collagenase clostridium histolyticum

kol-LA-jen-ase kloss-TRID-ee-yum HIS-toe-LIT-i-cum

Therapeutic Classification: none assigned

REMS

Xiaflex

Treatment of the following conditions:
- Dupuytren’s contracture with a palpable cord.
- Peyronie's disease in men with a palpable plaque and curvature deformity of at least 30 degrees.

Qwo

Moderate to severe cellulite in the buttocks of adult women.

Hydrolyzes collagen, resulting in breakdown of collagen deposits.

Therapeutic effects:

Reduction in contracture of affected joint in Dupuytren's contracture
Reduction in penile curvature deformity in Peyronie's disease.
Reduction in severity of buttock cellulite.

Absorption: Minimal systemic absorption following SUBQ administration or injection into palpable cord or plaque.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

ROUTE	ONSET	PEAK	DURATION
Injection into palpable cord‡	within 24 hr	unknown	unknown
Injection into plaque‡	unknown	unknown	unknown
SUBQ‡‡	unknown	unknown	unknown

‡Cord disruption; ‡Plaque disruption. ‡‡ Reduction in buttock cellulite severity.

Contraindicated in:

Hypersensitivity;
Peyronie's plaques that involve the urethra;
Infection at injection site (Qwo only).

Use Cautiously in:

Abnormal coagulation, including concurrent use of anticoagulants other than low-dose aspirin (≤150 mg/day) within 7 days of treatment;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

CV: chest pain, vasovagal syncope

Derm: pruritus, skin laceration, erythema, skin/soft tissue necrosis

GU: penile fracture, penile hematoma

Local: contusion, hemorrhage, injection site bruising, injection site reaction, pain, swelling

MS: acute back pain, complex regional pain syndrome (CRPS), ligament injury, sensory abnormality of hand, tendon rupture

Neuro: headache

Resp: dyspnea

Misc: axillary pain, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) , lymphadenopathy

Drug-drug:

Concurrent use of anticoagulants or antiplateletsmay ↑ risk of local bleeding.

Xiaflex and Qwo are NOT interchangeable products.

Dupuytren’s Contracture

Injection into palpable cord(Adults ): Xiaflex: 0.58 mg into a palpable cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint. If contracture persists, finger extension procedure should be performed 24 hr following injection to facilitate cord disruption. If MP or PIP contracture persists, may reinject cord 4 wk after initial injection; injections and finger extension procedures may be administered up to 3 times per cord separated by ~4 wk intervals. Can perform up to 2 injections in same hand during a treatment visit. 2 palpable cords affecting 2 joints may be injected or 1 palpable cord affecting 2 joints in the same finger may be injected at 2 locations during a treatment visit. If patient has other palpable cords with contractures of MP or PIP joints, these cords may be injected at other treatment visits ~4 wk apart.

Peyronie's Disease

Injection into plaque(Adults ): Xiaflex: 0.58 mg into a Peyronie's plaque (if >1 plaque present, inject into the plaque causing the curvature deformity); repeat injection 1–3 days later. Penile modeling procedure should be performed 1–3 days after the second injection. Administer second treatment cycle (two 0.58 mg injections and a penile modeling procedure) in ~6 wk if needed (maximum of 4 treatment cycles [total of 8 injection procedures and 4 penile modeling procedures]); subsequent treatment cycles should not be administered if the curvature deformity is <15 degrees after a treatment cycle or health care provider determines further treatment is not indicated.

Buttock Cellulite

SC (Adults ): Qwo: 0.84 mg into a single buttock administered via a maximum of 12 injections of 0.3 mL/injection (with each injection administered as three 0.1–mL aliquots). May repeat dose in other buttock during same visit. Treatments should be repeated every 21 days for a total of 3 treatment visits.

Lyophilized powder for injection (Qwo): 0.92 mg/vial; 1.84 mg/vial
Lyophilized powder for injection (Xiaflex): 0.9 mg/vial

Assess severity of Dupuytren’s contracture prior to and following injection.
Assess curvature, plaque, and amount of bother from Peyronie's disease before and after injection. Indicated for men with palpable plaque and curvature of at least 30°.
Assess severity of cellulite in the buttocks before and after injections.

Injection for Dupuytren’s contracture should be administered by a health care professional experienced in injection procedures of the hand.
Dupuytren’s Contracture: Allow powder and diluent vials to stand at room temperature for 15–60 min prior to mixing. Reconstitution: Use only diluent supplied for reconstitution. Use a syringe with 0.01 mL graduations with a 27 gauge, 1/2 inch needle to withdraw diluent. Withdraw 0.39 mL for cords affecting a MP joint and 0.31 mL for cords affecting a PIP joint. Inject diluent slowly into sides of vial; do not invert of shake vial. Slowly swirl solution to ensure all powder is in solution. Reconstituted solution should be clear without particulate matter. Solution is stable for 1 hr at room temperature or up to 4 hrs if refrigerated. If refrigerated, allow to stand at room temperature for 15 min before administering.
Injection into palpable cord: Do not administer local anesthesia prior to injection; may interfere with placement of medication. Use a new hubless syringe with 0.01 graduations with a permanently fixed, 27-gauge, 1/2 inch needle to withdraw volume to be injected. For MP joint, withdraw 0.25 mL. For PIP joint, withdraw 0.20 mL. Follow manufacturer’s instructions for injection procedure.
Wrap hand with a bulky dressing following injection.
Peyronie's Disease: REMS: Use for Peyronie's disease is only available through the Xiaflex REMS program. Prescribers and healthcare sites must be certified, enrolled, and have completed training to use Xiaflex.
Remove vial and diluent from refrigerator and allow to come to room temperature for at lease 15 and no longer than 60 min. Reconstitution: Using 1 mL syringe with 0.01 mL graduations with a 27-gauge -inch needle (not supplied), withdraw a volume of 0.39 mL of diluent supplied. Inject diluent slowly into sides of vial. Do not invert vial or shake the solution. Slowly swirl solution to ensure all of powder has gone into solution. Reconstituted solution is stable for 1 hr at room temperature or 4 hrs if refrigerated. If refrigerated, allow to come to room temperature for at least 15 min before injection. Discard syringe and needle used for dilution.
Prior to each treatment cycle, identify the treatment area. Induce a penile erection. A single intracavernosal injection of 10 or 20 mcg of alprostadil may be used. Apply antiseptic at site of the injection and allow skin to dry prior to intracavernosal injection. Locate plaque at point of maximum concavity (or focal point) in the bend of the penis. Mark point with a surgical marker indicating target area in the plaque for Xiaflex deposition.
Injection into plaque: Solution should be clear; do not administer solutions that are discolored or contain particulate matter. Using a new hubless syringe containing 0.01 mL graduations with a permanently fixed 27 gauge ½-inch needle (not supplied), withdraw 0.25 mL of reconstituted solution. Penis should be in flaccid state for injection. Make second injection of each treatment cycle approximately 2 to 3 mm apart from first injection.
Buttock Cellulite: Before reconstitution, remove vials from refrigerator and let stand at room temperature for at least 15 min. Powder cakes are white in color and intact, showing no signs of erosion. Diluent is colorless and free of particulate matter. Do not use vials that are discolored. Reconstitution: Withdraw amount of supplied diluent based on number of injection sites; use only supplied diluent for reconstitution. For a single treatment area withdraw 4 mL and for 2 areas withdraw 8 mL of diluent. Inject diluent slowly into sides of vial. Do not invert or shake vial. Slowly swirl solution to ensure that all of powder has gone into solution.Solution is clear and colorless; do not administer solutions that are cloudy, discolored or contain particulate matter.Concentration: 0.23 mg/mL. Solution is stable for 8 hrs at room temperature or up to 72 hrs if refrigerated. Discard solution remaining after injection session; use only for 1 patient.
SC: Use 1–mL syringe with removable needle for injection. Draw up 0.9 mL into each of 4 syringes for single treatment area and 8 syringes for 2 treatment areas. Replace needle with a 30–gauge 1/2 inch needle. Mark injection sites while patient is standing. Inject SUBQ while patient is in prone position. Administer each injection as three 0.1-mL aliquots injected at 90°, withdraw needle slightly and reposition at 45° towards head, and at 45° towards foot (for a total injection volume of 0.3 mL) in each cellulite dimple. Depth of injection should be 0.5 inches (corresponding to the length of the needle) without downward pressure. Withdraw needle from skin completely and move to next identified injection site. Each treatment area may receive up 12 injections. After treatment, patient should remain prone for at least 5 min. Discard unused solution.

Explain purpose of medication to patient.
Advise patient to notify health care professional if signs and symptoms of hypersensitivity reactions (hives, swollen face, trouble breathing, chest pain, low blood pressure, dizziness, fainting) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Dupuytren’s Contracture: Instruct patient to return to health care professional’s office in 1–3 days for an examination of the injected hand and for possible finger extension procedure to disrupt the cord.
Instruct patient not to flex fingers of injected hand to reduce extravasation of medication out of the cord.
Advise patient not to disrupt injected cord by manipulation.
Instruct patient to elevate hand as much as possible until bedtime, and once splint is applied, to avoid strenuous activity with the injected hand, wear the splint at bedtime for up to 4 mo, and to perform finger flexion and extension exercises daily.
Advise patient that injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.
Advise patient to promptly notify health care professional if signs of infection (fever, chills, increasing redness or swelling), sensory changes in the treated finger, trouble bending the finger after swelling goes down occur.
Peyronie's Disease: Instruct patient to return to health care professional’s office when directed for Penile Modeling Procedure for Peyronie’s Disease. Following a total of 3 modeling attempts at 30 seconds for each attempt, instruct patient to self-perform penile modeling activities at home daily for 6 wk. Provide patient with and advise patient to read What You Need to Know About Xiaflex Treatment for Peyronie's Disease: A Patient Guide.
Inform patient penis may appear bruised and/or swollen. May cause mild to moderate penile pain usually relieved with OTC analgesics.
Advise patient to notify health care professional immediately if severe pain or severe swelling of the penis, severe purple bruising and swelling of the penis, difficulty urinating or blood in the urine, or sudden loss of the ability to maintain an erection occurs. These symptoms may be accompanied by a popping or cracking sound from the penis.
Advise patient to avoid sexual activity between 1st and 2nd injections and to wait 4 wks after second injection of a treatment cycle before resuming sexual activity, provided pain and swelling have subsided and to avoid using a vacuum erection device during therapy.
Advise patient to avoid abdominal straining, such as straining during bowel movements.
Buttock Cellulite: Inform patient that bruising at injection site may occur.

Reduction in Dupuytren’s contracture.
Reduction in penile curvature deformity in Peyronie's disease.
Reduction in severity of buttock cellulite.

Qwo, Xiaflex

NDC Code

66887- Endo Pharmaceuticals Inc.
- 66887-003- XIAFLEX
  - 66887-003-01- 1 KIT in 1 CARTON (66887-003-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL

66887- Endo Pharmaceuticals Inc.
- 66887-003- XIAFLEX
  - 66887-003-02- 2 CARTON in 1 CARTON (66887-003-02) > 1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 3 mL in 1 VIAL

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