Xiaflex

— THERAPEUTIC CATEGORIES —
  • Miscellaneous musculoskeletal disorders
  • Miscellaneous urogenital disorders

Xiaflex Generic Name & Formulations

General Description

Collagenase clostridium histolyticum 0.9mg; per vial; lyophilized pwd for reconstitution with supplied diluent; for intralesional inj.

How Supplied

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

Manufacturer

Generic Availability

NO

Mechanism of Action

Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits.

Xiaflex Indications

Indications

Dupuytren's contracture with a palpable cord.

Xiaflex Dosage and Administration

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.

Xiaflex Contraindications

Contraindications

Allergy to collagenase used in other therapeutic applications.

Xiaflex Boxed Warnings

Boxed Warning

Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease.

Xiaflex Warnings/Precautions

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. Nursing mothers.

REMS

YES

Xiaflex Pharmacokinetics

See Literature

Xiaflex Interactions

Interactions

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

Xiaflex Adverse Reactions

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; acute post-inj back pain reactions, syncope, presyncope.

Xiaflex Clinical Trials

See Literature

Xiaflex Note

Not Applicable

Xiaflex Patient Counseling

See Literature

Xiaflex Generic Name & Formulations

General Description

Collagenase clostridium histolyticum 0.9mg; per vial; lyophilized pwd for reconstitution with supplied diluent; for intralesional inj.

How Supplied

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

Manufacturer

Generic Availability

NO

Mechanism of Action

Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits.

Xiaflex Indications

Indications

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

Xiaflex Dosage and Administration

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.

Xiaflex Contraindications

Contraindications

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

Xiaflex Boxed Warnings

Boxed Warning

Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease.

Xiaflex Warnings/Precautions

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. Nursing mothers.

REMS

YES

Xiaflex Pharmacokinetics

See Literature

Xiaflex Interactions

Interactions

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

Xiaflex Adverse Reactions

Adverse Reactions

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

Xiaflex Clinical Trials

See Literature

Xiaflex Note

Not Applicable

Xiaflex Patient Counseling

See Literature

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