Xeomin (Page 2 of 12)
2.3 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.
| Clinical PatternMuscle | 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
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.
| Clinical PatternMuscle | 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
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