Safety

Bruising should be expected, as 84% of patients in clinical trials experienced bruising1

Adverse Reactions Occurring in ≥ 1% of Subjects in RELEASE-1 and -2 Through Day 711

Table comparing adverse reactions for QWO vs. Placebo, where patients who received QWO experienced more adverse events than those who received placebo. Table comparing adverse reactions for QWO vs. Placebo, where patients who received QWO experienced more adverse events than those who received placebo.

Pooled terms:
*Bruising - injection site bruising, injection site hematoma, and injection site hemorrhage (refers to verbatim term injection site ecchymosis). Pain - injection site pain, injection site discomfort, and injection site dysesthesia. Swelling - injection site swelling, injection site edema, injection site induration. Discoloration - injection site discoloration. Nodule - injection site mass and injection site nodule.

Bruising on adult woman's buttocks.

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.

Adverse Events

In general, adverse events associated with QWO injection were mild to moderate and resolved within 2-3 weeks without treatment.1,3,11

No additional safety concerns were identified with six months of follow-up.1

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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.

View Full Prescribing Information for QWO.