Dosage & Administration
Chronic Sialorrhea:
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 Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines): When treating all three areas simultaneously (glabellar lines, horizontal forehead lines, and lateral canthal lines), the maximum recommended dose is 64 Units . When not treating simultaneously:
Administer retreatment with XEOMIN no more frequently than every three months.
Reconstituted XEOMIN:
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Xeomin Prescribing Information
Postmarketing reports indicate that 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 may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1)].
Chronic Sialorrhea
XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older.
Upper Limb Spasticity
Upper Limb Spasticity in Adult Patients
XEOMIN is indicated for the treatment of upper limb spasticity in adult patients.
Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy
XEOMIN is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy.
Cervical Dystonia
XEOMIN is indicated for the treatment of cervical dystonia in adult patients.
Blepharospasm
XEOMIN is indicated for the treatment of blepharospasm in adult patients.
Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines)
XEOMIN is indicated in adult patients for the temporary improvement in the appearance of upper facial lines:
- moderate to severe glabellar lines (GL) associated with corrugator and/or procerus muscle activity
- moderate to severe horizontal forehead lines (HFL) associated with frontalis muscle activity
- moderate to severe lateral canthal lines (LCL) associated with orbicularis oculi muscle activity.
Instructions for Safe Use
The potency Units of XEOMIN for injection 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 [see Warnings and Precautions (5.2) and Description (11)].
Reconstituted XEOMIN is intended for intramuscular or intra-salivary gland injection only.
Do not exceed the recommended maximum cumulative dose in a treatment session for any indication.
Recommended Dose for Chronic Sialorrhea
Chronic Sialorrhea in Adult Patients
The recommended total dose per treatment session is 100 Units. XEOMIN is injected into the parotid and submandibular glands on both sides (i.e., 4 injection sites per treatment session). The recommended total dose per treatment session is 100 Units. The dose is divided with a ratio of 3:2 between the parotid and submandibular glands (Table 1).
Figure 1: Glands for Injection in Chronic Sialorrhea in Adult Patients
Use the following guidelines if locating salivary glands using anatomic landmarks:
- 1)
- To inject the parotid gland, find the midpoint on the line connecting the tragus and mandible angle (Site A and B, respectively, Figure 1), approximately at the height of the ear lobe. Deliver the injection one finger breadth anterior to this site (Star 1, Figure 1).
- 2)
- To inject the submandibular gland, find the midpoint between the angle of the mandible and the tip of the chin (Site B and C, respectively, Figure 1). Deliver the injection one finger breadth medial to the inferior surface of the mandible at this site (Star 2, Figure 1).
| Gland(s) | Units Per Side | Total |
|---|---|---|
| Parotid gland(s) | 30 Units | 60 Units |
| Submandibular gland(s) | 20 Units | 40 Units |
| Both Glands | 50 Units | 100 Units |
The concentration used in the clinical study after reconstitution was 5 Units/0.1mL. Determine the timing for repeat treatment based on the actual clinical need of the individual patient, and no sooner than every 16 weeks.
Chronic Sialorrhea in Pediatric Patients
XEOMIN is injected into the parotid and submandibular glands on both sides (i.e., 4 injection sites per treatment session). Ultrasound imaging is recommended to guide needle placement into the salivary glands. The body-weight adjusted dose is divided with a ratio of 3:2 between the parotid and submandibular glands (Table 2). XEOMIN has not been studied in children weighing less than 12 kg [see Clinical Studies (14.1)].
Figure 2: Glands for Injection in Chronic Sialorrhea in Pediatric Patients
| 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 or more to less than 15 kg | 6 Units | 0.24 mL | 4 Units | 0.16 mL | 20 Units |
| 15 kg or more to less than 19 kg | 9 Units | 0.36 mL | 6 Units | 0.24 mL | 30 Units |
| 19 kg or more to less than 23 kg | 12 Units | 0.48 mL | 8 Units | 0.32 mL | 40 Units |
| 23 kg or more to less than 27 kg | 15 Units | 0.6 mL | 10 Units | 0.4 mL | 50 Units |
| 27 kg or more to less than 30 kg | 18 Units | 0.72 mL | 12 Units | 0.48 mL | 60 Units |
| 30 kg or more | 22.5 Units | 0.9 mL | 15 Units | 0.6 mL | 75 Units |
The concentration used in the clinical study after reconstitution was 2.5 Units/0.1 mL. Determine the timing for repeat treatment based on the actual clinical need of the individual patient, and no sooner than every 16 weeks.
Recommended Dose for Upper Limb Spasticity
Upper Limb Spasticity in Adult Patients
Tailor the dosage, frequency, and number of injection sites to the individual patient based on the size, number, and location of muscles to be treated, severity of spasticity, presence of local muscle weakness, patient's response to previous treatment, and adverse event history with XEOMIN. Administer repeat XEOMIN treatments no sooner than every 12 weeks. In patients not previously treated with a botulinum toxin, begin initial dosing at the low end of the recommended dosing range and titrate as clinically necessary. Most patients in clinical studies were retreated between 12 and 14 weeks.
| Clinical Pattern Muscle | Units (Range) | Number of injection sites per muscle |
|---|---|---|
| Clenched Fist | ||
| Flexor digitorum superficialis | 25 Units-100 Units | 2 |
| Flexor digitorum profundus | 25 Units-100 Units | 2 |
| Flexed Wrist | ||
| Flexor carpi radialis | 25 Units-100 Units | 1-2 |
| Flexor carpi ulnaris | 20 Units-100 Units | 1-2 |
| Flexed Elbow | ||
| Brachioradialis | 25 Units-100 Units | 1-3 |
| Biceps | 50 Units-200 Units | 1-4 |
| Brachialis | 25 Units-100 Units | 1-2 |
| Pronated Forearm | ||
| Pronator quadratus | 10 Units-50 Units | 1 |
| Pronator teres | 25 Units-75 Units | 1-2 |
| Thumb-in-Palm | ||
| Flexor pollicis longus | 10 Units-50 Units | 1 |
| Adductor pollicis | 5 Units-30 Units | 1 |
| Flexor pollicis brevis/Opponens pollicis | 5 Units-30 Units | 1 |
Figure 3: Muscles Involved In Adult Upper Limb Spasticity
Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy
Tailor the exact dosage, frequency, and number of injection sites to the individual patient based on size, number and localization of involved muscles; the severity of spasticity; and the presence of local muscle weakness.
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, do not exceed a total XEOMIN dosage of 16 Units/kg, up to a maximum of 400 Units.
Based on the selected dose, a reconstituted solution at a concentration between 1.25 Units/0.1 mL and 5 Units/0.1 mL is recommended [see Dosage and Administration (2.3)]. Determine the timing for repeat treatment based on the clinical need of the patient; administer repeat treatments no sooner than every 12 weeks. Most patients in clinical studies were retreated between 12 and 16 weeks.
Table 4 includes the recommended dose ranges for the treatment of the clinical patterns of flexed elbow, flexed wrist, pronated forearm, clenched fist, and thumb-in-palm.
| Clinical Pattern Muscle | Dosage | Number of Injection Sites per Muscle | |
|---|---|---|---|
| Range (Units/kg) | Maximum (Units) | ||
| Flexed Elbow | |||
| Brachioradialis | 1-2 | 50 | 1-2 |
| Biceps | 2-3 | 75 | 1-3 |
| Brachialis | 1-2 | 50 | 1-2 |
| Flexed Wrist | |||
| Flexor carpi radialis | 1 | 25 | 1 |
| Flexor carpi ulnaris | 1 | 25 | 1 |
| Pronated Forearm | |||
| Pronator quadratus | 0.5 | 12.5 | 1 |
| Pronator teres | 1-2 | 50 | 1-2 |
| Clenched Fist | |||
| Flexor digitorum superficialis | 1 | 25 | 1 |
| Flexor digitorum profundus | 1 | 25 | 1 |
| Thumb-in-Palm | |||
| Flexor pollicis longus | 1 | 25 | 1 |
| Adductor pollicis | 0.5 | 12.5 | 1 |
| Flexor pollicis brevis/ opponens pollicis | 0.5 | 12.5 | 1 |
Figure 4: Muscles Injected for Pediatric Upper Limb Spasticity
Recommended Dose for Cervical Dystonia
The recommended initial dose of XEOMIN for cervical dystonia is 120 Units. In a placebo-controlled trial utilizing initial XEOMIN doses of 120 Units and 240 Units, no meaningful difference in effectiveness was demonstrated between the doses [see Clinical Studies (14.3)]. 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.
In the treatment of cervical dystonia, XEOMIN is usually injected into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or the trapezius muscle(s) (see Figure 5). This list is not exhaustive, as any of the muscles responsible for controlling head position may require treatment [see Clinical Studies (14.3)]. The dose and number of injection sites in each treated muscle should be individualized based on the number and location of the muscle(s) to be treated, the degree of spasticity/dystonia, muscle mass, body weight, and response to any previous botulinum toxin injections.
The frequency of XEOMIN repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks [see Clinical Studies (14.3)].
Figure 5: Muscles Involved in Cervical Dsytonia
Recommended Dose for Blepharospasm
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 A, consider their past dose, response to treatment, duration of effect, and adverse event history when determining the XEOMIN dose.
Do not exceed a total XEOMIN dose of 100 Units per treatment session (50 Units per eye).
Inject XEOMIN into the lateral and medial orbicularis oculi muscle of the upper lid; lateral canthus and the lateral orbicularis oculi muscle of the lower lid; and the corrugator muscle, if necessary (see Figure 6). The number and location of injections may be changed in response to adverse reactions or based on the patient's response to treatment, but do not exceed a total dose of 50 Units per eye.
Figure 6: Injection Sites for Blepharospasm
Determine the frequency of XEOMIN repeat treatments by clinical response but administer repeat treatments no more frequent than every 12 weeks [see Clinical Studies (14.4)].
Recommended Dose for Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines)
The maximum recommended dose of XEOMIN for simultaneous treatment of upper facial lines [i.e., glabellar lines (GL), horizontal forehead lines (HFL) and lateral canthal lines (LCL)] in adult patients is 64 Units, comprised of 20 Units for GL, 20 Units for HFL, and 24 Units for LCL.
Administer retreatment with XEOMIN no more frequently than every three months.
When not treating upper facial lines (GL, HFL, and LCL) simultaneously in adult patients, refer to the following instructions:
Glabellar Lines
Equally distribute GL treatment to five equal intramuscular injections of 4 Units each. Inject 4 Units of reconstituted XEOMIN intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a maximum recommended dose of 20 Units (see Figure 7).
To reduce the complication of ptosis take the following steps:
- Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
- Place corrugator injections at least 1 cm above the bony supraorbital ridge.
Horizontal Forehead Lines in Conjunction with Glabellar Lines
Treat HFL in conjunction with GL to minimize the potential for brow ptosis. The maximum recommended dose for treatment of HFL (20 Units) in conjunction with GL (20 Units) is 40 Units.
Equally distribute HFL treatment to 5 horizontally orientated intramuscular injection sites (4 Units each) into the frontalis muscle, at least 2 cm above the orbital rim (see Figure 7).
Lateral Canthal Lines
Inject 4 Units of reconstituted XEOMIN into 3 sites per side (6 total injection sites) in the lateral orbicularis oculi muscle for a total of 12 Units per side (24 Units overall). Place one injection in the horizontal extension of the lateral canthus approximately 1 cm lateral from the bony orbital rim. Place the other two injections approximately 1 cm above and below the area of the first injection (see Figure 7). Give injections with the needle bevel tip up and oriented away from the eye. Avoid injections too close to the zygomaticus major muscle to prevent lip ptosis.
Figure 7: Injection Sites for Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines)
Preparation and Reconstitution Technique
Prior to injection, reconstitute each vial of XEOMIN with sterile, preservative-free 0.9% Sodium Chloride Injection, USP [see Dosage Form and Strengths (3)]. A 20-27 gauge short bevel needle is recommended for reconstitution. Draw up an appropriate amount of preservative-free 0.9% Sodium Chloride Injection, USP into a syringe (see Table 5). Clean the exposed portion of the rubber stopper of the vial with alcohol (70%) prior to insertion of the needle. 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. 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. Do not use XEOMIN if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.
After reconstitution, use XEOMIN for only one injection session and for only one patient. Administer reconstituted XEOMIN within 24 hours after dilution. During this time period, store unused reconstituted XEOMIN in the original container in a refrigerator 2°C -8°C (36°F -46°F) for up to 24 hours until time of use. XEOMIN vials are for single-dose only. Discard any unused portion.
Diluent volumes for reconstitution of XEOMIN are indicated in Table 5.
| Volume of preservative-free 0.9% Sodium Chloride Injection, USP | 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 Unit | 2 Units | 4 Units |
| 8 mL * | - | 1.25 Units | 2.5 Units |
| 16 mL † | - | - | 1.25 Units |
Administration
Reconstituted XEOMIN is intended for intramuscular or intra-salivary gland injection only.
If proposed injection sites are marked with a pen, DO NOT inject XEOMIN through the pen marks; otherwise a permanent tattooing effect may occur.
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.
Inject XEOMIN carefully when injected at sites close to sensitive structures, such as the carotid artery, lung apices, and esophagus. Before administering XEOMIN, the healthcare provider should be familiar with the patient's anatomy and any anatomic alterations, e.g., due to prior surgical procedures.
Chronic Sialorrhea
Chronic Sialorrhea in Adult Patients
Use a sterile needle (e.g., 27-30 gauge (0.30-0.40 mm diameter), 12.5 mm length) for intra-salivary gland administration for the treatment of chronic sialorrhea. Inject XEOMIN close to the center of the gland.
The salivary glands can be located using ultrasound imaging or surface anatomical landmarks [see Dosage and Administration (2.3)].
Chronic Sialorrhea in Pediatric Patients
Use a sterile needle (e.g., 27-30 gauge (0.30-0.40 mm diameter), 12.5 mm length) for intra-salivary gland administration for the treatment of chronic sialorrhea. Inject XEOMIN close to the center of the gland.
Ultrasound guidance is recommended for the localization of the involved salivary glands [see Clinical Studies (14.2)].
Upper Limb Spasticity
Upper Limb Spasticity in Adult Patients
Use a sterile needle (e.g., 26-gauge (0.45 mm diameter), 37 mm length for superficial muscles; or 22-gauge (0.70 mm diameter), 75 mm length for deeper musculature) in the intramuscular administration in the treatment of upper limb spasticity in adults.
Localization of the involved muscles with electromyographic guidance, nerve stimulation, or ultrasound techniques is recommended.
Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy
Use a sterile needle (e.g., 30-gauge (0.30 mm diameter), 25 mm length for superficial muscles; or 27-gauge (0.40 mm diameter), 37 mm length for deeper musculature) in the intramuscular administration in the treatment of upper limb spasticity in pediatric patients.
Localization of the involved muscles with techniques such as electromyographic guidance, nerve stimulation, or ultrasound is recommended.
Cervical Dystonia
Use a sterile needle (e.g., 26-gauge (0.45 mm diameter), 37 mm length for superficial muscles; or 22-gauge (0.70 mm diameter), 75 mm length for deeper musculature) in the intramuscular administration in the treatment of cervical dystonia.
Localization of the involved muscles with electromyographic guidance, ultrasound, or nerve stimulation techniques may be useful.
Blepharospasm
Use a sterile needle (e.g., 30-gauge (0.40 mm diameter), 12.5 mm length) in the intramuscular administration in the treatment of blepharospasm.
Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines)
Use a sterile needle [e.g., 30-33 gauge (0.3-0.2 mm diameter)], 13 mm length) for the intramuscular administration in the treatment of upper facial lines.
Monitoring to Assess Effectiveness
The median onset of XEOMIN treatment effect occurs within two to seven days after injection. The typical duration of effect of each treatment is up to 12-16 weeks; however, the duration of effect may vary in individual patients.
For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP.
Pregnancy
Risk Summary
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. XEOMIN was embryotoxic in rats and increased abortions in rabbits when given at doses higher than the maximum recommended human dose (MRHD) for cervical dystonia (120 Units), on a body weight basis.
In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data
Animal Data
When XEOMIN was administered intramuscularly to pregnant rats during organogenesis (3 Units/kg, 10 Units/kg, or 30 Units/kg on gestational days [GDs] 6, 12, and 19; or 7 Units/kg on GDs 6 to 19; or 2 Units/kg, 6 Units/kg, or 18 Units/kg on GDs 6, 9, 12, 16, and 19), decreases in fetal body weight and skeletal ossification were observed at doses that were also maternally toxic. The no-effect level for embryotoxicity in rats was 6 Units/kg (3 times the MRHD for cervical dystonia on a body weight basis). Intramuscular administration to pregnant rabbits during organogenesis (1.25 Units/kg, 2.5 Units/kg, or 5.0 Units/kg on GDs 6, 18, and 28) resulted in an increased rate of abortion at the highest dose, which was also maternally toxic. In rabbits, the no-effect level for increased abortion was 2.5 Units/kg (similar to the MRHD for cervical dystonia on a body weight basis).
Lactation
Risk Summary
There are no data on the presence of XEOMIN in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XEOMIN and any potential adverse effects on the breastfed infant from XEOMIN or from the underlying maternal conditions.
Pediatric Use
The safety and effectiveness of XEOMIN have not been established in pediatric patients for the treatment of lower limb spasticity, cervical dystonia, and blepharospasm, or the temporary improvement in the appearance of upper facial lines:
- moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
- moderate to severe horizontal forehead lines associated with frontalis muscle activity
- moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity [see Warnings and Precautions (5.1)].
Chronic Sialorrhea in Pediatric Patients
The safety and effectiveness of XEOMIN have been established by evidence from an adequate and well-controlled study of XEOMIN in patients 6 to 17 years of age with chronic sialorrhea [See Clinical Studies (14.1)]. Use of XEOMIN in patients 2 to 5 years of age is supported by the findings of efficacy and safety in patients 6 years and older with chronic sialorrhea, and by safety data in patients 2 to 5 years of age. Safety and effectiveness in pediatric patients below the age of 2 years have not been established [see Warnings and Precautions (5.1)].
Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy
Safety and effectiveness have been established in pediatric patients 2 to 17 years of age [see Warnings and Precautions (5.1), Adverse Reactions (6.1), and Clinical Studies (14.2)]. The safety and effectiveness of XEOMIN have been established by evidence from adequate and well-controlled studies of XEOMIN in patients 2 to 17 years of age with upper limb spasticity. A pediatric assessment for XEOMIN 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. Safety and effectiveness in pediatric patients below the age of 2 years have not been established [see Warnings and Precautions (5.1)].
Juvenile Animal Toxicity Data
In a study in which juvenile rats received intramuscular injections of Xeomin (0, 5, 10, or 30 Units/kg) every other week from postnatal day 21 for 10 weeks, decreased limb use, decreased body weight gain, skeletal muscle atrophy, and decreased bone growth and density were observed at all doses. Male reproductive organ histopathology (atrophy of the germinal epithelium of the testis, associated with hypospermia) was observed at the mid and high doses, and mating behavior was impaired at the high dose. A no-effect dose for adverse effects on development in juvenile animals was not established. The lowest dose tested (5 Units/kg) is less than the human dose of 400 Units on a body weight (kg) basis.
Geriatric Use
Chronic Sialorrhea
Of the total number of 184 patients in the placebo-controlled study in chronic sialorrhea in adult patients [see Clinical Studies (14.1)], 107 were 65 years of age and over (46 treated with XEOMIN 100 Units, 44 treated with XEOMIN 75 Units, and 17 received placebo). No differences in safety or effectiveness were observed between older and younger patients. Other clinical studies have not identified differences in responses between older and younger patients, but increased sensitivity in older patients cannot be ruled out.
Upper Limb Spasticity
Of the total number of 283 patients in the placebo-controlled studies in upper limb spasticity in adult patients [see Clinical Studies (14.2)], 118 were 65 years of age and over (70 treated with XEOMIN and 48 received placebo), which included 12 patients 75 years of age and over (7 treated with XEOMIN and 5 received placebo). No overall differences in safety or effectiveness were observed between older and younger adult patients. Other clinical studies have not identified differences in responses between older and younger adult patients, but increased sensitivity in older patients cannot be ruled out.
Cervical Dystonia
Of the total number of 233 patients in the placebo-controlled study in cervical dystonia [see Clinical Studies (14.3)], 29 were 65 years of age and over (19 treated with XEOMIN and 10 received placebo). Of these, ten XEOMIN-treated patients and four placebo-treated patients experienced an adverse event. For patients 65 years of age and over treated with XEOMIN, the most common adverse events were dysphagia (21%) and asthenia (11%).
Blepharospasm
Of the total number of 169 patients in the placebo-controlled studies in blepharospasm [see Clinical Studies (14.4)], 61 were 65 years of age and over (45 treated with XEOMIN and 16 received placebo). No overall difference in effectiveness was observed between older and younger patients.
Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines)
Of the total number of 547 subjects in the placebo-controlled clinical studies for glabellar lines [see Clinical Studies (14.5)], 21 subjects were 65 years of age and over.
Of the total number of 730 subjects in the placebo-controlled clinical studies for upper facial lines GL, HFL, and LCL [see Clinical Studies (14.5)], 46 subjects were 65 years of age and over.
Clinical trials of XEOMIN showed no increase in the incidence of adverse events related to treatment with XEOMIN in patients 65 years of age and over but the trials did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
XEOMIN is contraindicated in patients with:
- Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11)].
- Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.