IncobotulinumtoxinA (in-koe-bot-ue-LYE-num-tox-in-ay)

Treats muscle spasms in the neck, eyelids, and upper arms, and chronic excessive drooling. Also improves the appearance of upper facial lines or wrinkles.

Brand Name(s):

Xeomin

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles or as a needle placed into your saliva glands.
• You may be given medicine to numb the area where the shot will be injected. If you receive the medicine around your eyes, you may be given eye drops or ointment to numb the area. After your injection, you may need to wear a protective contact lens or eye patch.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how incobotulinumtoxinA works. Tell your doctor if you are using an allergy or cold medicine, aminoglycoside antibiotic, muscle relaxer, sleep medicine, or another botulinum toxin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have eye problems, trouble swallowing or breathing, or a nerve or muscle disorder (including Lou Gehrig disease, Lambert-Eaton syndrome, or myasthenia gravis), muscle problems (including weakness or atrophy) at the injection site, or a cranial nerve disorder. Tell your doctor if you had surgery where the injection will be given (including eye or face surgery). Tell your doctor if you have previously received botulinum toxin for any reason.
• This medicine may cause the following problems:
  • Muscle weakness, loss of bladder control, trouble swallowing, speaking, or breathing (caused by the toxin spreading to other parts of your body)
  • Reduced blinking, which could lead to ulcers or other damages to the cornea
• This medicine may cause vision problems or muscle weakness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine is made from donated human blood. Some human blood products have transmitted viruses, although the risk is low because donors and blood are both tested for viruses. Talk with your doctor if you are concerned.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, trouble urinating, painful urination
• Dizziness, headache, slow or fast heartbeat
• Eye pain, severe irritation, severe trouble seeing, double vision, vision problems that do not go away, droopy eyelids
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Muscle or bone pain
• Seizures
• Trouble swallowing, breathing, or speaking
• Unusual weakness or tiredness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Dry mouth
• Pain, swelling, or bruising where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088