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

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (14)

                • antithrombin alfa

                  antithrombin alfa increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • antithrombin III

                  antithrombin III increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • argatroban

                  argatroban increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • aspirin

                  aspirin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • bivalirudin

                  bivalirudin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • dabigatran

                  dabigatran increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • dalteparin

                  dalteparin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • desirudin

                  desirudin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • enoxaparin

                  enoxaparin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • fondaparinux

                  fondaparinux increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • heparin

                  heparin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • protein C concentrate

                  protein C concentrate increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • rivaroxaban

                  rivaroxaban increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                • warfarin

                  warfarin increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

                Minor (0)

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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

                  Back pain

                  Localized skin and soft tissue necrosis, occurring as sequelae of penile hematoma

                  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

                  Post-injection back pain

                  • Acute post-injection back pain reactions reported in postmarketing period in patients treated for Peyronie’s disease; these events typically have an onset immediately or within minutes of injection
                  • The acute lower back pain can be mild to severe in intensity and can radiate to the legs, arms and chest; other systemic symptoms, such as chest pain, headache, and dyspnea, reported along with back pain episodes
                  • None of the events were reported to occur after the patient’s first injection and a few were reported to occur during a second treatment course
                  • Reported events typically resolved within 15 minutes, but some lasted up to 30 minutes, and one event lasted 1.5 hours; reported events typically did not require intervention, but some required observation and treatment with analgesics

                  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%)
                  • Postmarketing cases of skin laceration requiring skin graft after finger extension procedures and local skin and soft-tissue necrosis, some requiring skin grafting or, other surgical interventions including finger amputation reported; signs or symptoms that may reflect serious injury to injected finger/hand should be promptly evaluated because surgical intervention may be required

                  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
                  • In the postmarketing setting, cases of localized skin and soft tissue necrosis occurring as sequelae of penile hematoma reported; some cases required surgical intervention

                  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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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Santyl topical
                  -
                  250 unit/gram ointment
                  Santyl topical
                  -
                  250 unit/gram ointment

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

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                  Patient Education
                  collagenase clostridium histolyticum topical

                  COLLAGENASE OINTMENT - TOPICAL

                  (coal-ADGE-ih-naze)

                  COMMON BRAND NAME(S): Santyl

                  USES: This product is used to help the healing of burns and skin ulcers. Collagenase is an enzyme. It works by helping to break up and remove dead skin and tissue. This effect may also help antibiotics to work better and speed up your body's natural healing process.

                  HOW TO USE: This medication is for use on the skin only. It is usually applied once daily or as directed by your doctor. If the dressing becomes soiled, collagenase may be applied more frequently.To apply, wash hands first. Clean the area as directed by your doctor. Cleaning solutions such as hydrogen peroxide, normal saline, or Dakin's solution may be used. If your doctor has directed you to use an antibiotic powder, apply it first before applying this medication. Use a wooden spatula or a gauze pad to carefully apply the collagenase ointment directly to the affected area. Bandage securely. If you are unclear about how to clean the affected area or apply this medication, consult your doctor.Avoid applying near the eyes. Be careful to apply the ointment only within the affected area. Wash hands thoroughly after applying the ointment.

                  SIDE EFFECTS: Pain or a burning feeling at the affected area may occur. Temporary redness/irritation may also occur in the skin around the affected area. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To avoid redness/irritation in the surrounding skin, be careful to apply the ointment only within the affected area.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Treatment of burns and skin ulcers by breaking up and removing dead skin and tissue may rarely increase the risk for serious infection (sepsis). Tell your doctor right away if you notice any symptoms of serious infection, including: fever/chills, fast breathing (hyperventilation), fast heartbeat, warm skin, weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Before using collagenase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Avoid using solutions that contain acid or metal as soaking liquids because these will decrease the effect of collagenase ointment (see also Drug Interactions section).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antiseptic skin products (especially those containing heavy metals such as lead, mercury, silver).Skin products containing heavy metals may decrease the effect of collagenase. If the affected area has been exposed to one of these products, wash the area well with normal saline solution before applying this ointment.

                  OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: Do not share this medication with others.

                  MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

                  STORAGE: Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                  Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  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
                  PA Prior Authorization
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                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.