Brand Information

XIAFLEX*

Brand:
XIAFLEX*

Manufacturer:
AUXILIUM INC.

Compositions:
Clostridial Collangenase- mg,

Strength	Rate	Packing Style
mg	0.00	unit

List of Related Indications:

Treatment of advanced Duputyrens disease

List Of Drugs:

Collagenase Clostridium Histolyticum - Metabolic Disorder

Indication Type Description:

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation

Drug Interaction:

Anticoagulant drugs: XIAFLEX should be used with caution in patients receiving

concomitant anticoagulants (except for low-dose aspirin)

Indication:

Proprietary Name- Xiaflex

Established Name - Clostradial collagenase

Applicant- Auxilium Pharamaceuticals Inc.

Indication-

Provides treatment for advanced Duputyrens disease

Approved by FDA on 2-2-2010 (Ref- FDA approved List- 2010)

Adverse Reaction:

Dupuytrenfs Contracture

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.

Peyroniefs Disease

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.

Contra-Indications:

CONTRAINDICATIONS

Peyronie’s plaques that involve the penile urethra

History of hypersensitivity to XIAFLEX or to collagenase used in other therapeutic

applications

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

palpable cord

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

Dupuytren’s Contracture

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.

Peyronie’s Disease

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

modeling procedure.

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

treatment cycle.

For each plaque causing the curvature deformity, up to four treatment cycles may

be administered.

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 Information:

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.

Pharmacology/ Pharmacokinetics:

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.

2. Pharmacokinetics

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

1 Pregnancy

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

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