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Xeomin Dosage

Medically reviewed by Drugs.com. Last updated on April 27, 2021.

Generic name: Botulinum Toxin Type A 50[USP'U]
Dosage form: powder, lyophilized, for solution

Instructions for Safe Use

The potency Units of XEOMIN for injection are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, 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.

The recommended maximum cumulative dose for any indication should not exceed 400 Units in a treatment session.

Chronic Sialorrhea

Chronic Sialorrhea in Adult Patients

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

Figure 1

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).
Table 1: Dosing by Gland for Treatment of Chronic Sialorrhea in Adult Patients
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. 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.

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

Figure 2

Table 2: Dosing by Body Weight Class for Treatment of 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 Unts 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. 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.

Upper Limb Spasticity

Upper Limb Spasticity in Adult Patients

The dosage, frequency, and number of injection sites should be tailored 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. The frequency of XEOMIN treatments should be no sooner than every 12 weeks. In patients not previously treated with a botulinum toxin, initial dosing should begin at the low end of the recommended dosing range and titrated as clinically necessary. Most patients in clinical studies were retreated between 12 and 14 weeks.

Table 3: XEOMIN Dosing by Muscle for Treatment of Adult Upper Limb Spasticity
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

Figure 3

Upper Limb Spasticity in Pediatric Patients, Excluding Spasticity Caused by Cerebral Palsy

The exact dosage, frequency, and number of injection sites should be tailored 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, total XEOMIN dosage should not exceed 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 (2.7)]. 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. 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.

Table 4: XEOMIN Dosing by Muscle for Treatment of Pediatric Upper Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy
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

Figure 4

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

Figure 5

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, their past dose, response to treatment, 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).

XEOMIN is injected 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 the total dose should not exceed 50 Units per eye.

Figure 6: Injection Sites for Blepharospasm

Figure 6

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 (14.4)].

Glabellar Lines

The total recommended XEOMIN dose is 20 Units per treatment session divided into five equal intramuscular injections of 4 Units each. The five injection sites are: two injections in each corrugator muscle and one injection in the procerus muscle.

Retreatment with XEOMIN should be administered no more frequently than every three months.

Figure 7: Injection Sites for Glabellar Lines

Figure 7

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. XEOMIN should not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.

After reconstitution, XEOMIN should be used for only one injection session and for only one patient. Reconstituted XEOMIN solution should be administered within 24 hours after dilution. During this time period, unused reconstituted XEOMIN may be stored 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.

Table 5: Diluent Volumes for Reconstitution of XEOMIN
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
*
When using 8 mL of diluent for a 100 Unit or 200 Unit vial of XEOMIN, complete the following steps:
  1. Reconstitute a 100 Unit or 200 Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, following instructions above.
  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 steps:
  1. Reconstitute a 200 Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, following instructions above.
  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.
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, the product must not be injected 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.

XEOMIN should be injected carefully when injected at sites close to sensitive structures, such as the carotid artery, lung apices, and esophagus. Before administering XEOMIN, the physician 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

A sterile needle (e.g., 27-30 gauge (0.30-0.40 mm diameter), 12.5 mm length) should be used for intra-salivary gland administration for the treatment of chronic sialorrhea. The injection site should be close to the center of the gland.

The salivary glands can be located using ultrasound imaging or surface anatomical landmarks [see Dosage and Administration (2.2)].

Chronic Sialorrhea in Pediatric Patients

A sterile needle (e.g., 27-30 gauge (0.30-0.40 mm diameter), 12.5 mm length) should be used for intra-salivary gland administration for the treatment of chronic sialorrhea. The injection site should be close to the center of the gland.

Ultrasound guidance is recommended for the localization of the involved salivary glands [see Clinical Studies (14.1)].

Upper Limb Spasticity

Upper Limb Spasticity in Adult Patients

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) should be used 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

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) should be used 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

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) should be used in the intramuscular administration in the treatment of cervical dystonia.

Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful.

Blepharospasm

A sterile needle (e.g., 30-gauge (0.40 mm diameter), 12.5 mm length) should be used in the intramuscular administration in the treatment of blepharospasm.

Glabellar Lines

A sterile needle (e.g., 30-33 gauge (0.3-0.2 mm diameter), 13 mm length) should be used in the intramuscular administration in the treatment of glabellar lines.

Monitoring to Assess Effectiveness

The median onset of XEOMIN treatment effect occurs within 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.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.