Xeomin

XEOMIN- botulinum toxin type a injection, powder, lyophilized, for solution
Merz North America, Inc.

WARNING: DISTANT SPREAD OF TOXIN EFFECT

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 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)].

1 INDICATIONS AND USAGE

1.1 Chronic Sialorrhea

XEOMIN is indicated for the treatment of chronic sialorrhea in adult patients.

1.2 Upper Limb Spasticity

XEOMIN is indicated for the treatment of upper limb spasticity in adult patients.

1.3 Cervical Dystonia

XEOMIN is indicated for the treatment of cervical dystonia in adult patients.

1.4 Blepharospasm

XEOMIN is indicated for the treatment of blepharospasm in adult patients.

1.5 Glabellar Lines

XEOMIN is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

2 DOSAGE AND ADMINISTRATION

2.1 Instructions for Safe Use

The potency Units of XEOMIN (incobotulinumtoxinA) 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.

2.2 Chronic Sialorrhea

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

Figure 1
(click image for full-size original)

M = Masseter

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
Gland(s)Units Per SideTotal
Parotid gland(s)30 Units60 Units
Submandibular gland(s)20 Units40 Units
Both Glands 50 Units100 Units

The concentration used in the clinical study after reconstitution is 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.

2.3 Upper Limb Spasticity

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 spasticity patients not previously treated with botulinum toxins, 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 12-14 weeks.

Table 2: XEOMIN Dosing by Muscle for Treatment of Upper Limb Spasticity
Clinical PatternMuscle Units (Range)Number of injection sites per muscle
Clenched Fist
Flexor digitorum superficialis 25 Units-100 Units2
Flexor digitorum profundus 25 Units-100 Units2
Flexed Wrist
Flexor carpi radialis 25 Units-100 Units1-2
Flexor carpi ulnaris 20 Units-100 Units1-2
Flexed Elbow
Brachioradialis 25 Units-100 Units1-3
Biceps 50 Units-200 Units1-4
Brachialis 25 Units-100 Units1-2
Pronated Forearm
Pronator quadratus 10 Units-50 Units1
Pronator teres 25 Units-75 Units1-2
Thumb-in-Palm
Flexor pollicis longus 10 Units-50 Units1
Adductor pollicis 5 Units-30 Units1
Flexor pollicis brevis/Opponens pollicis 5 Units-30 Units1

Figure 2: Muscles Involved In Adult Upper Limb Spasticity

Figure 2
(click image for full-size original)

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