Emtricitabine Tenofovir DF

Emtricitabine/tenofovir DF is a prescription medication used for the treatment of HIV infection and the prevention of sexually-acquired HIV infection.

• Emtricitabine/tenofovir DF is available under the following different brand names: Truvada

Adult dosage

Tablet

• 200mg/300mg

Pediatric dosage

• 100mg/150mg
• 133mg/200mg
• 167mg/250mg
• 200mg/300mg

HIV Infection

Adult dosage

• One 200 mg/300 mg tablet orally once daily

Pediatric dosage

• Children weighing below 17 kg: Safety and efficacy not established
• Children weighing above 17 kg
• 17 to 21 kg: One 100 mg/150 mg tablet orally once daily
• 22 to 27 kg: One 133 mg/200 mg tablet orally once daily
• 28 to 34  kg: One 167 mg/250 mg tablet orally once daily
• Above 35 kg: One 200 mg/300 mg tablet orally once daily

HIV-1 Pre-exposure Prophylaxis

Adult dosage

• One 200 mg/300 mg tablet orally once daily

Pediatric dosage

• Children weighing below 35 kg: Safety and efficacy not established
• Children weighing above 35 kg: One 200 mg/300 mg tablet orally once daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Emtricitabine/Tenofovir DF include:

• diarrhea,
• nausea,
• tiredness,
• headache,
• dizziness,
• depression,
• problems sleeping,
• abnormal dreams, 
• rash,
• headache,
• stomach-area (abdomen) pain, and
• decreased weight.

Serious side effects of Emtricitabine/tenofovir DF include:

• new or worsening kidney problems, including kidney failure
• bone problems,
• lactic acidosis,
• severe liver problem, and
• changes in the immune system.

Rare side effects of Emtricitabine/tenofovir DF include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Emtricitabine/tenofovir DF has severe interactions with the following drugs:

• elvitegravir/cobicistat/emtricitabine/tenofovir DF
• lamivudine

Emtricitabine/tenofovir DF has serious interactions with the following drug:

• cabotegravir

Emtricitabine/tenofovir DF has moderate interactions with at least 42 other drugs.

Emtricitabine/tenofovir DF has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Do not use PrEP in HIV-infected individuals or individuals with unknown HIV status
• Use as monotherapy in HIV-infected patients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Emtricitabine/tenofovir DF?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Emtricitabine/tenofovir DF?”

Cautions

• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogs, including emtricitabine and tenofovir; suspend dosing in those who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
• Do not coadminister with other drugs containing emtricitabine or tenofovir
• Severe exacerbation of hepatitis B may occur upon discontinuation (see Black Box Warning)
• Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Graves disease, polymyositis, and Guillain-Barré syndrome) have also been reported
• PrEP
  • Use for HIV-1 PrEP only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because emtricitabine/tenofovir AF is not always effective in preventing acquisition of HIV-1
  • Care should be taken to minimize the risk of initiating or continuing therapy before confirming individual is HIV-1 negative
  • Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use, knowledge of partner(s)’ HIV-1 status, including viral suppression status, regular testing for STIs that can facilitate HIV-1 transmission)
  • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior
  • While on therapy for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs
  • If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, convert the HIV-1 PrEP regimen to HIV treatment regimen until negative infection status is confirmed using a test approved or cleared by FDA as an aid in the diagnosis of acute or primary HIV-1 infection
  • Counsel HIV-1 uninfected individuals to strictly adhere to the once-daily dosing schedule
  • Some individuals, such as adolescents, may benefit from more frequent visits and counseling to support adherence
• Hepatitis B exacerbations
  • All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating therapy
  • Individuals infected with HBV who discontinue drugs should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment
  • If appropriate, anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure; HBV-uninfected individuals should be offered vaccination
• Renal toxicity
  • Increased risk of new-onset or worsening renal impairment
  • Obtain estimated CrCl in all patients before initiating
  • Routinely monitor calculated creatinine clearance and serum phosphorus
  • Avoid use if CrCl below 30 mL/min (below 60 mL/min for PrEP), hemodialysis, or concurrent or recent use of nephrotoxic drugs
  • Tenofovir DF may cause renal toxicity (acute renal failure and/or Fanconi syndrome); avoid administering therapy with concurrent or recent use of nephrotoxic drugs, including NSAIDs; consider an alternative to NSAIDs in patients taking tenofovir DF and at risk of renal impairment
  • Bone effects of tenofovir
    • Bone mineral density may decrease; consider the assessment of bone mineral density in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss
    • Osteomalacia associated with proximal renal tubulopathy manifested as bone pain or pain in extremities and which may contribute to fractures have been reported
    • Consider hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving TDF-containing products
• Drug interaction overview
  • Drug affecting renal function
  • Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion
  • No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration with drugs that are eliminated by active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or the coadministered drug
  • P-GP and BCRP inhibitors
    • Tenofovir DF is a substrate of P-glycoprotein (P-GP) and breast cancer resistance protein (BCRP) transporters
    • Increased tenofovir absorption may occur if coadministered with inhibitors of these transporters

Pregnancy and Lactation

• Data on the use during pregnancy from observational studies have shown no increased risk of major birth defects
• Available data from the Antiretroviral Regnancy Registry (APR) show no increase in the overall risk of major birth defects with first-trimester exposure for emtricitabine (2.3%) or tenofovir DF (2.1%) compared with the background rate for major birth defects of 2.7%
• Healthcare providers are encouraged to register pregnant women by calling the APR at 1-800-258-4263
• Pregnant women with HIV infection should continue antiretroviral drugs according to current guidelines during pregnancy to decrease maternal-fetal viral transmission (https://aidsinfo.nih.gov)

Lactation

• Emtricitabine and tenofovir have been shown to be present in human breast milk
• HIV-1 infected women
• The CDC recommends that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1
• Because of the potential for HIV transmission (in HIV-negative infants); developing viral resistance (in HIV-positive infants), and adverse reactions in a breastfed infant similar to those seen in adults
• Instruct mothers not to breastfeed
• Women taking PrEP
  • In HIV-uninfected women, consider the developmental and health benefits of breastfeeding and the mother’s clinical need of drug therapy for HIV-1 PrEP along with any potential adverse effects on the breastfed child from drug therapy and the risk of HIV-1 acquisition due to nonadherence and subsequent mother to child transmission
  • Women should not breastfeed if acute HIV-1 infection is suspected because of the risk of HIV-1 transmission to the infant.