Collagenase Clostridium Histolyticum-aaes Monograph for Professionals - Drugs.com

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# Collagenase Clostridium Histolyticum-aaes

Brand name: Qwo
Drug class: Enzymes

Medically reviewed by Drugs.com on Feb 8, 2021. Written by ASHP.

## Introduction

Collagenase clostridium histolyticum-aaes is a combination of bacterial collagenase enzymes.

## Uses for Collagenase Clostridium Histolyticum-aaes

### Collagenase clostridium histolyticum-aaes has the following uses:

Collagenase clostridium histolyticum-aaes is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.

## Collagenase Clostridium Histolyticum-aaes Dosage and Administration

### General

Collagenase clostridium histolyticum-aaes is available in the following dosage form(s) and strength(s):

For injection: 0.92 mg or 1.84 mg as a lyophilized powder in single-dose vials.

### Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

#### Adults

##### Dosage and Administration

- A treatment area is defined as a single buttock receiving up to 12 injections, 0.3 mL each (up to a total of 3.6 mL), of collagenase clostridium histolyticum-aaes.

- A treatment visit may consist of up to 2 treatment areas. Treatment visits should be repeated every 21 days for 3 treatment visits.

- Reconstitute collagenase clostridium histolyticum-aaes lyophilized powder with the supplied diluent prior to use.

- Inject 0.84 mg of collagenase clostridium histolyticum-aaes per treatment area as 12 subcutaneous injections (0.3-mL injection administered as three 0.1-mL aliquots per injection).

Detailed Collagenase clostridium histolyticum dosage information

## Cautions for Collagenase Clostridium Histolyticum-aaes

### Contraindications

- History of hypersensitivity to any collagenase or to any of the components in the formulation.

- Infection at the injection site.

### Warnings/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 collagenase clostridium histolyticum-aaes should be discontinued and appropriate medical therapy immediately instituted.

#### Injection Site Bruising

In clinical trials, 84% of subjects treated with collagenase clostridium histolyticum-aaes 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.

Collagenase clostridium histolyticum-aaes 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

Collagenase clostridium histolyticum-aaes must not be substituted with other injectable collagenase products. Collagenase clostridium histolyticum-aaes is not intended for the treatment of Peyronie’s disease or Dupuytren’s contracture.

#### Specific Populations

##### Pregnancy

Risk Summary: There are no available data on collagenase clostridium histolyticum use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Following subcutaneous injection, the systemic concentrations for collagenase clostridium histolyticum-aaes were below the bioanalytical assay limit of quantification.

In animal reproduction studies, intravenous administration of collagenase clostridium histolyticum to pregnant rats during organogenesis at doses up to 0.13 mg/rat (43 × human equivalent dose [HED] on a mg/kg basis) revealed no evidence of harm to the fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

##### Lactation

There are no data on the presence of collagenase clostridium histolyticum in human milk, or the effects of collagenase clostridium histolyticum on the breastfed child or on milk production. Following subcutaneous injection, the systemic concentrations for collagenase clostridium histolyticum-aaes were below the bioanalytical assay limit of quantification. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for collagenase clostridium histolyticum and any potential adverse effects on the breastfed child from collagenase clostridium histolyticum or from the underlying maternal condition.

##### Pediatric Use

The safety and effectiveness of collagenase clostridium histolyticum-aaes have not been established in pediatric patients.

##### Geriatric Use

In two double-blind, placebo-controlled, clinical trials in subjects with cellulite (Trials 1 and 2), 24 (5.7%) of the 424 subjects who received collagenase clostridium histolyticum-aaes were 65 years of age or older. No overall differences in safety of collagenase clostridium histolyticum-aaes were observed between these patients and younger patients.

### Common Adverse Effects

The most common adverse reactions (≥1%) were related to the injection site (bruising, pain, nodule, pruritus, erythema, discoloration, swelling, and warmth).

## Related/similar drugs

Xiaflex, collagenase clostridium histolyticum, Qwo

## Drug Interactions

### Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Collagenase clostridium histolyticum drug interactions (more detail)

## Actions

### Mechanism Of Action

Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions. The exact mechanism for the treatment of moderate to severe cellulite is unknown.

## Advice to Patients

- Advise the patient to read the FDA-approved patient labeling (Patient Information).

- Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.

- Advise patients that injection site bruising may occur with administration of collagenase clostridium histolyticum-aaes.

## Additional Information

AHFSfirstRelease™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

## Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Collagenase Clostridium histolyticum-aaes
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Parenteral | For injection, for subcutaneous use | 0.92 mg | Qwo | Endo Aesthetics LLC
|  | 1.84 mg | Qwo | Endo Aesthetics LLC

AHFS Drug Information. © Copyright 2023, Selected Revisions February 8, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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## More about collagenase clostridium histolyticum

- Check interactions
- Reviews (92)
- Side effects
- Dosage information
- During pregnancy
- Drug class: miscellaneous uncategorized agents
- En español

### Patient resources

- Drug Information

### Professional resources

- Prescribing Information

#### Other brands

Xiaflex, Qwo

### Related treatment guides

- Cellulite
- Dupuytren's contracture
- Peyronie's Disease

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