XEOMIN- botulinum toxin type a injection, powder, lyophilized, for solution
Merz North America, Inc.
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)].
XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older.
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.
XEOMIN is indicated for the treatment of cervical dystonia in adult patients.
XEOMIN is indicated for the treatment of blepharospasm in adult patients.
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.
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 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
Use the following guidelines if locating salivary glands using anatomic landmarks:
- 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).
- 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. 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
|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.
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