- This drug may cause a very bad and sometimes deadly type of heartbeat that is not normal (long QT on ECG, torsades de pointes). The chance may be raised if your child takes amphotericin B or some types of water pills (diuretics), if your child has low potassium or magnesium levels, or if your child has heart failure. If your child has ever had a long QT on ECG or other abnormal heartbeat, talk with your child’s doctor. This drug may not be right for your child. If you have questions, talk with your child’s doctor.
- Talk with the doctor if your child is taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask the doctor or pharmacist if you are not sure.
- Your child will need an ECG before starting this drug and during treatment. Talk with the doctor.
- Your child will need blood work checked before starting this drug and during treatment. Talk with the doctor.
- This drug may cause a very bad and sometimes deadly health problem called differentiation syndrome (retinoic-acid-APL syndrome). Most of the time, this problem happens during the first month of taking this drug and sometimes after the first dose. Call the doctor right away if your child has a fever, shortness of breath or trouble breathing; swelling; weight gain; very bad dizziness or passing out; 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; or signs of kidney problems like not able to pass urine, change in how much urine is passed, or blood in the urine.
- It is used to treat a type of leukemia.
- 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 any drugs that can cause electrolyte problems. There are many drugs that can do this. Ask your child’s doctor or pharmacist if you are not sure.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug and for 2 weeks after the last dose.
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.
- Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- This drug may add to the chance of getting some types of cancer. Talk with the doctor.
- If your child has an upset stomach or diarrhea, is throwing up, or is not hungry, talk with the doctor. There may be ways to lower these side effects.
- If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
- Have your child’s blood sugar checked as you have been told by your child’s doctor.
- This drug may affect sperm in males. This may affect being able to father a child later in life. Talk with the 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:
- Have your child use birth control to prevent pregnancy while taking this drug and for 6 months after stopping this drug.
- If your child is a male and has sex with a female who could get pregnant, they must prevent pregnancy during care and for 3 months after care ends. They must use birth control that can be trusted.
- If your child is a male and his sex partner gets pregnant while he takes this drug or within 3 months after his last dose, call the doctor right away.
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 6 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 infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
- Chest pain or pressure or a fast heartbeat.
- A heartbeat that does not feel normal.
- Feeling very tired or weak.
- Low mood (depression).
- A burning, numbness, or tingling feeling that is not normal.
- Blurred eyesight.
- Shortness of breath.
- Fast breathing.
- Feeling confused.
- Feeling agitated.
- Ringing in ears.
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.
- Belly pain.
- Not hungry.
- Weight gain or loss.
- Feeling tired or weak.
- Dry mouth.
- Not able to sleep.
- Feeling sleepy.
- Bone, joint, or muscle pain.
- Back pain.
- Sweating a lot.
- Pain where the shot was given.
- Redness or swelling where the shot is given.
- Eye irritation.
- Dry eyes.
- Pain in arms or legs.
- Dry skin.
- Neck pain.
- Pale skin.
- Skin irritation.
- Ear pain.
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.
- It is given as an infusion into a vein over a period of time.
- Call your child’s doctor to find out what to do.
- If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
- 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.
- 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.
- 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.