(em tri sit' uh bean)

Brand Name(s): Emtriva^®

IMPORTANT WARNING:

Emtricitabine should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection). Tell your doctor if you have or think you may have HBV. Your doctor may test you to see if you have HBV before you begin your treatment with emtricitabine. If you have HBV and you take emtricitabine, your condition may suddenly worsen when you stop taking emtricitabine. Your doctor will examine you and order lab tests regularly for several months after you stop taking emtricitabine to see if your HBV has worsened.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to emtricitabine. Talk to your doctor about the risks of taking emtricitabine.

WHY is this medicine prescribed?

Emtricitabine is used along with other medications to treat human immunodeficiency virus (HIV) infection. Emtricitabine is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood. Although emtricitabine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Emtricitabine comes as a capsule and an oral solution (liquid) to take by mouth. It is usually taken once a day with or without food. Take emtricitabine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take emtricitabine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Emtricitabine controls HIV infection but does not cure it. Continue to take emtricitabine even if you feel well. Do not stop taking emtricitabine without talking to your doctor. When your supply of emtricitabine starts to run low, get more from your doctor or pharmacist. If you miss doses or stop taking emtricitabine, your condition may become more difficult to treat.

Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking emtricitabine,

• tell your doctor and pharmacist if you are allergic to emtricitabine, any other medications. or any of the ingredients in emtricitabine capsules and oral solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other HIV medications containing emtricitabine (Atripla, Complera, Descovy, Genvoya, Odefsey, Stribild, Truvada) or containing lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, Triumeq, Trizivir, others). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section, any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems), or liver or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking emtricitabine, call your doctor. Tell your doctor if you are breastfeeding. You should not breastfeed if you are infected with HIV or if you are taking emtricitabine.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body. This may cause you to develop symptoms of those infections. If you have new or worsening symptoms after starting treatment with emtricitabine, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take more than one dose of emtricitabine in one day and do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Emtricitabine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• change in skin color, especially on the palms of the hands or the soles of the feet
• indigestion
• diarrhea
• nausea
• joint pain
• unusual dreams
• depression
• difficulty falling asleep or staying asleep
• numbness, burning, or tingling in the hands, arms, feet, or legs
• runny nose
• sinus pain

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately:

• fever, chills, sore throat, cough, or other signs of infection
• rash
• shortness of breath
• fast breathing
• fast or abnormal heartbeat
• pain in upper right part of stomach
• nausea
• vomiting
• dark yellow or brown urine
• light-colored bowel movements
• yellowing of skin or eyes
• loss of appetite
• weakness
• feeling cold, especially in the arms or legs
• extreme tiredness
• dizziness or lightheadedness
• muscle pain

Emtricitabine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the capsules at room temperature and away from excess heat and moisture (not in the bathroom). Store the oral solution in the refrigerator, but do not freeze it. If you prefer not to refrigerate the oral solution, you may store it at room temperature for up to 3 months. Discard any unused oral solution that has not been refrigerated after 3 months.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of emtricitabine on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2018.