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As a part of patient counseling, healthcare providers must review the emtricitabine and tenofovir disoproxil fumarate Medication Guide with every uninfected individual taking emtricitabine and tenofovir disoproxil fumarate to reduce the risk of acquiring HIV.
Important Information for All Patients and Uninfected Individuals: Advise patients and uninfected individuals that: The long term effects of emtricitabine and tenofovir disoproxil fumarate are unknown.
Emtricitabine and Tenofovir disoproxil fumarate Tablets are for oral ingestion only.
Patients and uninfected individuals should not discontinue emtricitabine and tenofovir disoproxil fumarate without first informing their physicians.
Patients and uninfected individuals should remain under the care of a physician when using emtricitabine and tenofovir disoproxil fumarate.
It is important to take emtricitabine and tenofovir disoproxil fumarate on a regular dosing schedule to avoid missing doses.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with emtricitabine and tenofovir disoproxil fumarate should be suspended in patients or uninfected individuals who develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) (see Precautions).
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus (HBV) and HIV-1 and have discontinued emtricitabine and tenofovir disoproxil fumarate. Before initiating emtricitabine and tenofovir disoproxil fumarate, test all patients and uninfected individuals for HBV. All patients who are infected with HBV need close medical follow-up for several months after stopping emtricitabine and tenofovir disoproxil fumarate to monitor for exacerbations of hepatitis (see Precautions).
Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of tenofovir disoproxil fumarate. Emtricitabine and Tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) (see Precautions). Dosing interval of emtricitabine and tenofovir disoproxil fumarate may need adjustment in HIV-1 infected patients with renal impairment. Emtricitabine and Tenofovir disoproxil fumarate for a PrEP indication should not be used in HIV-1 uninfected individuals if estimated creatinine clearance is less than 60 mL/min. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using emtricitabine and tenofovir disoproxil fumarate for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use (see Dosage and Administration).
Do not administer emtricitabine and tenofovir disoproxil fumarate with ATRIPLA, COMPLERA, emtricitabine, GENVOYA, ODEFSEY, STRIBILD, or tenofovir disoproxil fumarate; or with drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Triumeq (abacavir sulfate/dolutegravir/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine) (see Precautions).
Do not administer emtricitabine and tenofovir disoproxil fumarate with HEPSERA (see Precautions).
Decreases in bone mineral density have been observed with the use of tenofovir disoproxil fumarate or emtricitabine and tenofovir disoproxil fumarate. Consider bone monitoring in patients and uninfected individuals who have a history of pathologic bone fracture or at risk for osteopenia (see Precautions).
Patients and uninfected individuals should avoid doing things that can spread HIV-1 or HBV infection.
Do not share needles or other injection equipment.
Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
Patients and uninfected individuals should not breastfeed because the drugs in emtricitabine and tenofovir disoproxil fumarate can be passed to the baby in breast milk, and it is not known whether they can harm the baby. HIV-positive women should also not breastfeed because of the risk of passing the HIV-1 virus to the baby.
Treatment of HIV-1 Infection: When emtricitabine and tenofovir disoproxil fumarate is used in the treatment of HIV-infection, advise patients that:
Emtricitabine and Tenofovir disoproxil fumarate is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.
It is important to take emtricitabine and tenofovir disoproxil fumarate in a regular dosing schedule with combination therapy to avoid missing doses.
All patients with HIV-1 should be tested for hepatitis B virus (HBV) before initiating and monitored after discontinuing taking emtricitabine and tenofovir disoproxil fumarate.
Pre-Exposure Prophylaxis: When emtricitabine and tenofovir disoproxil fumarate is used to reduce the risk of acquiring HIV-1, advise uninfected individuals about the importance of the following:
Confirming that they are HIV-negative before starting to take emtricitabine and tenofovir disoproxil fumarate to reduce the risk of acquiring HIV-1.
Emtricitabine and Tenofovir disoproxil fumarate should only be used as part of a complete prevention strategy including other prevention measures. In clinical trials, emtricitabine and tenofovir disoproxil fumarate only protected some subjects from acquiring HIV-1.
Using condoms consistently and correctly to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Knowing their HIV status and the status of their partner(s).
Getting tested regularly (at least every 3 months) for HIV-1 and ask their partner(s) to get tested as well.
HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking emtricitabine and tenofovir disoproxil fumarate, because emtricitabine and tenofovir disoproxil fumarate alone does not constitute a complete regimen for HIV-1 treatment (see Precautions).
Reporting any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately.
Signs and symptoms of acute infection include: fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal).
Getting tested for other sexually transmitted infections such as syphilis and gonorrhea that may facilitate HIV- 1 transmission.
Learning about sexual risk behavior and getting support to help reduce sexual risk behavior.
Taking emtricitabine and tenofovir disoproxil fumarate on a regular dosing schedule and strictly adhere to the recommended dosing schedule to reduce the risk of acquiring HIV-1. Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses. (See Precautions.)
Women who are pregnant should learn about the risks and benefits of emtricitabine and tenofovir disoproxil fumarate to reduce the risk of acquiring HIV-1 during their pregnancy.
Encourage use of the Agreement Form for Initiating emtricitabine and tenofovir disoproxil fumarate for PrEP of Sexually Acquired HIV-1 Infection.
