PrEP Dosing and Administration – Generic Version of Truvada®

TESTING PRIOR TO INITIATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR TREATMENT OF HIV-1 INFECTION OR FOR HIV-1 PrEP¹

Test patients for hepatitis B virus infection prior to or when initiating Emtricitabine and Tenofovir Disoproxil Fumarate Tablets.

Prior to initiation and during use of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, on a clinically appropriate schedule, assess in all patients:

Serum creatinine
Estimated creatinine clearance
Urine glucose
Urine protein

In patients with chronic kidney disease, also assess serum phosphorus.

HIV-1 SCREENING FOR INDIVIDUALS RECEIVING EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PrEP¹

Screen all individuals for HIV-1 infection immediately prior to initiating Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP and at least once every 3 months while taking Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, and upon diagnosis of any other sexually transmitted infections (STIs).

ONCE-DAILY DOSING¹

Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg and for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg.

Tablets contain 200 mg of emtricitabine and 300 mg of tenofovir fumarate; they are to be taken orally, with or without food.

Additional Dose Recommendations

Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Tablet

Body Weight (kg) Dosing of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

17 to less than 22 one 100 mg/150 mg tablet once daily

22 to less than 28 one 133 mg/200 mg tablet once daily

28 to less than 35 one 167 mg/250 mg tablet once daily

Weight should be monitored periodically and the Emtricitabine and Tenofovir Disoproxil Fumarate Tablets dose adjusted accordingly.

Dosage Interval Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance

No dosage adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 5O to 80 mL/min). The safety and effectiveness of the dosing interval adjustment recommendations in patients with moderate renal impairment (creatinine clearance 30 to 49 mL/min) have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients.

Creatinine Clearance (mL/min) ^a

>50

30 to 49

<30 (Including Patients Requiring Hemodialysis)

Recommended Dosing Interval

Every 24 hours

Every 48 hours

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are not recommended.

^aCalculated using ideal (lean) body weight

HIV-1 PrEP

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP is not recommended in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.

If a decrease in estimated creatinine clearance is observed in uninfected individuals while using Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP, evaluate potential causes and reassess potential risks and benefits of continued use.

DISCOVER MORE ABOUT EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS

Therapeutic Equivalence

Dosing and Administration

Identifying and Counseling Appropriate PrEP Patients

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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets can cause serious side effects, including:

Worsening of hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before start or when you start treatment with emtricitabine and tenofovir disoproxil fumarate tablets. If you have HBV infection and take emtricitabine and tenofovir disoproxil fumarate tablets, your HBV may get worse (flare-up) if you stop taking emtricitabine and tenofovir disoproxil fumarate tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
- Do not run out of emtricitabine and tenofovir disoproxil fumarate tablets. Refill your prescription or talk to your healthcare provider before your emtricitabine and tenofovir disoproxil fumarate tablets is all gone.
- Do not stop taking emtricitabine and tenofovir disoproxil fumarate tablets without first talking to your healthcare provider.
- If you stop taking emtricitabine and tenofovir disoproxil fumarate tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking emtricitabine and tenofovir disoproxil fumarate tablets.

For more information about side effects, see the section “What are the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets?”

Other important information for people who take emtricitabine and tenofovir disoproxil fumarate tablets to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or “PrEP”:

Before taking emtricitabine and tenofovir disoproxil fumarate tablets to reduce your risk of getting HIV-1:

You must be HIV-1 negative to start emtricitabine and tenofovir disoproxil fumarate tablets. You must get tested to make sure that you do not already have HIV-1 infection.
Do not take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP unless you are confirmed to be HIV-1 negative.
- Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting emtricitabine and tenofovir disoproxil fumarate tablets or at any time while taking emtricitabine and tenofovir disoproxil fumarate tablets. Symptoms of new HIV-1 infection include tiredness, vomiting or diarrhea, fever, rash, joint or muscle aches, night sweats, headache, enlarged lymph nodes in the neck or groin, and sore throat.

While you are taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP:

Emtricitabine and tenofovir disoproxil fumarate tablets does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
You must stay HIV-negative to keep taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP.
- Know your HIV-1 status and the HIV-1 status of your partners.
- Ask your partners with HIV-1 if they are taking anti-HIV-1 medicines and have an undetectable viral load. An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment.
- Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you.
- Get tested for other STIs such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.
- If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative.
- Get information and support to help reduce sexual risk behaviors.
- Do not miss any doses of emtricitabine and tenofovir disoproxil fumarate tablets. Missing doses increases your risk of getting HIV-1 infection.
If you do become HIV-1 positive, you need more medicine than emtricitabine and tenofovir disoproxil fumarate tablets alone to treat HIV-1. Emtricitabine and tenofovir disoproxil fumarate tablets by themselves are not a complete treatment for HIV-1.
- If you have HIV-1 and take only emtricitabine and tenofovir disoproxil fumarate tablets, over time your HIV-1 may become harder to treat.

For people taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP: Do not take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if:

you already have HIV-1 infection. If you are HIV-1 positive, you need to take other medicines with emtricitabine and tenofovir disoproxil fumarate tablets to treat HIV-1. Emtricitabine and tenofovir disoproxil fumarate tablets by themselves are not a complete treatment for HIV-1.
you do not know your HIV-1 infection status. You may already be HIV-1 positive. You need to take other HIV-1 medicines with emtricitabine and tenofovir disoproxil fumarate tablets to treat HIV-1.

Emtricitabine and tenofovir disoproxil fumarate tablets can only help reduce your risk of getting HIV-1 before you are infected.

What should I tell my healthcare provider before taking emtricitabine and tenofovir disoproxil fumarate tablets?

Before taking emtricitabine and tenofovir disoproxil fumarate tablets, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems, including HBV infection
have kidney problems or receive kidney dialysis treatment
have bone problems
are pregnant or plan to become pregnant. It is not known if emtricitabine and tenofovir disoproxil fumarate can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with emtricitabine and tenofovir disoproxil fumarate tablets.

Pregnancy Registry: There is a pregnancy registry for people who take emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. Emtricitabine and tenofovir disoproxil fumarate can pass to your baby in your breast milk.
- Do not breastfeed if you have HIV-1 or if you think you have recently become infected with HIV-1 because of the risk of passing HIV-1 to your baby.
- If you take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may interact with emtricitabine and tenofovir disoproxil fumarate tablets. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with emtricitabine and tenofovir disoproxil fumarate tablets.
Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take emtricitabine and tenofovir disoproxil fumarate tablets with other medicines.

What are the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets may cause serious side effects, including:

See “What is the most important information I should know about emtricitabine and tenofovir disoproxil fumarate tablets?”
New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with emtricitabine and tenofovir disoproxil fumarate tablets. Your healthcare provider may tell you to take emtricitabine and tenofovir disoproxil fumarate tablets less often, or to stop taking emtricitabine and tenofovir disoproxil fumarate tablets if you get new or worse kidney problems.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when taking medicines to treat HIV-1 infection. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
Bone problems can happen in some people who take emtricitabine and tenofovir disoproxil fumarate tablets. Bone problems include bone pain, or softening or thinning of bones, which may lead to fractures. Your healthcare provider may need to do tests to check your bones.
Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effects of emtricitabine and tenofovir disoproxil fumarate tablets for treatment of HIV-1 include diarrhea, depression, nausea, problems sleeping, tiredness, abnormal dreams, headache, rash, and dizziness.

Common side effects in people who take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP include headache, stomach-area (abdomen) pain, and decreased weight. These are not all the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Approved Uses

What are emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets are a prescription medicine that may be used in two different ways. Emtricitabine and tenofovir disoproxil fumarate tablets are used:

to treat HIV-1 infection when used with other anti-HIV-1 medicines in adults and children who weigh at least 37 pounds (at least 17 kg).
for HIV-1 PrEP to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (at least 35 kg).

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). Emtricitabine and tenofovir disoproxil fumarate tablets contain the prescription medicines emtricitabine and tenofovir disoproxil fumarate.

It is not known if emtricitabine and tenofovir disoproxil fumarate tablets for treatment of HIV-1 infection are safe and effective in children who weigh less than 37 pounds (17 kg).

It is not known if emtricitabine and tenofovir disoproxil fumarate tablets are safe and effective in reducing the risk of HIV-1 infection in people who weigh less than 77 pounds (35 kg).

Please read the Medication Guide in the full Prescribing Information including Boxed Warning.

IMPORTANT SAFETY INFORMATION

WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B AND RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PREEXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine and tenofovir disoproxil fumarate tablets. If appropriate, anti-hepatitis B therapy may be warranted.

Emtricitabine and tenofovir disoproxil fumarate tablets used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

Contraindications: Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.

Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection: All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating emtricitabine and tenofovir disoproxil fumarate tablets. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Individuals infected with HBV who discontinue emtricitabine and tenofovir disoproxil fumarate tablets should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.

Comprehensive Management to Reduce the Risk of Sexually Transmitted Infections, Including HIV-1, and Development of HIV-1 Resistance When Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Is Used for HIV-1 PrEP: Use emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes other prevention measures, 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 and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown .

Use emtricitabine and tenofovir disoproxil fumarate tablets to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only emtricitabine and tenofovir disoproxil fumarate tablets, because emtricitabine and tenofovir disoproxil fumarate tablets alone does not constitute a complete regimen for HIV-1 treatment; therefore, care should be taken to minimize the risk of initiating or continuing emtricitabine and tenofovir disoproxil fumarate tablets before confirming the individual is HIV-1 negative. While using emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs.

Counsel HIV-1 uninfected individuals to strictly adhere to the once daily emtricitabine and tenofovir disoproxil fumarate tablets dosing schedule. The effectiveness of emtricitabine and tenofovir disoproxil fumarate tablets in reducing the risk of acquiring HIV-1 is strongly correlated with adherence, as demonstrated by measurable drug levels in clinical trials of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP. Some individuals, such as adolescents, may benefit from more frequent visits and counseling to support adherence.

New Onset or Worsening Renal Impairment: Emtricitabine and tenofovir are principally eliminated by the kidney. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of TDF, a component of emtricitabine and tenofovir disoproxil fumarate tablets. Emtricitabine and tenofovir disoproxil fumarate tablets should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs [NSAIDs]). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on TDF. Some patients required hospitalization and renal replacement therapy. Alternatives to NSAIDs should be considered, if needed, in patients at risk for renal dysfunction.

Immune Reconstitution Syndrome: Immune reconstitution syndrome has been reported in HIV-1 infected patients treated with combination antiretroviral therapy, including emtricitabine and tenofovir disoproxil fumarate tablets.

Bone Loss and Mineralization Defects: In clinical trials in HIV-1 infected adults and in a clinical trial of HIV-1 uninfected individuals, TDF (a component of emtricitabine and tenofovir disoproxil fumarate tablets) was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover relative to comparators. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher in subjects receiving TDF. Assessment of BMD should be considered for adult and pediatric patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with TDF use.

Lactic Acidosis/Severe Hepatomegaly with Steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including FTC and TDF, components of emtricitabine and tenofovir disoproxil fumarate tablets, alone or in combination with other antiretrovirals.

Risk of Adverse Reactions Due to Drug Interactions: The concomitant use of emtricitabine and tenofovir disoproxil fumarate tablets and other drugs may result in known or potentially significant drug interactions, some of which may lead to possible clinically significant adverse reactions from greater exposures of concomitant drugs. Consider the potential for drug interactions prior to and during therapy with emtricitabine and tenofovir disoproxil fumarate tablets; review concomitant medications during therapy with emtricitabine and tenofovir disoproxil fumarate tablets; and monitor for adverse reactions associated with the concomitant drugs.

Pregnancy: There is an Antiretroviral Pregnancy Registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy. Data on the use of emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy from observational studies have shown no increased risk of major birth defects. Available data from the APR show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine or tenofovir disoproxil fumarate compared with the background rate for major birth defects in a U.S. reference population.

Lactation: Based on published data, FTC and tenofovir have been shown to be present in human breast milk. 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 if they are taking emtricitabine and tenofovir disoproxil fumarate tablets for the treatment of HIV-1. In HIV-uninfected women, the developmental and health benefits of breastfeeding and the mother’s clinical need for emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP should be considered along with any potential adverse effects on the breastfed child from emtricitabine and tenofovir disoproxil fumarate tablets and the risk of HIV-1 acquisition due to nonadherence and subsequent mother to child transmission.

Common Adverse Reactions: In clinical trials, the most common adverse reactions (incidence greater than or equal to 10%, all grades) in HIV-1 infected subjects included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of participants and more frequently than by placebo participants were headache, abdominal pain, and decreased weight.

INDICATIONS AND USAGE

Treatment of HIV-1 Infection

Emtricitabine and tenofovir disoproxil fumarate tablets are a prescription medicine indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.

HIV-1 Pre-Exposure Prophylaxis (PrEP)

Emtricitabine and tenofovir disoproxil fumarate tablets are a prescription medicine indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP.

Please see full Prescribing Information, including Boxed Warning.

REFERENCE

Emtricitabine and tenofovir disoproxil fumarate. Prescribing Information. Teva Pharmaceuticals, Inc; 2020.

Dosing and Administration

TESTING PRIOR TO INITIATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR TREATMENT OF HIV-1 INFECTION OR FOR HIV-1 PrEP1

HIV-1 SCREENING FOR INDIVIDUALS RECEIVING EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PrEP1

DISCOVER MORE ABOUT EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS

REFERENCE

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TESTING PRIOR TO INITIATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR TREATMENT OF HIV-1 INFECTION OR FOR HIV-1 PrEP¹

HIV-1 SCREENING FOR INDIVIDUALS RECEIVING EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PrEP¹