collagenase clostridium histolyticum

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collagenase clostridium histolyticum

(kol-la-jen-ase kloss-trid-ee-yum his-toe-lit-i-cum) ,

Xiaflex

(trade name)

Classification

Therapeutic: none assigned
Pregnancy Category: B

Indications

Treatment of Dupuytren’s contracture with a palpable cord in adults.

Action

Lysis of collagen deposits present in Dupuytren’s cord.

Therapeutic effects

Enzymatic disruption of Dupuytren’s cord.

Pharmacokinetics

Absorption: Unknown.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (cord disruption)

ROUTEONSETPEAKDURATION
Intralesionalwithin 24 hrunknownunknown

Contraindications/Precautions

Contraindicated in: None known.
Use Cautiously in: Abnormal coagulation, including concurrent anticoagulants other than low-dose aspirin within 7 days of treatment; Obstetric: Use only if clearly needed; Lactation: Use cautiously; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Cardiovascular

  • vasovagal syncope

Musculoskeletal

  • ligament injury
  • complex regional pain syndrome (CRPS)
  • sensory abnormality of hand
  • tendon rupture

Local

  • contusion (most frequent)
  • hemorrhage (most frequent)
  • injection site reaction (most frequent)
  • pain (most frequent)
  • pruritus (most frequent)
  • swelling (most frequent)

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • axillary pain
  • lymphadenopathy

Interactions

Drug-Drug interaction

Concurrent use of anticoagulants may ↑ risk of local bleeding.

Route/Dosage

Intralesional (Adults) 0.58 mg into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint.

Availability

Lyophilized powder for injection (requires reconstitution): 0.9 mg/vial (delivers 0.58 mg/dose)

Nursing implications

Nursing assessment

  • Assess severity of Dupuytren’s contracture prior to and following injection.

Potential Nursing Diagnoses

Impaired physical mobility (Indications)
Acute pain (Adverse Reactions)

Implementation

  • Allow powder and diluent vials to stand at room temperature for 15–60 min prior to mixing. Use only diluent supplied for reconstitution. Use a syringe with 0.01 mL graduations with a 27 gauge, 1/2 inch needle to withdraw diluent. Withdraw 0.39 mL for cords affecting a MP joint and 0.31 mL for cords affecting a PIP joint. Inject diluent slowly into sides of vial; do not invert of shake vial. Slowly swirl solution to ensure all powder is in solution. Reconstituted solution should be clear without particulate matter. Solution is stable for 1 hr at room temperature or up to 4 hrs if refrigerated. If refrigerated, allow to stand at room temperature for 15 min before administering.
  • Intralesional: Do not administer local anesthesia prior to injection; may interfere with placement of medication. Use a new hubless syringe with 0.01 graduations with a permanently fixed, 27-gauge, 1/2 inch needle to withdraw volume to be injected. For MP joint, withdraw 0.25 mL. For PIP joint, withdraw 0.20 mL. Follow manufacturer’s instructions for injection procedure.
  • Wrap hand with a bulky dressing following injection.

Patient/Family Teaching

  • Instruct patient to return to health care professional’s office the next day for an examination of the injected hand and for possible finger extension procedure to disrupt the cord.
  • Instruct patient not to flex fingers of injected hand to reduce extravasation of medication out of the cord.
  • Advise patient not to disrupt injected cord by manipulation.
  • Instruct patient to elevate hand as much as possible until bedtime.
  • Advise patient that injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.
  • Advise patient to promptly notify health care professional if signs of infection (fever, chills, increasing redness or swelling), sensory changes in the treated finger, trouble bending the finger after swelling goes down occur.

Evaluation/Desired Outcomes

  • Reduction in Dupuytren’s contracture.
References in periodicals archive ?
Prior to FDA approval of Xiaflex, the primary treatment for Peyronie's disease was surgical, owing to limited trials and unreliable results of other medical treatments, resulting in a very limited evidence base.
The increase in total revenues for the quarterly period was due mainly to royalties and the mark-up on cost of goods sold revenue associated with an increase in sales of XIAFLEX for the treatment of Peyronie's disease and Dupuytren's contracture.
In the interim, she will assist with the transition and will serve as an adviser and, after her departure, will provide consultative services in connection with the development of Xiaflex for cellulite.
Collagenase injections are fairly new and can be used on thicker cords; the physician injects a drug called Xiaflex which breaks down and digests the fibers in the cord.
Xiapex/ Xiaflex is a first-in-class biologic approved in the US, EU, Canada and Australia for the treatment of adult Dupuytren's contracture patients with a palpable cord and in the US for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
The Xiaflex treatment breaks down this scar tissue and reduces curvature.
Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie s disease.
BioSpecifics has initiated a placebo-controlled, single-injection randomized Phase II clinical trial to evaluate the efficacy of XIAFLEX for treatment of benign subcutaneous lipomas in 32 canines in a study to be completed in 2013.
Disclosures: The studies were sponsored by Auxillium, which markets Xiaflex.
Wentworth Mailing, a New Member Welcome Mailer and Membership Card for the Nittany CO-OP, a Solutions for Global Trading Brochure, the Xiaflex Reference Guide, an American Bible Society Folder, a J.
We believe that there is tremendous promise for XIAFLEX in these two indications and we look forward to reporting these results.
Upon approval, Actelion will have exclusive rights to commercialize Xiaflex in Canada, Australia, Brazil and Mexico, and will be responsible for regulatory and commercialization activities in these countries.