XIAFLEX (collagenase clostridium histolyticum)
OFFICE ADMINISTRATION
Indications for Prior Authorization:
- Dupuytren's contracture (hand) in Adults
- Peyronie's Disease
Patients must meet the following criteria for the indications above:
- Patient must have a palpable cord
Dupuytren's Contracture
- Diagnosis of Dupuytren's Contracture AND
- Have at least one finger (not thumb) flexion contracture with a palpable cord of 20 to 100 degrees in the metatarsophalangeal joint (MP) or a proximal interphalageal (PIP) joint
Peyronie's Disease
- Diagnosis of Peyronie's disease diagnosed by a urologist (prescriber need not be urologist)
The drug is not approved for any use not mentioned above:
- Any condition not listed above as an approved condition
Dosing:
- Xiaflex must be administered by a healthcare provider experienced in injection procedures of the hand
Dupuytren's Contracture
- The dose of Xiaflex is 0.58 mg per injection into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint
- Approximately 24 hours after injection, perform a finger extension procedure to facilitate cord disruption
- Four weeks after the initial injection and finger extension, if a MP or PIP contracture remains, the cord may be re-injected with a single dose of 0.58 mg. Repeat finger extension in 24 hours
- Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals
Peyronie’s Disease
- Up to 2 injections of 0.58 mg injected into target plaque, administered 1 to 3 days apart
- For each plaque causing the curvature deformity, up to four treatment cycles may be administered
- Each treatment cycle consists of two injections given at six-week intervals for up to four cycles (maximum of 8 injections per plaque for the entire treatment course)
Approval:
- Initial approval to assess patient’s response
- Renew for 2 more injections if contracture persists
- Maximum treatment 3 injections per cord
Last review date: July 20, 2016