incobotulinumtoxinA

What is the most important information I should know about incobotulinumtoxinA?

The botulinum toxin contained in this medicine can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

What is incobotulinumtoxinA?

IncobotulinumtoxinA is used in adults to treat:

• muscle spasms and stiffness of the arms (upper limb spasticity);
• cervical dystonia (severe spasms in the neck muscles), or muscle stiffness in the elbows, wrists, fingers, ankles, or toes;
• certain eye muscle conditions caused by nerve disorders (including uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction); or
• to temporarily lessen the appearance of facial wrinkles (sometimes called "frown lines") between the eyebrows.

IncobotulinumtoxinA is also used in children at least 2 years old to treat:

• upper limb spasticity that is not caused by cerebral palsy; or
• chronic drooling (sialorrhea).

IncobotulinumtoxinA may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using incobotulinumtoxinA?

Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past.

Tell your doctor if you have ever had:

• other botulinum toxin injections such as Botox, Dysport, or Myobloc (especially in the last 4 months);
• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a breathing disorder such as asthma or emphysema;
• problems with swallowing, or accidentally inhaling food or drink into your lungs;
• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
• a change in the normal appearance of your face;
• a seizure disorder;
• bleeding problems;
• heart disease; or
• surgery (especially on your face or eyes).

IncobotulinumtoxinA is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

How is incobotulinumtoxinA given?

This medicine is injected into a muscle or into a gland. A healthcare provider will give you this injection once every 12 to 16 weeks. IncobotulinumtoxinA injections should be spaced at least 12 weeks apart.

Your injections may be given into more than one area at a time, depending on the condition being treated.

While receiving injections for eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

It may take up to 7 days after injection before neck muscle spasm symptoms begin to improve.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Using this medicine more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since botulinum toxin has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Overdose symptoms may not appear right away, but can include severe muscle weakness, trouble swallowing, weak or shallow breathing, or loss of movement in any part of your body.

What should I avoid while using incobotulinumtoxinA?

Avoid going back to your normal physical activities too quickly after receiving an injection.

This medicine may impair your vision or depth perception. Avoid driving or hazardous activity until you know how this medicine will affect you.

What are the possible side effects of incobotulinumtoxinA?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• trouble breathing, talking, or swallowing;
• hoarse voice, drooping eyelids;
• blurred vision, double vision;
• seizure;
• vision changes, eye pain or irritation;
• wheezing, tightness in your chest;
• eyelid swelling, crusting or drainage from your eyes, problems with vision;
• feeling like you might pass out; or
• loss of strength, loss of bladder control.

Common side effects may include:

• pain where the medicine was injected;
• dry mouth, tooth problems;
• muscle weakness;
• vision problems;
• trouble swallowing;
• dry eyes, drooping eyelids;
• headache, neck pain, body aches;
• a seizure;
• increased blood pressure;
• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat, cough, and chest congestion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect incobotulinumtoxinA?

Tell your doctor about all your other medicines, especially:

• an antibiotic such as amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin;
• muscle relaxers;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• bronchodilator asthma medication.

This list is not complete. Other drugs may affect incobotulinumtoxinA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about incobotulinumtoxinA.