- 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.
- 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.
- It is used to treat HIV infection.
- It is used to treat hepatitis B 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 is taking another drug that has the same drug in it.
- If your child is taking adefovir.
- If your child is taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
For all patients taking this drug:
- 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.
- Give calcium and vitamin D as you were told by your child’s doctor.
- Have your child’s blood work checked often. Talk with your child’s 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 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:
- 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.
Treating HIV infection:
- This drug is not a cure for HIV. Be sure your child stays under the care of the doctor.
- Hepatitis B or C testing may be done. A hepatitis B or C infection may get worse during care. 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.
- Be sure your child does not breast-feed a baby if she has HIV disease unless the doctor tells her to.
- This drug is not a cure for hepatitis infection. Be sure your child stays under the care of the doctor.
- Your child will need to have an HIV test as you were told by the doctor. Talk with the doctor.
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
For all patients taking this drug:
- 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 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.
- Low mood (depression).
- Bone pain.
- Muscle pain or weakness.
- Pain in arms or legs.
- Change in body fat.
Treating HIV infection:
- 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).
- Feeling tired or weak.
- Trouble sleeping.
- Give this drug at the same time of day.
- It is important that your child does not miss or skip a dose of this drug during treatment.
- 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.
- Give this drug with or without food. Give with food if it causes an upset stomach.
- Wash your hands before and after use.
- Use only the scoop that comes with the powder to measure powder.
- Mix powder with 2 to 4 ounces (60 to 120 mL) of a soft food like applesauce, baby food, or yogurt. Have your child swallow right away without chewing. Chewing the food may make it taste very bad.
- Do not mix with any liquid.
- Wash and dry the scoop after each use. Do not store it in the bottle.
- 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.
- 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, 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.