Efavirenz

Efavirenz is an antiviral medicine that stops the human immunodeficiency virus (HIV) from growing in your body.

Efavirenz is used to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). Efavirenz is for adults and children who are at least 3 months old and weigh at least 8 pounds. Efavirenz does not cure HIV or AIDS.

Efavirenz may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Efavirenz must be taken with other antiviral medications and should not be used alone. Your disease may become resistant to efavirenz if you do not take it with other HIV medicines your doctor has prescribed.

Take efavirenz on an empty stomach at bedtime.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Swallow the tablet whole and do not crush, chew, or break it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce, yogurt, grape jelly, or infant formula (if you are giving the medicine to a baby). Swallow the mixture right away. Do not save it for later use.

After taking efavirenz using the sprinkle method, do not eat for the next 2 hours. If you give efavirenz mixed with infant formula to a baby, do not feed more formula for at least 2 hours afterward.

Efavirenz doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

You will need frequent medical tests.

Take efavirenz regularly to get the most benefit. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine.

Store at room temperature away from moisture and heat.

This medicine may affect a drug-screening urine test and you may get false results. Tell the laboratory staff that you use efavirenz.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

You should not use efavirenz if you are also taking elbasvir and grazoprevir (Zepatier) to treat hepatitis C.

You should not use efavirenz if you are allergic to it, or if you also take elbasvir and grazoprevir (Zepatier) to treat hepatitis C.

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

Tell your doctor if you have ever had:

• liver disease (including hepatitis B or C);
• long QT syndrome;
• a seizure;
• mental illness or psychosis;
• heart disease; or
• if you drink large amounts of alcohol or have a history of injection drug use.

Do not use efavirenz if you are pregnant. It could harm the unborn baby or cause birth defects. Use 2 forms of birth control, including a barrier form (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy while you are using efavirenz and for at least 12 weeks after your last dose. Tell your doctor if you become pregnant during treatment.

Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy while you are taking efavirenz.

HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

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.

Get emergency medical help if you notice signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Efavirenz may cause serious side effects. Contact your doctor right away if you experience:

• a seizure;
• hallucinations, difficulty concentrating, trouble speaking or moving (these symptoms may appear months or years after you start taking efavirenz);
• nervous system issues—dizziness, drowsiness, confusion, trouble concentrating, unusual dreams, insomnia, or difficulties with speech, balance, or muscle movement;
• serious psychiatric symptoms—anxiety, paranoia, unusual behavior, feelings of sadness or hopelessness, hallucinations, or suicidal thoughts; or
• liver problems—nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Psychiatric symptoms or nervous system issues may occur even months or years after you have been taking efavirenz.

Efavirenz affects your immune system, which may lead to certain side effects (even weeks or months after you've taken efavirenz). Inform your doctor if you have:

• signs of a new infection—fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• difficulty speaking or swallowing, balance or eye movement problems, weakness or a prickly sensation; or
• swelling in your neck or throat (enlarged thyroid), changes in menstrual cycle, or impotence.

Common side effects of efavirenz may include:

• nausea, vomiting;
• dizziness, drowsiness, difficulty concentrating;
• rash;
• headache, feeling tired;
• sleep issues (insomnia), unusual 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. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for HIV Infection:

600 mg orally once a dayComments:-This drug should be used with a protease inhibitor and/or NRTIs.Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC Recommendations: 600 mg orally once a dayDuration of therapy: 28 daysComments:-Only with expert consultation, as part of an alternative antiretroviral regimen for use as HIV nonoccupational postexposure prophylaxis (nPEP)-This drug is contraindicated as nPEP in pregnant patients; it should be avoided in nPEP regimens during the first trimester and should not be used for patients of childbearing potential who might become pregnant during antiretroviral prophylaxis.-Prophylaxis should be started as soon as possible, within 72 hours of exposure.-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service Working Group Recommendations: 600 mg orally once a dayDuration of therapy: 28 days, if toleratedComments:-Only with expert consultation, as part of an alternative antiretroviral regimen for use as HIV postexposure prophylaxis-Prophylaxis should be started as soon as possible, preferably within hours after exposure.-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

3 months and older:-Weight 3.5 to less than 5 kg: 100 mg orally once a day-Weight 5 to less than 7.5 kg: 150 mg orally once a day-Weight 7.5 to less than 15 kg: 200 mg orally once a day-Weight 15 to less than 20 kg: 250 mg orally once a day-Weight 20 to less than 25 kg: 300 mg orally once a day-Weight 25 to less than 32.5 kg: 350 mg orally once a day-Weight 32.5 to less than 40 kg: 400 mg orally once a day-Weight at least 40 kg: 600 mg orally once a dayUse: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Take the medicine as soon as you can, but if it's almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Get your prescriptions refilled before you completely run out of medicine.

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

• Avoid driving or hazardous activity until you know how efavirenz will affect you. Your reactions could be impaired.

• Drinking alcohol can increase certain side effects of efavirenz.

• Using this medicine will not prevent your disease from spreading. 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.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Efavirenz can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may affect efavirenz, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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