Emtriva

• Gilead Sciences, Inc.

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals.

Emtriva is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Emtriva have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Emtriva. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Your pharmacist can provide more information about emtricitabine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Emtricitabine is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Emtricitabine is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Emtricitabine is not a cure for HIV or AIDS.

Emtricitabine may also be used for purposes not listed in this medication guide.

Other drugs may interact with emtricitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Contraindications

• Known hypersensitivity to emtricitabine or any ingredient in the formulation.1

• Emtricitabine/tenofovir alafenamide (Descovy): Manufacturer states none known.245

• Emtricitabine/tenofovir DF: Do not use alone for treatment of HIV-1 infection;230 do not use for preexposure prophylaxis of HIV-1 infection in individuals with unknown or positive HIV-1 status.230 (See Precautions Related to HIV-1 Preexposure Prophylaxis [PrEP] under Cautions.)

• Efavirenz/emtricitabine/tenofovir DF (Atripla): History of clinically important hypersensitivity reaction (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic skin eruption) to efavirenz;232 concomitant use with voriconazole contraindicated (because of efavirenz component).232

• Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) or emtricitabine/rilpivirine/tenofovir DF (Complera): Concomitant use with certain drugs that induce CYP3A or elevate gastric pH contraindicated (because of rilpivirine component);233 244 substantially decreased plasma concentrations of rilpivirine may occur and may result in loss of virologic response and development of resistance to rilpivirine and/or class resistance to HIV NNRTIs.233 244

• Fixed combinations containing emtricitabine: Consider contraindications associated with each drug in the fixed combination.230 232 233 244 245

Warnings/Precautions

Warnings

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving HIV NRTIs, including emtricitabine with or without a tenofovir prodrug, in conjunction with other antiretrovirals.1 230 232 233 244 245 Reported most frequently in women;1 230 232 233 244 245 obesity and long-term NRTI therapy also may be risk factors.1 230 232 233 244 245 Cases reported in patients with no known risk factors.1 230 232 233 244 245

Use emtricitabine (single entity or fixed combinations) with caution in patients with known risk factors for liver disease.1 230 232 233 244 245

Discontinue if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).1 230 232 233 244 245

Test all HIV-infected patients for presence of HBV before initiating antiretroviral therapy.1 230 232 233 244 245

Emtricitabine (single entity or fixed combinations) not indicated for treatment of chronic HBV infection.1 230 232 233 244 245

Safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV.1 230 232 233 244 245 (See Treatment of HIV Infection under Uses.)

Severe acute exacerbations of HBV reported following discontinuance of emtricitabine with or without a tenofovir prodrug.1 230 232 233 244 245 HBV exacerbations have been associated with hepatic decompensation and hepatic failure.1 230 232 233 244 245

If emtricitabine (single entity or fixed combinations) used in patients coinfected with HIV and HBV, closely monitor hepatic function (using both clinical and laboratory follow-up) for at least several months after emtricitabine or fixed combinations containing emtricitabine are discontinued.1 230 232 233 244 245 If appropriate, initiation of HBV treatment may be warranted.1 230 232 233 244 245

Use emtricitabine/tenofovir DF (Truvada) for HIV-1 PrEP only in HIV-1-negative adults at high risk.230

Confirm a negative HIV-1 test immediately prior to initiating PrEP and screen for HIV-1 infection at least once every 3 months during PrEP.230 Also test for HBV prior to initiating PrEP.230 (See Individuals with HBV Infection under Cautions.)

Emtricitabine/tenofovir DF PrEP not always effective in preventing acquisition of HIV-1 infection.230

Must be used as part of a comprehensive HIV prevention strategy that includes other prevention measures (e.g., safer sex practices).230 (See REMS.) Counsel all uninfected individuals about safer sex practices that include consistent and correct use of condoms, knowledge of their own HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (e.g., syphilis, gonorrhea).230 Inform and support uninfected individuals regarding efforts to reduce sexual risk behavior.230

Because emtricitabine/tenofovir DF alone does not constitute a complete antiretroviral regimen for treatment of HIV-1 infection, HIV-1 resistance-associated mutations may emerge if emtricitabine/tenofovir DF PrEP is used in individuals with undetected HIV-1 infection.230 Drug-resistant HIV-1 variants have been identified in such individuals.230

Many HIV-1 tests (e.g., rapid tests) detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection.230 Prior to initiating PrEP, evaluate HIV-negative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, rash) and ask about any potential exposure events within the last month (e.g., unprotected sex, condom broke during sex with HIV-infected partner).230

If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures to HIV-1 are suspected, delay initiating PrEP for at least 1 month and reconfirm HIV-1 status or use a test approved by FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection.230

During PrEP, if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, discontinue the drugs until negative infection status is confirmed using a test approved by FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection.230

Counsel uninfected individuals to strictly adhere to recommended emtricitabine/tenofovir DF dosage schedule.230 (See Preexposure Prophylaxis [PrEP] for Prevention of HIV-1 Infection under Dosage and Administration.) Effectiveness in reducing risk of acquiring HIV-1 is strongly correlated with adherence.230

Adverse effects similar to those reported in HIV-infected patients receiving the drugs for treatment of HIV-1 infection.230

Other Warnings/Precautions

Emtricitabine/tenofovir alafenamide, emtricitabine/tenofovir DF, efavirenz/emtricitabine/tenofovir DF, emtricitabine/rilpivirine/tenofovir alafenamide, emtricitabine/rilpivirine/tenofovir DF: Consider cautions, precautions, contraindications, and interactions associated with each drug in the fixed combination.230 232 233 244 245 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug.230 232 233 244 245

Because the antiretrovirals contained in the fixed-combination preparations also may be available in single-entity or other fixed-combination preparations, take care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals.230 232 233 244 245

Do not use multiple emtricitabine-containing preparations concomitantly.1 230 232 233 244 245

Because of similarities between emtricitabine and lamivudine, do not use emtricitabine (single entity or fixed combinations) concomitantly with any preparation containing lamivudine.1 200 232 233 244 245 In addition, do not use fixed combinations containing tenofovir DF concomitantly with adefovir.200 232 233

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, breast enlargement, and general cushingoid appearance.1 230 232 233 244 245

Mechanisms and long-term consequences of adipogenic effects unknown; causal relationship not established.1 230 232 233 244 245

During initial treatment, HIV-infected patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii]);1 230 232 233 244 245 this may necessitate further evaluation and treatment.1 230 232 233 244 245

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported in the setting of immune reconstitution;1 230 232 233 244 245 time to onset is more variable and can occur many months after initiation of antiretroviral therapy.1 230 232 233 244 245

Specific Populations

Emtricitabine (Emtriva): Category B.1 230 233

Emtricitabine/tenofovir alafenamide (Descovy): Insufficient human data to assess risk of birth defects and miscarriage if used in pregnant women.245

Emtricitabine/tenofovir DF (Truvada): Category B.230 233

Efavirenz/emtricitabine/tenofovir DF (Atripla): Category D.232

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Insufficient human data to assess risk of birth defects and miscarriage if used in pregnant women.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Category B.233

Antiretroviral Pregnancy Registry at 800-258-4263 or .1 202 230 232 233 244 245

Experts state that emtricitabine and tenofovir DF is a preferred dual NRTI option for use in conjunction with an INSTI, NNRTI, or PI for initial treatment of HIV-1 infection in antiretroviral-naive pregnant women, and is a preferred dual NRTI option in pregnant HIV-infected women coinfected with HBV.202

Experts state that the dual NRTI option of tenofovir DF and emtricitabine in conjunction with the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir) is a preferred regimen for treatment of HIV type 2 (HIV-2) infection† in pregnant women.202

If HIV-negative woman receiving emtricitabine/tenofovir DF (Truvada) for HIV-1 PrEP becomes pregnant, carefully consider whether PrEP regimen should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy.230

Emtricitabine distributed into human milk in low concentrations.1 34

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.1 202 230 232 233 244 245

Emtricitabine (Emtriva): Safety and efficacy for treatment of HIV-1 infection in pediatric patients ≥3 months of age is supported by evidence from studies in pediatric patients.1 Adverse effects reported in children similar to adults.1 Pharmacokinetics evaluated in a limited number of neonates born to HIV-infected mothers; efficacy in preventing or treating HIV infection in these neonates not determined.1 20

Emtricitabine/tenofovir alafenamide (Descovy): Should not be used in pediatric patients <12 years of age or weighing <35 kg.245

Emtricitabine/tenofovir DF (Truvada): Safety and efficacy for treatment of HIV-1 infection not established in pediatric patients weighing <17 kg;230 safety and efficacy for HIV-1 PrEP not established in pediatric patients.230

Efavirenz/emtricitabine/tenofovir DF (Atripla): Do not use in pediatric patients <12 years of age or weighing <40 kg.232

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Safety and efficacy not established in pediatric patients <12 years of age or weighing <35 kg.244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Safety and efficacy not established in pediatric patients <12 years of age or weighing <35 kg.233

Insufficient experience in those ≥65 years of age to determine whether they respond differently to emtricitabine (single-entity or fixed-combination preparations) than younger adults.1 230 232 233

Emtricitabine not metabolized by liver enzymes; any impact of hepatic impairment expected to be limited.1 (See Hepatic Impairment under Dosage and Administration.)

Emtricitabine/tenofovir alafenamide (Descovy): Not studied in patients with severe hepatic impairment (Child-Pugh class C).245

Emtricitabine/tenofovir DF (Truvada): Not studied in patients with hepatic impairment.230

Efavirenz/emtricitabine/tenofovir DF (Atripla): Not recommended in those with moderate or severe hepatic impairment.232

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Not studied in patients with severe hepatic impairment (Child-Pugh class C).244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Not studied in patients with severe hepatic impairment (Child-Pugh class C).233

Dosage adjustment of emtricitabine (Emtriva) necessary based on degree of renal impairment.1 Monitor clinical response and renal function in patients with renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Emtricitabine/tenofovir alafenamide (Descovy): Not recommended in patients with severe renal impairment (estimated Clcr <30 mL/minute).245

Emtricitabine/tenofovir DF (Truvada): Do not use for treatment of HIV-1 in patients with Clcr <30 mL/minute or patients with end-stage renal disease requiring dialysis.230 Do not use for PrEP in HIV-1 uninfected adults with Clcr <60 mL.230 If Clcr decreases during emtricitabine/tenofovir DF (Truvada) PrEP, evaluate potential causes and reassess potential risks and benefits of continued use.230

Efavirenz/emtricitabine/tenofovir DF (Atripla): Do not use in those with estimated Clcr <50 mL/minute.232

Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey): Not recommended in those with severe renal impairment (estimated Clcr <30 mL/minute).244

Emtricitabine/rilpivirine/tenofovir DF (Complera): Do not use in those with moderate, severe, or end-stage renal impairment (estimated Clcr <50 mL/minute) or if dialysis required.233

Common Adverse Effects

Mild to moderate headache, GI effects (diarrhea, nausea), rash.1

• Emtricitabine is an HIV NRTI.1 26 Inactive until converted intracellularly to an active 5′-triphosphate metabolite.1 26

• Active in vitro against HIV-1 and HIV-2.1 Also has some activity against HBV.5 7

• Inhibits replication of HIV by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).1

• HIV-1 with reduced susceptibility to emtricitabine have been produced in vitro and have emerged during therapy with the drug.1

• HIV resistant to emtricitabine may be cross-resistant to some other NRTIs (e.g., lamivudine).1

• Cross-resistance between emtricitabine and PIs is highly unlikely since the drugs have different target enzymes.200 Cross-resistance between emtricitabine and NNRTIs is considered to be low since the drugs bind at different sites on reverse transcriptase and have different mechanisms of action.200

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Emtricitabine is used in combination with other medicines for the treatment of the infection caused by human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Emtricitabine will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Emtricitabine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Emtriva is available as capsules and oral solution.

Emtriva capsules, containing 200 mg of emtricitabine, are size 1 hard gelatin capsules with a blue cap and white body, printed with "200 mg" in black on the cap and "GILEAD" and the corporate logo in black on the body.

Emtriva oral solution is a clear, orange to dark orange liquid containing 10 mg of emtricitabine per mL.

Emtriva® (em-treev'-ah) capsules

Emtriva oral solution

Generic name: emtricitabine (em tri SIT uh bean)

Read the Patient Information that comes with Emtriva before you start using it 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 treatment.

You should stay under a healthcare provider's care when taking Emtriva. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about Emtriva.

What is the most important information I should know about Emtriva?

If you are also infected with the Hepatitis B Virus (HBV), you need close medical follow-up for several months after stopping treatment with Emtriva. Follow-up includes medical exams and blood tests to check for HBV that is getting worse. Patients with HBV infection who take Emtriva and then stop it may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before.

What is Emtriva?

Emtriva is a type of medicine called an HIV-1 (human immunodeficiency virus) nucleoside reverse transcriptase inhibitor (NRTI). Emtriva is always used with other anti-HIV-1 medicines to treat people with HIV-1 infection. Emtriva is for adults and children, but has not been studied fully in adults over age 65.

HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

Emtriva helps to block HIV-1 reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV-1 to multiply. Emtriva may lower the amount of HIV-1 in the blood (viral load). Emtriva may also help to increase the number of T cells, called CD4+ cells. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

Emtriva does not cure HIV-1 infection or AIDS. The long-term effects of Emtriva are not known at this time. People taking Emtriva may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your healthcare provider regularly while taking Emtriva.

Who should not take Emtriva?

Do not take Emtriva if you are allergic to Emtriva or any of its ingredients. The active ingredient is emtricitabine. See the end of this leaflet for a complete list of ingredients.

Do not take Emtriva if you are already taking ATRIPLA®, COMPLERA®, DESCOVY®, GENVOYA®, ODEFSEY®, STRIBILD®, TRUVADA®, Combivir, Epivir, Epivir-HBV, Epzicom, Triumeq, or Trizivir because these medicines contain the same or similar active ingredients.

What should I tell my healthcare provider before taking Emtriva?

Tell your healthcare provider

If you are pregnant or planning to become pregnant. We do not know if Emtriva can harm your unborn child. You and your healthcare provider will need to decide if Emtriva is right for you. If you use Emtriva while you are pregnant, talk to your healthcare provider about how you can be on the Emtriva Antiviral Pregnancy Registry.

If you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, Emtriva can pass into your breast milk and it is not known if it can harm your baby. If you are a woman who has or will have a baby, talk with your healthcare provider about the best way to feed your baby.

If you have kidney problems. You may need to take Emtriva less often.

If you have any liver problems including Hepatitis B Virus infection.

Tell your healthcare provider about all your medical conditions.

Tell your healthcare provider about all the medicines you take such as prescription and nonprescription medicines and dietary supplements. Keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your healthcare providers and pharmacist every time you visit or fill a prescription.

How should I take Emtriva?

Take Emtriva by mouth exactly as your healthcare provider prescribed it. Follow the directions from your healthcare provider, exactly as written on the label.

• Dosing in adults: The usual dose of Emtriva is 1 capsule once a day.
• Dosing in children: The child's doctor will calculate the right dose of Emtriva (oral solution or capsule) based on the child's weight.

Emtriva is always used with other anti-HIV-1 medicines.

Emtriva may be taken with or without a meal. Food does not affect how Emtriva works.

If you forget to take Emtriva, take it as soon as you remember that day. Do not take more than 1 dose of Emtriva in a day. Do not take 2 doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do. It is important that you do not miss any doses of Emtriva or your other anti-HIV-1 medicines.

When your Emtriva supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because 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 Emtriva and become harder to treat.

Stay under a healthcare provider's care when taking Emtriva. Do not change your treatment or stop treatment without first talking with your healthcare provider.

If you take too much Emtriva, call your local poison control center or emergency room right away.

What should I avoid while taking Emtriva?

Avoid doing things that can spread HIV-1 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 or razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood.
• Do not breastfeed. Emtriva can be passed to your baby in your breast milk. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

What are the possible side effects of Emtriva?

Emtriva may cause the following serious side effects (See "What is the most important information I should know about Emtriva?"):

"flare-ups" of Hepatitis B Virus infection, in which the disease suddenly returns in a worse way than before, can occur if you stop taking Emtriva. Emtriva is not for the treatment of Hepatitis B Virus (HBV) infection.

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 Emtriva used with other anti-HIV-1 medicines are headache, diarrhea, and nausea. Other side effects include allergic reaction, dizziness, sleeping problems, abnormal dreams, vomiting, indigestion, stomach pain, pain, weakness, and rash. Skin discoloration may also happen with Emtriva.

There have been other side effects in patients taking Emtriva. However, these side effects may have been due to other medicines that patients were taking or to HIV-1 itself. Some of these side effects can be serious.

This list of side effects is not complete. If you have questions about side effects, ask your healthcare provider or pharmacist. You should report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects.

How do I store Emtriva?

• Keep Emtriva and all other medicines out of reach of children.
• Store Emtriva capsules between 59 °F and 86 °F (15 °C to 30 °C).
• Store Emtriva oral solution in a refrigerator between 36 °F and 46 °F (2 °C–8 °C). Do not freeze. Alternatively, the product may be stored at room temperature for up to 3 months and any remaining solution in the bottle must be discarded after the 3 months.
• Do not keep your medicine in places that are too hot or cold.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

General information about Emtriva:

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Emtriva for a condition for which it was not prescribed. Do not give Emtriva to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Emtriva. If you would like more information, talk with your doctor. You can ask your healthcare provider or pharmacist for information about Emtriva that is written for health professionals. For more information, you may also call 1-800-GILEAD5.

What are the ingredients of Emtriva?

Active Ingredient: emtricitabine

Inactive Ingredients for Emtriva capsules: Crospovidone, magnesium stearate, microcrystalline cellulose, povidone, titanium dioxide, gelatin, and FD&C blue No. 2.

Inactive Ingredients for Emtriva oral solution: Cotton candy flavor, FD&C yellow No. 6, edetate disodium, methylparaben and propylparaben, sodium phosphate (monobasic), propylene glycol, water, and xylitol. Sodium hydroxide and hydrochloric acid may be used to adjust pH.

Revised: April 2017

© 2017 Gilead Sciences, Inc. All rights reserved.

Manufactured for and distributed by:

Gilead Sciences, Inc.

Foster City, CA 94404

COMPLERA, DESCOVY, Emtriva, GENVOYA, ODEFSEY, STRIBILD, and TRUVADA are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.

21-500-896-GS-018

PRINCIPAL DISPLAY PANEL - Representative Bottle Label

NDC 61958-0601-1

Emtriva®
(emtricitabine)
Capsules, 200 mg

30 capsules

Rx only

PRINCIPAL DISPLAY PANEL - 170 mL Bottle Carton

NDC-61958-0602-1

Emtriva®
(emtricitabine)
Oral Solution
10 mg/mL

170 mL

Rx only

Each mL contains
10 mg of emtricitabine

GILEAD

Emtriva (emtricitabine) is an antiviral medication that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Emtriva is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Emtricitabine is not a cure for HIV or AIDS.

Emtriva may also be used for purposes not listed in this medication guide.

Emtriva should not be taken together with any HIV combination medicine that contains Emtriva or lamivudine. This includes: Atripla, Combivir, Complera, Epivir, Epzicom, Stribild, Trizivir, and Truvada.

Emtriva may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Emtriva may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Emtriva. Visit your doctor regularly.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.