Xeomin Injection

Botulinum Toxin Type A is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/ or procerus muscle activity in adult patients. The treatment of cervical dystonia in adult patients. Glabellar Lines Botulinum Toxin Type A 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. Cervical Dystonia Botulinum Toxin Type A is indicated for the treatment of cervical dystonia in adult patients.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including Botulinum Toxin Type A, 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, an unapproved use for Botulinum Toxin Type A, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of Botulinum Toxin Type A and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. The potency units of Botulinum Toxin Type A are not interchangeable with other preparations of other botulinum toxin products. Spread of toxin effects, swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur. Adverse event reports have been received involving the cardiovascular system with botulinum toxin products, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment. Use with caution in patients with compromised respiratory function or dysphagia. Potential serious adverse reactions after administration of Botulinum Toxin Type A for unapproved use. Spread of Toxin Effect Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may 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. 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 greatest in children treated for spasticity, an unapproved use for Botulinum Toxin Type A, 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. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Spread of Toxin Effect Hypersensitivity Reactions Cardiovascular System Adverse Reactions Increased Neuromuscular Compromise in Patients with Pre-Existing Neuromuscular Disorders Dysphagia and Breathing Difficulties Ophthalmic Adverse Reactions in Patients Treated for Glabellar Lines The most commonly observed adverse reactions are: Glabellar Lines (≥1%): headache (6%), eyelid ptosis (2%), and facial paresis (1%). Cervical Dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%). Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common side effects from treatment with Botulinum Toxin Type A usually occur within one to two weeks after injection and, while generally transient, may have a duration of several weeks or months. Glabellar Lines In the two randomized, placebo-controlled, Phase 3 clinical trials that assess the use of Botulinum Toxin Type A for the temporary improvement in the appearance of moderate to severe glabellar lines, GL-1 and GL-2, 406 subjects received a single-dose treatment of 40 Units Botulinum Toxin Type A, and 203 subjects received placebo. The most frequent adverse reactions are presented in Table 3. TABLE 3: Most Common Adverse Reactions ≥1% and More Frequent than Placebo in Pooled Double- Blind, Placebo-Controlled Trials for Glabellar Lines Adverse Reaction Botulinum Toxin Type A N=406 n (%) Placebo N=203 n (%) Headache 26 (6%) 4 (2%) Eyelid ptosis 9 (2%) 0 (0%) Facial paresis, including facial asymmetry. 5 (1%) 0 (0%) Injection site reactions were reported in 6% of subjects treated with Botulinum Toxin Type A and in 6% of subjects treated with placebo (these reactions included injection site pain, injection site erythema, injection site oedema, injection site bruising, injection site hematoma, injection site papule, and injection site pruritus). In an 84-week, open-label, repeat-dose safety study in glabellar lines, 2691 subjects were treated with 40 Units of Botulinum Toxin Type A. Of these, 2380 subjects received one treatment with Botulinum Toxin Type A, 882 received two treatments with Botulinum Toxin Type A, and 568 subjects received three treatments with Botulinum Toxin Type A. Adverse reactions were reported in 535 of the 2691 subjects (20%). Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.