Pronunciation:

em-trye-SYE-ta-been

Brand Names:

• Emtriva

Dosage Forms:

• Capsule
• Solution

Warnings:

Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. 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 emtricitabine. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of emtricitabine in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment of the dose in patients receiving emtricitabine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Acyclovir
• Amikacin
• Amikacin Liposome
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Cabotegravir
• Capreomycin
• Celecoxib
• Choline Salicylate
• Cidofovir
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ganciclovir
• Gentamicin
• Horsetail
• Ibuprofen
• Indomethacin
• Kanamycin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Neomycin
• Nepafenac
• Netilmicin
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Orlistat
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Paromomycin
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Plazomicin
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Spectinomycin
• Streptomycin
• Sulindac
• Tacrolimus
• Tenoxicam
• Tiaprofenic Acid
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Valacyclovir
• Valdecoxib
• Valganciclovir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or
• Liver disease (including hepatitis B)—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe (requires dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

It is important to take emtricitabine as part of a combination regimen. Take all other medicines your doctor prescribed at the right time of the day. This will make your medicines work better.

Keep using emtricitabine for the full time of treatment, even if you or your child begin to feel better. Do not stop using it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

You may take this medicine with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of HIV infection:
  • For oral dosage form (capsules):
    • Adults—200 milligrams (mg) once a day.
    • Children 3 months to 17 years of age and weighs more than 33 kilograms (kg) who can swallow an intact capsule—200 mg once a day.
    • Children younger than 3 months of age or weighs less than 33 kg—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults—240 milligrams (mg) or 24 milliliters (mL) once a day.
    • Children 3 months to 17 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 6 milligrams (mg) per kilograms (kg) of body weight per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 240 mg (24 mL) per day.
    • Children up to 3 months of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 3 mg per kg of body weight per day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the capsules in a closed container at room temperature, away from heat, moisture, and direct light.

Store the oral liquid in the refrigerator. Do not freeze. You may also keep it at room temperature for up to 3 months. Throw away any unused oral liquid after 3 months.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you or your child are also taking lamivudine, Atripla®, Combivir®, Complera®, Epivir®, Epivir-HBV®, Epzicom®, Odefsey®, Stribild®, Triumeq®, Trizivir®, or Truvada®. Tell your doctor right away if you or your child are using any of these medicines. Do not start using emtricitabine until your doctor tells you to.

Two rare but serious reactions to this medicine are lactic acidosis (build up of acid in the blood) and liver toxicity. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have abdominal or stomach discomfort or cramping, dark urine, a decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Do not change your dose or stop using this medicine, even for a short time, without talking to your doctor.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

chest pain or tightness

chills

cough

diarrhea

difficulty in breathing

ear congestion

earache

fever

headache

hoarseness

loss of appetite

loss of voice

lower back or side pain

nasal congestion

nausea

painful or difficult urination

pale skin

redness or swelling in the ear

runny nose

sneezing

sore throat

stomach pain

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Bloody urine

blurred vision

dry mouth

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

sweating

unexplained weight loss

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abnormal dreams

belching

darkening of the skin

difficulty in moving

discouragement

feeling sad or empty

heartburn

indigestion

irritability

joint pain or swelling

lack or loss of strength

loss of interest or pleasure

muscle pain, cramps, or stiffness

skin rash

stomach discomfort or upset

trouble concentrating

trouble sleeping

Less common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dizziness

stabbing pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.