Xiaflex (Collagenase Clostridium Histolyticum)

Xiaflex (Collagenase Clostridium Histolyticum)

Xiaflex

Collagenase Clostridium Histolyticum

Single-use glass vials containing 0.9 mg

Endo Pharmaceuticals Inc.

Medical Use

Xiaflex is a combination of bacterial collagenases used to treat:

  • -Adult patients with Dupuytren’s contracture (palmar fibromatosis) with a palpable cord.
  • -Adult males with Peyronie’s disease (penile fibrosis) with a palpable plaque and a curvature deformity of at least 30 degrees at the start of therapy.

Recommended Dosage:

Dupuytren’s Contracture: Xiaflex should be administered by a healthcare professional experienced in hand injection procedures and treating Dupuytren’s contracture. Reconstitute the lyophilized powder with the supplied diluent before use. Inject 0.58 mg of Xiaflex into each palpable Dupuytren’s cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint as per the injection procedure.

  • -Up to two joints in the same hand may be treated during a single visit.
  • -If a contracture persists, perform a finger extension procedure 24 to 72 hours after the injection.
  • -Injections and finger extension procedures can be repeated up to three times per cord at approximately 4-week intervals.
  • -Treat up to two cords in the same hand during a visit. If other cords have contractures, treat them at a subsequent visit.

 Peyronie’s Disease:

 Xiaflex injections for Peyronie’s disease should be administered by a healthcare professional experienced in treating male urological conditions. Reconstitute the lyophilized powder with the supplied diluent before use.

  • -A treatment cycle typically includes two Xiaflex injection procedures and a penile modeling procedure.
  • -Induce a penile erection, possibly using a single intracavernosal injection of 10 or 20 micrograms of alprostadil.
  • -With the penis erect, identify and mark the target area in the Peyronie’s plaque for injection. Ensure the penis is flaccid before administering the injection.
  • -Administer Xiaflex 0.58 mg into the target plaque once on each of two days, spaced 1 to 3 days apart, following the specified injection procedure.
  • -Perform the penile modeling procedure 1 to 3 days after the second injection of each Peyronie’s disease treatment cycle.
  • -For each plaque causing the curvature deformity, up to four treatment cycles can be given. Each cycle may be repeated approximately every six weeks. If the curvature deformity is less than 15 degrees after the first, second, or third treatment cycle, or if further treatment is not clinically necessary, then proceed with the subsequent treatment cycles accordingly.