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XIAFLEX
Miscellaneous musculoskeletal disorders
Miscellaneous urogenital disorders
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Drug Name:

XIAFLEX Rx

Generic Name and Formulations:
Collagenase clostridium histolyticum 0.9mg; per vial; lyophilized pwd for reconstitution with supplied diluent; for intralesional inj.

Company:
Auxilium Pharmaceuticals, Inc.

Therapeutic Use:

Indications for XIAFLEX:

Dupuytren's contracture with a palpable cord.

Adult:

See full labeling for injection and finger extension procedure. 0.58mg per injection into a palpable cord with a contracture of a metacarpophalangeal joint (MP) or a proximal interphalangeal (PIP) joint. Approx. 24–72hrs after inj, perform finger extension procedure if contracture persists to facilitate cord disruption. Four weeks after inj and finger extension procedure, if a MP or PIP contracture remains, the cord may be re-injected with a single dose of 0.58mg and finger extension procedure repeated (approx. 24–72hrs after inj). Injections and finger extension procedures may be given up to 3 times per cord at approx. 4-week intervals. May inject up to 2 palpable cords affecting 2 joints or 1 palpable cord affecting 2 joints in same finger at 2 locations during the same visit; if other palpable cords with MP or PIP joint contractures, may inject at other treatment visits approx. 4 weeks apart.

Children:

<18yrs: not established.

Contraindications:

Allergy to collagenase used in other therapeutic applications.

Warnings/Precautions:

Should be administered by person experienced in inj procedures of the hand and in treatment of Dupuytren's contracture. Avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand; tendon rupture or ligament damage possible. Be prepared to address possible severe allergic reactions. Avoid in coagulation disorders. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Caution with concomitant anticoagulants (except for low-dose aspirin).

Adverse Reactions:

Edema peripheral (eg, swelling of injected hand), contusion, inj site hemorrhage, inj site reaction, pain in the injected extremity, tenderness, inj site swelling, pruritus, lymphadenopathy.

REMS:

YES

How Supplied:

Single-use vial—1 (w. diluent); Dual-pack—1 (2 single-use vials + 2 diluents)

Indications for XIAFLEX:

Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Adult:

See full labeling for injection and penile modeling procedure. 0.58mg per injection into a Peyronie's plaque; max 4 treatment cycles at approx. 6-week intervals. If more than one plaque present, inject into plaque causing the curvature deformity. Each treatment cycle consists of 2 injection procedures and 1 penile modeling procedure. Perform 2nd injection procedure 1–3 days after the first, then perform penile modeling procedure 1–3 days after 2nd injection of the treatment cycle. Treatment course = max 8 injection procedures + 4 penile modeling procedures. If curvature deformity is <15 degrees after the 1st, 2nd, or 3rd cycle, or if further treatment is not clinically indicated, then subsequent cycles should not be administered.

Children:

<18yrs: not established.

Contraindications:

Peyronie's plaques involving the penile urethra due to potential risk to this structure. Allergy to collagenase used in other therapeutic applications.

Warnings/Precautions:

Should be administered by person experienced in inj procedures of male urological diseases and in treatment of Peyronie's disease. Risk of corporal rupture or other serious penile injury; evaluate promptly if signs/symptoms develop. Avoid injecting into urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis; penile fracture possible. Be prepared to address possible severe allergic reactions. Avoid in coagulation disorders. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Caution with concomitant anticoagulants (except for low-dose aspirin).

Adverse Reactions:

Penile hematoma, penile swelling, penile pain, penile ecchymoses, blood blister, penile blister, pruritus genital, painful erection.

REMS:

YES

How Supplied:

Single-use vial—1 (w. diluent); Dual-pack—1 (2 single-use vials + 2 diluents)

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