- This drug may cause very bad and sometimes deadly side effects. These side effects may happen anywhere in the body. Most of the time, they happen in the bowels, liver, skin, and nerves. They may also affect organs that change hormone levels in the body. Side effects that happen in the nerves can lead to not being able to move a part of the body (paralysis). Most of the time, these side effects have happened during the use of this drug but sometimes have happened weeks to months after this drug was stopped. If you have questions, talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
Call your child’s doctor 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 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 bowel problems like black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; very bad belly pain; or very bad hard stools (constipation) or loose stools (diarrhea).
- Signs of hormone problems like change in how you act, dizziness or passing out, feeling cold all the time, feeling sluggish, lowered interest in sex, memory problems, mood changes, very bad headache, weight gain.
- Signs of a very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Signs of nerve problems like a burning, numbness, or tingling feeling that is not normal; weakness; or not being able to move a part of the body (paralysis).
- It is used to treat a type of skin cancer (melanoma).
- It may be given to your child for other reasons. Talk with the doctor.
- 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 breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug or for 3 months after her last dose.
This drug may interact with other drugs or health problems.
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.
- If your child has an upset stomach or loose stools (diarrhea), is throwing up, or is not hungry, talk with the doctor. There may be ways to lower these side effects.
- This drug may be used with another drug called nivolumab. Some side effects may happen more often when this drug is used with nivolumab. Some side effects can be deadly. If your child is also using nivolumab, talk with your child’s doctor about the risks and side effects that may happen.
- Some people have had side effects during the infusion. Sometimes, these could be very bad or life-threatening. Tell your child’s doctor if your child has any of these side effects during the infusion: back or neck pain, chills or shaking, dizziness, feeling like passing out, fever, flushing, itching, rash, shortness of breath, swelling of the face, or wheezing.
- Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy while taking this drug and for 3 months after stopping 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 thyroid, pituitary, or adrenal gland problems. Some signs may be change in mood or the way you act, change in weight, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, headache that lasts or is very bad, or lowered interest in sex.
- 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 lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
- Signs of meningitis like headache with fever, stiff neck, upset stomach, confusion, or if lights bother your eyes.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Any unexplained bruising or bleeding.
- Feeling very tired or weak.
- Change in bowel habits.
- A very bad heart problem (myocarditis) has happened with this drug. Sometimes, this has been deadly. Call your doctor right away if you have a big weight gain, a heartbeat that does not feel normal, chest pain or pressure, fast heartbeat, shortness of breath, swelling in the arms or legs, or very bad dizziness or passing out.
- Eye problems have happened with this drug. Some types of eye problems may need to be treated right away to lower the chance of long-lasting eyesight loss. Call your child’s doctor right away if your child has any changes in eyesight, eye pain, or very bad eye irritation.
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:
- Feeling tired or weak.
- Loose stools (diarrhea).
- Upset stomach or throwing up.
- Not hungry.
- Not able to sleep.
- Weight loss.
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 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.