Emtriva is an antiviral medicine 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).

Emtriva is not a cure for HIV or AIDS.

Do not take Emtriva if you also take other medicines that contain emtricitabine or lamivudine.

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.

If you have hepatitis B you may develop liver symptoms after you stop taking Emtriva, even months after stopping.

Take Emtriva exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Emtriva can be taken with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Emtricitabine doses are based on weight in children, and any changes may affect your child's dose.

Do not take Emtriva as your only HIV medication. HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

While using Emtriva, you may need frequent blood tests. Your kidney and liver function may also need to be checked.

Get your prescription refilled before you run out of medicine completely. Your disease may become resistant to emtricitabine if you stop taking the medication even for a short time.

Store capsules at room temperature away from moisture, heat, and direct light.

Store liquid in the refrigerator. Do not freeze.

Emtriva liquid kept at room temperature must be used within 3 months.

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.

Usual Adult Dose for HIV Infection:

Capsules: 200 mg orally once a day
Oral solution: 240 mg (24 mL) orally once a day

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Occupational Exposure:

(Not approved by FDA)

US Public Health Service working group recommendations:
Capsules: 200 mg orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Emtricitabine plus tenofovir plus raltegravir is recommended as the preferred regimen for HIV postexposure prophylaxis; emtricitabine is also recommended as a component in various alternative regimens.
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on the institution's protocol.
-The most current therapeutic guidelines should be consulted for more information.

Usual Adult Dose for Nonoccupational Exposure:

(Not approved by FDA)

CDC recommendations:
Capsules: 200 mg orally once a day
Duration of therapy: 28 days

Comments:
-Emtricitabine should be used in combination with efavirenz plus (tenofovir or zidovudine), or with lopinavir-ritonavir plus zidovudine.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.

Usual Pediatric Dose for HIV Infection:

Oral solution:
0 to 3 months: 3 mg/kg orally once a day
3 months through 17 years: 6 mg/kg orally once a day
Maximum dose: 240 mg (24 mL)

Capsules:
3 months through 17 years, weighing more than 33 kg, and able to swallow intact capsule: 200 mg orally once a day

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

You should not take Emtriva if you are allergic to emtricitabine.

Do not take Emtriva if you also use other medicines that contain emtricitabine or lamivudine (such as Atripla, Combivir, Complera, Descovy, Dutrebis, Epivir, Epzicom, Genvoya, Odefsey, Stribild, Triumeq, or Trizivir).

To make sure Emtriva is safe for you, tell your doctor if you have ever had:

• liver disease (especially hepatitis B); or

• kidney disease.

Some people taking this medicine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Emtriva on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Emtriva is not approved for use by anyone younger than 3 months old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Get emergency medical help if you have signs of an allergic reaction to Emtriva: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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.

Call your doctor at once if you have symptoms of liver problems: swelling around your midsection, upper stomach pain, nausea, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Emtriva may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with this medicine. Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

• trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Emtriva side effects may include:

• headache, dizziness, weakness;

• indigestion, stomach pain, nausea, vomiting, diarrhea;

• sleep problems, strange dreams;

• rash, skin discoloration; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with emtricitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.