collagenase clostridium histolyticum (Rx)

Brand and Other Names:Xiaflex, Qwo, more...collagenase clostridium histolyticum-aaes
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for injection plus diluent

  • 0.9mg/vial (Xiaflex)
  • 0.92mg/vial (Qwo)
  • 1.84mg/vial (Qwo)

Dupuytren Contracture

Xiaflex only

Indicated for Dupuytren contracture with a palpable cord

Inject 0.58 mg into palpable Dupuytren cord with a contracture of metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint

If contracture persists 24-72 hr following injection, perform finger extension procedure

May repeat injection and finger extension procedures up to 3 times per cord at 4-week intervals

Inject only 1 cord at a time; if other cords with contractures exist, inject each cord in sequential order

Each vial of drug and sterile diluent should only be used for a single injection; if 2 joints on the same hand are to be treated during a treatment visit, separate vials and syringes should be used for each reconstitution and injection

Approximately 24-72 hr after injection, perform a finger extension procedure if a contracture persists to facilitate cord disruption

May reinject four weeks after the initial injection if MP or PIP contracture still present; may reinject with a single dose of collagenase C histolyticum

2 injections on same hand per treatment visit

  • Perform up to 2 injections in the same hand during a treatment visit
  • Two 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 a 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 Disease

Xiaflex only

Available for treatment of Peyronie disease only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program called the XIAFLEX REMS Program

Indicated in men with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy

Inject 0.58 mg into a Peyronie plaque; if >1 plaque present, inject into the plaque causing the curvature deformity

Treatment course consists of a maximum of 4 treatment cycles; each treatment cycle consists of 2 injection procedures and 1 penile modeling procedure for a maximum of 8 injection procedures and 4 modeling procedures

Perform 2nd injection procedure 1-3 days after the 1st

Interval between treatment cycles is ~6 weeks

Induce a penile erection; to achieve it, may use a single intracavernosal injection of 10 or 20 mcg of alprostadil

With the penis in the erect state, identify and mark the target area in the Peyronie plaque to be injected

The penis should be in flaccid state before injecting

Inject 0.58 mg into target plaque once on each of 2 days, 1 to 3 days apart, according to injection procedure

Perform a penile modeling procedure 1 to 3 days after second injection of each treatment cycle

For each plaque causing the curvature deformity, may administer up to four treatment cycles; may repeat each treatment cycle at approximately six-week intervals; if curvature deformity is <15 degrees after 1st, 2nd, or 3rd treatment cycle, or if further treatment not clinically indicated, do not administer subsequent treatment cycles

If curvature deformity is <15 degrees after 1st, 2nd, or 3rd treatment cycle, or if healthcare provider determines that further treatment not clinically indicated, then do not administer subsequent treatment cycles

Cellulite

Qwo only

Up to twelve 0.07-mg (0.3-mL) SC injections totaling 0.84 mg per treatment area (ie, single buttock)

Treatment visit may consist of up to 2 treatment areas

Repeat q21Days for 3 treatment visits

Safety and efficacy not established

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Interactions

Interaction Checker

and collagenase clostridium histolyticum

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dupuytren contracture

            • Peripheral edema (ie, swelling of injected hand) (73%)
            • Contusion (70%)
            • Injection site hemorrhage (38%)
            • Injection site reaction (35%)
            • Pain in injected extremity (35%)
            • Tenderness (24%)
            • Injection site swelling (24%)
            • Pruritus (15%)
            • Lymphadenopathy (13%)

            Peyronie Disease

            • Penile hematoma (65.5%)
            • Penile swelling (55%)
            • Penile pain (45.4%)
            • Penile ecchymoses (14.5%)

            Cellulite

            • Bruising (84%)
            • Pain (48%)
            • Nodule (33%)
            • Pruritus (15%)

            1-10%

            Dupuytren contracture

            • Skin laceration (9%)
            • Lymph node pain (8%)
            • Erythema (6%)
            • Axillary pain (6%)

            Peyronie Disease

            • Blood blister (4.5%)
            • Penile blister (3.3%)
            • Pruritus genital (3.1%)
            • Painful erection (2.9%)
            • Erectile dysfunction (1.8%)
            • Procedural pain (1.6%)
            • Injection site vesicles (1.3%)
            • Localized edema (1.3%)
            • Dyspareunia (1.1%)
            • Injection site pruritus (1.1%)
            • Nodule (1.1%)
            • Suprapubic pain (1.1%)

            Cellulite

            • Erythema (9%)
            • Discoloration (8%)
            • Swelling (8%)
            • Warmth (3%)

            <1%

            Peyronie Disease

            • Corporal rupture

            Postmarketing Reports

            Cellulite

            • Immune system disorders: serious hypersensitivity reactions including anaphylaxis
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            Warnings

            Black Box Warnings

            Peyronie disease

            • Corporal rupture (penile fracture) was reported as adverse reaction in clinical trials
            • Promptly evaluate signs or symptoms reflecting serious penile injury to assess for corporal rupture or severe penile hematoma which may require surgical intervention
            • Because of risks of corporal rupture or other serious penile injury, available for the treatment of Peyronie’s disease only through the XIAFLEX REMS Program

            Contraindications

            Hypersensitivity

            Peyronie plaques that involve the penile urethra

            Cautions

            Do not substitute injectable collagenase products (ie, do not use Xiaflex for cellulite treatment of use Qwo for Dupuytren contracture or Peyronie disease)

            Serious hypersensitivity, including anaphylaxis, reported; if hypersensitivity occurs, discontinue and institute appropriate medical therapy

            Pruritus experienced especially after more injections

            Use with caution in patients with coagulation disorders, including in patients who have received anticoagulant medications other than low- dose aspirin within 7 days of the injection

            Administration in patients with abnormal coagulation may result in ecchymosis/contusion or an injection site hemorrhage

            Dupuytren contracture

            • Tendon rupture of other serious injury to the injected extremity reported in clinical trials; avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structure of the hand
            • Healthcare providers should be prepared to address hypersensitivity reactions, including anaphylaxis, following injections
            • Incidence of skin laceration (22%) was higher when treating 2 concurrent injections compared with up to 3 single injections in the placebo-controlled premarketing trials (9%)

            Peyronie Disease

            • Advise patients not to have sex between first and second injections of treatment cycle; patients should wait 2 weeks after second injection of treatment cycle before resuming sexual activity, provided pain and swelling have subsided
            • May cause corporal rupture (penile fracture) or other serious injury to penis; avoid injecting into urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis since may result in possible permanent injury (eg, corporal rupture)
            • If patient experiences severe pain or swelling of the penis, severe purple bruising and swelling of the penis, difficulty urinating or blood in the urine, sudden loss of ability to maintain an erection, should contact health care provider

            Cellulite

            • Injection site bruising is common; patients with coagulation disorders or using anticoagulants or antiplatelets (except aspirin <150 mg/day) were excluded from clinical trials
            • Caution if administered to patients with coagulation disorders or coadministered with anticoagulant or antiplatelet agents

            Drug interaction overview

            • Safety and efficacy when coadministered with anticoagulants (other than low-dose aspirin up to 150 mg/day) within 7 days of administration is unknown
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            Pregnancy & Lactation

            Pregnancy

            Data are not available regarding use in pregnant females to evaluate for a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Animal studies

            • IV administration to pregnant rats during organogenesis at doses up to 0.13 mg/rat (43x human equivalent dose [HED] on a mg/kg basis) revealed no evidence of fetal harm

            Lactation

            Data are not available regarding presence in human milk, effects on breastfed children, or on milk production

            Following SC injection, systemic concentrations were below the bioanalytical assay limit of quantification

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Proteinase that hydrolyzes collagen in its native triple-helical conformation, resulting in lysis of collagen deposits

            Injection of into a Dupuytren’s cord, which is comprised mostly of collagen, may result in enzymatic disruption of the cord

            Believed to work for Peyronie’s disease by breaking down the buildup of collagen (a structural protein in connective tissue) that causes the curvature deformity

            Mechanism for treatment of moderate-to-severe cellulite is unknown

            Pharmacokinetics

            Absorption: Not absorbed

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            Administration

            Xiaflex Preparation

            Reconstitution of lyophilized powder

            • Must reconstitute lyophilized powder with provided diluent prior to use
            • Remove lyophilized powder and diluent from refrigerator and allow to stand at room temperature for at least 15 min (not to exceed 60 min)
            • Remove flip off cap from each vial, utilize aseptic technique and swab rubber stoppers of each vial with sterile alcohol
            • Use only the supplied diluent for reconstitution (contains calcium required for activity of collagenase clostridium histolyticum
            • Use 1-mL syringe with 0.01 mL gradations and 27-ga 0.5-in needle to withdraw diluent
            • Inject diluent slowly into side of lyophilized powder vial, then slowly swirl solution to ensure al powder has gone into solution
            • Do not invert vial or shake the solution

            Sterile diluent volume for specific indication

            • Dupuytren contracture
              • MP joints: Reconstitute with 0.39 mL diluent (resulting concentration 0.58 mg/0.25 mL)
              • PIP joints: Reconstitute with 0.31 mL diluent (resulting concentration 0.58 mg/0.2 mL)
            • Peyronie disease
              • Reconstitute with 0.39 mL diluent (resulting concentration 0.58 mg/0.25 mL)

            Qwo Preparation

            Before reconstitution, remove vials from refrigerator and let stand at room temperature for at least 15 minutes

            Inspect vials; lyophilized powder cake should be white in color and intact, showing no signs of erosion; diluent solution should appear colorless and free of particulate matter

            After removal of the flip-off cap from the vial(s), using aseptic technique swab the rubber stopper and surrounding surface of the vial(s) with sterile alcohol (no other antiseptics should be used)

            Use only the supplied diluent for reconstitution

            Using appropriate sized syringe and needle (not supplied), withdraw the amount of supplied diluent based on the number of injection sites

            Inject diluent slowly into the sides of vial containing lyophilized powder

            Do not invert or shake solution; slowly swirl solution to ensure that all of the lyophilized powder has gone into solution

            Sterile diluent volume

            • 1 treatment area: Reconstitute 0.92-mg vial with 4 mL diluent
            • 2 treatment areas: Reconstitute 1.84-mg vial with 8 mL diluent
            • Resulting concentration is 0.23 mg/mL

            Xiaflex Administration

            See prescribing information for specific injection techniques for Dupuytren contracture or Peyronie disease

            Dupuytren contracture: Follow-up visit needed 24-72 hr following injection for finger extension procedure

            Peyronie disease: Follow-up visit needed 24-72 hr following injection for penile modeling procedure

            Qwo SC Administration

            Using 1-mL syringes with removable needles (not supplied), draw up 0.9 mL of the reconstituted solution into each syringe (0.21 mg/0.9 mL)

            Single treatment visit: Four syringes totaling 0.84 mg

            Two treatment visit: Eight syringes totaling 1.68 mg

            Mark injection sites while the patient is standing

            Inject SC while patient is in prone position

            Each injection should be administered as three 0.1-mL aliquots to 3 different positions (see prescribing information image for angle and direction of each injection); for a total injection volume of 0.3 mL

            Injection depth is 0.5 inches (corresponding to the length of the needle) without downward pressure

            Each treatment area may receive up 12 injections

            Patient should remain prone for at least 5 minutes after completion

            Storage

            Xiaflex

            • Before reconstitution: Refrigerate lyophilized powder for injection and diluent at 2-8ºC (36-46ºF); do not freeze
            • Reconstituted solution: May store at room temperature (20-25ºC [68-77ºF]) up to 1 hr, or refrigerate (2-8ºC [36-46ºF) up to 4 h before administration

            Qwo

            • Before reconstitution: Refrigerate lyophilized powder and diluent at 2-8ºC (36-46ºF); do not freeze
            • Reconstituted solution: May store at room temperature (20-25ºC [68-77ºF]) up to 8 hr, or refrigerated (2-8ºC [36-46ºF) up to 72 hr before administration
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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