sustiva

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

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

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

Important information

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

Do not take Sustiva with cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or ergot medicines such as dihydroergotamine (D.H.E. 45), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Wigraine), or methylergonovine (Methergine). These drugs can cause life-threatening side effects if you use them while you are taking Sustiva.

Sustiva 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.

Do not use Sustiva without telling your doctor 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 this medicine, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

Taking Sustiva will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Before taking this medicine

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

Some medicines can cause unwanted or dangerous effects when used with Sustiva. 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 Sustiva can cause serious medical problems or death.

To make sure Sustiva 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 Sustiva 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 Sustiva, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

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 Sustiva?

Take Sustiva exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

To make swallowing easier, you may open the Sustiva capsule and sprinkle the medicine into a spoonful of applesauce, yogurt, or grape jelly. You may also mix the medicine with infant formula if you are giving the medicine to a baby too young for solid foods. Swallow right away without chewing. Do not save the mixture for later use.

After taking Sustiva using the sprinkle method, do not eat for the next 2 hours. If you have given this medicine mixture to a baby, do not feed infant formula for at least 2 hours.

This medicine comes with patient instructions for mixing the capsule contents with soft food or infant formula. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Sustiva doses are based on weight in children, and any changes may affect your child"s dose.

While using Sustiva, you may need frequent blood tests.

Take Sustiva regularly to get the most benefit. Get your prescriptions refilled before you run out of medicine completely. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine.

HIV/AIDS is usually treated with a combination of drugs. Do not take Sustiva 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.

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 Sustiva.

Store at room temperature away from moisture and heat.

Sustiva 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 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 Sustiva?

Sustiva 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 Sustiva.

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.

Sustiva side effects

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

Call your doctor at once if you have:

• seizure (convulsions);

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• 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.

Sustiva may cause serious psychiatric symptoms including confusion, severe depression (feeling sad or hopeless), 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.

Sustiva 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 this medicine. 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 Sustiva side effects may include:

• 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)

What other drugs will affect Sustiva?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Sustiva, especially:

• artemether/lumefantrine, bupropion, rifabutin, sertraline, warfarin (Coumadin, Jantoven);

• antifingal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;

• cholesterol-lowering medicine - atorvastatin (Lipitor), pravastatin, simvastatin (Zocor);

• heart or blood pressure medicine - diltiazem, felodipine, nicardipine, nifedipine, verapamil;

• hepatitis C medication - boceprevir, simeprevir, telaprevir;

• an immunosuppressant - cyclosporine, sirolimus, tacrolimus;

• other HIV or AIDS medications - atazanavir, indinavir, lopinavir/ritonavir, maraviroc, raltegravir, saquinavir; or

• seizure medicine - carbamazepine, phenytoin.

This list is not complete. Other drugs may interact with efavirenz, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.