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XEOMIN

Last Updated: October 14, 2010

Manufacturer:

Merz Pharmaceuticals

Pharmacological Class:

Neuromuscular blocker.

Active Ingredient(s):

IncobotulinumtoxinA 50 Units, 100 Units; per vial; lyophilized pwd; for IM inj after reconstitution and dilution; contains human albumin; preservative-free.

Indication(s):

Cervical dystonia in adults, to reduce severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients. Blepharospasm in adults previously treated with onabotulinumtoxinA.

Pharmacology:

Xeomin exerts its effect in the management of dystonias by blocking cholinergic transmission at the neuromuscular junction. This action is achieved through inhibition of acetylcholine release from peripheral cholinergic nerve endings that occurs in the following sequence: Xeomin binds to and is internalized into cholinergic nerve terminals, the light-chain part of the molecule is then translocated into the cytosol of the nerve terminal, and followed by enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine. Impulse transmission is re-established by the formation of new nerve endings.

Clinical Trials:

The efficacy of Xeomin in cervical dystonia was evaluated in a Phase 3, randomized, double-blind, placebo-controlled study involving 233 patients with predominantly rotational cervical dystonia, with baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥20, TWSTRS severity score ≥10, TWSTRS disability score ≥3, and TWSTRS pain score ≥1. Patients were randomized to receive a single administration (4.8mL) of the study agent (Xeomin 240 Units, Xeomin 120 Units, or placebo). The primary efficacy endpoint was the change in the TWSTRS total score from baseline to Week 4 post-injection. In the intent-to-treat (ITT) population, the difference between the Xeomin 240 Unit group and the placebo group in the change of TWSTRS total score from baseline to Week 4 was -9 points; the difference between the Xeomin 120 Unit group and the placebo group was -7.5 points. Comparison of each Xeomin group to the placebo group was statistically significant at p<0.001. Efficacy of Xeomin was similar in patients who were botulinum toxin naïve and those who had received botulinum toxin prior to this study.

Xeomin was investigated in a Phase 3, randomized, double-blind, placebo-controlled study involving 109 patients with benign essential blepharospasm, with baseline Jankovic Rating Scale (JRS) Severity subscore ≥2, and a stable satisfactory therapeutic response to previous administrations of onabotulinumtoxinA (Botox). Patients were randomized to receive a single Xeomin treatment that was similar to the most recent Botox injection prior to study, or placebo. At primary efficacy endpoint, in the ITT population, the difference between the Xeomin group and the placebo group in the change of JRS Severity subscore from baseline to Week 6 was -1 point. Comparison of the Xeomin group to the placebo group was statistically significant at p<0.001.

Legal Classification:

Adults:

Should be administered and managed by experienced physicians. ≥18yrs: Individualize; see literature. Cervical dystonia: initial total dose: 120 Units per treatment session. Blepharospasm: (previously-treated): use same dose as previous treatment of onabotulinumtoxinA; (previous-dose unknown): initially 1.25–2.5 Units/injection site. Both eyes: total initial dose: max 70 Units (35 Units/eye). For both: dose, number, and location of inj sites should be based on the number and location of muscles involved, dystonia or blepharospasm severity, and response to any previous botulinum toxin inj. May repeat treatments every 12 weeks if insufficient response.

Children:

<18yrs: not recommended.

Contraindication(s):

Infection at proposed injection site.

Warnings/Precautions:

Not interchangeable with other botulinum toxin products. Pre-existing dysphagia or breathing difficulties. Patients with smaller neck muscle mass or those who require bilateral inj into the sternocleidomastoid muscles: increased risk of dysphagia. Neuromuscular disorders (eg, myasthenia gravis, ALS, Lambert-Eaton syndrome); monitor closely. Compromised respiratory function; monitor. Narrow angle glaucoma. Contains human albumin; monitor for possible viral disease transmission. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, tubocurarine-type muscle relaxants). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.

Adverse Reaction(s):

Cervical dystonia: dysphagia (may be severe), neck pain, muscle weakness, inj site reactions, musculoskeletal pain; blepharospasm: eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, respiratory tract infection; corneal exposure/ulceration, ectropion (avoid injection of lower lid area); both: respiratory failure, allergic reactions (discontinue if occurs), spread of toxin effect (may be fatal), possible antibody formation.