Xeomin (Page 4 of 12)

2.8 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.

2.9 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.

3 DOSAGE FORMS AND STRENGTHS

For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP.

4 CONTRAINDICATIONS

XEOMIN is contraindicated in patients with:

• Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11)].
• Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.

5 WARNINGS AND PRECAUTIONS

5.1 Spread of Toxin Effect

​ Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and 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 related to the spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can occur in adults treated for spasticity and other conditions, and 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, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

5.2 Lack of Interchangeability between Botulinum Toxin Products

The potency Units of XEOMIN are specific to the preparation and assay method utilized. They are not interchangeable with the 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 Description (11)].

5.3 Hypersensitivity Reactions

Serious hypersensitivity reactions have been reported with botulinum toxin products. Hypersensitivity reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction [see Contraindications (4)].

5.4 Dysphagia and Breathing Difficulties

Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved [see Warnings and Precautions (5.1)].

Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia, and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.

Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post-marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products.

Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles have been reported to be at greater risk of dysphagia. In general, limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.

Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Patients with neuromuscular disorders with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.