IncobotulinumtoxinA Injection

IncobotulinumtoxinA injection may spread from the area of injection and cause symptoms of botulism, including severe or life threatening difficulty breathing or swallowing. People who develop difficulty swallowing during their treatment with this medication may continue to have this difficulty for several months. They may need to be fed through a feeding tube to avoid getting food or drink into their lungs. Symptoms can occur within hours of an injection with incobotulinumtoxinA or as late as several weeks after treatment. Symptoms may occur in people of any age being treated for any condition. The risk is probably highest in children being treated for spasticity (muscle stiffness and tightness). Tell your doctor if you have or have ever had any swallowing problems or breathing problems, such as asthma or emphysema, or any condition that affects your muscles or nerves such as amyotrophic lateral sclerosis (ALS, Lou Gehrig’s disease; condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken), motor neuropathy (condition in which the muscles weaken over time), myasthenia gravis (condition that causes certain muscles to weaken, especially after activity), or Lambert-Eaton syndrome (condition that causes muscle weakness that may improve with activity). If you experience any of the following symptoms, call your doctor immediately: loss of strength or muscle weakness all over the body; double or blurred vision; drooping eyelids; difficulty swallowing, breathing, or speaking; or inability to control urination.

Your doctor will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with incobotulinumtoxinA injection and each time you receive treatment. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

🔔 Why is this medication prescribed?

IncobotulinumtoxinA injection is used to treat a number of conditions.

IncobotulinumtoxinA injection is used to:

• treat chronic sialorrhea (ongoing drooling or excessive salivation) in adults and children 2 years of age and older;
• treat spasticity (muscle stiffness and tightness) of muscles in the arms in adults;
• treat spasticity (muscle stiffness and tightness) of muscles in the arms in children 2 years of age or older who do not have cerebral palsy (condition that causes difficulty with movement and balance);
• 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;
• treat blepharospasm (uncontrollable tightening of the eyelid muscles that may cause blinking, squinting, and abnormal eyelid movements) in adults;
• and temporarily smooth frown lines (wrinkles between the eyebrows) in adults.

IncobotulinumtoxinA injection is in a class of medications called neurotoxins. When incobotulinumtoxinA injection is injected into saliva glands, it blocks the nerve signals that causes excessive saliva production. When incobotulinumtoxinA injection is injected into a muscle, it blocks the nerve signals that cause uncontrollable tightening and movements of the muscle.

🔔 How should this medicine be used?

IncobotulinumtoxinA injection comes as a powder to be mixed with a liquid and injected into the saliva glands or 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 3–4 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 to 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.

🔔 Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.