Clostridial Collangenase- mg,
Clostridial Collangenase- mg,
List of Related Indications:
- Treatment of advanced Duputyrens disease
List Of Drugs:
- Collagenase Clostridium Histolyticum - Metabolic Disorder
Indication Type Description:
Dosages/ Overdosage Etc
Pregnancy and lactation
Anticoagulant drugs: XIAFLEX should be used with caution in patients receiving
concomitant anticoagulants (except for low-dose aspirin)
Proprietary Name- Xiaflex
Established Name - Clostradial collagenase
Applicant- Auxilium Pharamaceuticals Inc.
Provides treatment for advanced Duputyrens disease
Approved by FDA on 2-2-2010 (Ref- FDA approved List- 2010)
The most common adverse reactions reported in . 25% of patientstreated with
XIAFLEX and at an incidence greater than placebo were edema peripheral
(e.g., swelling of the injected hand), contusion,injection site hemorrhage,
injection site reaction, and pain in the injected extremity.
The most frequently reported adverse drug reactions reported with 25%
of patients treated with XIAFLEX and at an incidence greater than placebo
were penile hematoma, penile swelling and penile pain.
Peyronie’s plaques that involve the penile urethra
History of hypersensitivity to XIAFLEX or to collagenase used in other therapeutic
WARNINGS AND PRECAUTIONS
Tendon rupture or serious injury to the injected finger/hand: Avoid injecting
XIAFLEX into tendons, nerves, blood vessels, or other collagen-containing
structure of the hand.
Injection into these structures may result in possible permanent injury, such as
tendon rupture, ligament damage, or skin laceration.
Corporal rupture (penile fracture) or other serious injury to the penis:
Avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or
other collagen-containing structures of the penis. Injection into these structures
may result in possible permanent injury such as corporal rupture (penile fracture).
Hypersensitivity reactions, including anaphylaxis:
Healthcare providers should be prepared to address hypersensitivity reactions,
including anaphylaxis, following XIAFLEX injections.
Patients with abnormal coagulation: Use with caution, including in patients who
have received anticoagulant medications other than low-dose aspirin within
7 days of the injection.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
XIAFLEX is a combination of bacterial collagenases indicated for:
The treatment of adult patients with Dupuytren’s contracture with a
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
DOSAGE AND ADMINISTRATION
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 procedure.
Up to two joints in the same hand may be treated during a treatment visit
Approximately 24 to 72 hours following an injection, perform a finger extension
procedure if a contracture persists.
Injections and finger extension procedures may be administered up to 3 times
per cord at approximately 4-week intervals.
Inject up to two cords in the same hand at a treatment visit. If a patient has other
cords with contractures, inject those cords at another treatment visit.
XIAFLEX should be administered by a healthcare provider experienced in the treatment
of male urological diseases.
Reconstitute XIAFLEX lyophilized powder with only the supplied diluent prior to use
A treatment cycle consists of two XIAFLEX injection procedures and a penile
Induce a penile erection. A single intracavernosal injection of 10 or 20 micrograms
of alprostadil may be used for this purpose.
With the penis in the erect state, identify and mark the target area in the Peyronie’s
plaque to be injected.
The penis should be in a flaccid state before injecting XIAFLEX.
Inject 0.58 mg XIAFLEX into the target plaque once on each of two days, 1 to 3 days
apart, according to the injection procedure.
Perform a penile modeling procedure 1 to 3 days after the second injection of each
For each plaque causing the curvature deformity, up to four treatment cycles may
Each treatment cycle may be repeated at approximately six-week intervals.
If the curvature deformity is less than 15 degrees after the first, second or third
treatment cycle, or if further treatment is not clinically indicated,then subsequent
treatment cycles should not be administered.
DOSAGE FORMS AND STRENGTHS
Single-use glass vials containing 0.9 mg of collagenase clostridium histolyticum
as a sterile, lyophilized powder for reconstitution. Sterile diluent for reconstitution
is also provided in a single-use glass vial.
Patient Counseling for Dupuytren’s Contracture
Advise patients of the following:
Serious complications of XIAFLEX injection include tendon rupture, serious ligament
damage, or skin laceration that may result in the inability to fully bend the finger and
may require surgery to correct the complication.
XIAFLEX injection is likely to result in swelling, bruising, bleeding, and/or pain of the
injected site and surrounding tissue.
After the XIAFLEX injections, instruct patients:
Not to flex or extend the fingers of the injected hand to reduce extravasation of
XIAFLEX out of the cord(s).
Not to attempt to disrupt the injected cord(s) by self-manipulation.
To elevate the injected hand until bedtime.
To promptly contact their physician if there is evidence of infection (e.g., fever,
chills, increasing redness or edema), sensory changes in the treated finger(s),
trouble bending the finger(s) after the swelling goes down (symptoms of tendon rupture),
or skin laceration.
1 Mechanism of Action
Collagenases are proteinases that hydrolyze collagen in its native triple helical
conformation under physiological conditions, resulting in lysis of collagen deposits.
Injection of XIAFLEX into a Dupuytren’s cord, which is comprised mostly of collagen
may result in enzymatic disruption of the cord.
Following administration of either a single injection of XIAFLEX 0.58 mg into a
Dupuytren’s cord in 20 patients or two concurrent injections of XIAFLEX 0.58 mg into
Dupuytren’s cords of 12 patients, no quantifiable levels of XIAFLEX (AUX-I or AUX-II)
were detected in plasma up to 30 days post injection.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
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.
2. Nursing Mothers
It is not known whether collagenase clostridium histolyticum is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised
when XIAFLEX is administered to a nursing woman.
3. Pediatric Use
The safety and effectiveness of XIAFLEX in pediatric patients less than 18 years old
have not been established.
4. Geriatric Use
Of the 551 XIAFLEX-treated patients in the double-blind, placebo-controlled,
clinical trials in Peyronie’s disease (Studies 1 and 2), 100 (18%) were 65 years
of age or older and 5 (0.9 %) were 75 years of age or older.
No overall differences in safety or effectiveness of XIAFLEX were observed
between these patients and younger patients