Endo Announces Publication of Phase 3 Qwo (collagenase clostridium histolyticum-aaes) Data in Peer-Reviewed Dermatologic Surgery - Seite 2
INDICATION
QWO is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.
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.
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About Cellulite
Cellulite is a localized alteration in the contour of the skin that has been reported in over 90 percent of post-pubertal females and affects women of all races and ethnicities.1,2 The
presence of cellulite is associated with changes in dermal thickness and in the fat cells and connective tissue below the skin.3 A primary factor in the cause of the condition is the
collagen containing septae which attach the skin to the underlying fascia layers.4,5 The septae tether the skin which, with additional contributing protrusions of subcutaneous fat,
causes the surface dimpling characteristic of cellulite.6,7 These fibrous septae are oriented differently with varying thickness in females than in males, which informs our understanding
of cellulite as a gender-related condition.8 Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.