RimabotulinumtoxinB

(rime uh BOT yoo lin num TOKS in bee)

What key warnings do I need to know about before giving this drug to my child?

• Very bad side effects have happened when this drug has spread from where it is being used.
• This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled.

Is it safe for my child to take this drug?

• Not if your child has an allergy to rimabotulinumtoxinB, albumin, or any other part of this drug.
• Be sure to let the doctor know if your child has any allergies or side effects to drugs, foods, or dyes. Make sure to tell about the allergy and what signs your child had. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• Not if your child has an infection where the shot will be given.
• Not if your child has had a botulinum toxin product in the last 4 months.

Why does my child need this drug?

• It is used to treat spasms of the head. It may take 2 weeks to get better.

How is this drug given?

• It is given as a shot into the muscle(s) causing the spasms.

What safety measures do I need to take when my child is using this drug?

• If your child has lung disease, talk with the doctor.
• If your child has a nerve disease, talk with the doctor.
• If your child has trouble swallowing, talk with the doctor.
• Check all drugs your child is taking with your child's doctor. This drug may not mix well with some other drugs.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.

What are some side effects of this drug?

• Irritation where the shot is given.
• Muscle weakness or changes in eyesight may happen. Have your child avoid tasks or actions that call for being alert or having clear eyesight until you see how this drug affects him/her.
• Headache.
• Dry mouth. Good mouth care may help. Older children may suck hard, sugar-free candy. Have your child see a dentist often.
• Neck pain.

When do I need to call my child's doctor?

• If any of this news causes you to be worried, any of the unwanted side effects happen, or if your child is not better after taking this drug.
• If you think there has been an overdose, call 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room (ER) right away.http://www.aapcc.org), or emergency room (ER) right away.
• If your child shows signs of a very bad reaction, call your child's doctor or the ER right away. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; swelling of face, lips, tongue, or throat; or if your child is not acting normal.
• If your child shows any signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color or sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
• If your child has trouble breathing.
• If your child has trouble swallowing.
• If your child has trouble speaking.
• If your child has very bad muscle pain or weakness.
• If your child has a sudden change in eyesight, eye pain, or irritation.
• If your child is not able to control his/her bladder.
• If your child gets a rash.
• If your child’s health problem does not get better or if you believe your child’s health problem is worse.

General drug facts

• If your child has a very bad allergy, he/she needs to wear an allergy ID at all times.
• You may get this drug by drug order only.
• Get rid of this drug when your child no longer needs it or if the drug is outdated.
• If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
• In Canada, take any unused drugs to the pharmacy. Also, visit http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/disposal-defaire-eng.php#th to learn about the right way to get rid of unused drugs.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep all drugs out of the reach of children and pets.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
• Talk with the doctor before giving your child any new drug, including OTC, natural products, or vitamins.
• If you do not use a drug the right way, it may not be safe. Follow what your child’s doctor tells you.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only your healthcare provider has the knowledge and training to decide which medicines are right for you. 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 your healthcare provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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