Incobotulinumtoxin A Injection

Conditions Treated

IncobotulinumtoxinA 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) in adults and blepharospasm (uncontrollable tightening of the eyelid muscles that may cause blinking, squinting, and abnormal eyelid movements) in adults who have used onabotulinumtoxinA (Botox). IncobotulinumtoxinA injection is in a class of medications called neurotoxins. When incobotulinumtoxinA injection is injected into a muscle, it blocks the nerve signals that cause uncontrollable tightening and movements of the muscle.

Possible Side Effects

What Side Effects Can This Cause?

IncobotulinumtoxinA injection may cause side effects. Ask your doctor which side effects you are most likely to experience since some side effects may be related to (or occur more often in) the part of the body where you received the injection. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, tenderness, or bruising in the place where you received the injection
• headache
• tiredness
• dry mouth
• diarrhea
• joint or muscle pain
• dry eyes
• reduced blinking or effectiveness of blinking

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:

• vision changes
• eyelid swelling
• eye pain or irritation
• neck pain
• shortness of breath
• fainting
• dizziness
• rash
• hives
• itching
• swelling of the hands, feet, ankles, or lower legs

IncobotulinumtoxinA 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

IncobotulinumtoxinA injection comes as a powder to be mixed with a liquid and injected into a muscle 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 every 3 months, depending on your condition and on how long the effects of the treatment last. Your doctor will probably start you on a low dose of incobotulinumtoxinA 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. IncobotulinumtoxinA injection may help control your condition but will not cure it. It may take a few days or up to several weeks before you feel the full benefit of incobotulinumtoxinA injection.

What Dietary Instructions Should I Follow

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

Are There Any Special Instructions

Before receiving incobotulinumtoxinA injection, tell your doctor and pharmacist if you are allergic to incobotulinumtoxinA, abobotulinumtoxinA (Dysport), onabotulinumtoxinA (Botox), rimabotulinumtoxinB (Myobloc), any other medications, or any of the ingredients in incobotulinumtoxinA 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); anticoagulants ('blood thinners'); 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 incobotulinumtoxinA will be injected. Your doctor will not inject the medication into an infected area. tell your doctor if you have ever had any side effect from any botulinum toxin product or eye or face surgery and if you have or have ever had bleeding problems. if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving incobotulinumtoxinA injection. you should know that incobotulinumtoxinA 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. if you are receiving incobotulinumtoxinA injection to treat a condition that limited your activities, talk to your doctor about increasing your activities after your treatment. Your doctor will probably want you to increase your activities gradually as your body adjusts to the effects of your treatment.