Pronunciation:

ef-a-VYE-renz

Brand Names:

• Sustiva

Dosage Forms:

• Capsule
• Tablet

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Non-Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Efavirenz 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.

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—

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.

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 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 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 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 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.

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.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Depression

skin rash or itching

Less common

Blood in urine

difficult or painful urination

pain in lower back and/or side

Rare

Abdominal pain

changes in vision

blistering

clumsiness or unsteadiness

confusion

convulsions (seizures)

cough

dark urine

delusions

double vision

fainting

fast or pounding heartbeat

fever or chills

headache (severe and throbbing)

hives

inappropriate behavior

loss of appetite

mood or mental changes (severe)

muscle cramps or pain

nausea or vomiting

nerve pain

open sores

pain, tenderness, bluish color, or swelling of leg or foot

rapid weight gain

seeing, hearing, or feeling things that are not there

sense of constant movement of self or surroundings

sores, ulcers, or white spots in mouth or on lips

speech disorder

swelling and/or tenderness in upper abdominal or stomach area

swelling of hands, arms, feet, or legs

thoughts of suicide or attempts at suicide

tightness in chest

tingling, burning, or prickling sensations

tingling, burning, numbness, or pain in the hands, arms, feet, or legs

tremor

troubled breathing

unusual tiredness

weight loss

wheezing

yellow eyes or skin

Incidence not known

Actions that are out of control

attack, assault, force

continuing vomiting

delusions of persecution, mistrust, suspiciousness, and/or combativeness

difficult or labored breathing

early appearance of redness or swelling of the skin

general feeling of tiredness or weakness

irritability

late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, may extend to unexposed areas

light-colored stools

nervousness

neurosis

shortness of breath

stomach pain

talking, feeling, and acting with excitement

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

drowsiness

fatigue

headache

increased sweating

poor concentration

trouble in sleeping

Less common or rare

Abnormally decreased sensitivity, particularly to touch

agitation or anxiety

belching

change in sense of taste or smell

dry mouth

excessive gas

false sense of well-being

flaking and falling off of skin

flushing

general feeling of discomfort

heartburn

indigestion

joint pain

lack of feeling or emotion

loss of hair

loss of memory

loss of sense of reality

mood changes

nervousness

pain

painful, red, hot or irritated hair follicles

ringing in the ears

stomach discomfort

unusual dreams

weakness

Incidence not known

Difficulty having a bowel movement (stool)

discoloration of fingernails or toenails

large amount of triglyceride in the blood

malabsorption

redistribution/accumulation of body fat

swelling of the breasts or breast soreness in both females and males

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