XIAFLEX- collagenase clostridium histolyticum kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM (UNII: 9X7O8V25IT) (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM - UNII:9X7O8V25IT)

Available from:

Endo Pharmaceuticals Inc.

INN (International Name):

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Composition:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 0.9 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. XIAFLEX is indicated for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX is contraindicated in: - the treatment of Peyronie’s plaques that involve the penile urethra due to potential risk to this structure. - patients with a history of hypersensitivity to XIAFLEX or to collagenase used in any other therapeutic application or application method [see Warnings and Precautions (5.4)] . Pregnancy Category B There are no adequate and well-controlled studies of XIAFLEX in pregnant women. Because animal reproduction studies are not always predictive of human response, XIAFLEX should be used during pregnancy only if clearly needed. Risk Summary Based on animal data, XIAFLEX is not predicted to increase the risk for major developmental abnormalities in humans. Human Data Human pharmacokinetic studies

Product summary:

XIAFLEX is available in single-use, glass vials containing 0.9 mg of collagenase clostridium histolyticum as a sterile, lyophilized powder. Sterile diluent for reconstitution is available in single-use, glass vials containing 3 mL of 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride. Storage and Stability Prior to reconstitution, the vials of XIAFLEX and diluent should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.1, 2.2)] . Do not freeze. The reconstituted XIAFLEX solution can be kept at room temperature (20°C to 25°C/68°F to 77°F) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration [see Dosage and Administration (2.1, 2.2)] .

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Endo Pharmaceuticals Inc.
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Medication Guide
XIAFLEX® (Zī a flex)
(collagenase clostridium histolyticum)
For injection, for intralesional use
XIAFLEX is approved for two uses: Dupuytren's contracture and
Peyronie's disease. Information is provided
separately for each use. Use for treating Dupuytren's contracture is
described first, followed by use for
treating Peyronie's disease.
Read this Medication Guide before you receive XIAFLEX for the
treatment of Dupuytren’s contracture and
each time you get an injection. There may be new information. This
Medication Guide does not take the
place of talking with your healthcare provider about your medical
condition or treatment.
What is the most important information I should know about XIAFLEX for
the treatment of Dupuytren’s
contracture?
XIAFLEX may cause serious side effects, including:
1.
Tendon rupture or ligament damage. Receiving an injection of XIAFLEX
may cause damage to a
tendon or ligament in your hand and cause it to break or weaken. This
could require surgery to fix
the damaged tendon or ligament. Call your healthcare provider right
away if you have trouble
bending your injected finger (towards the wrist) after the swelling
goes down or you have problems
using your treated hand after your follow-up visit.
2.
Nerve injury or other serious injury of the hand. After finger
procedures, some people developed
tears in the skin (lacerations), and local skin and soft-tissue
necrosis (death of skin cells). Some
lacerations and necrosis required skin grafting, or other surgery
including amputation. Call your
healthcare provider right away if you get numbness, tingling,
increased pain, or tears in the skin
(laceration) in your treated finger or hand after your injection or
after your follow-up visit.
3.
Hypersensitivity reactions, including anaphylaxis. Severe allergic
reactions can happen in people
who receive XIAFLEX, because it contains foreign proteins.
Call your healthcare provider right away if you have any of these
symptoms of an allergic reaction a

Summary of Product characteristics

XIAFLEX- COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
ENDO PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XIAFLEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR XIAFLEX.
XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) FOR INJECTION, FOR
INTRALESIONAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE
INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CORPORAL RUPTURE (PENILE FRACTURE) WAS REPORTED AS AN ADVERSE REACTION
IN 5 OF 1044
(0.5%) XIAFLEX-TREATED PATIENTS IN CLINICAL STUDIES. IN OTHER
XIAFLEX-TREATED PATIENTS
(9 OF 1044; 0.9%), A DIAGNOSIS OF CORPORAL RUPTURE CANNOT BE EXCLUDED.
SEVERE PENILE
HEMATOMA WAS ALSO REPORTED AS AN ADVERSE REACTION IN 39 OF 1044 (3.7%)
XIAFLEX-
TREATED PATIENTS. (5.2)
XIAFLEX IS AVAILABLE FOR THE TREATMENT OF PEYRONIE’S DISEASE ONLY
THROUGH A
RESTRICTED PROGRAM CALLED THE XIAFLEX REMS PROGRAM. (5.3)
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 04/2021
Warnings and Precautions (5.1) 08/2021
Warnings and Precautions (5.2) 08/2021
Warnings and Precautions (5.7) 06/2022
INDICATIONS AND USAGE
XIAFLEX is a combination of bacterial collagenases indicated for:
The treatment of adult patients with Dupuytren’s contracture with a
palpable cord (1)
The treatment of adult men with Peyronie’s disease with a palpable
plaque and curvature deformity of
at least 30 degrees at the start of therapy (1)
DOSAGE AND ADMINISTRATION
DUPUYTREN’S CONTRACTURE (2.1)
XIAFLEX should be administered by a healthcare provider experienced in
injection procedures of the
hand and in the treatment of Dupuytren’s contracture.
Reconstitute XIAFLEX lyophilized powder with only the supplied diluent
prior to use.
Inject 0.58 mg of XIAFLEX into each palpable Dupuytren’s cord with a
contracture of a
metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP)
joint according to the injection
procedu