IncobotulinumtoxinA

What is IncobotulinumtoxinA?

• IncobotulinumtoxinA (Xeomin) is an acetylcholine release inhibitor and neuromuscular blocking agent.

Botulinum toxin 3BTA

What are the uses of this medicine?

IncobotulinumtoxinA (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.
• improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) for a short period of time (temporary) in adults.

How does this medicine work?

Botulinum Toxin Mechanism

• Xeomin blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings.
• This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine.
• In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to Xeomin or any of the ingredients in Xeomin.
• had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), or abobotulinumtoxinA (DYSPORT).
• have a skin infection at the planned injection site.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• certain antibiotics such as amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin; anticoagulants ('blood thinners')
• medicine for allergies, colds or sleep
• muscle relaxants

• Also tell your doctor if you have received injections of any botulinum toxin product in the last 4 months.

Is this medicine FDA approved?

• Initial U.S. Approval: 2010

How should this medicine be used?

Recommended dosage: Chronic Sialorrhea: Chronic Sialorrhea in Adults:

• The recommended total dose is 100 Units per treatment session consisting of 30 Units per parotid gland and 20 Units per submandibular gland, no sooner than every 16 weeks.

Chronic Sialorrhea in Pediatric Patients:

• The recommended dose is based on body weight administered in a 3:2 dose ratio into the parotid and submandibular glands, respectively, no sooner than every 16 weeks; ultrasound guidance recommended.

Upper limb spasticity, cervical dystonia, and blepharospasm:

• The optimum dose, frequency, and number of injection sites in the treated muscle(s) should be based on severity and prior treatment response in patients previously treated with botulinum toxin; individualize dosing for each patient.

Upper Limb Spasticity in Adults:

• The recommended total dose is up to 400 Units, divided among affected muscles.

Upper Limb Spasticity in Pediatric Patients, excluding spasticity caused by cerebral palsy:

• The recommended total dose is 8 Units/kg (maximum 200 Units) per single upper limb or 16 Units/kg (maximum 400 U) in both upper limbs, divided among affected muscles.

Cervical Dystonia:

• The recommended initial dose is 120 Units per treatment session.

Blepharospasm:

• The recommended initial dose is 50 Units (25 Units per eye).

Administration:

• IncobotulinumtoxinA injection comes as a powder to be mixed with a liquid to be injected by a doctor into your salivary glands or a muscle.
• Your doctor will decide the best place to inject the medication to treat your condition.
• You may receive additional injections every 3 to 4 months, depending on your condition and the duration of treatment effects.
• Your doctor will likely start you on a low dose of incobotulinumtoxinA injection and gradually change your dose according to your response to the medication.
• You should not substitute the brand or type of botulinum toxin you receive.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial

This medicine is available in fallowing brand namesː

• Xeomin

What side effects can this medication cause?

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

The most common side effect of Xeomin in adults with glabellar lines include:

• headache

Xeomin may cause serious side effects, including:

• Problems with swallowing, speaking, or breathing
• Spread of toxin effects
• Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm
• allergic reactions

What special precautions should I follow?

• Xeomin may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking Xeomin. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
• Postmarketing safety data from Xeomin and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
• Serious hypersensitivity reactions have been reported with botulinum toxin products. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of Xeomin and institute appropriate medical therapy immediately.
• Advise patients to inform their healthcare provider if they develop any unusual symptoms, including difficulty with swallowing, speaking, or breathing, or if any existing symptom worsen. Inform patients of the risk of aspiration.
• Inform patients that injections of Xeomin may cause reduced blinking or effectiveness of blinking, and that they should seek immediate medical attention if eye pain or irritation occurs following treatment.
• Do not exceed the recommended dosage and frequency of administration of Xeomin.
• This product contains albumin, a derivative of human blood. 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.
• One brand or type of botulinum toxin cannot be substituted for another.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• Excessive doses of Xeomin may be expected to produce neuromuscular weakness with a variety of symptoms, particularly when treated intramuscularly.
• Symptoms of overdose are not likely to be present immediately following injection.
• Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.

Management of overdosage:

• In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis.
• Symptomatic treatment may be necessary.
• In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA.
• In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC.
• If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100.

Can this medicine be used 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.

Can this medicine be used in children?

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, blepharospasm, or glabellar lines

What are the active and inactive ingredients in this medicine?

• Active ingredient: botulinum toxin type A
• Inactive ingredients: human albumin and sucrose

Who manufactures and distributes this medicine?

• Manufactured by: Merz Pharmaceuticals GmbH, Eckenheimer Landstrasse 100, Frankfurt Germany U.S. License Number 1830
• Distributed by: Merz Pharmaceuticals, LLC, Six Forks Road, Suite 430, Raleigh, NC and Merz North America, Inc. 4133 Courtney Street, Suite 10, Franksville, WI

What should I know about storage and disposal of this medication?

• Unopened vials of Xeomin should be stored at or below 25°C (77°F).
• Refrigeration of unopened vials is not required.
• Do not use after the expiration date on the vial.
• Reconstituted Xeomin may be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours until time of use.

• Dailymed label info on IncobotulinumtoxinA
• FDA IncobotulinumtoxinA

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