Pronunciation:

in-koe-bot-ue-LYE-num-tox-in-ay

Dosage Forms:

• Powder for Solution

Warnings:

Distant Spread of Toxin EffectThe effects of incobotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms .

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Botulinum Toxin Type A

Uses of This Medicine:

IncobotulinumtoxinA is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). It is also used to treat upper limb spasticity (muscle spasms in the upper arms). This medicine is also used to treat blepharospasm, a condition wherein the eyelid will not stay open because of a muscle spasm. It is also used to treat long-lasting sialorrhea (excessive drooling). IncobotulinumtoxinA is also used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines).

IncobotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of incobotulinumtoxinA in children with lower limb spasticity, cervical dystonia, blepharospasm, or glabellar frown lines. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of incobotulinumtoxinA in children 2 to 17 years of age with sialorrhea or upper limb spasms, excluding spasms caused by cerebral palsy. Safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of incobotulinumtoxinA in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and are more likely to have side effects (eg, difficulty with swallowing, lack or loss of strength, or dizziness), which may require caution in patients receiving incobotulinumtoxinA.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
• Cornea or eye problems (eg, ulcers) or
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle and nerve problem) or
• Myasthenia gravis (severe muscle weakness) or
• Surgery where the injection will be given (eg, eye or face surgery)—May increase risk for more serious side effects.

• Breathing problems (eg, asthma, emphysema) or
• Dysphagia (trouble with swallowing) or
• Glaucoma, narrow angle or
• Muscle weakness or atrophy at the injection site or
• Ptosis (droopy eyelid)—Use with caution. May make these conditions worse.

• Infection at the injection site—Should not be used in patients with this condition.

Proper Use of This Medicine:

Your doctor will give you this medicine in a medical facility. It is given as a shot into one of your muscles or as a needle placed into your saliva gland.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor will only use incobotulinumtoxinA (Xeomin®) to treat your condition. Other botulinum toxin products may not work the same way.

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.

You may see the effects of this medicine for your condition within 7 days after the injection, which may last up to 12 to 16 weeks. However, the duration of the effects may differ from person to person.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require treatment in a hospital or clinic.

This medicine may cause serious allergic reactions, including anaphylaxis and serum sickness, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble breathing or swallowing, fever, joint swelling, muscle aches, or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may make your muscles weak and cause eye or vision problems (eg, bleeding inside the eye). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may reduce blinking of the eye which can lead to an increased risk of eye problems (eg, corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.

After you have received this medicine and your vision or muscle spasms get better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, talk with your doctor.

A part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common—for blepharospasm

Dry eyes

fever

More common—for cervical dystonia

Chills

cough

difficulty with swallowing

lower back or side pain

muscle or bone pain

muscle weakness

painful or difficult urination

pain in the neck

Less common—for blepharospasm

Difficult or labored breathing

muscle aches

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Less common—for sialorrhea

Blurred vision

chest tightness

cough producing mucus

difficulty breathing

dizziness

falls

headache

nervousness

pounding in the ears

slow or fast heartbeat

sore throat

Less common—for upper limb spasticity

Body aches or pain

chills

cough

ear congestion

fever

headache

loss of voice

muscle aches

seizures

sore throat

stuffy or runny nose

unusual tiredness or weakness

Rare—for glabellar lines

Itching, pain, redness, or swelling at the injection site

pain in the face

swelling of the eyelids

Incidence not known

Changes in patterns and rhythms of speech

chest tightness

fast heartbeat

fever

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

muscle spasm

pain at the injection site

redness of the skin

slurred speech

swelling of the eyes or eyelids

swelling of the face, lips, hands, or feet

trouble with speaking

trouble breathing or swallowing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common—for blepharospasm

Blurred vision

diarrhea

drooping upper eyelids

dry mouth

headache

Less common—for sialorrhea

Back pain

diarrhea

dry eye

dry mouth

hoarseness

voice changes

Less common—for upper limb spasticity

Dry mouth

Rare—for glabellar lines

Drooping of the eyelids

increased blinking

twitching of the eyelids

Incidence not known

Difficulty with moving

joint pain or swelling

muscle ache, cramps, pain, or stiffness

nausea

painful blisters on the trunk of the body

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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