Pronunciation:

ef-a-VYE-renz, em-trye-SYE-ta-been, te-NOE-fo-veer dye-soe-PROX-il FOO-ma-rate

Brand Names:

• Atripla

Dosage Forms:

• Tablet

Warnings:

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.

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

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine or tenofovir. Monitor hepatic function upon discontinuation of therapy .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Non-Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Efavirenz, emtricitabine, and tenofovir combination is used alone or with other anti-HIV medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS) .

This medicine does not cure or prevent HIV or AIDS, but it may slow the worsening of the disease. It 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 have not been performed on the relationship of age to the effects of efavirenz, emtricitabine, and tenofovir combination in children up to 18 years of age. Safety and efficacy have not been established .

Older adults—

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

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Bepridil
• Cisapride
• Dihydroergotamine
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Methylergonovine
• Methysergide
• Midazolam
• Pimozide
• St John's Wort
• Triazolam

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:

• Alcohol or drug abuse—May increase the side effect of this medicine, such as dizziness or drowsiness.

• Infections—When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor .

• Bone problems or
• Kidney problems or
• Liver disease (especially hepatitis B infection) or
• Mental illness (severe depression) or
• Seizure history—Use with caution. Condition may worsen .

Proper Use of This Medicine:

Do not change the dose or stop using this medicine without checking with your doctor first. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine .

You should take this medicine on an empty stomach .

Take this medicine at the same time each day, preferably at bedtime .

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 (tablets):
    • Adults—1 tablet once a day with water. Each tablet contains 600 milligrams (mg) of efavirenz, 200 mg emtricitabine and 300 mg of tenofovir disoproxil fumarate.
    • Children—Use and dose must be determined by your doctor .

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—

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

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.

Precautions While Using This Medicine:

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

You should not use any of the following medicines while you are taking efavirenz, emtricitabine, and tenofovir:

• Astemizole (e.g., Hismanal®).
• Cisapride (e.g., Propulsid®).
• Ergot medicine (e.g., Wigraine® or Cafergot®).
• Lamivudine-containing medicines (e.g., Combivir®, Epivir®, Epivir-HBV®, Epzicom™, or Trizivir®).
• Midazolam (e.g., Versed®).
• Other anti-HIV medicines containing efavirenz, emtricitabine, and tenofovir (e.g., Emtriva®, Sustiva®, Truvada®, or Viread®).
• Triazolam (e.g., Halcion®).
• Voriconazole (e.g., Vfend®) .

A rare but serious reaction to this medicine is lactic acidosis (build-up of acid in the blood) and liver toxicity, including an enlarged liver. This is 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 experience abdominal discomfort or cramping, nausea, vomiting, diarrhea, decreased appetite, discomfort, muscle cramping or pain, or unusual tiredness or weakness, trouble breathing, or if your skin or eyes have turned yellow .

This medicine may increase your risk of having serious mental or behavioral problems. Tell your doctor if you develop any mood changes, strange thoughts, or any unusual behavior while you are using this medicine .

This medicine may also increase your risk of developing fractures. Ask your doctor about this if you have any concerns .

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. This medicine may cause harm to the fetus if used during the first three months of pregnancy or if you become pregnant upon taking this medicine .

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control. Other forms include condoms, a diaphragm, or contraceptive foam or jelly .

You must avoid breast-feeding if you have HIV or AIDS, because you may give the infection to your baby through your breast milk .

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

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert .

While you are taking this medicine, be careful to limit the amount of alcohol that you drink .

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:

Less common

Abdominal pain or tenderness

blistering, peeling, loosening of skin, itching

body aches or pain

chills

clay colored stools

cough

dark urine

ear congestion

fever

headache

itching

loss of voice

muscle aches

nasal congestion

nausea and vomiting

right upper abdominal pain and fullness

severe skin rash

shortness of breath

sneezing

sore throat

swelling of feet or lower legs

tightness of chest

trouble breathing

trouble concentrating

wheezing

yellow eyes or skin

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

Diarrhea

dizziness

unusual tiredness or weakness

Less common

Abnormal dream

decreased appetite

discouragement

feeling sad or empty

irritability

loss of appetite

loss of interest or pleasure

mild rash

pain or tenderness around eyes and cheekbones

sleepiness

sleeplessness

stuffy or runny nose

trouble sleeping

unable to sleep

unusual drowsiness

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