Xeomin (IncobotulinumtoxinA)

Your doctor may have suggested this medication for conditions other than those listed in this drug information. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop receiving this medication without consulting your doctor.

XEOMIN should not be used by anyone who:

• is allergic to XEOMIN or to any of the ingredients of the medication
• has a generalized disorder of muscle activity, such as myasthenia gravis or Eaton Lambert syndrome
• has an infection at the site where the injection is to be given

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Angle-closure glaucoma: XEOMIN can cause angle-closure glaucoma in those who are at risk. Your doctor will monitor for this if necessary.

Distant toxin spread: Very rarely, this medication may spread to other parts of the body other than where it was injected, leading to muscle weakness, difficulty swallowing, pneumonia, speech difficulties, and breathing problems. Distant toxin spread can be fatal. If you develop severe difficulty swallowing, speaking, or breathing while using this medication, contact your doctor immediately.

Occupational hazards: Your ability to drive and use machines may be affected either because of the disease for which you are being treated, the way XEOMIN works in your body, or the possible side effects of XEOMIN. People using XEOMIN should not drive a car or perform hazardous tasks until they have fully recovered from the effects of this medication.

Other medical conditions: People with amyotrophic lateral sclerosis, bleeding disorders, with disorders that produce a depletion of acetylcholine, or disorders that produce peripheral neuromuscular dysfunction should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while receiving this medication, contact your doctor immediately.

Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are receiving this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

When used for blepharospasm:

• drooping of the upper eyelid
• dry eyes
• irritation or watering of the eye
• pain, soreness, or bruising at the place of injection
• sensitivity of the eye to light

When used for cervical dystonia:

• drooping eyelid
• drowsiness
• dry mouth
• fever
• flu-like symptoms
• headache
• local or general weakness
• muscle tightness
• nausea
• numbness
• pain, soreness, or bruising at the place of injection
• runny nose
• stiffness

When used for upper limb spasticity after a stroke:

• arm pain
• fever
• flu symptoms
• headache
• muscle tightness or weakness
• pain, soreness, or bruising at the place of injection

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• difficult or painful swallowing, dizziness, shortness of breath, or vision changes (when used for cervical dystonia)
• facial paralysis or persistent eye irritation or pain (when used for eye conditions)
• fever, especially when accompanied by coughing and shortness of breath
• irregular heartbeat
• shortness of breath
• skin rash

Stop using the medication and seek immediate medical attention if any of the following occur:

• breathing problems
• difficulty swallowing
• peeling or blistering skin
• signs of a heart attack (e.g., chest pain or pressure; shortness of breath; jaw, shoulder, or arm pain; nausea; lightheadedness; sweating)
• signs of an allergic reaction (e.g., hives; difficulty breathing; swelling of the mouth, tongue, or throat)
• speech problems

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

There may be an interaction between XEOMIN and any of the following:

• aminoglycoside antibiotics (e.g., gentamicin, neomycin, tobramycin, streptomycin)
• anticoagulants (blood thinners, e.g., warfarin)
• certain antimalarial or antirheumatic medications (e.g., chloroquine, hydroxychloroquine)
• lincomycin
• muscle relaxants (tubocuraine-type)
• polymyxins (e.g., polymyxin B)
• spectinomycin
• tetracyclines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

XEOMIN is injected into a muscle by a qualified health professional. When given for conditions of the eye, the medication is injected into the surrounding muscle or tissue of the eye.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive XEOMIN, contact your doctor as soon as possible to reschedule your appointment. It is very important to keep your appointments for treatment and follow-up.

This medication is stored at room temperature. Once the dried powder has been mixed, it should ideally be used immediately. However, it may be stored in the refrigerator for up to 24 hours.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.