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efavirenz

Generic Name: efavirenz (e FAV ir enz)
Brand Name: Sustiva

What is efavirenz?

Efavirenz is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Efavirenz is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Efavirenz is not a cure for HIV or AIDS.

Efavirenz may also be used for purposes not listed in this medication guide.

What is the most important information I should know about efavirenz?

Some medicines can interact with efavirenz and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs: midazolam, pimozide, St. John's wort, triazolam; or ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine.

Slideshow: Flashback: FDA Drug Approvals 2013

What should I discuss with my healthcare provider before taking efavirenz?

You should not use this medication if you have ever had a severe allergic reaction to efavirenz.

Some medicines can cause unwanted or dangerous effects when used with efavirenz. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • midazolam, pimozide, St. John's wort; or

  • ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine.

Using any of these medicines while you are taking efavirenz can cause serious medical problems or death.

To make sure efavirenz is safe for you, tell your doctor if you have:

  • liver disease (including hepatitis B or C);

  • seizures or epilepsy;

  • a history of mental illness, injection drug use, or taking an anti-psychotic medicine;

  • high cholesterol or triglycerides; or

  • if you have ever taken delavirdine (Rescriptor) or nevirapine (Viramune) and they were not effective in treating your condition.

FDA pregnancy category D. Do not use efavirenz if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide gel) while you are taking efavirenz, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

HIV can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take efavirenz?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take efavirenz on an empty stomach at bedtime, unless your doctor tells you otherwise.

While using efavirenz, you may need frequent blood tests.

HIV/AIDS is usually treated with a combination of drugs. Do not take efavirenz as your only HIV medication. Your disease may become resistant to efavirenz if you do not take it in combination with other HIV medicines your doctor has prescribed. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Take efavirenz regularly to get the most benefit. Get your prescriptions refilled before you run out of medicine completely.

This medicine can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking efavirenz.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking efavirenz?

Efavirenz may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of efavirenz.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Efavirenz side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Efavirenz may cause serious psychiatric symptoms including confusion, severe depression, suicidal thoughts, aggression, extreme fear, hallucinations, or unusual behavior. Contact your doctor at once if you have any of these side effects, even if you have had them before.

Efavirenz may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with efavirenz. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • mild nausea, vomiting;

  • dizziness, drowsiness, trouble concentrating;

  • mild skin rash;

  • headache, tired feeling;

  • sleep problems (insomnia), strange dreams; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Efavirenz dosing information

Usual Adult Dose for HIV Infection:

600 mg orally once a day

Usual Adult Dose for Nonoccupational Exposure:

(Not approved by FDA)

Centers for Disease Control and Prevention (CDC) recommendations: 600 mg orally once a day
Duration of therapy: 28 days

Comments:
-Efavirenz should be used in combination with (lamivudine or emtricitabine) plus (zidovudine or tenofovir).
-Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.

Usual Adult Dose for Occupational Exposure:

(Not approved by FDA)

CDC recommendations: 600 mg orally once a day
Duration of therapy: Generally 28 days; however, the exact duration of therapy may differ based on the institution's protocol.

Comments:
-Recommended as an alternate expanded regimen for HIV postexposure prophylaxis
-Efavirenz should be used in combination with (lamivudine plus zidovudine) or (emtricitabine plus zidovudine) or (lamivudine plus tenofovir) or (emtricitabine plus tenofovir).
-Prophylaxis should be initiated immediately, preferably within hours after exposure.

Usual Pediatric Dose for HIV Infection:

3 months or older:
3.5 to less than 5 kg: 100 mg orally once a day
5 to less than 7.5 kg: 150 mg orally once a day
7.5 to less than 15 kg: 200 mg orally once a day
15 to less than 20 kg: 250 mg orally once a day
20 to less than 25 kg: 300 mg orally once a day
25 to less than 32.5 kg: 350 mg orally once a day
32.5 to less than 40 kg: 400 mg orally once a day
40 kg or more: 600 mg orally once a day

What other drugs will affect efavirenz?

Do not take efavirenz together with Atripla (combination efavirenz, emtricitabine, and tenofovir), unless your doctor tells to.

Other drugs may interact with efavirenz, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about efavirenz.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 15.01. Revision Date: 2013-06-27, 2:50:38 PM.

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