Rimabotulinumtoxin B Injection

Conditions Treated

RimabotulinumtoxinB injection is used to relieve the symptoms of cervical dystonia (spasmodic torticollis; uncontrollable tightening of the neck muscles that may cause neck pain and abnormal head positions). RimabotulinumtoxinB injection is in a class of medications called neurotoxins. It works by blocking the nerve signals that cause uncontrollable tightening and movement of the muscles.

Possible Side Effects

What Side Effects Can This Cause?

RimabotulinumtoxinB injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain or tenderness in the area where the medication was injected
• back pain
• headache
• nausea
• heartburn
• dry mouth

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• itching
• rash
• hives
• dizziness
• fainting

RimabotulinumtoxinB injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

RimabotulinumtoxinB injection comes as a liquid to be injected into affected muscles by a doctor. Your doctor will choose the best place to inject the medication in order to treat your condition. You may receive additional injections of rimabotulinumtoxinB every 3 to 4 months, depending on your condition and how long the effects of the treatment last. Your doctor will probably start you on a low dose of rimabotulinumtoxinB injection and gradually change your dose according to your response to the medication. One brand or type of botulinum toxin cannot be substituted for another. RimabotulinumtoxinB injection controls cervical dystonia but does not cure it. It may take 5 days or longer before you feel the full benefit of rimabotulinumtoxinB injection.

What Dietary Instructions Should I Follow

Unless your doctor tells you otherwise, continue your normal diet.

Are There Any Special Instructions

Before receiving rimabotulinumtoxinB injection, tell your doctor and pharmacist if you are allergic to rimabotulinumtoxinB, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), any other medications, or any of the ingredients in rimabotulinumtoxinB injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antibiotics such as amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, kanamycin, lincomycin (Lincocin), neomycin (Neo-Fradin, Neo-Rx), polymyxin, streptomycin, and tobramycin (Tobi); cholinesterase inhibitors such as ambenonium (Mytelase), donepezil (Aricept), galantamine (Razadyne), neostigmine (Prostigmin), physostigmine, pyridostigmine (Mestinon, Regonol), rivastigmine (Exelon), and tacrine (Cognex); magnesium sulfate; medications for allergies, colds, or sleep; muscle relaxants; and quinidine. Also tell your doctor if you have received injections of any botulinum toxin product in the past four months. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have swelling or other signs of infection in the area where rimabotulinumtoxinB will be injected. Your doctor will not inject the medication into an infected area. tell your doctor if you have or have ever had any side effect from any botulinum toxin product or bleeding problems. if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving rimabotulinumtoxinB injection. you should know that rimabotulinumtoxinB injection may cause loss of strength or muscle weakness all over the body or impaired vision. If you have any of these symptoms, do not drive a car, operate machinery, or do other dangerous activities.