Xiaflex for injection
Dosage form

 Injection, provided as a lyophilized powder for reconstitution. 

Please note that the appearance of the packaging may vary depending on the manufacturer and region of sale.
Active ingredient

 Collagenase Clostridium Histolyticum. 

Dosage

 Each vial contains 0.9 mg of Collagenase Clostridium Histolyticum. 


Indications for Use
Xiaflex is indicated for the treatment of:

  • Dupuytren's Contracture with a palpable cord in adult patients.
  • Peyronie's Disease in adult males with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy.

Contraindications

  • Hypersensitivity to Collagenase Clostridium Histolyticum or any component of the product.
  • Use in areas of infection at the injection site.
  • Patients with coagulation disorders or those taking anticoagulants (except low-dose aspirin).

Side Effects
Common side effects may include:

  • Swelling, bruising, and pain at the injection site.
  • Lymphadenopathy (enlarged lymph nodes).
  • Pruritus, erythema, or other local skin reactions.
  • Systemic reactions such as fever, chills, and flu-like symptoms.

Rare but serious side effects:

  • Tendon rupture or other serious injury to the injected area.
  • Severe allergic reactions, including anaphylaxis.

Recommendations for Use

  • Administration: Xiaflex should be administered by a healthcare professional trained in the appropriate use of the product.
  • Preparation: Reconstitute the lyophilized powder with the diluent provided. Use immediately or store refrigerated (2°C to 8°C) for up to 1 hour.
  • Dosage Schedule:
    • For Dupuytren's Contracture: Inject directly into the palpable cord. Up to 3 injections may be administered per cord, spaced approximately 4 weeks apart.
    • For Peyronie's Disease: Administer two injections per treatment cycle into the plaque, with up to 4 treatment cycles, spaced approximately 6 weeks apart.
  • Post-Injection Care:
    • Instruct patients to avoid heavy use of the treated hand or area for at least 24 hours post-injection.
    • Follow physical therapy or manipulation instructions provided by the healthcare professional.
  • Monitoring: Observe patients for signs of hypersensitivity or serious local reactions.

For detailed dosing and administration information, refer to the prescribing information and consult a healthcare professional.

Xiaflex for injection