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Movement Disorders

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XEOMIN^® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

Warnings

XEOMIN may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of XEOMIN:

Problems swallowing, speaking, or breathing can happen if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
- People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
- Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Read the Medication Guide before you start receiving XEOMIN^® (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

Talk to your health care provider or pharmacist
Visit www.xeomin.com to obtain the FDA-approved product labeling
Call 1-855-4MERZTX (1-855-463-7989)

Uses

XEOMIN is a prescription medicine:

that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea) in adults and in children 2 to 17 years of age.
that is injected into muscles and used to:
- treat increased muscle stiffness in the arm because of upper limb spasticity in adults.
- treat increased muscle stiffness in the arm in children 2 to 17 years of age with upper limb spasticity, excluding spasticity caused by cerebral palsy.
- treat the abnormal head position and neck pain with cervical dystonia (CD) in adults.
- treat abnormal spasm of the eyelids (blepharospasm) in adults.

It is not known if XEOMIN is safe and effective in children younger than:

2 years of age for the treatment of chronic sialorrhea
2 years of age for the treatment of upper limb spasticity
18 years of age for the treatment of cervical dystonia or blepharospasm

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN (see below for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc^®), onabotulinumtoxinA (Botox^®, Botox^® Cosmetic), or abobotulinumtoxinA (Dysport^®) or have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)
have had any side effect from any other botulinum toxin in the past
have a breathing problem, such as asthma or emphysema
have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
have drooping eyelids
have had eye surgery
have had surgery on your face
are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.

Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past.

Especially tell your doctor if you:

have received any other botulinum toxin product in the last four months
have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC^®), onabotulinumtoxinA (BOTOX^®, BOTOX^® COSMETIC) and abobotulinumtoxinA (DYSPORT^®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
have recently received an antibiotic by injection or inhalation
take muscle relaxants
take an allergy or cold medicine
take a sleep medicine

Ask your doctor if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Possible Side Effects

XEOMIN can cause serious side effects including:

Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN.
XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

The most common side effects of XEOMIN in adults with chronic sialorrhea include:

needing to have a tooth pulled (extracted)
dry mouth
diarrhea
high blood pressure

The most common side effects of XEOMIN in children 2 to 17 years of age with chronic sialorrhea include:

bronchitis
nausea
headache
vomiting

The most common side effects of XEOMIN in adults with upper limb spasticity include:

seizure
nasal congestion, sore throat and runny nose
dry mouth
upper respiratory infection

The most common side effects of XEOMIN in children 2 to 17 years of age with upper limb spasticity include:

nasal congestion, sore throat and runny nose
bronchitis

The most common side effects of XEOMIN in adults with cervical dystonia include:

difficulty swallowing
neck pain
muscle weakness
pain at the injection site
muscle and bone pain

The most common side effects of XEOMIN in adults with blepharospasm include:

drooping of the eyelid
dry eye
vision problems
dry mouth

These are not all the possible side effects of XEOMIN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

Active Ingredient: botulinum toxin type A

Inactive Ingredients: human albumin and sucrose

Please see Full Prescribing Information and Medication Guide.

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

XEOMIN^® (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, is a prescription medicine indicated for:

the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adults
chronic sialorrhea in patients 2 years of age and older
upper limb spasticity in adults
upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
cervical dystonia in adults
blepharospasm in adults

WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete BOXED WARNING.

The effects of XEOMIN 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.

CONTRAINDICATIONS

Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection

WARNINGS AND PRECAUTIONS

The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
Serious hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken:
- avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes;
- corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post-marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for albumin.

ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

Glabellar Lines in adults: (≥2% of patients) headache.
Chronic Sialorrhea:
- in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
- in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
Upper Limb Spasticity:
- in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
- in pediatric patients in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
Cervical Dystonia in adults: (≥5% of patients) dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
Blepharospasm in adults: (≥10% of patients) eyelid ptosis, dry eye, visual impairment, and dry mouth.

DRUG INTERACTIONS

Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.

Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

USE IN PREGNANCY

There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.

XEOMIN® for:Frown Lines

XEOMIN® for:Movement Disorders

XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION