Zolgensma 3.6-4.0 KG, Zolgensma 3.1-3.5 KG, Zolgensma 2.6-3.0 KG

Onasemnogene Abeparvovcec Infusion

(ON a SEM noe jeen A be PAR voe vek)

Zolgensma

Liver problems have happened with this drug. The risk of liver problems may be higher if your child already has liver problems. Your child will need to have liver function checked as you have been told by your child's doctor.

It is used to treat spinal muscular atrophy.

If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had. 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. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug is used with a steroid drug like prednisolone. Talk with your child's doctor before your child gets any vaccines. Take special care when handling and throwing away the patient's stools. Throw diapers away in household trash sealed in trash bags. Be sure to wash your hands well if coming into contact with stools. Do this for 1 month after your child gets this drug. If you have questions, talk with your child's doctor.

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 liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes. Any unexplained bruising or bleeding. Cough. Sneezing. Runny nose. Sore throat. Fever.

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: Throwing up. 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.

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 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.