Merz Pharmaceuticals receives US FDA approval on Xeomin® (incobotulinumtoxinA) botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm.
The FDA approval of XEOMIN is based on the results of two pivotal U.S. clinical trials involving adult patients diagnosed with either cervical dystonia or blepharospasm. XEOMIN is the only botulinum toxin that does not require refrigeration prior to reconstitution and it will be available in 50-unit and 100-unit vials. XEOMIN is also free from complexing proteins. More than 84,000 patients have been treated with XEOMIN worldwide since 2005. The U.S. is the 20thcountry to approve XEOMIN for the treatment of cervical dystonia and blepharospasm.
Important Safety Information About XEOMIN
WARNING: Distant Spread of Toxin Effect
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 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, particularly in those patients who have underlying conditions that would predispose them to these symptoms. See full prescribing information for complete boxed warning.
WARNINGS AND PRECAUTIONS
- The potency Units of XEOMIN are not interchangeable with other preparations of botulinum toxin products. Therefore, units of biological activity of XEOMIN cannot be compared to or converted into units of any other botulinum toxin products.
- Spread of toxin effects may cause swallowing and breathing difficulties that can lead to death. Immediate medical attention may be required in cases of respiratory, speech or swallowing difficulties. Use with caution in patients with compromised respiratory function or dysphagia. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.
- Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted.
- Cervical Dystonia: Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
- Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. Lower lid injections should not be repeated if diplopia occurred with previous botulinum toxin injections.
Cervical Dystonia: The most commonly observed adverse reactions (≥5% of patients and > placebo) were: dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
Blepharospasm: The most commonly observed adverse reactions (≥5% of patients and > placebo) were: eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, and respiratory tract infection.
Please see full prescribing information for XEOMIN, including Boxed WARNING, available at www.merzusa.com.
SOURCE: Merz Pharmaceuticals