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Tenofovir Disoproxil Fumarate: Brands, Price & Uses in Bangladesh
Tenofovir Disoproxil Fumarate is a nucleotide reverse transcriptase inhibitor (NtRTI) used in the following clinical settings: Established / FDA-approved uses Treatment of HIV-1 infection: Tenofovir…
About Tenofovir Disoproxil Fumarate
Indications of Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate is a nucleotide reverse transcriptase inhibitor (NtRTI) used in the following clinical settings:
Established / FDA-approved uses
- Treatment of HIV-1 infection: Tenofovir Disoproxil Fumarate is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 10 kg.
- HIV pre-exposure prophylaxis (PrEP): Tenofovir Disoproxil Fumarate, combined with emtricitabine in a fixed-dose combination product, is indicated to reduce the risk of sexually acquired HIV-1 infection in HIV-negative adults and adolescents (weighing at least 35 kg) at high risk. Tenofovir Disoproxil Fumarate is not approved and is not effective for PrEP when used alone, without its combination partner.
- Chronic hepatitis B virus (HBV) infection: Tenofovir Disoproxil Fumarate is indicated for treatment of chronic hepatitis B in adults and pediatric patients with evidence of active viral replication and evidence of liver disease.
Uses requiring combination therapy
For the HIV-1 treatment and HIV PrEP indications, Tenofovir Disoproxil Fumarate must always be given as part of a complete antiretroviral regimen together with other agents; it must never be used as HIV monotherapy, since this risks development of viral resistance.
Off-label use
Tenofovir Disoproxil Fumarate is used off-label in some prevention-of-mother-to-child-transmission (PMTCT) protocols for pregnant women living with HIV, under specialist guidance, and in some settings as part of post-exposure prophylaxis (PEP) regimens.
Dosage & Administration of Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate is administered orally, generally once daily, with or without food (though absorption is improved when taken with food, especially a high-fat meal). The dose depends on the indication, age, body weight, and renal function.
Adult dosing
| Indication | Usual adult dose |
|---|---|
| HIV-1 infection (in combination with other antiretrovirals) | 300 mg once daily |
| HIV pre-exposure prophylaxis (PrEP), combined with emtricitabine | 300 mg once daily |
| Chronic hepatitis B infection | 300 mg once daily |
Pediatric dosing
For HIV-1 treatment, Tenofovir Disoproxil Fumarate may be used in pediatric patients weighing at least 10 kg, with weight-band-based tablet or oral-powder dosing determined by a specialist. For chronic hepatitis B, use in pediatric patients is generally reserved for those aged 12 years and older weighing at least 35 kg, dosed at 300 mg once daily; safety and efficacy in younger children for the hepatitis B indication have not been fully established in all age groups. See Use in Special Populations and Pediatric Uses for further detail.
Renal impairment dose adjustment
| Creatinine clearance | Adjusted dosing interval |
|---|---|
| ≥50 mL/min | 300 mg every 24 hours (standard) |
| 30–49 mL/min | 300 mg every 48 hours |
| 10–29 mL/min | 300 mg approximately twice weekly (every 72–96 hours), under close medical supervision |
| <10 mL/min, not on dialysis | Not recommended; no dosing recommendation established |
| On hemodialysis | 300 mg every 7 days, administered after completion of a dialysis session |
Renal function should be assessed before starting Tenofovir Disoproxil Fumarate and monitored periodically during treatment; see Precautions and Warnings.
Missed dose
If a dose of Tenofovir Disoproxil Fumarate is missed, it should be taken as soon as remembered on the same day; if it is almost time for the next dose, the missed dose should be skipped rather than doubling up. Maintaining consistent, uninterrupted dosing is important for treatment effectiveness and to reduce the risk of viral resistance.
Side Effects of Tenofovir Disoproxil Fumarate
Common and clinically important side effects of Tenofovir Disoproxil Fumarate include:
- Renal effects: Renal impairment, including acute kidney injury, Fanconi syndrome (renal tubular dysfunction), and, rarely, acute tubular necrosis, have been reported with Tenofovir Disoproxil Fumarate. This is a notable and somewhat distinguishing safety concern requiring periodic monitoring of renal function (see Precautions and Warnings).
- Decreased bone mineral density: Long-term use of Tenofovir Disoproxil Fumarate has been associated with decreases in bone mineral density; monitoring may be considered in patients with a history of pathologic fracture or risk factors for osteoporosis.
- Gastrointestinal effects: Nausea, diarrhea, vomiting, and flatulence.
- Other common effects: Headache, dizziness, asthenia (weakness), and rash.
- Serious but rare effects: Lactic acidosis and severe hepatomegaly with steatosis, and immune reconstitution syndrome in HIV patients starting combination therapy (see Precautions and Warnings for details).
Patients should seek medical attention promptly for symptoms such as unusual muscle pain, difficulty breathing, marked fatigue, decreased urination, or swelling of the legs/ankles while taking Tenofovir Disoproxil Fumarate.
Contraindications of Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate is contraindicated in patients with known hypersensitivity to Tenofovir Disoproxil Fumarate, tenofovir, or any component of the formulation.
Frequently Asked Questions about Tenofovir Disoproxil Fumarate
What is Tenofovir Disoproxil Fumarate used for?
Tenofovir Disoproxil Fumarate is an antiretroviral medicine used, in combination with other antiretroviral agents, to treat HIV-1 infection; combined with emtricitabine, it is also used for HIV pre-exposure prophylaxis (PrEP) in high-risk, HIV-negative adults and adolescents; and it is used on its own to treat chronic hepatitis B virus infection in patients with active viral replication and liver disease.
Is it safe to suddenly stop taking Tenofovir Disoproxil Fumarate?
No. Patients being treated for hepatitis B with Tenofovir Disoproxil Fumarate must not stop the medicine without medical supervision, because severe acute flares of hepatitis B, which can be serious or life-threatening, have been reported after stopping Tenofovir Disoproxil Fumarate. Anyone who needs to stop Tenofovir Disoproxil Fumarate for any reason should be closely monitored by their physician, with follow-up blood tests, for several months afterward.
What are the most important side effects of Tenofovir Disoproxil Fumarate to watch for?
The most notable side effects of Tenofovir Disoproxil Fumarate involve the kidneys, including reduced kidney function and a condition called Fanconi syndrome, so kidney function is usually checked before starting and periodically during treatment. Long-term use has also been linked to decreased bone mineral density. Rarely, Tenofovir Disoproxil Fumarate and similar medicines have caused a serious condition called lactic acidosis with liver enlargement; patients should seek urgent medical care for symptoms such as unusual muscle pain, difficulty breathing, or marked tiredness.
Can Tenofovir Disoproxil Fumarate be taken during pregnancy or while breastfeeding?
Tenofovir Disoproxil Fumarate is one of the more well-studied antiretrovirals in pregnancy and is commonly used in programs to prevent mother-to-child transmission of HIV, but it should still be used in pregnancy only if a physician determines the benefits outweigh the potential risks, and only under medical supervision. Tenofovir passes into breast milk in small amounts, so whether to breastfeed while taking Tenofovir Disoproxil Fumarate should also be decided together with a physician, based on individual circumstances.
How should Tenofovir Disoproxil Fumarate be taken, and what if I miss a dose?
Tenofovir Disoproxil Fumarate is usually taken as one tablet by mouth, once daily, with or without food (though food, especially a high-fat meal, improves absorption). If a dose is missed, take it as soon as remembered the same day; if it is almost time for the next dose, skip the missed dose rather than doubling up. Tenofovir Disoproxil Fumarate should be taken consistently, at the same time each day, exactly as prescribed.
Does Tenofovir Disoproxil Fumarate interact with other medicines?
Yes. Tenofovir Disoproxil Fumarate should generally not be combined with didanosine, as it raises didanosine levels and toxicity risk. It should also be used cautiously with other medicines that can affect the kidneys, such as certain painkillers (NSAIDs) and some antibiotics, since Tenofovir Disoproxil Fumarate itself can affect kidney function. Certain HIV medicines, such as atazanavir and lopinavir/ritonavir, can raise tenofovir levels and require closer monitoring. Always tell your physician about all medicines and supplements you are taking before starting Tenofovir Disoproxil Fumarate.
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.