Medesthetics

MAY-JUN 2014

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ADVERSE REACTIONS The following adverse reactions to XEOMIN are discussed in greater detail in other sections of the labeling: » Hypersensitivity [see Contraindications and Warnings and Precautions] » Spread of Effects from Toxin [see Warnings and Precautions] Glabellar Lines In three placebo-controlled trials in 803 subjects with glabellar lines, 535 subjects received a single dose of 20 Units XEOMIN and 268 subjects received placebo. XEOMIN treated subjects were 24 to 74 years old, and were predominantly female (88%). The most frequent adverse reactions in XEOMIN treated subjects were: headache 29 (5.4%), facial paresis 4 (0.7%), injection site hematoma 3 (0.6%) and eyelid edema 2 (0.4%). Four serious adverse events occurred in two placebo-treated subjects. Six XEOMIN treated subjects experienced six serious adverse events. All serious adverse events were assessed as unrelated to study drug. The adverse reactions below reflect exposure to XEOMIN with glabellar lines in placebo-controlled studies. Adverse reactions are adverse events in which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event. 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. Table 4: Adverse Reactions in Placebo-Controlled Trials Adverse reactions XEOMIN (N=535) (%) Placebo (N=268) (%) Nervous system disorders Headache 1 Facial paresis (brow ptosis) 33 (6.1) 29 (5.4) 4 (0.7) 6 (2.2) 6 (2.2) 0 General disorders and administration site conditions Injection site hematoma Injection site pain Facial pain Injection site swelling Sensation of pressure 5 (0.9) 3 (0.6) 1 (0.2) 1 (0.2) 0 0 2 (0.7) 0 0 0 1 (0.4) 1 (0.4) Eye disorders Eyelid edema Blepharospasm Eye disorder Eyelid ptosis 5 (0.9) 2 (0.4) 1 (0.2) 1 (0.2) 1 (0.2) 0 0 0 0 0 In open label, multiple dose trials, adverse reactions were reported for 105 of the 800 subjects (13.1%). Headache was the most common adverse reaction, reported for 57 subjects (7.1%), followed by injection site hematoma in 8 subjects (1.0%). Adverse reactions reported in less than 1% of subjects were: facial paresis (brow ptosis), muscle disorder (elevation of eyebrow), injection site pain, and eyelid edema. Immunogenicity-As with all therapeutic proteins, there is a potential for immunogenicity. Postmarketing Experience-The following adverse reactions have been reported during post-approval use with XEOMIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: eye swelling, eyelid edema, dysphagia, nausea, flu-like symptoms, injection site pain, injection site reaction, allergic dermatitis, localized allergic reactions like swelling, edema, erythema, pruritus or rash, herpes zoster, muscular weakness, muscle spasm, dysarthria, myalgia and hypersensitivity. DRUG INTERACTIONS No formal drug interaction studies have been conducted with XEOMIN. Coadministration of XEOMIN and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type muscle relaxants, should only be performed with caution as these agents may potentiate the effect of the toxin. Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of XEOMIN. USE IN SPECIFIC POPULATIONS Pregnancy-Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers-It is not known whether botulinum toxin type A is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XEOMIN is administered to a nursing woman. Pediatric Use-Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established [see Warnings and Precautions]. Geriatric Use-Glabellar Lines There are limited clinical data with XEOMIN in subjects over 65 years of age and over in clinical studies with glabellar lines. Of the total number of subjects in the placebo- controlled clinical studies GL1 and GL2, 21 (4%) subjects were 65 and over. Efficacy was observed in 20% (3/15) of XEOMIN subjects 65 years and over. For the entire safety database of geriatric subjects, there was no increase in the incidence of adverse events related to treatment with XEOMIN. OVERDOSAGE Excessive doses of XEOMIN may be expected to produce neuromuscular weakness with a variety of symptoms. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis [see Warnings and Precautions]. Symptomatic treatment may be necessary. Symptoms of overdose are not likely to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis. In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at http://www.cdc.gov/ncidod/srp/drugs/formulary.html#1a. Please visit www.xeomin.com for full Prescribing Information. © Copyright 2013 Merz North America, Inc. All rights reserved. XEOMIN is a registered trademark of Merz Pharma GmbH & Co. KGaA. ML00988-00 M e r t z M E 5 p 6 - 7 . i n d d 7 MertzME5p6-7.indd 7 4 / 1 6 / 1 4 2 : 5 1 P M 4/16/14 2:51 PM

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