibitor (NtRTI) prodrug of tenofovir and more.
About Tenofovir Alafenamide
Indications of Tenofovir Alafenamide
Tenofovir Alafenamide is a nucleotide analog reverse transcriptase inhibitor (NtRTI) prodrug of tenofovir, approved for the following uses:
Established / FDA-approved uses
- Chronic Hepatitis B Virus (HBV) infection - as a standalone 25 mg once-daily tablet, in adults and pediatric patients aged 6 years and older weighing at least 25 kg, with compensated liver disease.
- HIV-1 infection - Tenofovir Alafenamide is not used alone for HIV-1; it is a component of fixed-dose combination antiretroviral regimens (with other agents such as emtricitabine plus an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor) for treatment of HIV-1 infection in adults and pediatric patients, and for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents as part of an approved combination product.
Important notes on evidence and combination requirement
- Tenofovir Alafenamide must always be used in combination with other antiretroviral agents for HIV-1 treatment or prevention; it is never given as HIV-1 monotherapy because of the risk of resistance development.
- Before starting Tenofovir Alafenamide for the hepatitis B indication, patients should be tested for HIV-1 infection; if HIV-1 is undiagnosed and untreated, Tenofovir Alafenamide alone may allow HIV-1 resistance to develop.
Dosage & Administration of Tenofovir Alafenamide
Chronic Hepatitis B Virus infection
| Population | Dose |
|---|---|
| Adults | One 25 mg tablet of Tenofovir Alafenamide orally, once daily, with food |
| Pediatrics (6 to less than 18 years, weight at least 25 kg) | One 25 mg tablet of Tenofovir Alafenamide orally, once daily, with food |
| Pediatrics under 6 years or weighing less than 25 kg | Safety and efficacy not established; not recommended |
HIV-1 infection (combination therapy) / pre-exposure prophylaxis
Tenofovir Alafenamide is only available and administered as part of a fixed-dose combination tablet with other antiretroviral agents. The dose of Tenofovir Alafenamide in these products (commonly 10 mg or 25 mg) and the dosing schedule follow the specific combination product's approved labeling; Tenofovir Alafenamide is never prescribed alone for this indication.
Renal impairment
- Estimated creatinine clearance (CrCl) ≥15 mL/min: no dose adjustment required.
- CrCl less than 15 mL/min and not on chronic hemodialysis: use of Tenofovir Alafenamide-containing products is not recommended.
- Patients on chronic hemodialysis: Tenofovir Alafenamide may be used, administered after completion of dialysis on dialysis days.
Hepatic impairment
- Mild impairment (Child-Pugh A): no dose adjustment required.
- Moderate to severe (decompensated) hepatic impairment (Child-Pugh B or C): not recommended; safety and efficacy have not been established.
See Precautions and Warnings for the boxed warning regarding hepatitis B exacerbation after discontinuation.
Side Effects of Tenofovir Alafenamide
Most patients tolerate Tenofovir Alafenamide well. Reported adverse effects include:
Common
- Headache
- Nausea and abdominal pain
- Fatigue
- Cough
- Back pain
- Diarrhea
Less common but serious
- Severe acute exacerbation of hepatitis B after stopping treatment (see boxed warning under Precautions and Warnings)
- Lactic acidosis and severe hepatomegaly with steatosis (class effect of nucleoside/nucleotide analogs)
- New-onset or worsening renal impairment
- Decreases in bone mineral density
- Immune reconstitution syndrome (when used as part of HIV-1 combination therapy)
Contraindications of Tenofovir Alafenamide
Tenofovir Alafenamide is contraindicated in patients with known hypersensitivity to tenofovir alafenamide or to any component of the formulation.
No other absolute contraindications are established. Situations such as severe renal impairment not on hemodialysis or decompensated liver disease are labeled as "not recommended" rather than absolute contraindications; see Precautions and Warnings and Use in Special Populations.
Frequently Asked Questions about Tenofovir Alafenamide
What is Tenofovir Alafenamide used for?
Tenofovir Alafenamide is an antiviral medicine used to treat chronic hepatitis B virus infection, taken as a single 25 mg tablet once daily. It is also used, as part of combination antiretroviral regimens with other drugs, for treatment or prevention of HIV-1 infection; it is never used alone for HIV-1.
Can I stop taking Tenofovir Alafenamide on my own if I feel better?
No. Do not stop Tenofovir Alafenamide without consulting your physician. Stopping anti-hepatitis B treatment, including Tenofovir Alafenamide, has been associated with severe, sometimes life-threatening flare-ups of hepatitis B. Your doctor will monitor your liver function closely for several months if treatment is ever discontinued.
Is Tenofovir Alafenamide safe during pregnancy?
Tenofovir Alafenamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under a physician's supervision. Pregnancy registry data so far have not shown an increased rate of birth defects, but this is not enough to call Tenofovir Alafenamide definitively safe in pregnancy, so always consult your physician.
What are the most common side effects of Tenofovir Alafenamide?
The most commonly reported side effects of Tenofovir Alafenamide include headache, nausea, abdominal pain, fatigue, cough, back pain, and diarrhea. Most are mild. Serious but less common effects include kidney problems, decreases in bone density, and lactic acidosis; report any unusual symptoms to your doctor promptly.
Do I need any tests before starting Tenofovir Alafenamide?
Yes. Before starting Tenofovir Alafenamide, your doctor will typically test kidney function, liver function, and screen for HIV-1 infection (if Tenofovir Alafenamide is being started for hepatitis B), because using Tenofovir Alafenamide alone in someone with unrecognized HIV-1 infection can lead to HIV-1 drug resistance.
Can Tenofovir Alafenamide be taken with other medicines?
Tenofovir Alafenamide can interact with certain medicines, especially strong inducers of P-glycoprotein such as rifampin, rifabutin, carbamazepine, phenytoin, and St. John's wort, which can reduce the effectiveness of Tenofovir Alafenamide. Always tell your doctor and pharmacist about all medicines, herbal products, and supplements you are taking before starting Tenofovir Alafenamide.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.