Emfovir Tablet (Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg))
Prescription RequiredManufactured By
Arechar Healthcare
Pack Of
30
Salt Composition
Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg)
Storage
Cool, dry place / below 30°C
Overview
Emfovir Tablet combines tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine (FTC) 200 mg, two nucleotide/nucleoside reverse-transcriptase inhibitors (NRTIs). Together they form a two-drug antiretroviral backbone. For HIV-1 treatment, TDF/FTC must be used with another fully active antiretroviral agent or as part of a complete regimen. The same fixed-dose combination is also widely used for HIV pre-exposure prophylaxis (PrEP) in appropriately tested HIV-negative people, subject to the approved label and renal/bone assessment. Because both agents are active against hepatitis B virus, stopping them in a person with HBV can trigger severe hepatitis flares.Brand
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Emfovir |
| Molecule / Combination | Tenofovir disoproxil fumarate 300 mg + Emtricitabine 200 mg |
| Strength / Composition | 300mg/200mg |
| Dosage form | Tablet |
| Manufacturer / Marketer | Arechar Healthcare |
| Pack / Presentation | 30 tablets |
| Storage | Cool, dry place / below 30°C |
| Prescription | Required |
Uses and Indications
Emfovir Tablet is prescribed for:
- HIV-1 infection—In combination with antiretroviral drugs to control the viral infection.
- HIV prevention (PrEP)—In patients at high risk of contracting HIV infection who are HIV negative.
- Hepatitis B virus (HBV)—The combination of tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg has shown efficacy against HBV infection, but the treatment protocol will depend upon the individual patient's condition.
For treating HIV infection, Emfovir Tablet is not taken as monotherapy but in combination with other HIV medications. For HIV prophylaxis, an HIV test needs to be performed before beginning the treatment to ensure that there is no pre-existing infection, and further HIV tests need to be performed during the treatment course. As the medication acts against both HIV and hepatitis B, stopping its use in individuals having an HBV infection can lead to severe consequences.
How Emfovir Tablet Works
Both tenofovir and emtricitabine have to undergo metabolism before becoming biologically active. The resultant compounds block the reverse transcriptase of HIV, an essential enzyme that HIV uses in order to produce viral DNA. In doing so, they prevent the virus from replicating. They are also capable of inhibiting one of the enzymes needed for HBV replication.
Clinical Evidence for Emfovir Tablet
iPrEx: Daily oral tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg reduced HIV acquisition among adherent men who have sex with men and transgender women.
Partners PrEP and other studies: Tenofovir disoproxil fumarate-containing PrEP regimens showed strong preventive efficacy when taken consistently.
ART evidence: Tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg has been a widely validated NRTI backbone in combination ART.
Side Effects of Emfovir Tablet
Just like any other medication, Emfovir Tablet is also associated with some side effects. Most of the side effects are minor and usually go away within some time. Here are some of the symptoms, including:
Common side effects
- Headache
- Nausea
- Diarrhoea
- Fatigue
- Abdominal discomfort
- Mild creatinine changes
Serious side effects
- Renal impairment/Fanconi syndrome
- Loss of bone mineral density
- Severe HBV flare after discontinuation
- Lactic acidosis/severe hepatomegaly (rare)
Critical Safety Warning
HIV/HBV TESTING WARNING: Use of tenofovir disoproxil fumarate and emtricitabine on their own for treating HIV infection is not advised. Prior to beginning PrEP and subsequently while on PrEP, HIV testing is necessary to verify the individual is still HIV negative. However, discontinuing these medications abruptly in individuals without doctor guidance who have HBV infection increases the severity of the disease.
Emfovir Tablet Dosage and How To Take It
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.
| Clinical situation | Dose |
|---|---|
| Fixed dose | One tablet once per day, with 300 mg tenofovir disoproxil fumarate and emtricitabine 200 mg, in HIV treatment and PrEP regimens |
| HIV treatment | Usage of Emfovir Tablet is not recommended on its own. Rather, it must be taken together with other medications against HIV. |
| PrEP | It is taken once per day as a preventive measure against HIV. Testing for HIV infection and kidney function is required both before and while taking the medication. |
| Renal impairment | This fixed dose tablet may not be appropriate when the renal functions have been affected to some extent. The medical practitioner will assess the renal functions prior to prescribing Emfovir tablet. |
Emfovir Tablet Missed Dose
In case there is a skipped dose of the Emfovir Tablet, take the dose as soon as you remember it unless the time for the subsequent dose is close by. In that case, avoid taking the skipped dose and proceed as per your schedule. Do not consume two doses at once. Repeated skipping of doses can reduce the effectiveness of HIV treatment and may need medical consultation.
Safety Advice for Emfovir Tablet
| Category | Status | Guidance |
|---|---|---|
| Kidney | Monitor | Kidney function should be checked before and during treatment because tenofovir disoproxil fumarate 300 mg can affect the kidneys. |
| Bone | Caution | Tenofovir disoproxil fumarate 300mg may reduce bone mineral density in some people. |
| HBV | Do not stop abruptly | Stopping treatment can make hepatitis B worse, so medical follow-up is needed. |
| Pregnancy | Specialist guided | However, emtricitabine 200 mg have been extensively used in pregnant patients, but treatment should follow the doctor’s HIV/HBV guidance. |
| Driving | Usually minimal | Driving is generally not affected, but avoid it if dizziness or unusual tiredness occurs. |
Monitoring During Emfovir Tablet Treatment
- It is important to test HIV and viral load to verify the HIV status and the efficacy of the treatment.
- It is important to test creatinine, eGFR, and urine to assess the functioning of the kidneys.
- Testing for hepatitis B virus (HBV) may be recommended prior to the start of PrEP or a change in HIV treatment.
- Bone health may be assessed in patients with increased risk of bone problems.
- Regular monitoring should include medication use and adherence and STI screening in case of PrEP.
Emfovir Tablet Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Emfovir |
| Generic / Combination | Tenofovir disoproxil fumarate 300 mg + Emtricitabine 200 mg |
| Strength | 300mg/200mg |
| Form | Tablet |
| Manufacturer / Marketer | Arechar Healthcare |
| Pack | 30 tablets |
| Storage | Cool, dry place / below 30°C |
| Major safety theme | HIV/HBV TESTING WARNING |
| Prescription | Yes |
Emfovir Tablet Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Didanosine | Increases didanosine exposure/toxicity | Do not use the drug combination unless recommended and supervised by a specialist. |
| Nephrotoxic medicines/high-dose NSAIDs | Increase kidney risk | Do not use unnecessarily and check for kidney function if Tenofovir disoproxil fumarate 300 mg are used. |
| Other tenofovir-containing products | Duplicate therapy | These should never be mixed unless advised by a physician. |
FAQs About Emfovir Tablet
Is Emfovir Tablet an entire HIV treatment?
No. Emfovir Tablet has two antiretroviral drugs that have to be used with yet another active antiretroviral drug for comprehensive HIV treatment.
Can Emfovir Tablet be taken as PrEP?
Yes. The combination of tenofovir disoproxil fumarate and emtricitabine can be taken as PrEP in the case of appropriate HIV-negative people after approval for such use.
Why should there be HIV testing prior to using PrEP?
It is vital to conduct such testing because Emfovir tablets alone is not sufficient for HIV treatment. In case someone has undetected HIV, taking two medicines mentioned above might lead to the development of resistance to the drugs.
Why does one need to check kidneys while taking Emfovir Tablet?
Tenofovir disoproxil fumarate 300mg can affect kidneys of certain patients. However, regular tests will allow us to detect any possible problems.
What about if I am also suffering from hepatitis B?
Do not abruptly stop taking Emfovir Tablets without consulting your physician. Both medicines can treat hepatitis B, and hence you may experience a relapse by stopping them.
Can Emfovir Tablet cause any bone-related issues?
Yes. Tenofovir disoproxil fumarate 300mg tablets can lead to decreased bone mineral density in certain individuals, particularly those who already have risks of bone loss.
When should Emfovir Tablet be taken?
The emtricitabine 200 mg tablet is usually administered once daily. But this varies depending upon its usage for HIV therapy or PrEP.
References
- Current TDF/emtricitabine (Truvada/reference) prescribing information https://www.gilead.com/-/media/736839e6330640e58f0d73f518c9abaf.ashx
- CDC/WHO current PrEP guidance https://www.cdc.gov/hivnexus/hcp/prep/index.html
- Grant RM, et al. iPrEx. New England Journal of Medicine https://pubmed.ncbi.nlm.nih.gov/21091279/
- Baeten JM, et al. Partners PrEP. New England Journal of Medicine https://www.nejm.org/doi/full/10.1056/NEJMoa1108524
Marketer Details
Arechar Healthcare
Author Details
Written By:
Nonish Sharma
I am a medical content writer with a strong academic background in life sciences, holding an M.Sc. in Biotechnology... Read More
Reviewed By:
Vaibhav Shakya
Dr. Vaibhav Shakya, MD, is a Medical reviewer and medicine expert at Globans Pharma, with more than 9 years of experienc... Read More
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