What is Brineura used for?
- Brineura is used to slow the loss of being able to walk around in some children.
Before taking Brineura, tell your doctor:
- If your child is allergic to Brineura; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has an infection in the brain or spine (central nervous system or CNS).
- If your child has had a shunt placed to lower pressure on the brain.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Brineura with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Brineura?
- Tell all of your child's health care providers that your child is taking Brineura. This includes your child's doctors, nurses, pharmacists, and dentists.
- Have your child's blood pressure and heart rate checked often.
- Some people have unsafe allergic effects or bad side effects during the infusion or within 24 hours of the infusion. Talk with the doctor.
- Other drugs may be given before Brineura to help avoid side effects.
- Tell your child's doctor right away if your child has problems with the device used to give Brineura. This includes leakage, device failure, or bulging of the scalp around or above the device. You will also need to tell your child's doctor right away if your child has signs of an infection (like redness, tenderness, swelling, or discharge) on or around the device.
If your child is pregnant or breast-feeding a baby:
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
How is Brineura best taken?
Give Brineura as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.
- It is given into the spinal fluid.
What do I do if I miss a dose?
- Call your child's doctor to find out what to do.
What are the side effects of Brineura that I need to call my doctor about immediately?
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 meningitis like headache with fever, stiff neck, upset stomach, confusion, or if lights bother the eyes.
- A heartbeat that does not feel normal.
- Fast or slow heartbeat.
- Very bad dizziness or passing out.
- Seizures.
- Feeling irritable.
- Feeling jittery.
- Throwing up.
What are some other side effects of Brineura?
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:
- Headache.
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 the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
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.
How do I store and/or throw out Brineura?
- If you need to store Brineura at home, talk with your child's doctor, nurse, or pharmacist about how to store it.
Consumer information use and disclaimer
- 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 Brineura, please talk with your child's doctor, nurse, pharmacist, or other health care provider.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Brineura, 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 Brineura 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 Brineura. 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.
