Efavirenz capsules

What is this medicine?

EFAVIRENZ (e fa VEER ens) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

How should I use this medicine?

Take this medicine by mouth. It can be swallowed whole or the capsules may be opened carefully and the contents mixed in a small container with about 1 to 2 teaspoonfuls of food such as jelly, yogurt, or applesauce or mixed with 2 teaspoonfuls of formula for infants. This mixture must be taken within 30 minutes of mixing. No additional food should be taken for 2 hours after the dose. Take your dose at bedtime. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 months old for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in behavior like severe depression, strange thoughts, thoughts of suicide, or angry behavior

• hallucinations

• not able to move or speak normally

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• difficulty sleeping, strange dreams

• dizziness

• trouble concentrating

• upset stomach, vomiting

• weight gain around waist, back, or thinning of face, arms, legs

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• disopyramide

• elbasvir; grazoprevir

• rifapentine

• voriconazole

This medicine may also interact with the following medications:

• amiodarone

• artemether; lumefantrine

• clarithromycin

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• medicines for blood pressure like diltiazem, nifedipine, verapamil

• medicines for cholesterol like simvastatin

• medicines for depression, anxiety, or psychotic disturbances

• medicines for fungal infections like ketoconazole, itraconazole, and posaconazole

• medicines for seizures like carbamazepine, phenobarbital, phenytoin

• medicines for sleep

• methadone

• other medicines for HIV

• red yeast rice

• rifabutin

• rifampin

• sirolimus

• tacrolimus

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• history of a drug or alcohol abuse problem

• history of depression or other mental illness

• liver disease

• seizures

• taking any other medicines

• an unusual or allergic reaction to efavirenz, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or healthcare provider for regular checkups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid alcohol and mood altering (street) drugs while taking this medicine because they can make these side effects worse.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.