idecabtagene vicleucel (Rx)

Brand and Other Names:Abecma
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Single-dose units contain specific amounts of T cells depending on the patient’s body weight that are suspended in a patient-specific infusion bag

See the certificate of analysis (CoA) for actual cell count following individual preparation

injection, suspension

300-460 x 106 CAR-positive viable T cells in 1 or more infusion bags

infusion bags

50mL

250mL

500mL

Multiple Myeloma

Indicated for relapsed or refractory multiple myeloma after ≥4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

Confirm availability of idecabtagene vicleucel before starting lymphodepleting chemotherapy

One treatment course consists of fludarabine- and cyclophosphamide-lymphodepleting chemotherapy followed by IV infusion of idecabtagene vicleucel

Lymphodepleting chemotherapy

  • Fludarabine 30 mg/m2 IV qDay for 3 days
  • Cyclophosphamide 300 mg/m2 IV qDay for 3 days starting with the first dose of fludarabine

Idecabtagene vicleucel IV infusion

  • Administer 2 days after completing lymphodepleting chemotherapy
  • Premedicate with acetaminophen and diphenhydramine (see Administration)
  • Dose based on the number of chimeric antigen receptor (CAR)–positive viable T cells
  • Recommended dose range: 300-460 x 106 CAR-positive viable T cells
  • Administer autologously prepared, IV infusion for individual patient within 30 minutes by either gravity or peristaltic pump

Dosage Modifications

Cytokine release syndrome (CRS) management

  • Grade ≥2 CRS (eg, hypotension not responsive to fluids, or hypoxia requiring supplemental oxygenation): Monitor with continuous cardiac telemetry and pulse oximetry
  • For severe or life-threatening CRS, consider intensive care unit level monitoring and supportive therapy
  • Refractory CRS is characterized by fevers, end-organ toxicity (eg, hypoxia, hypotension) not improving within 12 hr of first-line interventions or development of hemophagocytic lymphohistiocytosis/macrophage activation syndrome
  • Grade 1
    • Symptoms: Fever, nausea, fatigue, headache, myalgia, malaise
    • Onset ≥72 hr after infusion: Treat symptomatically
    • Onset <72 hr after infusion: Consider tocilizumab 8 mg/kg IV over 1 hr; not to exceed 800 mg
    • Consider dexamethasone 10 mg IV q24hr
  • Grade 2
    • Symptoms require moderate intervention; oxygen requirement <40% FiO2 or hypotension responsive to fluids or low dose of one vasopressor or Grade 2 organ toxicity
    • Administer tocilizumab 8 mg/kg IV infused over 1 hr; not to exceed 800 mg
    • Repeat tocilizumab q8hr as needed if not responsive to IV fluids or increasing supplemental oxygen; not to exceed 3 doses/24 hr or 4 doses in total
    • Consider dexamethasone 10 mg IV q12-24hr
    • If no improvement within 24 hr or rapid progression, repeat tocilizumab and escalate dose and frequency of dexamethasone 20 mg IV q6-12 hr
    • If no improvement within 24 hr or continued rapid progression, switch to methylprednisolone 2 mg/kg followed by 2 mg/kg divided QID
    • After 2 doses of tocilizumab, consider alternative anticytokine agents; do not exceed 3 doses of tocilizumab in 24 hr or 4 doses in total
  • Grade 3
    • Symptoms require aggressive intervention; oxygen requirement ≥40% FiO2 or hypotension requiring high-dose or multiple vasopressors or Grade 3 organ toxicity or Grade 4 transaminitis
    • Tocilizumab administration per Grade 2; if improving, discontinue
    • Administer dexamethasone 10 mg IV q12hr
    • If no improvement within 24 hr, follow Grade 2 recommendations
  • Grade 4
    • Life-threatening symptoms; requires ventilator support, continuous venovenous hemodialysis, or Grade 4 organ toxicity (excluding transaminitis)
    • Tocilizumab administration per Grade 2; if improving, discontinue
    • Administer dexamethasone 20 mg IV q6hr
    • After 2 doses of tocilizumab, consider alternative anticytokine agents; do not exceed 3 doses of tocilizumab in 24 hr or 4 doses in total
    • If no improvement within 24 hr, consider methylprednisolone (1-2 g, repeat q24hr if needed; taper as clinically indicated) or other anti–T-cell therapies

Neurologic toxicity grading and management

  • Grades 1-4: Start nonsedating, antiseizure medicines (eg, levetiracetam) for seizure prophylaxis
  • Grade 1
    • ≥72 hr after infusion: Observe
    • <72 hr after infusion: Consider dexamethasone 10 mg IV q12-24hr for 2-3 days
  • Grade 2
    • Start dexamethasone 10 mg IV q12hr for 2-3 days, or longer for persistent symptoms
    • Consider taper for a total corticosteroid exposure >3 days; not recommended for isolated Grade 2 headaches
    • If no improvement after 24 hr or worsening of neurologic toxicity, increase dose and/or frequency of dexamethasone; not to exceed 20 mg IV q6hr
  • Grade 3 or 4
    • Grade 3: Start dexamethasone 10-20 mg IV q6-12 hr
    • Grade 4: Start dexamethasone 20 mg IV q6hr
    • Corticosteroids are not recommended for isolated Grade 3 headaches
    • If no improvement after 24 hr or worsening of neurologic toxicity, escalate to methylprednisolone (2 mg/kg loading dose, followed by 2 mg/kg divided into QID; taper within 7 days)
    • If cerebral edema is suspected, consider hyperventilation and hyperosmolar therapy
    • Give high-dose methylprednisolone (1-2 g, repeat q24hr if needed; taper as clinically indicated) and cyclophosphamide 1.5 g/m2
  • Renal or hepatic impairment

    • Not studied

Dosing Considerations

Administer at a certified healthcare facility

Monitor for signs/symptoms of CRS and neurologic toxicities at least daily for 7 days following infusion

Instruct patients to remain within proximity of the certified healthcare facility at least 4 weeks following infusion

Verify pregnancy status in females of reproductive potential

Delay idecabtagene vicleucel infusion up to 7 days for the following conditions

  • Unresolved serious adverse events (especially pulmonary events, cardiac events, or hypotension), including those after preceding chemotherapies
  • Active infections or inflammatory disorders

Safety and efficacy not established

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Interactions

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                    Adverse Effects

                    >10%

                    Any grade

                    • Cytokine release syndrome (85%)
                    • Infections, unspecified pathogen (51%)
                    • Fatigue (45%)
                    • Musculoskeletal pain (45%)
                    • Hypogammaglobulinemia (41%)
                    • Diarrhea (35%)
                    • Upper respiratory tract infection (34%)
                    • Nausea (29%)
                    • Viral infections (27%)
                    • Encephalopathy (26%)
                    • Pyrexia (25%)
                    • Edema (25%)
                    • Headache (23%)
                    • Cough (23%)
                    • Decreased appetite (22%)
                    • Tachycardia (19%)
                    • Dizziness (17%)
                    • Peripheral neuropathy (17%)
                    • Hypotension (17%)
                    • Pneumonia (17%)
                    • Constipation (16%)
                    • Febrile neutropenia (16%)
                    • Bacterial infections (15%)
                    • Vomiting (15%)
                    • Rash (14%)
                    • Weight decreased (13%)
                    • Insomnia (13%)
                    • Dyspnea (13%)
                    • Anxiety (12%)
                    • Oral pain (12%)
                    • General physical health deterioration (11%)
                    • Chills (11%)
                    • Motor dysfunction (11%)
                    • Xerosis (11%)
                    • Hypertension (11%)

                    Grade ≥3

                    • Neutropenia (96%)
                    • Leukopenia (96%)
                    • Lymphopenia (92%)
                    • Thrombocytopenia (63%)
                    • Anemia (63%)
                    • Hypophosphatemia (45%)
                    • Febrile neutropenia (16%)
                    • Infections, unspecified pathogen (15%)

                    1-10%

                    Any grade

                    • Tremor (10%)
                    • Renal failure (10%)
                    • Coagulopathy (9%)
                    • Sepsis (9%)
                    • Fungal infections (8%)
                    • Aphasia (7%)
                    • Delirium (6%)
                    • Atrial fibrillation (4.7%)
                    • Gastrointestinal hemorrhage (3.1%)
                    • Hemophagocytic lymphohistiocytosis (3.1%)
                    • Thrombosis (3.1%)
                    • Ataxia (3.1%)
                    • Paresis (2.4%)
                    • Hypoxia (2.4%)
                    • Pulmonary edema (2.4%)
                    • Cardiomyopathy (1.6%)
                    • Seizure (1.6%)

                    Grade ≥3

                    • General physical health deterioration (10%)
                    • Hyponatremia (10%)
                    • Activated partial thromboplastin time increased (10%)
                    • ALT increased (<10%)
                    • AST increased (<10%)
                    • Hypoalbuminemia (<10%)
                    • Alkaline phosphatase increased (<10%)
                    • Hyperglycemia (<10%)
                    • Hypokalemia (<10%)
                    • Bilirubin increased (<10%)
                    • Hypofibrinogenemia (<10%)
                    • Hypocalcemia (<10%)
                    • Cytokines release syndrome (9%)
                    • Viral infections (9%)
                    • Pneumonia (9%)
                    • Encephalopathy (6%)
                    • Bacterial infections (3.9%)
                    • Musculoskeletal pain (3.1%)
                    • Fatigue (3.1%)
                    • Hypertension (3.1%)
                    • Renal failure (2.4%)
                    • Dyspnea (2.4%)
                    • Pyrexia (1.6%)
                    • Diarrhea (1.6%)
                    • Weight decreased (1.6%)
                    • Upper respiratory tract infection (1.6%)

                    <1%

                    Grade ≥3

                    • Hypogammaglobulinemia (0.8%)
                    • Decreased appetite (0.8%)
                    • Dizziness (0.8%)
                    • Peripheral neuropathy (0.8%)
                    • Anxiety (0.8%)
                    • Rash (0.8%)
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                    Warnings

                    Black Box Warnings

                    Cytokine release syndrome

                    • Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment
                    • Do not administer to patients with active infection or inflammatory disorders
                    • Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids

                    Neurological toxicities

                    • Neurologic toxicities, including severe or life-threatening reactions, reported; these may occur concurrently with CRS, after CRS resolution, or in absence of CRS; monitor and provide supportive care and/or corticosteroids as needed
                    • Most common neurological toxicities were encephalopathy, headache, tremor, aphasia, and delirium
                    • Monitor for neurological events for at least 7 days at the certified healthcare facility following infusion for signs and symptoms of neurologic toxicities

                    Hemophagocytic lymphohistiocytosis/macrophage activation syndrome

                    • Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment
                    • HLH/MAS can occur with CRS or neurologic toxicities

                    Prolonged cytopenia

                    • Prolonged cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment

                    Restricted access program

                    • Available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Abecma REMS program
                    • Further information is available at www.AbecmaREMS.com [insert link] or contact Bristol-Myers Squibb at 1-888-423-5436
                    • REMS requirements
                      • Healthcare facilities that dispense and administer idecabtagene vicleucel must be enrolled and comply with the REMS requirements
                      • Certified healthcare facilities must have onsite immediate access to tocilizumab
                      • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for administration within 2 hr after idecabtagene vicleucel IV infusion, if needed for treatment of CRS
                      • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer idecabtagene vicleucel are trained about the management of CRS and neurological toxicities

                    Contraindications

                    None

                    Cautions

                    Neurological toxicities, which may be severe or life-threatening, can occur following treatment; monitor for signs and symptoms of neurologic toxicity at least daily for 7 days following after idecabtagene vicleucel infusion at REMS-certified healthcare facility; continue monitoring for at least 4 weeks further; rule out other causes of neurologic symptoms; treat promptly and manage with supportive care and/or corticosteroids as needed

                    Hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) reported: it is a potentially life-threatening condition with a high mortality rate if left undetected and untreated; in clinical trials, the median onset was 7 days (range: 4-9 days) and occurred in the setting of ongoing or worsening CRS; manifestations of HLH/MAS include: hypotension, hypoxia, multiple organ dysfunction, renal dysfunction, and cytopenia; treat HLH/MAS per institutional standards

                    Available only through a restricted access program owing to CRS and neurologic toxicities

                    Allergic reactions may occur during infusion; serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide in the product

                    Prolonged cytopenias may occur following lymphodepleting chemotherapy and idecabtagene vicleucel infusion; monitor blood cell counts before and after idecabtagene vicleucel infusion; manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines

                    Hypogammaglobulinemia and plasma cell aplasia can occur; monitor immunoglobulin levels after treatment and administer IV immunoglobulin for IgG<400 mg/dL; manage per local institutional guidelines

                    Secondary malignancies or recurrence of leukemia may occur; monitor life-long for secondary malignancies; if secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555

                    Owing to potential neurological events (eg, altered mental status, seizures), patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following treatment; advise patients to refrain from driving or engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period

                    Cytokine release syndrome

                    • CRS, including fatal or life-threatening reactions, occurred following treatment
                    • Median time to CRS onset was 1 day (range: 1-23 days)
                    • Most common manifestations of CRS included pyrexia, hypotension, tachycardia, chills, hypoxia, fatigue, and headache
                    • Grade ≥3 events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, acute respiratory distress syndrome, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS
                    • Identify CRS based on clinical presentation; evaluate for and treat other causes of fever, hypoxia, and hypotension
                    • CRS has been associated with findings of HLH/MAS, and physiology of syndromes may overlap
                    • In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS
                    • Treat severe or life-threatening CRS with tocilizumab
                    • At first sign of CRS, institute treatment with supportive care, tocilizumab, and/or corticosteroids as indicated
                    • Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time

                    Infections

                    • Serious infections, including life-threatening or fatal infections, reported
                    • Do not administer to patients with active infections or inflammatory disorders
                    • Monitor for signs and symptoms of infection before and after idecabtagene vicleucel infusion
                    • Administer prophylactic, empiric, and/or therapeutic antimicrobials according to standard institutional guidelines
                    • Febrile neutropenia observed after idecabtagene vicleucel infusion and may be concurrent with CRS; if febrile neutropenia occurs, manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated
                    • Viral reactivation
                      • Cytomegalovirus (CMV) infection resulting in pneumonia and death occurred; monitor and treat for CMV reactivation in accordance with clinical guidelines
                      • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells
                      • Perform screening for CMV, HBV, hepatitis C virus, and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing
                      • Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice

                    Drug interaction overview

                    • Immunization with live viral vaccines
                      • Safety of immunization with live viral vaccines during or following treatment has not been studied
                      • Vaccination with live-virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel treatment, and until immune recovery afterwards
                    • HIV nucleic acid tests
                      • HIV and the lentivirus used to make idecabtagene vicleucel have limited, short spans of identical genetic material (RNA)
                      • Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients receiving idecabtagene vicleucel
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                    Pregnancy & Lactation

                    Pregnancy

                    Data are not available in pregnant women

                    No animal reproductive and developmental toxicity studies have been conducted

                    Unknown if idecabtagene vicleucel may potentially transfer to fetus; based on the mechanism of action, if transduced cells cross placenta, fetal toxicity, including B-cell lymphocytopenia, may occur; not recommended for females who are pregnant, and consult with treating physician on pregnancy after infusion

                    Treated patients may have hypogammaglobulinemia; assess immunoglobulin levels in newborns of treated mothers

                    Verify pregnancy status of females with reproductive potential before initiating treatment

                    There are no data on effects on fertility

                    Contraception

                    • See prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy
                    • Insufficient exposure data are available to provide recommendations on duration of contraception following treatment

                    Lactation

                    There is no information regarding presence in human milk, effects on the breastfed infants, and effects on milk production

                    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

                    B-cell maturation antigen (BCMA)–directed genetically modified autologous T-cell immunotherapy consisting of a patient’s own T cells that are harvested and genetically modified ex vivo through transduction with an anti-BCMA02 CAR lentiviral vector

                    CAR-positive T-cell therapy targeting BCMA, which is expressed on the surface of normal and malignant plasma cells

                    Antigen-specific activation of idecabtagene vicleucel results in CAR-positive T-cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells

                    Absorption

                    Peak plasma concentration: 256,333 copies/mcg

                    Peak plasma time: 11 days

                    AUC: 3,088,455 copies⋅days/mcg

                    Median peak plasma levels in responders were ~4.6-fold higher than corresponding levels in nonresponders

                    Median AUC in responding patients was ~5.6-fold higher than nonresponders

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                    Administration

                    IV Preparation

                    Confirm availability of idecabtagene vicleucel before starting lymphodepleting chemotherapy regimen

                    Confirm infusion time in advance, and adjust start time for thaw so that idecabtagene vicleucel is available for infusion when recipient is ready

                    Before thawing, confirm tocilizumab and emergency equipment are available before infusion and during recovery period

                    Verify number of bags received for indicated dose before preparation of idecabtagene vicleucel

                    Confirm patient identity: Match patient's identity with patient identifiers on idecabtagene vicleucel cassette(s) and infusion bag(s); and eRlease for Infusion Certificate

                    Note: Patient identifier number may be preceded by letters DIN or Aph ID

                    Once patient identity is confirmed, remove infusion bag(s) from cassette(s) and check patient information on the cassette label(s) matches with bag label(s); do not remove from cassette(s) if patients-specific cassette label(s) do not match; contact Bristol-Myers Squibb at 1-888-805- 4555 if there are any discrepancies between labels and patient identifiers

                    Inspect infusion bag for any breaks or cracks before thawing; if bag is compromised, do not infuse the contents; contact Bristol-Myers Squibb at 1-888-805- 4555

                    If >1 infusion bag is needed, thaw each infusion bag one at a time; do not thaw the next bag until previous infusion bag is complete; place infusion bag(s) inside a second sterile bag per local guidelines

                    Thaw infusion bag at 37°C using either a water bath or dry thaw method until there is no visible ice in infusion bag; gently mix contents of bag to disperse clumps of cellular material

                    If visible cell clumps remain, continue to gently mix contents of bag; disperse small clumps of cellular material with gentle manual mixing; do not wash, spin down, and/or resuspend idecabtagene vicleucel in new media before infusion

                    Administer within 1 hr of the start of thaw; stable for 2 hr at room temperature once thawed

                    Premedication

                    Administer ~30-60 minutes before idecabtagene vicleucel infusion

                    • Acetaminophen 650 mg PO
                    • Diphenhydramine 12.5 mg IV or 25-50 mg PO, or another H1-antihistamine
                    • Always avoid prophylactic use of systemic corticosteroids (may interfere with idecabtagene vicleucel activity), except in the case of a life-threatening emergency

                    IV Administration

                    • For autologous use only
                    • Ensure a minimum of 2 doses of tocilizumab and emergency equipment are available before infusion and during recovery period
                    • May use central venous access for infusion and is recommended in patients with poor peripheral access
                    • Do not use a leukocyte-depleting filter; prime tubing of infusion set with 0.9% NaCl before infusion
                    • Administer entire contents of infusion bag within 1 hr after start of thaw by gravity flow
                    • Once infused, rinse tubing with 30-60 mL of 0.9% NaCl at same infusion rate to ensure all product is delivered
                    • If >1 infusion bag is needed, administer all bags as directed, following steps above for all subsequent infusion bags; do not initiate thaw of next bag until infusion of the previous bag is complete
                    • Follow local biosafety guidelines applicable for handling and disposal of such products

                    Storage

                    Refer to prescribing information for details on shipment

                    Frozen cassettes and infusion bags

                    • Store frozen in vapor phase of liquid nitrogen ≤-266°F (≤-130°C) in a temperature-monitored system
                    • Use closed, break-proof, leak-proof containers when transporting infusion bags within the facility

                    Thawed infusion bag

                    • Stored at room temperature 68-77°F (20-25°C) for up to 1 hr
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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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.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
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                    ST Step Therapy
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