Emtricitabine-Tenofovir AF

Emtricitabine-Tenofovir AF is a combination medication used for the treatment of HIV Infection and HIV-1 Pre-exposure Prophylaxis. 

• Emtricitabine-Tenofovir AF is available under the following different brand names: Descovy

Common side effects of  Emtricitabine-Tenofovir AF include:

• Headache,
• Tiredness,
• Abdominal pain,
• Nausea, and
• Diarrheal

Serious side effects of  Emtricitabine-Tenofovir AF include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Blood in the urine,
• Dark urine,
• Loss of appetite,
• Little or no urine,
• Diarrheal,
• Fast or shallow breathing,
• Increased thirst,
• Clay-colored stools,
• Lower back or side pain,
• Muscle pain,
• Muscle cramps,
• Nausea,
• Sleepiness,
• Stomach pain (upper right side),
• Unusual tiredness or weakness,
• Vomiting,
• Weight gain, and
• Yellowing of the skin or eyes (jaundice)

Rare side effects of  Emtricitabine-Tenofovir AF include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because 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.

Adult and pediatric dosage

Tablet

• 200 mg/25 mg
• 120 mg/15 mg

HIV Infection Treatment

Adult dosage

• 200 mg/25 mg orally once a day

Pediatric dosage

• In combination with ARTs
  • Above 35 kg: 200 mg/25 mg orally once a day
• In combination with ARTs other than PIs requiring a CYP3A inhibitor
  • Safety and efficacy of  Emtricitabine-Tenofovir AF coadministered with an HIV-1 PI that is boosted with either ritonavir or cobicistat have not been established in pediatric patients weighing below 35 kg
  • 25 to below 35 kg: 200 mg/25 mg orally once a day
  • 14 to below 25 kg: 120 mg/15 mg orally once a day

HIV-1 Pre-exposure Prophylaxis

Adult dosage

• 200 mg/25 mg orally once a day

Pediatric dosage

• Below 35 kg: Safety and efficacy not established
• Above 35 kg: 200 mg/25 mg orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

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 AF has severe interactions with the following drugs
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • lamivudine
• Emtricitabine-Tenofovir AF has serious interactions with the following drugs:
  • betibeglogene autotemcel
  • cabotegravir
  • elivaldogene autotemcel
  • letermovir
• Emtricitabine-Tenofovir AF has moderate interactions with at least 66 other drugs.
• Emtricitabine-Tenofovir AF has severe interactions with the following drug
  • nirmatrelvir/ritonavir

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 about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Use for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Emtricitabine-Tenofovir AF?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Emtricitabine-Tenofovir AF?”

Cautions

• All individuals should be tested for the presence of chronic HBV infection before initiating ART therapy or PrEP;  Emtricitabine-Tenofovir AF is not approved for the treatment of chronic HBV infection, and safety and efficacy are not established in patients coinfected with HIV-1 and HBV (see Black Box Warnings)
• The use of HIV-1 PrEP to reduce the risk of HIV-1 infection is part of a comprehensive prevention strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs); the time from initiation of  Emtricitabine-Tenofovir AF for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown
• Before initiating PrEP, individuals must be confirmed to be HIV-1 negative; HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only  Emtricitabine-Tenofovir AF, which alone does not constitute a complete HIV-1 treatment regimen; while using for PrEP, testing should be repeated at least every 3 months, and upon diagnosis or any other STD
• Immune reconstitution syndrome reported with combination ART therapy, including emtricitabine; during the initial phase of combination ART treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (.g, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment; autoimmune disorders (.g, Grave disease, polymyositis, Guillain-Barré syndrome) may also emerge
• New-onset or worsening renal impairment reported with tenofovir, including cases of acute renal failure and Fanconi syndrome
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with the use of nucleoside analogs, alone or in combination with other ARTs; suspend treatment with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
• Worsening renal impairment
  • Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome reported; while most of these cases were characterized by potential confounders that may have contributed to reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related adverse reactions
  • Not recommended in individuals with estimated creatinine clearance of 15 to below 30 mL/min, or individuals with estimated creatinine clearance below 15 mL/min who are not receiving chronic hemodialysis
  • Individuals taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents including non-steroidal anti-inflammatory drugs are at increased risk of developing renal-related adverse reactions
  • Before or when initiating therapy and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals
  • In individuals with chronic kidney disease, also assess serum phosphorus; discontinue the drug in individuals who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
• Drug interaction overview
  • Not for administration with other drugs containing emtricitabine or tenofovir DF, or containing tenofovir AF
  • Tenofovir AF
    • Tenofovir AF is a substrate of P-gp, BCRP, OATP1B1, and OATP1B3
    • Drugs that strongly affect P-gp and BCRP activity may lead to changes in tenofovir AF absorption
    • Drugs that induce P-gp activity are expected to decrease tenofovir AF absorption, resulting in decreased plasma concentration, which may lead to loss of therapeutic effect and development of resistance
    • Coadministration with drugs that inhibit P-gp and BCRP may increase tenofovir AF absorption and plasma concentration
• Effects on renal function
  • Emtricitabine and tenofovir are primarily excreted by the kidneys by glomerular filtration and active tubular secretion
  • Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome reported with tenofovir AF-containing products reported
  • Coadministration of  Emtricitabine-Tenofovir AF with drugs that reduce renal function or compete for active tubular secretion may increase  Emtricitabine-Tenofovir AF; thereby, increasing the risk for adverse effects

Pregnancy and Lactation

• Pregnancy exposure registry monitors pregnancy outcomes in women exposed to the drugs during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263
• There are insufficient human data on use during pregnancy to inform a drug-associated risk of birth defects and miscarriage; tenofovir alafenamide (TAF) use in women during pregnancy has not been evaluated; however, emtricitabine (FTC) use during pregnancy has been evaluated in a limited number of women reported to the APR
• Available data from APR show no difference in risk of overall major birth defects for FTC (2.4%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of Metropolitan Atlanta Congenital Defects Program (MACDP); the rate of miscarriage is not reported in the APR
• Lactation
  • The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed infants, to avoid risking postnatal transmission of HIV
  • FTC is present in human breast milk; not known if TAF is present in human breast milk; tenofovir is present in the milk of lactating rats and rhesus monkeys after administration of TDF; not known if TAF is present in animal milk
  • Not known if the drug combination affects milk production or has effects on the breastfed child; because of the potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions in breastfed infants like those seen in adults, instruct mothers not to breastfeed if they are receiving therapy