Brand Name(s): Sustiva

Generic Name Efavirenz

What are efavirenz capsules?

EFAVIRENZ (Sustiva®) is an antiviral drug called a nonnucleoside reverse transcriptase inhibitor or NNRTI. Efavirenz is used to treat human immunodeficiency virus (HIV) infection. Efavirenz may reduce the amount of HIV in the blood and increase the number of CD4 cells (T-cells) in the blood. Efavirenz is used in combination with other drugs to treat the HIV virus. Efavirenz will not cure or prevent HIV infection or AIDS. You may still develop other infections or conditions associated with HIV. Generic efavirenz capsules or tablets are not yet available.

What should my health care professional know before I take efavirenz?

They need to know if you have any of these conditions:

• liver disease or hepatitis
• high levels of cholesterol or lipids in your blood
• history of mental illness (like depression), substance abuse, or alcohol abuse
• history of seizures or convulsions
• an unusual or allergic reaction to efavirenz, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take efavirenz by mouth. Follow the directions on the prescription label. Swallow capsules or tablets with a drink of water. Efavirenz should be taken on an empty stomach at bedtime. Do not take your medicine more often than directed.

If you can not swallow capsules, efavirenz capsules may be opened so the powder inside can be added to a small amount of liquid or food. Efavirenz has a peppery taste, some people disguise this taste by mixing efavirenz with grape jelly. Once mixed, eat or drink the full amount to make sure you get the entire dose.

To make sure that your medication works as well as possible to treat your condition, take all of your medicine exactly as prescribed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you need help in planning the best times to take your medicine, ask your prescriber or health care professional.

What drug(s) may interact with efavirenz?

Efavirenz can interact with a large number of other drugs. Make sure to discuss all of your medicines with your health care prescriber before starting efavirenz or any other new medicine.

The following drugs should NOT be taken with efavirenz:

• alprazolam (Xanax®)
• astemizole (Hismanal®)
• cisapride (Propulsid®)
• ergotamine medicines (Cafergot®, Migranal®, D.H.E. 45®, and others)
• midazolam (Versed®)
• St. John's wort or products containing St. John's Wort
• terfenadine (Seldane®)
• triazolam (Halcion®)

As an interaction is possible, discuss your medicines with your prescriber before taking any these drugs with efavirenz:

• anti-HIV protease inhibitors (Agenerase®, Crixivan®, Fortovase®, Invirase®, Kaletra™, Norvir®, and Viracept™)
• amiodarone
• birth control pills or other hormonal birth control medicines (like the patch, ring, or injections)
• clarithromycin
• cyclosporine
• imatinib, STI-571
• itraconazole
• ketoconazole
• levomethadyl
• lovastatin
• certain medicines for anxiety or difficulty sleeping
• medicines to control seizures (e.g., Dilantin®, Tegretol®, phenobarbital, and others)
• methadone
• nelfinavir
• omeprazole
• pimozide
• rifabutin
• rifampin
• sildenafil
• simvastatin
• sirolimus
• tacrolimus
• tolbutamide
• tolterodine
• topiramate
• warfarin
• went yeast (Cholestin™)
• zonisamide

Tell your prescriber or health care professional about all other medicines you are taking, including nonprescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking efavirenz?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• changes in behavior including severe depression, strange thoughts, thoughts of suicide, or angry behavior
• hallucinations (seeing things that are not there)
• skin rash, especially in children or if it is associated with redness, blistering, peeling or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• abnormal dreams
• diarrhea
• difficulty sleeping
• dizziness
• drowsiness
• nausea, vomiting
• trouble concentrating
• upset stomach

Many of these effects tend to improve after the first two weeks of taking efavirenz. Also, taking efavirenz at bedtime helps with some of the effects such as dizziness and drowsiness.

What should I watch for while taking efavirenz?

Visit your prescriber or health care professional for regular checks on your progress. Discuss any new symptoms with your prescriber or health care professional.

Efavirenz will not cure HIV and you can still get other illnesses or complications associated with your health condition. Taking efavirenz does not reduce the risk of passing HIV infection to others through sexual or blood contact. It is best to avoid sexual contact so that you do not spread the disease to others. For any sexual contact, use a condom. Be careful about cuts, abrasions and other possible sources of blood contact. Never share a needle or syringe with anyone.

Skin rash is common in people taking efavirenz. The rash is most common 1—2 weeks after you start taking efavirenz, and it usually lasts no more than a month. If you notice a severe rash or a rash accompanied by fever, blisters, mouth sores, and/or eye irritation, contact your prescriber immediately. Patients who develop these symptoms may need to stop treatment with efavirenz. If any type of rash develops in a child taking efavirenz contact the prescriber immediately. Rash may be a serious problem in children.

Efavirenz may cause dizziness, problems concentrating, and/or drowsiness. Therefore, do not drive or operate heavy machinery until you know how you will react to efavirenz. These symptoms may decrease or go away after 4 months. Drinking alcohol or alcohol-containing beverages may worsen these effects. Contact your health care prescriber if you experience side effects that affect your mood or concentration.

Changes in body fat develop in some patients taking anti-HIV medicines. These changes may include an increased amount of fat in the upper back and neck ('buffalo hump'), in the breasts, and around the mid-section of the body. Loss of fat from the legs, arms and face may also occur. The cause and long-term health effects of these changes is not known.

If you are a women of childbearing age and are using hormone contraceptives, then you should use another form of birth control while taking efavirenz. Efavirenz may decrease the effectiveness of hormone birth control agents, including pills, injections, and implants. When taking efavirenz, women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control.

For help in finding information on insurance coverage and reimbursement, the manufacturer has an assistance program that can be reached at 1—800—272—4878.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 °C (59 and 86 °F). Throw away any unused medicine after the expiration date.