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Collagenase Clostridium Histolyticum

Pronunciation: kol-AJ-e-nase klos-TRID-ee-um HIS-toe-LIT-ik-um
Class: Enzyme preparation

Trade Names

Xiaflex
- Injection, lyophilized powder for solution 0.9 mg

Pharmacology

Hydrolyzes collagen, resulting in lysis of collagen deposits. Injection into a Dupuytren cord, which is comprised mostly of collagen, may result in enzymatic disruption of the cord.

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Pharmacokinetics

Absorption

Following administration of a single 0.58 mg dose, no quantifiable levels of collagenase Clostridium histolyticum (AUX-I or AUX-II) were detected in plasma up to 30 days postinjection.

Indications and Usage

Treatment of adult patients with Dupuytren contracture with a palpable cord.

Contraindications

None well documented.

Dosage and Administration

Adults

Intralesional 0.58 mg per injection into a palpable cord with a contracture of a metacarpophalangeal (MP) or a proximal interphalangeal (PIP) joint. A finger extension procedure should be performed approximately 24 h after injection if contracture persists. If contracture persists, injections and finger extension procedures may be administered up to 3 times per cord at approximately 4–wk intervals.

General Advice

  • For intralesional injection only. Not for intradermal, subcutaneous, IM, IV, or intra-arterial use.
  • Inject only 1 cord at a time. If a patient has other palpable cords with contractures, these cords may be injected with collagenase C. histolyticum in a sequential order.
  • Reconstitute following the manufacturer's guidelines using only the supplied diluent.
  • Refer to the manufacturer's full prescribing information for injection and finger extension procedures.
  • Administration of a local anesthetic prior to injection is not recommended.
  • Do not administer if particulate matter or discoloration is noted in reconstituted solution.
  • Discard the unused portion of the reconstituted solution and diluent after injection; do not store, use, or pool unused reconstituted solution or diluent.

Storage/Stability

Store in the refrigerator at 36° to 46°F prior to reconstitution. Do not freeze. Reconstituted solution may be kept at room temperature (68° to 77°F) for up to 1 h or refrigerated (36° to 46°F) for up to 4 h prior to administration.

Drug Interactions

Anticoagulant drugs (eg, warfarin)

Use collagenase C. histolyticum with caution in patients receiving concomitant anticoagulants, except low-dose aspirin (ie, up to 150 mg/day), within 7 days prior to administering collagenase C. histolyticum .

Adverse Reactions

Dermatologic

Pruritus, including pruritus at the injection site (15%); skin laceration (9%); erythema (6%).

Local

Injection-site hemorrhage (38%); injection-site reaction, including erythema, inflammation, irritation, pain, and warmth (35%); injection-site edema and swelling, tenderness (24%).

Miscellaneous

Peripheral edema, mostly swelling of the injected hand (73%); contusion (70%); pain in extremity (35%); lymphadenopathy or axillary mass (13%); lymph node pain (8%); axillary pain (6%).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hypersensitivity

The incidence of mild allergic reactions (pruritus) increased after more collagenase C. histolyticum injections. Severe allergic reactions, including anaphylaxis, could occur following injection.

Coagulation disorders

Because of the potential for ecchymosis/contusion of an injection-site hemorrhage, use with caution in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin).

Local effects

Serious local adverse reactions include complex regional pain syndrome, ligament injury, pulley rupture, and sensory injury of the hand.

Tendon rupture

Flexor tendon ruptures have occurred after injection. Inject collagenase C. histolyticum only into the collagen cord with an MP or PIP joint contracture and take care to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand.

Overdosage

Symptoms

None well documented. Severe local effects, including tendon ruptures, may occur.

Patient Information

  • Advise patients to read the Medication Guide prior to each treatment with collagenase C. histolyticum .
  • Inform patients that serious complications include tendon rupture or serious ligament damage that may result in inability to fully bend the finger and may require surgery to correct the complication.
  • Advise patients that injection is likely to result in bleeding, bruising, pain, and/or swelling of the site and surrounding tissue.
  • Instruct patients not to flex or extend the fingers of the injected hand to reduce extravasation of collagenase C. histolyticum out of the cord, and not to attempt to disrupt the injected cord by self-manipulation.
  • Advise patients to elevate the injected hand until bedtime and to promptly contact their health care provider if there is evidence of infection (eg, chills, fever, increasing redness or edema), sensory changes in the treated finger, or trouble bending the finger after the swelling goes down (symptoms of tendon rupture).
  • Instruct patients to return to their health care provider's office the day after the injection for an examination of the injected hand and for a possible finger extension procedure to disrupt the cord.
  • Following the finger extension procedure(s) and fitting the patient with a splint, instruct patients not to perform any strenuous activity with the injected hand until advised to do so, to wear the splint at bedtime for up to 4 mo, and to perform a series of finger flexion and extension exercises each day.

Copyright © 2009 Wolters Kluwer Health.

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