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Thursday, September 30, 2021
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IMPORTANT SAFETY INFORMATION FOR QWO | CONTRAINDICATIONS | QWO is contraindicated in patients with a history of hypersensitivity to collagenase or to any of the excipients or the presence of infection at the injection sites. | WARNINGS AND PRECAUTIONS | Hypersensitivity Reactions | Serious hypersensitivity reactions including anaphylaxis have been reported with the use of collagenase clostridium histolyticum. If such a reaction occurs, further injection of QWO should be discontinued and appropriate medical therapy immediately instituted. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. | Injection Site Bruising | In clinical trials, 84% of subjects treated with QWO experienced injection site bruising. Subjects with coagulation disorders or using anticoagulant or antiplatelet medications (except those taking ≤150 mg aspirin daily) were excluded from participating in Trials 1 and 2. | QWO should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet (except those taking ≤150 mg aspirin daily) or anticoagulant therapy. | Substitution of Collagenase Products | QWO must not be substituted with other injectable collagenase products. QWO is not intended for the treatment of Peyronie's Disease or Dupuytren's Contracture. | ADVERSE REACTIONS | In clinical trials, the most commonly reported adverse reactions in patients treated with QWO with an incidence ≥ 10% were at the injection site: bruising, pain, nodule and pruritus. | | |
| Best Regards, | Brittany Bureski bureski.brittany@endo.com | | EA-QW-05527/May 2021 | | |
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