- Hepatitis B has gotten worse when this drug was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop giving this drug to your child without calling your child’s doctor.
- This drug is not approved to treat hepatitis B. Hepatitis B testing needs to be done before your child takes this drug. Talk with the doctor.
- It is used to treat HIV infection.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has had red, blistered, swollen, or peeling skin after taking efavirenz.
- If your child has any of these health problems: Kidney disease or liver disease.
- If your child takes any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this drug.
- If your child is taking adefovir.
- If your child is taking lamivudine.
- If your child is taking another drug that has the same drug in it.
- Do not give this drug to your child if your child is taking any drugs that can cause kidney problems. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
- If your child is younger than 12 years of age. Do not give this drug to a child younger than 12 years of age.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Bone problems like bone pain, soft bones, and thin bones have happened with this drug. This may lead to broken bones. A test may need to be done to check your child’s bones. Talk with the doctor.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
- Give calcium and vitamin D as you were told by your child’s doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- This drug is not a cure for HIV. Be sure your child stays under the care of the doctor.
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood. Be sure needles and other things like toothbrushes or razors are not shared. Talk with the doctor.
- This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
- This drug may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your child’s doctor.
- If your child is of childbearing age, a pregnancy test will need to be done before starting this drug to make sure she is not pregnant.
If your child is or may be sexually active:
- This drug does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Be sure your child does not have any kind of sex without using a latex or polyurethane condom. Talk with the doctor.
- Have your child use birth control to prevent pregnancy while taking this drug and for 3 months after stopping this drug.
- Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Be sure your child uses some other kind of birth control also, like a condom, when taking this drug.
If your child is pregnant:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy.
- If your child gets pregnant while taking this drug or within 3 months after her last dose, call the doctor right away.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
- If your child shows signs of low mood (depression), thoughts of killing him/herself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
- Bone pain.
- Muscle pain or weakness.
- Pain in arms or legs.
- Change in body fat.
- Changes in your child’s immune system can happen when your child starts taking drugs to treat HIV. If your child has an infection that you did not know was there, it may show up when your child takes this drug. Tell your child’s doctor right away if your child has any new signs after starting this drug, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call the doctor right away if your child has a fast heartbeat, a heartbeat that does not feel normal, or if your child passes out.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Change in color of skin.
- Feeling tired or weak.
- This drug may cause your child to have dizziness, sleepiness, trouble sleeping, trouble focusing, or dreams that are not normal. Most of the time, these effects go away after taking this drug for 2 to 4 weeks. It may help if you give this drug to your child at bedtime. If your child feels dizzy or sleepy, or has trouble focusing, have your child avoid tasks or actions that call for alertness. Call the doctor if these effects last, they bother your child, or are very bad.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Give on an empty stomach.
- Give this drug with a full glass of water.
- Giving this drug at bedtime may help with some side effects.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- It is important that your child does not miss or skip a dose of this drug during treatment.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- If you are not sure what to do if you miss giving your child a dose, call the doctor.
- Store in the original container at room temperature.
- Keep lid tightly closed.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.