Xiaflex Generic Name & Formulations
Legal Class
Rx
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
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 (Cat.B). Nursing mothers.
REMS
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
Legal Class
Rx
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
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 (Cat.B). Nursing mothers.
REMS
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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