IncobotulinumtoxinA Injection

IMPORTANT WARNING:

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 medicine prescribed?

IncobotulinumtoxinA injection is used to treat chronic sialorrhea (ongoing drooling or excessive salivation) in adults and children 2 years of age and older. It is also used to 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). IncobotulinumtoxinA injection is also used to treat spasticity (muscle stiffness and tightness) of muscles in the armsand blepharospasm (uncontrollable tightening of the eyelid muscles that may cause blinking, squinting, and abnormal eyelid movements) in adults. It is also 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) and to 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.

Are there OTHER USES for this medicine?

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

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.

What SPECIAL PRECAUTIONS should I follow?

Before receiving incobotulinumtoxinA injection,

• tell your doctor and pharmacist if you are allergic to incobotulinumtoxinA, abobotulinumtoxinA (Dysport), onabotulinumtoxinA (Botox), prabotulinumtoxinA-xvfs (Jeuveau), 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. Also tell your doctor if you have received injections of any botulinum toxin product in the past 4 months. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with incobotulinumtoxinA injection: medications for allergies, colds, or sleep. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving incobotulinumtoxinA injection. Do not start any of these medications while receiving incobotulinumtoxinA injection without discussing with your healthcare provider.

• 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.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving incobotulinumtoxinA injection, call your doctor.

• 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.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine 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
• nasal congestion, sore throat, or runny nose
• headache
• dry mouth
• problems with your teeth or gums
• diarrhea
• joint, bone, 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
• seizures
• 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose usually do not appear right after receiving the injection. If you received too much incobotulinumtoxinA or if you swallowed the medication, tell your doctor right away and also tell your doctor if you experience any of the following symptoms during the next several weeks:

• weakness
• difficulty moving any part of your body
• difficulty breathing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about incobotulinumtoxinA injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.