Emtricitabine and Tenofovir Disoproxil Fumarate (Page 9 of 10)

14.3 Clinical Trial Results for HIV-1 PrEP: iPrEx

The iPrEx trial was a randomized, double-blind, placebo-controlled multinational study evaluating emtricitabine and tenofovir disoproxil fumarate in 2,499 HIV-seronegative men or transgender women who have sex with men and with evidence of high-risk behavior for HIV-1 infection. Evidence of high-risk behavior included any one of the following reported to have occurred up to six months prior to study screening: no condom use during anal intercourse with an HIV-1 positive partner or a partner of unknown HIV status; anal intercourse with more than 3 sex partners; exchange of money, gifts, shelter, or drugs for anal sex; sex with male partner and diagnosis of sexually transmitted infection; no consistent use of condoms with sex partner known to be HIV-1 positive.

All subjects received monthly HIV-1 testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. Of the 2,499 enrolled subjects, 1,251 received emtricitabine and tenofovir disoproxil fumarate and 1,248 received placebo. The mean age of subjects was 27 years; 5% were Asian, 9% Black, 18% White, and 72% Hispanic/Latino.

Subjects were followed for 4,237 person-years. The primary outcome measure was the incidence of documented HIV seroconversion. At the end of treatment, emergent HIV-1 seroconversion was observed in 131 subjects, of which 48 occurred in the emtricitabine and tenofovir disoproxil fumarate group and 83 occurred in the placebo group, indicating a 42% (95% CI: 18% to 60%) reduction in risk. Risk reduction was found to be higher (53%; 95% CI: 34% to 72%) among subjects who reported previous unprotected anal intercourse (URAI) at screening (732 and 753 subjects reported URAI within the last 12 weeks at screening in the emtricitabine and tenofovir disoproxil fumarate and placebo groups, respectively). In a post-hoc case control study of plasma and intracellular drug levels in about 10% of study subjects, risk reduction appeared to be greatest in subjects with detectable intracellular tenofovir diphosphate concentrations. Efficacy was therefore strongly correlated with adherence.

14.4 Clinical Trial Results for HIV-1 PrEP: Partners PrEP

The Partners PrEP trial was a randomized, double-blind, placebo-controlled 3-arm trial conducted in 4,758 HIV-1 serodiscordant heterosexual couples in Kenya and Uganda to evaluate the efficacy and safety of TDF (N=1,589) and FTC/TDF (N=1,583) versus (parallel comparison) placebo (N=1,586) in preventing HIV-1 acquisition by the uninfected partner.

All uninfected partner subjects received monthly HIV-1 testing, evaluation of adherence, assessment of sexual behavior, and safety evaluations. Women were also tested monthly for pregnancy. Women who became pregnant during the trial had study drug interrupted for the duration of the pregnancy and while breastfeeding. The uninfected partner subjects were predominantly male (61% to 64% across study drug groups) and had a mean age of 33 years to 34 years.

Following 7,827 person-years of follow-up, 82 emergent HIV-1 seroconversions were reported, with an overall observed seroincidence rate of 1.05 per 100 person-years. Of the 82 seroconversions, 13 and 52 occurred in partner subjects randomized to emtricitabine and tenofovir disoproxil fumarate and placebo, respectively. Two of the 13 seroconversions in the emtricitabine and tenofovir disoproxil fumarate arm and 3 of the 52 seroconversions in the placebo arm occurred in women during treatment interruptions for pregnancy. The risk reduction for emtricitabine and tenofovir disoproxil fumarate relative to placebo was 75% (95% CI: 55% to 87%). In a post-hoc case control study of plasma drug levels in about 10% of study subjects, risk reduction appeared to be greatest in subjects with detectable plasma tenofovir concentrations. Efficacy was therefore strongly correlated with adherence.

16. HOW SUPPLIED/STORAGE AND HANDLING

Emtricitabine and tenofovir disoproxil fumarate tablets, 100 mg of FTC and 150 mg of TDF (equivalent to 123 mg of tenofovir disoproxil) are white to off-white-colored, oval-shaped, film-coated tablets, debossed with “1364” on one side and plain on other side and are supplied as follows:

NDC 70710-1364-3 in bottles of 30 tablets with child-resistant closure

NDC 70710-1364-9 in bottles of 90 tablets with child-resistant closure

NDC 70710-1364-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)

Emtricitabine and tenofovir disoproxil fumarate tablets, 133 mg of FTC and 200 mg of TDF (equivalent to 163 mg of tenofovir disoproxil) are white to off-white-colored, rectangular-shaped, film-coated tablets, debossed with “1365” on one side and plain on other side and are supplied as follows:

NDC 70710-1365-3 in bottles of 30 tablets with child-resistant closure

NDC 70710-1365-9 in bottles of 90 tablets with child-resistant closure

NDC 70710-1365-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)

Emtricitabine and tenofovir disoproxil fumarate tablets, 167 mg of FTC and 250 mg of TDF (equivalent to 204 mg of tenofovir disoproxil) are white to off-white-colored, modified capsule-shaped, film-coated tablets, debossed with “1366” on one side and plain on other side and are supplied as follows:

NDC 70710-1366-3 in bottles of 30 tablets with child-resistant closure

NDC 70710-1366-9 in bottles of 90 tablets with child-resistant closure

NDC 70710-1366-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) are white to off-white-colored, capsule-shaped, film-coated tablets, debossed with “1367” on one side and plain on other side and are supplied as follows:

NDC 70710-1367-3 in bottles of 30 tablets with child-resistant closure

NDC 70710-1367-9 in bottles of 90 tablets with child-resistant closure

NDC 70710-1367-4 in unit-dose blister cartons of 100 tablets (10 x 10 unit-dose)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

  • Keep container tightly closed
  • Dispense only in original container

17. PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Important Information for Uninfected Individuals Taking Emtricitabine and Tenofovir Disoproxil Fumarate for HIV-1 PrEP

Advise HIV-uninfected individuals about the following [see Warnings and Precautions (5.2)]:

  • The need to confirm that they are HIV-negative before starting to take emtricitabine and tenofovir disoproxil fumarate to reduce the risk of acquiring HIV-1.
  • That 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.
  • The importance of taking emtricitabine and tenofovir disoproxil fumarate on a regular dosing schedule and strict adherence 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.
  • That emtricitabine and tenofovir disoproxil fumarate does not prevent other sexually acquired infections and should only be used as part of a complete prevention strategy including other prevention measures.
  • To use condoms consistently and correctly to lower the chances of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
  • The importance of knowing their HIV-1 status and the HIV-1 status of their partner(s).
  • The importance of virologic suppression in their partner(s) with HIV-1.
  • The need to get tested regularly for HIV-1 (at least every 3 months, or more frequently for some individuals such as adolescents) and to ask their partner(s) to get tested as well.
  • To report any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately.
  • That the signs and symptoms of acute infection include fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal).
  • To get tested for other sexually transmitted infections, such as syphilis, chlamydia, and gonorrhea, that may facilitate HIV-1 transmission.
  • To assess their sexual risk behavior and get support to help reduce sexual risk behavior.

Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV

Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued emtricitabine and tenofovir disoproxil fumarate [see Warnings and Precautions (5.1)]. Advise HBV-infected individuals to not discontinue emtricitabine and tenofovir disoproxil fumarate without first informing their healthcare provider.

New Onset or Worsening Renal Impairment

Inform HIV-1 infected patients and uninfected individuals that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of TDF, a component of emtricitabine and tenofovir disoproxil fumarate. Advise patients to avoid emtricitabine and tenofovir disoproxil fumarate with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Warnings and Precautions (5.3)]. The 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 HIV-1 PrEP 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 HIV-1 PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [see Dosage and Administration (2.6)].

Immune Reconstitution Syndrome

Inform HIV-1 infected patients that in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients to inform their healthcare provider immediately of any symptoms of infection [see Warnings and Precautions (5.4)].

Bone Loss and Mineralization Defects

Inform patients that decreases in bone mineral density have been observed with the use of TDF 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 Warnings and Precautions (5.5)].

Lactic Acidosis and Severe Hepatomegaly

Inform HIV-1 infected patients and uninfected individuals that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with emtricitabine and tenofovir disoproxil fumarate should be suspended in any person who develops clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.6)].

Drug Interactions

Advise individuals that emtricitabine and tenofovir disoproxil fumarate may interact with many drugs; therefore, advise individuals to report to their healthcare provider the use of any other medication, including other HIV drugs and drugs for treatment of hepatitis C virus [see Warnings and Precautions (5.7) and Drug Interactions (7)].

Dosage Recommendations for Treatment of HIV-1 Infection

Inform HIV-1 infected patients that it is important to take emtricitabine and tenofovir disoproxil fumarate with other antiretroviral drugs for the treatment of HIV-1 on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance.

Pregnancy Registry

Inform individuals using emtricitabine and tenofovir disoproxil fumarate for HIV-1 treatment or HIV-1 PrEP that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to emtricitabine and tenofovir disoproxil fumarate [see Use in Specific Populations (8.1)].

Lactation

Instruct mothers not to breastfeed if they are taking emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection or if acute HIV-1 infection is suspected in a mother taking emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP because of the risk of passing the HIV-1 virus to the baby. In HIV-uninfected women, the benefits and risks of emtricitabine and tenofovir disoproxil fumarate while breastfeeding should be evaluated, including the risk of HIV-1 acquisition due to medication nonadherence and subsequent mother to child transmission [see Use in Specific Populations (8.2)].

ATRIPLA, COMPLERA, EMTRIVA, EPCLUSA, HARVONI, SOVALDI, STRIBILD, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.

Manufactured by

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev: 03/21

Medication Guide Emtricitabine (em” trye sye’ ta been) and Tenofovir Disoproxil Fumarate (ten of’ oh vir dye” soe prox’ il fue’ ma rate) Tablets
Read this Medication Guide before you start taking emtricitabine and tenofovir disoproxil fumarate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. This Medication Guide provides information about two different ways that emtricitabine and tenofovir disoproxil fumarate tablets may be used. See the section “What are emtricitabine and tenofovir disoproxil fumarate tablets?” for detailed information about how emtricitabine and tenofovir disoproxil fumarate tablets may be used.
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 are 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
  • fever
  • joint or muscle aches
  • headache
  • sore throat
  • vomiting or diarrhea
  • rash
  • night sweats
  • enlarged lymph nodes in the neck or groin
While you are taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP:
  • Emtricitabine and tenofovir disoproxil fumarate tablet 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 tablet by itself is 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.
What are emtricitabine and tenofovir disoproxil fumarate tablets? Emtricitabine and tenofovir disoproxil fumarate tablets are prescription medicine that may be used in two different ways. Emtricetabine 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 tablet contains 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 is 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).
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 itself is 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 tablets 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.
How should I take emtricitabine and tenofovir disoproxil fumarate tablets?
  • Take emtricitabine and tenofovir disoproxil fumarate tablets exactly as your healthcare provider tells you to take it.
  • If you take emtricitabine and tenofovir disoproxil fumarate tablets to treat HIV-1 infection, you need to take other HIV-1 medicines. Your healthcare provider will tell you what medicines to take and how to take them.
  • Take emtricitabine and tenofovir disoproxil fumarate tablets 1 time each day with or without food.
  • Children who take emtricitabine and tenofovir disoproxil fumarate tablets are prescribed a lower strength tablet than adults. Children should swallow the emtricitabine and tenofovir disoproxil fumarate tablet. Tell your healthcare provider if your child cannot swallow the tablet, because they may need a different HIV-1 medicine.
  • Your healthcare provider will change the dose of emtricitabine and tenofovir disoproxil fumarate tablets as needed based on your child’s weight.
  • Do not change your dose or stop taking emtricitabine and tenofovir disoproxil fumarate tablets without first talking with your healthcare provider. Stay under a healthcare provider’s care when taking emtricitabine and tenofovir disoproxil fumarate tablets. Do not miss a dose of emtricitabine and tenofovir disoproxil fumarate tablets.
  • If you take too much emtricitabine and tenofovir disoproxil fumarate tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
  • When your emtricitabine and tenofovir disoproxil fumarate tablets supply starts to run low, get more from your healthcare provider or pharmacy.
○ If you are taking emtricitabine and tenofovir disoproxil fumarate tablets for treatment of HIV-1, the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to emtricitabine and tenofovir disoproxil fumarate tablets and become harder to treat. ○ If you are taking emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, missing doses increases your risk of getting HIV-1 infection.
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
  • nausea
  • tiredness
  • headache
  • dizziness
  • depression
  • problems sleeping
  • abnormal dreams
  • rash
Common side effects in people who take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP include:
  • headache
  • stomach-area (abdomen) pain
  • 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 may report side effects to FDA at 1-800-FDA-1088.
How should I store emtricitabine and tenofovir disoproxil fumarate tablets?
  • Store emtricitabine and tenofovir disoproxil fumarate tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep emtricitabine and tenofovir disoproxil fumarate tablets in its original container.
  • Keep the container tightly closed.
  • Do not use emtricitabine and tenofovir disoproxil fumarate tablets if seal over bottle opening is broken or missing.
Keep emtricitabine and tenofovir disoproxil fumarate tablets and all other medicines out of reach of children.
General information about emtricitabine and tenofovir disoproxil fumarate tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use emtricitabine and tenofovir disoproxil fumarate tablets for a condition for which it was not prescribed. Do not give emtricitabine and tenofovir disoproxil fumarate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about emtricitabine and tenofovir disoproxil fumarate tablets that is written for health professionals.
What are the ingredients in emtricitabine and tenofovir disoproxil fumarate tablets? Active ingredients: emtricitabine and tenofovir disoproxil fumarate. Inactive ingredients: croscarmellose sodium, glyceryl monocaprylocaprate type I, hypromellose, kaolin, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch (maize), sodium lauryl sulfate, sodium stearyl fumarate and titanium dioxide. This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Rev.: 12/20

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