Emtricitabine / Tenofovir Disoproxil Fumarate

Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg / 300 mg tablets are prescription antiviral medications used for the treatment of HIV-1 infection and for HIV-1 pre-exposure prophylaxis (PrEP) in certain adults and adolescents. This tablet combines two antiviral medicines that work together to reduce the amount of HIV in the body or lower the risk of acquiring HIV when taken as directed. It is not a cure for HIV or AIDS.

Below is a quick overview of important facts for patients and caregivers:

This medication is prescribed for the treatment of HIV-1 infection and for HIV-1 pre-exposure prophylaxis (PrEP) in eligible adults and adolescents. This combination medication is used for:

HIV-1 treatment:

It is indicated for the treatment of HIV-1 infection in:

• Adults
• Pediatric patients weighing at least 17 kg should use weight-based dosing as recommended.

It must not be used alone for HIV treatment. It is a part of a complete antiretroviral therapy regimen.

HIV-1 pre-exposure prophylaxis (PrEP):

It is also indicated for the treatment of HIV-1 PrEP to reduce the risk of sexually acquired HIV-1 infection in:

• At-risk adults
• Adolescents weighing at least 35 kg

Before starting PrEP, individuals must be confirmed HIV-negative.

Hepatitis B consideration:

Both active ingredients are active against the hepatitis B virus (HBV). However, severe acute exacerbations of hepatitis B have been reported after discontinuation in patients co-infected with HIV-1 and HBV.

This Emtricitabine and Tenofovir combination medication works by targeting HIV-1 during its replication process. It contains two reverse transcriptase inhibitors that block viral DNA formation.

• Emtricitabine:
  • Converted inside cells to its active form (emtricitabine triphosphate)
  • Competes with the natural building blocks of viral DNA
  • Incorporates into viral DNA and causes chain termination
  • Inhibits HIV-1 reverse transcriptase enzyme
• Tenofovir Disoproxil Fumarate:
  • Converted in the body to tenofovir diphosphate
  • Competes with natural substrates used by HIV
  • Blocks HIV-1 reverse transcriptase
  • Prevents completion of viral DNA synthesis
• Combined Effect:
  • Reduces viral replication in HIV-1 treatment
  • Helps lower viral load when used with other antiretroviral agents
  • Reduces the risk of establishing HIV infection when used for PrEP

Always take this medication exactly as prescribed by your healthcare provider. General guidelines include:

• Take one tablet by mouth once daily
• May be taken with or without food
• Swallow the tablet whole (do not crush or chew)
• Take at the same time each day for consistent results
• Do not skip doses
• Do not take more or less than prescribed
• Do not stop suddenly without medical advice

The recommended dosage depends on the indication (treatment or PrEP), body weight, and kidney function. A general overview is provided below:

Recommended dosage for HIV-1 treatment:

Weight should be monitored periodically in pediatric patients.

Recommended dosage for HIV-1 PrEP:

For PrEP:

• Individuals must have a confirmed negative HIV-1 test before starting.
• HIV testing should be performed at least every 3 months during use.

Renal function adjustments:

• No dose adjustment is required for HIV-1 treatment if creatinine clearance is ≥50 mL/min.
• For creatinine clearance 30-49 mL/min, the dosing interval should be adjusted to every 48 hours (treatment only).
• Not recommended for HIV-1 treatment if creatinine clearance is <30 mL/min or in patients requiring hemodialysis.
• For HIV-1 PrEP, it is not recommended in individuals with creatinine clearance below 60 mL/min.

Testing before and during treatment:

Before starting Emtricitabine / Tenofovir Disoproxil Fumarate:

• Test for hepatitis B virus infection
• Evaluate urine glucose and urine protein
• Assess serum creatinine and estimated creatinine clearance

Ongoing renal monitoring should be performed during treatment, especially in individuals with kidney risk factors.

What Would Happen If You Overdose on Emtricitabine / Tenofovir Disoproxil Fumarate?

If too much is taken, medical monitoring and supportive care for signs of toxicity may be required. The dialysis information is given below:

• Emtricitabine: Approximately 30% of the dose may be removed by hemodialysis during a 3-hour session. It is unknown whether emtricitabine is removed by peritoneal dialysis.
• Tenofovir Disoproxil Fumarate: Tenofovir is removed by hemodialysis, with approximately 10% of a 300 mg dose removed during a 4-hour dialysis session.

If an overdose is suspected, stop use and seek immediate medical support or contact a poison control center immediately.

Like most prescription medications, this dual-therapy tablet may cause side effects, especially when treatment is initiated or the dose is increased. Many people tolerate it well when taken as prescribed. Commonly reported Emtricitabine / Tenofovir Disoproxil Fumarate side effects are listed below:

Most Common Side Effects (HIV-1 Treatment)

• Tiredness
• Nausea
• Diarrhea
• Headache
• Depression
• Dizziness
• Problems sleeping
• Abnormal dreams
• Rash

Common Side Effects (HIV-1 PrEP)

• Headache
• Stomach-area (abdominal) pain
• Decreased weight

Rare or Serious Side Effects

• Worsening of hepatitis B (HBV) after stopping treatment
• New or worsening kidney problems, including kidney failure
• Bone problems, including thinning, bone pain, or fractures
• Immune reconstitution syndrome (new or worsening symptoms of hidden infections)
• Lactic acidosis (rare but serious buildup of lactic acid in the blood)
• Severe liver problems, including yellowing of the skin or eyes, dark urine, or abdominal pain
• Allergic reactions, such as swelling, rash, or difficulty breathing

If any side effects bother you, last longer than expected, or worsen, contact your healthcare provider.

It is essential to inform your healthcare provider about your medical history and any medications you are currently using before taking this medication.

What Are the Precautions for Emtricitabine / Tenofovir Disoproxil Fumarate?

Before starting treatment, consider the following precautions:

• Test for hepatitis B virus (HBV) before initiation.
• Assess kidney function before and during treatment.
• Use caution in individuals with kidney disease or risk factors for renal impairment.
• Bone problems, including reduced bone mineral density, may occur.
• Avoid concurrent use with nephrotoxic agents (such as high-dose or multiple NSAIDs).
• Strict adherence to once-daily dosing is essential to reduce the risk of HIV acquisition and drug resistance.

Other Important Warnings for Emtricitabine / Tenofovir Disoproxil Fumarate

Some other important warnings should be known to ensure safe use:

• New or worsening renal impairment, including acute renal failure and Fanconi syndrome, has been reported.
• Immune Reconstitution Syndrome may occur in individuals receiving combination antiretroviral therapy.
• Lactic acidosis and serious hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogs.
• Bone mineral density decreases have been observed; evaluation may be necessary in at-risk individuals.
• Drug interactions may increase the risk of adverse reactions.

Pregnancy and Breastfeeding

A pregnancy exposure registry monitors outcomes in individuals exposed to Emtricitabine / Tenofovir Disoproxil Fumarate during pregnancy. Available human data have not shown an increased risk of major congenital disabilities with first-trimester exposure. For HIV-1 treatment, breastfeeding is not recommended due to the risk of HIV transmission. For HIV-1 PrEP, the benefits of breastfeeding and the mother’s clinical need for therapy should be carefully considered. Women should not breastfeed if acute HIV-1 infection is suspected.

Certain medications can affect how this combination drug works or increase the risk of side effects. Always inform your doctor about all prescription drugs, over-the-counter medicines, and supplements you are taking. Medications that may interact include:

Drugs affecting renal function:

Since both active ingredients are primarily eliminated by the kidneys, caution is advised when used with:

• Adefovir dipivoxil
• Cidofovir
• Ganciclovir / Valganciclovir
• Acyclovir / Valacyclovir
• Aminoglycosides (e.g., gentamicin)
• High-dose or multiple NSAIDs

Coadministration with drugs that reduce kidney function may increase levels of emtricitabine and/or tenofovir.

Other HIV regimens may be appropriate depending on whether treatment of HIV-1 or HIV-1 PrEP is needed. The appropriate option depends on individual medical history, kidney function, resistance patterns, and risk factors.

Important points:

• Descovy is approved for PrEP except for individuals at risk from receptive vaginal sex, as it has not been studied for this exposure route.
• Some regimens are complete treatment therapies, while Emtricitabine / Tenofovir Disoproxil Fumarate must be combined with other antiretrovirals for HIV treatment.
• A healthcare provider determines the most appropriate regimen based on resistance testing and clinical factors.

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All Emtricitabine / Tenofovir Disoproxil Fumarate orders are processed through licensed Canadian pharmacies that follow strict quality and safety standards. A valid prescription is required for every purchase to ensure proper medical use and patient protection.

• https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bc37cba9-83c8-4660-a527-cd77fae9ea87
• https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/201806PI.pdf
• https://medlineplus.gov/druginfo/meds/a612036.html