Does not require refrigeration prior to reconstitution1

Can be shipped and stored at room temperature
Better for transport and multiple office locations
Not dependent on the cold chain from pharmacy to office

On hand when your patients need it

3 vial options allow for precise ordering
No polystyrene waste
No need for dry ice disposal
Recyclable packaging

XEOMIN has been studied in 6.5 million patients with various conditions in more than 70 countries, for more than 12 years2

To order XEOMIN now, call 1-855-4MERZTX (1-855-463-7989)

50 unit, 100 unit, and 200 unit vials of XEOMIN

Reconstitution to Flip For

Prior to injection, reconstitute each vial of XEOMIN with sterile, preservative-free 0.9% sodium chloride injection, USP. A 20-27-gauge short-bevel needle is recommended for reconstitution. Draw up the recommended volume of preservative-free 0.9% sodium chloride injection, USP into a syringe.1

IMPORTANT – Do not pry or pop the cap off of the XEOMIN vial, as it is vacuum-packed and doing so will result in XEOMIN powder dispersing into the air

Vial Preparation Image
Step 1: Vial preparation

Clean the exposed portion of the rubber stopper of the vial with alcohol (70%) prior to insertion of the needle.

Saline Injection Image
Step 2: Saline injection

After vertical insertion of the needle through the rubber stopper, the vacuum will draw the saline into the vial. Gently inject any remaining saline into the vial to avoid foam formation. If the vacuum does not pull the saline into the vial, then XEOMIN must be discarded.

Mixing Image
Step 3: Mixing

Remove the syringe from the vial and mix XEOMIN with the saline by carefully swirling and inverting/flipping the vial—do not shake vigorously.

Reconstituted XEOMIN is a clear, colorless solution free of particulate matter. XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter

Intended for intramuscular or intrasalivary gland injection only
Each vial should be used for only 1 injection session and only 1 patient
#
For intramuscular injections, the number of injection sites is dependent upon the size of the muscle to be treated and the volume of reconstituted XEOMIN injected
Reconstitution Video

Watch how to reconstitute XEOMIN

Diluent tables for XEOMIN

Diluent volumes for XEOMIN reconstitution
Volume of preservative-free 0.9%
sodium chloride
50-Unit vial:
resulting dose in Units per 0.1 mL
100-Unit vial:
resulting dose in Units per 0.1 mL
200-Unit vial:
resulting dose in Units per 0.1 mL
0.25 mL
20 Units
-
-
0.5 mL
10 Units
20 Units
40 Units
1 mL
5 Units
10 Units
20 Units
1.25 mL
4 Units
8 Units
16 Units
2 mL
2.5 Units
5 Units
10 Units
2.5 mL
2 Units
4 Units
8 Units
4 mL
1.25 Units
2.5 Units
5 Units
5 mL
1 Units
2 Units
4 Units
8 mL
-
1.25 Units
2.5 Units
16 mL
-
-
1.25 Units
When using 8 mL of diluent for a 100-Unit or 200-Unit vial of XEOMIN, complete the following steps1
  1. Reconstitute a 100-Unit or 200-Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP.
  2. Withdraw 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, into an appropriately sized syringe for 8 mL in total.
  3. Using the same syringe, draw up the 4 mL of XEOMIN solution from the reconstituted vial and mix gently.
When using 16 mL of diluent for a 200-Unit vial of XEOMIN, complete the following steps1
  1. Reconstitute a 200-Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP.
  2. Withdraw 12 mL of preservative-free 0.9% Sodium Chloride Injection, USP, into an appropriately sized syringe for 16 mL in total.
  3. Using the same syringe, draw up the 4 mL of XEOMIN solution from the reconstituted vial and mix gently.
Review dosing & administration for XEOMIN

Select a Xeomin Indication

Adult Upper Limb Spasticity

Dosing & Administration

Download the Injection Tracker for Adult Upper Limb Spasticity
Flexed Elbow
A
Biceps brachii
(50-200 Units, 1-4 inj. sites)
B
Brachioradialis
(25-100 Units, 1-3 inj. sites)
C
Brachialis
(25-100 Units, 1-2 inj. sites)
Pronated Forearm
D
Pronator quadratus
(10-50 Units, 1 inj. site)
E
Pronator teres
(25-75 Units, 1-2 inj. sites)
Flexed Wrist
F
Flexor carpi radialis
(25-100 Units, 1-2 inj. sites)
G
Flexor carpi ulnaris
(20-100 Units, 1-2 inj. sites)
XEOMIN dosing and admin instructions for adults with upper limb spasticity
Clenched Fist
H
Flexor digitorum superficialis
(25-100 Units, 2 inj. sites)
I
Flexor digitorum profundus
(25-100 Units, 2 inj. sites)
Thumb-in-palm
J
Flexor pollicis brevis/opponens
pollicis (5-30 Units, 1 inj. site)
K
Flexor pollicis longus
(10-50 Units, 1 inj. site)
L
Adductor pollicis
(5-30 Units, 1 inj. site)
Initial and subsequent dosing1
  • In spasticity patients not previously treated with botulinum toxins, initial dosing should begin at the low end of the recommended dosing range and be titrated as clinically necessary
  • The recommended total dose is up to 400 Units, divided among affected muscles
Dosing frequency1
  • The frequency of XEOMIN treatments should be no sooner than every 12 weeks
  • Most patients in clinical studies were retreated between 12 and 14 weeks
Duration of effect2
  • Long duration of effect is possible with XEOMIN for adult upper limb spasticity
    • In a clinical study, XEOMIN efficacy lasted between 20 and 28 weeks in some adult patients with upper limb spasticity
Download the Injection Tracker for Adult Upper Limb Spasticity
Worried about waning efficacy?
Consider XEOMIN
Learn More Back to Indications

Adult Cervical Dystonia

Dosing & Administration

Download the Injection Tracker for Adult Cervical Dystonia
XEOMIN dosing and admin instructions for adults with cervical dystonia

Median-dose and number of injections for each site are reported from a randomized, double-blind, placebo-controlled trial used for FDA approval.3

Initial dose1

  • The recommended initial dose is 120 Units
  • In previously treated patients, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the XEOMIN dose

Dosing frequency1

  • The frequency of XEOMIN repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks

Duration of effect4,6

  • Some patients can experience long duration of effect with XEOMIN for cervical dystonia
    • In clinical studies, some patients with cervical dystonia were re-treated with XEOMIN every 20 weeks
Download the Injection Tracker for Adult Cervical Dystonia
Worried about waning efficacy?
Consider XEOMIN
Learn More Back to Indications

*Excluding spasticity caused by cerebral palsy.

Adult Blepharospasm

Dosing & Administration

Download the Injection Tracker for Adult Blepharospasm

A dose of 25 Units per eye was proven to effectively treat adult blepharospasm for up to 20 weeks.

Number of XEOMIN Units and injection sites is based on a median per eye.

XEOMIN dosing and admin instructions for adults with blepharospasm
A
B
Lateral and medial super pretarsal part of the orbicularis oculi muscle
C
D
Lateral canthus of the orbicularis oculi muscle
E
Inferolateral portion of the orbicularis oculi muscle
F
Corrugator muscle

Initial dose1

  • In treatment-naïve patients, the recommended initial dose of XEOMIN is 50 Units (25 Units per eye)
  • In patients previously treated with a botulinum toxin type A, their past dose, treatment response, duration of effect, and adverse event history should be taken into consideration when determining the XEOMIN dose
  • The total dose of XEOMIN should not exceed 100 Units per treatment session (50 Units per eye)

Dosing frequency1

  • The frequency of XEOMIN repeat treatment should be determined by clinical response, but should generally be no more frequent than every 12 weeks

Duration of effect4,7,8

  • Long-lasting symptom relief may be possible with XEOMIN for blepharospasm
    • In an open-label clinical trial, the median treatment interval was 19.9 weeks
Download the Injection Tracker for Adult Blepharospasm
Worried about waning efficacy?
Consider XEOMIN
Learn More Back to Indications

Excluding spasticity caused by cerebral palsy.

Median dose and number of injections for each site are reported from a randomized, double–blind, placebo–controlled trial used for FDA approval.

Adult Chronic Sialorrhea

Dosing & Administration

Download the Injection Tracker for Adult Chronic Sialorrhea

A single 100-Unit XEOMIN treatment was proven to effectively treat adult patients with chronic sialorrhea up to 16 weeks.1

The salivary gland can be located using ultrasound imaging or surface anatomical landmarks.

XEOMIN dosing and admin instructions for adults with chronic sialorrhea
Injection Guidelines for Chronic Sialorrhea

Injection details using anatomical landmarks1

1
To inject the parotid gland, find the midpoint on the line connecting the tragus and mandible angles (sites A and B, respectively), approximately at the height of the earlobe. Deliver the injection 1 finger-breadth anterior to this site (area 1).
2
To inject the submandibular gland, find the midpoint between the angle of the mandible and the tip of the chin (sites B and C, respectively). Deliver the injection 1 finger-breadth medial to the inferior surface of the mandible at this site (area 2).
M
Masseter

Total dose1

  • The recommended total dose is 100 Units per treatment session

Dosing frequency1

  • The timing for repeat treatment should be determined based on the actual clinical need of the individual patient, and no sooner than every 16 weeks

Duration of effect9,10

  • In clinical studies, some patients did not return to their baseline-level of chronic sialorrhea through the 16-week follow-up period after injection

Dosing & Administration Videos

Anatomical localization of glands for injection
Ultrasound localization of glands for injection
Download the Injection Tracker for Adult Chronic Sialorrhea
Worried about waning efficacy?
SConsider XEOMIN
Learn More Back to Indications

*Excluding spasticity caused by cerebral palsy.

Pediatric Upper Limb Spasticity

Dosing & Administration

Download the Injection Tracker for Pediatric Upper Limb Spasticity

XEOMIN treatment response in pediatric patients (≥2 years) with ULS was evaluated in 12 muscles in 5 muscle groups, allowing for flexible, weight-based dosing.1

Flexed Elbow
A
Biceps
(2-3 U/kg, 75 U max, 1-3 inj. sites)
B
Brachialis
(1-2 U/kg, 50 U max, 1-2 inj. sites)
C
Brachioradialis
(1-2 U/kg, 50 U max, 1-2 inj. sites)
Pronated Forearm
D
Pronator teres
(1-2 U/kg, 50 U max, 1-2 inj. sites)
E
Pronator quadratus
(0.5 U/kg, 12.5 U max, 1 inj. site)
Flexed Wrist
F
Flexor carpi radialis
(1 U/kg, 25 U max, 1 inj. site)
G
Flexor carpi ulnaris
(1 U/kg, 25 U max, 1 inj. site)
XEOMIN dosing and admin instructions for pediatric upper limb spasticity
Clenched Fist
H
Flexor digitorum superficialis
(1 U/kg, 25 U max, 1 inj. site)
I
Flexor digitorum profundus
(1 U/kg, 25 U max, 1 inj. site)
Thumb-in-palm
J
Flexor pollicis brevis/opponens
pollicis (0.5 U/kg, 12.5 U max, 1 inj. site)
K
Flexor pollicis longus
(1 U/kg, 25 U max, 1 inj. site)
L
Adductor pollicis
(0.5 U/kg, 12.5 U max, 1 inj. site)

Initial and subsequent dosing1

  • The maximum recommended dose is 8 Units/kg, divided among affected muscles, up to a maximum dose of 200 Units per single upper limb. If both upper limbs are treated, total XEOMIN dosage should not exceed 16 Units/kg, up to a maximum of 400 Units

Dosing frequency1

  • The timing for repeat treatment should be determined based on the clinical need of the patient; the frequency of repeat treatments should be no sooner than every 12 weeks

Duration of effect

  • In a clinical study, most pediatric patients with upper limb spasticity were reinjected with XEOMIN every 12-14 weeks
Download the Injection Tracker for Pediatric Upper Limb Spasticity
Worried about waning efficacy?
Consider XEOMIN
Learn More Back to Indications

*Excluding spasticity caused by cerebral palsy.

Pediatric Chronic Sialorrhea

Dosing & Administration

Download the Injection Tracker for Pediatric Chronic Sialorrhea

XEOMIN has flexible, weight-based dosing to help optimize safety and efficacy, with 4 injection sites.

XEOMIN dosing and admin instructions for pediatric chronic sialorrhea
Dosing recommendations for children
Body weight
Parotid gland, each side
Submandibular gland, each side
Total dose, both glands, both sides
Dose per gland
Volume per injection
Dose per gland
Volume per
injection
≥12 kg† to <15 kg
6 Units
0.24 mL
4 Units
0.16 mL
20 Units
≥15 kg to <19 kg
9 Units
0.36 mL
6 Units
0.24 mL
30 Units
≥19 kg to <23 kg
12 Units
0.48 mL
8 Units
0.32 mL
40 Units
≥23 kg to <27 kg
15 Units
0.60 mL
10 Units
0.40 mL
50 Units
≥27 kg to <30 kg
18 Units
0.72 mL
12 Units
0.48 mL
60 Units
>30 kg
22.5 Units
0.90 mL
15 Units
0.60 mL
75 Units

†No dosage recommendation for children <12 kg.

Recommended dosing1

  • The recommended dosing is based on body weight with a 3:2 dose ratio in the parotid and submandibular glands, respectively
  • Ultrasound guidance is recommended

Dosing frequency1

  • The timing for repeat treatment should be determined based on the actual clinical need of the individual patient, and no sooner than every 16 weeks
Download the Injection Tracker for Pediatric Chronic Sialorrhea
Worried about waning efficacy?
Consider XEOMIN
Learn More Back to Indications

*Excluding spasticity caused by cerebral palsy.

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023.
  2. Kaňovský P, Elovic EP, Hanschmann A, et al. Duration of treatment effect using incobotulinumtoxinA for upper-limb spasticity: a post-hoc analysis. Front Neurol. 2021;11:615706.
  3. Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; US XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN®, botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011;308(1-2):103-109.
  4. Data on file. Raleigh, NC: Merz Pharmaceuticals, LLC; 2021.
  5. Evidente VG, Fernandez HH, LeDoux MS, et al. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia. J Neural Transm (Vienna). 2013;120(12):1699-1707.
  6. Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin®) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014;346(1-2):116-120.
  7. Mitsikostas DD, Dekundy A, Hanschmann A, et al. Duration and onset of effect of incobotulinumtoxinA for the treatment of blepharospasm in botulinum toxin-naïve subjects. Curr Med Res Opin. 2021;37(10):1761-1768.
  8. Truong DD, Gollomp SM, Jankovic J, et al; Xeomin US Blepharospasm Study Group. Sustained efficacy and safety of repeated incobotulinumtoxinA (Xeomin®) injections in blepharospasm. J Neural Transm (Vienna). 2013;120(9):1345-1353.
  9. Jost WH, Friedman A, Michel O, et al. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: efficacy and safety over 64 weeks. Parkinsonism Relat Disord. 2020;70:23-30.
  10. Jost WH, Friedman A, Michel O, et al. SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea. Neurology. 2019;92(17):e1982-e1991.
Back to Top
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
IMPORTANT SAFETY INFORMATION (continued)
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components (human albumin, sucrose) 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 utilized. Units of biological activity of Xeomin cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.
  • Serious hypersensitivity reactions (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea) 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.
  • 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.
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • 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: Reduced blinking from injection of botulinum toxin products into the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Patients with previous eye surgery should be carefully assessed for corneal sensation before treatment. Xeomin should be used with caution in patients at risk of developing narrow angle glaucoma. 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). No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for licensed albumin or albumin contained in other licensed products.
  • Use caution when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Use caution when XEOMIN is used in patients who have marked facial asymmetry, with surgical alterations to the facial anatomy, pre-existing eyelid or eyebrow ptosis, when excessive weakness or atrophy is present in the target muscles, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin (e.g., the inability to substantially lessen glabellar lines even by physically spreading them apart).
ADVERSE REACTIONS

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

  • 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 (≥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.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of XEOMIN.

USE IN PREGNANCY

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 have not been established in pediatric patients 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.

Visit www.xeomin.com to obtain the Full Prescribing Information and Medication Guide.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
IMPORTANT SAFETY INFORMATION (continued)
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components (human albumin, sucrose) 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 utilized. Units of biological activity of Xeomin cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.
  • Serious hypersensitivity reactions (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea) 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.
  • 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.
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • 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: Reduced blinking from injection of botulinum toxin products into the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders. Patients with previous eye surgery should be carefully assessed for corneal sensation before treatment. Xeomin should be used with caution in patients at risk of developing narrow angle glaucoma. 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). No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for licensed albumin or albumin contained in other licensed products.
  • Use caution when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Use caution when XEOMIN is used in patients who have marked facial asymmetry, with surgical alterations to the facial anatomy, pre-existing eyelid or eyebrow ptosis, when excessive weakness or atrophy is present in the target muscles, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin (e.g., the inability to substantially lessen glabellar lines even by physically spreading them apart).
ADVERSE REACTIONS

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

  • 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 (≥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.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of XEOMIN.

USE IN PREGNANCY

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 have not been established in pediatric patients 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.

Visit www.xeomin.com to obtain the Full Prescribing Information and Medication Guide.