QWO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for QWO (QWO).
QWO (collagenase clostridium histolyticum-aaes) is a combination of two collagenases (AUX-I and AUX-II) that hydrolyze collagen in the extracellular matrix of adipose tissue, leading to adipocyte rupture and reduction of fat.
| Metabolism | Metabolized by proteolytic degradation into smaller peptides and amino acids; not metabolized by CYP450 enzymes. |
| Excretion | Not metabolized; eliminated via the lymphatic system. No renal or biliary/fecal excretion data available. |
| Half-life | Not applicable; QWO contains collagenase which acts locally and is not systemically absorbed. |
| Protein binding | Not applicable; no systemic absorption. |
| Volume of Distribution | Not applicable; no systemic distribution. |
| Bioavailability | 0% systemic bioavailability due to local degradation. |
| Onset of Action | Within 1 to 2 days following subcutaneous injection. |
| Duration of Action | Single treatment; effects persist for at least 24 months. Repeat treatments may be required. |
QWO (collagenase clostridium histolyticum-aaes) is administered via intralesional injection. For the treatment of moderate to severe cellulite in the buttocks, the recommended dose is 0.84 mg (0.6 mL of 1.4 mg/mL solution) per injection site, with up to 12 injection sites per treatment session, repeated at 21-day intervals for up to 3 sessions.
| Dosage form | SOLUTION |
| Renal impairment | No specific dose adjustments for renal impairment are provided in the labeling. QWO is not significantly renally cleared; however, caution should be exercised in severe renal impairment due to limited data. |
| Liver impairment | No specific dose adjustments for hepatic impairment are provided in the labeling. QWO is metabolized by endogenous proteases; hepatic impairment is not expected to significantly alter clearance, but data are limited. |
| Pediatric use | Safety and effectiveness in pediatric patients have not been established. QWO is not indicated for use in individuals under 18 years of age. |
| Geriatric use | Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. No specific dose adjustment is recommended, but caution is advised due to potential age-related comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for QWO (QWO).
| Breastfeeding | It is unknown if QWO is excreted in human breast milk. The M/P ratio has not been determined. Due to the large molecular weight (collagenase ~68-100 kDa), excretion into milk is likely low. However, caution should be exercised as the effects on the nursing infant are unknown. The manufacturer recommends weighing the benefits of breastfeeding against the potential risk to the infant. |
| Teratogenic Risk | QWO (collagenase clostridium histolyticum) is a Pregnancy Category B drug. No adequate and well-controlled studies in pregnant women. In animal reproduction studies, no evidence of fetal harm was observed at doses 5 times the human dose. However, because animal studies are not always predictive of human response, QWO should be used during pregnancy only if clearly needed. Trimester-specific risks are not established due to lack of human data; caution is advised throughout gestation. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to collagenase or any product components.","Current or prior infection at the injection site."]
| Precautions | ["Hypersensitivity reactions including anaphylaxis have been reported.","Do not inject into areas with active infection, inflammation, or skin disorders.","Risk of injection site reactions and ecchymosis."] |
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| Fetal Monitoring | No specific fetal monitoring is required during QWO therapy. Routine prenatal care is recommended. Monitor injection site for signs of serious adverse reactions (e.g., tendon rupture, nerve injury) that may affect mobility during pregnancy. No additional maternal monitoring beyond usual clinical practice is indicated. |
| Fertility Effects | There are no human data on the effect of QWO on fertility. In animal studies, there were no adverse effects on male or female fertility at doses up to 5 times the human dose. Therefore, QWO is not expected to impair fertility in humans based on available preclinical evidence. |