Miscellaneous musculoskeletal disorders:
Indications for: XIAFLEX
Dupuytren's contracture with a palpable cord.
Adult Dosage:
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 Dosage:
<18yrs: not established.
XIAFLEX Contraindications:
Allergy to collagenase used in other therapeutic applications.
Boxed Warning:
Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease.
XIAFLEX 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.
XIAFLEX 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; acute post-inj back pain reactions, syncope, presyncope.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1 (w. diluent); Dual-pack—1 (2 single-use vials + 2 diluents)
Miscellaneous urogenital disorders:
Indications for: XIAFLEX
Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Adult Dosage:
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 Dosage:
<18yrs: not established.
XIAFLEX Contraindications:
Peyronie's plaques involving the penile urethra due to potential risk to this structure. Allergy to collagenase used in other therapeutic applications.
Boxed Warning:
Corporal rupture (penile fracture) or other serious penile injury in the treatment of Peyronie's disease.
XIAFLEX 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.
XIAFLEX 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; syncope, presyncope.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-use vial—1 (w. diluent); Dual-pack—1 (2 single-use vials + 2 diluents)