References

  1. QWO [prescribing information]. Malvern, PA: Endo Aesthetics LLC.
  2. Data on File. EA-QW-05073. Endo Aesthetics LLC.
  3. Data on File. REF-007561. Endo Aesthetics LLC.
  4. Hexsel D, Mazzuco R. Cellulite. In: Tosti A, Hexsel D, editors. Update in Cosmetic Dermatology. Berlin/Heidelberg, Germany: Springer-Verlag Berlin Heidelberg; 2013:21–32.
  5. Data on File. EA-EA-05052. Endo Aesthetics LLC.
  6. Data on File. EA-QW-05087. Endo Aesthetics LLC.
  7. Rudolph C, Hladik C, Hamade H, et al. Structural Gender Dimorphism and the Biomechanics of the Gluteal Subcutaneous Tissue: Implications for the Pathophysiology of Cellulite. Plast Reconstr Surg. 2019;143(4):1077-1086.
  8. Pierard GE, Nizet JL, Pierard-Franchimont C. Cellulite: from standing fat herniation to hypodermal stretch marks. Am J Dermatopathol. 2000;22(1):34-7.
  9. Nurnberger F, Muller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 1978;4(3):221-229.
  10. Sibilla S, et al. An overview of the beneficial effects of hydrolysed collagen as a nutraceutical on skin properties: Scientific background and clinical studies. Open Nutraceuticals J. 2015;8:29-42.
  11. Data on File. REF-007562. Endo Aesthetics LLC.
  12. Hexsel D, Hexsel CL. Chapter 1: Social impact of cellulite and its impact on quality of life. In: Goldman M, Bacci PA, Leibaschoff, Hexsel D, Angelini F. Cellulite Pathophysiology and Treatment. New York NY: Taylor & Francis Group. 2006: 159-170. DOI 10.12.01/9780849374548
  13. Cohen JL, Sadick NS, Kirby MT, et al. Development and Validation Clinician and Patient Reported Photonumeric Scales to Assess Buttocks Cellulite Severity. Dermatol Surg. 2020;46(12):1628-1635.
  14. Data on File. EA-QW-05085. Endo Aesthetics LLC.

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.