AbobotulinumtoxinA Injection

IMPORTANT WARNING:

AbobotulinumtoxinA 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 weeks, may need to be fed through a feeding tube, and may breathe food or drink into their lungs. Symptoms can occur within hours of an injection with abobotulinumtoxinA or as late as several weeks after treatment. Symptoms may occur in people of any age being treated for any condition, but 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 abobotulinumtoxinA 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?

AbobotulinumtoxinA 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). It is also used to temporarily smooth frown lines (wrinkles between the eyebrows). AbobotulinumtoxinA injection is used to treat spasticity (muscle stiffness and tightness) of muscles in the arms and legs in adults and children 2 years of age and older. AbobotulinumtoxinA 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.

Are there OTHER USES for this medicine?

AbobotulinumtoxinA injection is also sometimes used to treat blepharospasm (uncontrollable tightening of the eyelid muscles that may cause blinking, squinting, and abnormal eyelid movements) in adults. Talk to your doctor about the risks of using this medication for your condition.

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

HOW should this medicine be used?

AbobotulinumtoxinA injection comes as a powder to be mixed with a liquid and 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 abobotulinumtoxinA every 3 to 4 months, depending on your condition and how long the effects of the treatment last.

If you are receiving abobotulinumtoxinA injection for cervical dystonia, your doctor will probably start you on a low dose and gradually change your dose according to your response to the medication.

One brand or type of botulinum toxin cannot be substituted for another.

AbobotulinumtoxinA injection may help control your condition but will not cure it. If you are using abobotulinumtoxinA to treat cervical dystonia, it may take 2 weeks or longer before you feel the full benefit of abobotulinumtoxinA injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving abobotulinumtoxinA injection,

• tell your doctor and pharmacist if you are allergic to abobotulinumtoxinA, incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), prabotulinumtoxinA-xvfs (Jeuveau), rimabotulinumtoxinB (Myobloc), any other medications, cow's milk protein, or any of the other ingredients in abobotulinumtoxinA 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 while receiving abobotulinumtoxinA. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription products may interact with abobotulinumtoxinA: allergy products (such as diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine) and cold products. Be sure to let your doctor and pharmacist know that you are taking these medications before you start receiving abobotulinumtoxinA. Do not start any of these medications while taking abobotulinumtoxinA without discussing with your healthcare provider.

• tell your doctor if you have swelling or other signs of infection in the area where abobotulinumtoxinA will be injected. Your doctor will not inject the medication into an infected area.

• tell your doctor if you have ever had eye or face surgery; or any side effect from any botulinum toxin product and if you have or have ever had any changes in the way your face looks; bleeding problems; diabetes; or a slow or irregular heartbeat.

• if you will be receiving abotulinumtoxinA to treat wrinkles, your doctor will examine you to see if the medication is likely to work for you. AbotulinumtoxinA may not smooth your wrinkles or may cause other problems if you have drooping eyelids; trouble raising your eyebrows; excess skin on your eyelids; deeply scarred, thick, or oily skin; or if your wrinkles cannot be smoothed by spreading them apart with your fingers.

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

• you should know that abobotulinumtoxinA injection may cause loss of strength or muscle weakness all over the body; blurred vision; or drooping eyelids. If you have any of these symptoms, do not drive a car, operate machinery, or do other dangerous activities.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

AbobotulinumtoxinA 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, bruising, redness, or tenderness in the place where you received the injection
• headache
• dry mouth
• bone or muscle pain
• pain in arms or legs
• tiredness
• nausea
• depression
• difficulty falling asleep or staying asleep
• cough, sneezing, fever, nasal congestion, or sore throat

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
• sensitivity to light
• reduced blinking or eye dryness
• eyelid swelling, irritation, or pain
• itching
• rash
• hives
• swelling of the hands, feet, ankles, or lower legs
• shortness of breath
• dizziness
• fainting
• falling or problems with coordination
• blood in urine
• seizures

AbobotulinumtoxinA 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 abobotulinumtoxinA, 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 abobotulinumtoxinA 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.