Usual Adult Dose for Dupuytren's Contracture

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

Comments:

• This drug should be administered by a healthcare provider experienced in injection procedures of the hand and in the treatment of patients with Dupuytren's contracture.
• Up to 2 joints in the same hand may be treated during a treatment visit. Two palpable cords affecting 2 joints may be injected or one palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit. If a patient has other palpable cords with contractures of MP or PIP joints, these cords may be injected at other treatment visits approximately 4 weeks apart.
• Approximately 24 to 72 hours following an injection, a finger extension procedure should be performed if a contracture persists. Consult manufacturer product information or local protocol for information on the finger extension procedure.
• Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
• Up to 2 cords in the same hand may be injected at a treatment visit. If a patient has other cords with contractures, those cords should be injected at another treatment visit.
• Vital signs should be monitored and appropriate equipment should be available to address any severe local or systemic reactions including the potential for anaphylaxis that may occur following injection.

Usual Adult Dose for Peyronie's Disease

0.58 mg injected into the target plaque once on each of two days, 1 to 3 days apart

Comments:

• This drug should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of this drug in the treatment of Peyronie's disease.
• A treatment cycle consists of 2 injection procedures and a penile modeling procedure.
• For each plaque causing the curvature deformity, up to 4 treatment cycles may be administered. Each treatment cycle may be repeated at approximately 6 week intervals. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if further treatment is not indicated, then subsequent treatment cycles should not be administered.
• The safety of more than one treatment course for Peyronie's disease is not known.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for collagenase clostridium histolyticum. It includes elements to assure safe use, and implementation system. For additional information: htmhttp://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:

• This drug can cause corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease. Corporal rupture (penile fracture) has been reported in 0.5% of patients in clinical studies. In 0.9% of treated patients, a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile "popping" sound or sensation has been reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma has also been reported in 3.7% of treated patients. Signs of serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention.

Dialysis

Data not available

Other Comments

Administration advice:

• Consult the manufacturer product information or local protocol.

• Consult the manufacturer product information.

• The reconstituted solution can be kept at room temperature 20C to 25C (68F to 77F) for up to one hour or refrigerated at 2C to 8C (36F to 46F) for up to 4 hours prior to administration. If the reconstituted solution is refrigerated, this solution should be allowed to return to room temperature for approximately 15 minutes before use.