- Unsafe and sometimes deadly allergic effects may happen with this drug. Tell your child’s doctor about any fever, rash, feeling tired, upset stomach, throwing up, loose stools, belly pain, flu-like signs, sore throat, cough, or trouble breathing. Do not restart this drug if your child has had an allergic effect.
- The chance of allergic effects is raised in people who have a certain gene called HLA-B*5701. The doctor may check your child’s blood work before starting this drug. Talk with the doctor.
- 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.
- 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 liver disease.
- If your child is taking another drug that has the same drug in it.
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- 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.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Read the warning card and carry it with you at all times. It tells the signs to watch for in case an allergy happens.
- If this drug is stopped because your child has an allergy to it, do not restart it. It may not be safe to restart this drug.
- If this drug is stopped for any other reason, do not restart it without talking to the doctor. It could be very risky to restart on your own.
- Do not run out of this drug.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- 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.
- If giving to your child, the dose of this drug may need to be changed as your child’s weight changes. Have your child’s weight checked often. Talk with the doctor before changing your child’s dose.
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.
If your child is pregnant or breast-feeding a baby:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- Be sure your child does not breast-feed a baby if she has HIV disease unless the doctor tells her to.
- 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- 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.
- 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.
- 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.
- Chest pain or pressure.
- Very bad dizziness or passing out.
- Mouth sores.
- Swollen gland.
- This drug may help the immune system work. 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 you see any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after your child starts this drug.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Not hungry.
- Change in body fat.
- Not able to sleep.
- Bad dreams.
- To gain the most benefit, do not miss giving your child doses.
- Give as you have been told, even if your child feels well.
- Give this drug at the same time of day.
- Give this drug with or without food.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, get an oral syringe, a dropper, a spoon, or a cup (only for older children) from your pharmacist.
- 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 at room temperature.
- Store in the original container at room temperature or in a refrigerator.
- Do not freeze.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- 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, 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.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.