Xeomin Dosage

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

Medically reviewed by Drugs.com. Last updated on Jul 17, 2024.

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).

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. 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

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
Body weight	Dose per gland	Volume per injection	Dose per gland	Volume per injection	Total dose, both glands, both sides
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.

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

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.

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
Clinical Pattern Muscle	Range (Units/kg)	Maximum (Units)	Number of Injection Sites per Muscle
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 dose of XEOMIN for cervical dystonia ranges from 120 Units to 240 Units given intramuscularly as a divided dose among affected muscles. In previously treated patients, consider their past dose, response to treatment, duration of effect, and adverse event history 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)]. Tailor the dose and number of injection sites in each treated muscle to the individual patient 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.

Determine the frequency of XEOMIN repeat treatments by clinical response, but administer repeat treatments no more frequent than every 12 weeks [see Clinical Studies (14.3)].

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.

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: 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. Withdraw 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, into an appropriately sized syringe for 8 mL in total. 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: Reconstitute a 200 Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, following instructions above. Withdraw 12 mL of preservative-free 0.9% Sodium Chloride Injection, USP, into an appropriately sized syringe for 16 mL in total. 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, 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

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

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.