collagenase clostridium histolyticum

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 ?
Collagenase clostridium histolyticum (Xiaflex[R]) was approved on December 6, 2013, by the United States Food and Drug Administration (FDA) for use with patients with Peyronie's disease.
M2 EQUITYBITES-November 21, 2016-BioSpecifics Technologies reveals positive results from phase 2b study of collagenase clostridium histolyticum
M2 PHARMA-November 21, 2016-BioSpecifics Technologies reveals positive results from phase 2b study of collagenase clostridium histolyticum
Xiapex - collagenase clostridium histolyticum - offers an alternative treatment option to surgery for the condition and can be administered by a trained physician.
You can have surgery or radiation, and a treatment is available called collagenase clostridium histolyticum that is injected.
Collagenase Clostridium histolyticum (Xiaflex; B) is given intramuscularly for the treatment of Dupuytren's contracture with a palpable cord.
The product, collagenase Clostridium histolyticum, was approved specifically for adults with Dupuytren's contracture with a palpable cord, and will be marketed as Xiaflex by Auxilium Pharmaceuticals Inc.
The product, collagenase clostridium histolyticum (CC), was approved specifically for adults with Dupuytren's contracture with a palpable cord, and will be marketed as Xiaflex by Auxilium Pharmaceuticals Inc.
1 Collagenase clostridium histolyticum is the first injectable treatment to be approved in the EU for the treatment of Dupuytren's contracture.
Key Words: Peyronie's disease, penile curvature, plaque, collagenase Clostridium histolyticum, intralesional, advanced practice registered nurse (APRN).
The FDA's Arthritis Advisory Committee voted 12-0 that the treatment, collagenase Clostridium histolyticum, should be approved for treating advanced Dupuytren's, based on the available safety and efficacy data.
Auxilium Pharmaceuticals, a fully integrated specialty pharmaceutical company, has announced on Friday its positive results from a randomised double-blind Phase 2a study of collagenase clostridium histolyticum.