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|Sustiva

EFAVIRENZ (Systemic)

Some commonly used brand names are:

In the U.S.—

• Sustiva

Category

• Antiviral (systemic)

Description

Efavirenz (eh-FAH-vih-rehnz) is used with other medicines in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Efavirenz will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Efavirenz 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, in the following dosage form(s):

• Oral
• Capsules (U.S.)
• Tablets (U.S.)

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 efavirenz, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to efavirenz. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Efavirenz has been shown to cause birth defects in humans. However, this medicine may be needed in serious diseases or other situations that threaten the mother"s life. A pregnancy test is recommended before starting treatment with efavirenz. In addition, it is recommended that women with the potential to become pregnant use two methods of contraception. One method of contraception should be a reliable barrier contraceptive, such as condoms, and the other method should be an oral or other hormone contraceptive, such as birth control pills. Before taking efavirenz, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether efavirenz passes into the breast milk. However, patients with HIV infection should not breast-feed because of the risk of passing the virus on to the nursing infant.

Children—Children have a higher risk of developing a rash, which is sometimes severe, while taking this medicine. Your doctor may suggest that an additional medicine, an antihistamine, be taken to prevent a rash from occurring. The appearance of a rash should be reported to your doctor as soon as possible.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of efavirenz in the elderly with use in other age groups.

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. It is important that you inform your health care professional of any prescription or nonprescription (OTC) medicine you are taking, especially if you are taking any of the following:

• Amprenavir (e.g., Agenerase)—Efavirenz may decrease the amount of this medicine in the body

• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid)—Efavirenz may increase the amount of these medicines in the body, which may cause cardiac arrythmias (irregular heartbeat)

• Ergot derivatives (e.g., Gerimal, Hydergine, Hydergine LC, Ergotrate, Methergine, Bellergal-S)—Efavirenz may increase the amount of these medicines in the body, which could lead to breathing problems

• Indinavir (e.g., Crixivan)—Efavirenz may decrease the amount of this medicine in the body

• Midazolam (e.g., Versed) or
• Triazolam (e.g., Halcion)—Efavirenz may increase the amount of these medicines in the body, which may lead to severe drowsiness

• Rifabutin (e.g., Mycobutin)—Efavirenz may decrease the amount of this medicine in the body

• Ritonavir (e.g., Norvir)—Taking efavirenz with this medicine may increase the chance of side effects

• Saquinavir (e.g., Invirase)—Efavirenz may decrease the amount of this medicine in the body

• St. John"s wort (Hypericum perforatum ) (herbal supplement) —Taking efavirenz with this herbal supplement may make your body resistant to efavirenz and it may lose its effect.

• Voriconazole (e.g., VFend)—Efavirenz should not be taken with this medicine. It can make voriconazole less effective for treating an infection.

• Warfarin (e.g., Coumadin)—Efavirenz may either increase or decrease the amount of warfarin in the body

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

• Alcohol or drug abuse history or
• Mental illness history—May increase the chance of having serious psychiatric side effects.

• Hepatitis B or C (history of) or
• Liver disease—Efavirenz may cause unwanted effects in the liver

• Seizures history—May increase chances of convulsions occurring

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. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking efavirenz for the full time of treatment even if you begin to feel better. It is also important that you continue taking all other medicines for HIV infection your doctor has instructed you to take. Efavirenz will not work if it is taken alone. It must be taken with other HIV medication.

Efavirenz should be taken on an empty stomach because the amount of efavirenz absorbed into the body may be increased when taken with food, which might increase the chance of side effects.

Take efavirenz at bedtime, especially during the first 2 to 4 weeks, to lessen central nervous system (CNS) side effects that may occur with this medicine. These effects usually lessen after you have been taking this medicine for awhile.

Dosing—The dose of efavirenz 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 efavirenz. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.

• For oral dosage form (capsules or tablets):
  • For treatment of HIV infection:
    • Adults—600 milligrams (mg) once a day, taken with other medicines.
    • Children 3 years of age and older (by weight)—
      • 10 to 15 kilograms (22 to 33 pounds) of body weight: 200 mg once a day, taken with other medicines.
      • 15 to 20 kilograms (33 to 44 pounds) of body weight: 250 mg once a day, taken with other medicines.
      • 20 to 25 kilograms (44 to 55 pounds) of body weight: 300 mg once a day, taken with other medicines.
      • 25 to 32.5 kilograms (55 to 71.5 pounds) of body weight: 350 mg once a day, taken with other medicines.
      • 32.5 to 40 kilograms (71.5 to 88 pounds) of body weight: 400 mg once a day, taken with other medicines.
      • 40 kilograms (88 pounds) of body weight or over: 600 mg once a day, taken with other medicines.
    • Children up to 3 years of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as you remember. 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—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Efavirenz may cause dizziness, difficulty in concentrating, or drowsiness. 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 dizzy or are not alert.

Check with your physician before taking efavirenz with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with efavirenz may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble in sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; medicine for depression; medicine for anxiety; prescription pain medicine or narcotics; barbiturates; medicine for attention deficit and hyperactivity disorder; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics.

Check with your doctor right away if you have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior.

Efavirenz does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood.

Women of childbearing potential should use two forms of birth control while taking this medicine, a barrier method of contraception and an oral or other hormonal method of contraception.

Check with your doctor promptly, if you develop a skin rash.

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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Developed: 12/14/1998
Revised: 06/07/2005

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