blinatumomab (Rx)

Brand and Other Names:Blincyto
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 35mcg/vial
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Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

See also Dosage Modifications and Administration

Indicated for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Induction and consolidation: Allow for 2 week treatment-free interval between cycles (total 42 days)

Continued therapy: Allow for an 8-week treatment-free interval between cycles (total 84 days)

A treatment course consists of up to 2 cycles for induction followed by 3 additional cycles for consolidation treatment and up to 4 additional cycles of continued therapy

≥45 kg (fixed dose)

  • Induction
    • Cycle 1: 9 mcg/day continuous IV infusion on Days 1-7, THEN 28 mcg/day on Days 8-28 of a 42-day cycle
    • Cycle 2: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle
  • Consolidation
    • Cycle 3-5: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle
  • Continued therapy
    • Cycle 6-9: 28 mcg/day continuous IV infusion on Days 1-28 of an 84-day cycle

<45 kg (BSA-based dose)

  • Induction
    • Cycle 1: 5 mcg/m²/day continuous IV infusion (not to exceed 9 mcg/day) on Days 1-7, THEN 15 mcg/m²/day (not to exceed 28 mcg/day) on Days 8-28 of a 42-day cycle 
    • Cycle 2: 15 mcg/m²/day continuous IV infusion (not to exceed 28 mcg/day) on Days 1-28 of a 42-day cycle
  • Consolidation
    • Cycle 3-5: 15 mcg/m²/day continuous IV infusion (not to exceed 28 mcg/day) on Days 1-28 of a 42-day cycle 
  • Continued therapy
    • Cycle 6-9: 15 mcg/m²/day continuous IV infusion (not to exceed 28 mcg/day) on Days 1-28 of an 84-day cycle 

Premedication

  • Dexamethasone 20 mg IV 1 hr prior to the first dose of each cycle, prior to a step dose (eg, Cycle 1 day 8), or when restarting an infusion after an interruption of ≥4 hr

Minimal Residual Disease-positive B-cell Precursor Acute Lymphoblastic Leukemia

See also Dosage Modifications and Administration

Indicated for B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) ≥0.1%

A treatment course consists of 1 cycle for induction followed by up to 3 additional cycles for consolidation

Induction and consolidation: Allow for 2 week treatment-free interval between cycles (total 42 days)

≥45 kg (fixed dose)

  • Induction
    • Cycle 1: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle
  • Consolidation
    • Cycle 2-4: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle

<45 kg (BSA-based dose)

  • Induction
    • Cycle 1: 15 mcg/m²/day continuous IV infusion on Days 1-28 of a 42-day cycle; not to exceed 28 mcg/day 
  • Consolidation
    • Cycle 2-4: 15 mcg/m²/day continuous IV infusion on Days 1-28 of a 42-day cycle; not to exceed 28 mcg/day 

Premedication

  • Premedicate with prednisone 100 mg IV or equivalent (eg, dexamethasone 16 mg) 1 hr before first dose in each cycle and when restarting an infusion after an interruption of ≥4 hr

Dosage Modifications

If the interruption after an adverse event is ≤7 days, continue the same cycle to a total of 28 days of infusion, inclusive of days before and after the interruption in that cycle

If an interruption due to an adverse event is >7 days, start a new cycle

Cytokine release syndrome (CRS)

  • Grade 3: Withhold until resolved, then restart at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg); escalate to 28 mcg/day (≥45 kg) or 15 mcg/m²/day (<45 kg) after 7 days if the toxicity does not recur
  • Grade 4: Discontinue permanently

Neurological toxicity

  • Seizure: Discontinue permanently if >1 seizure occurs
  • Grade 3: Withhold until ≤Grade 1 (mild) for at least 3 days, then restart at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg); escalate to 28 mcg/day (≥45 kg) or 15 mcg/m²/day (<45 kg) after 7 days if the toxicity does not recur; if the toxicity occurred at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg), or if the toxicity takes >7 days to resolve, discontinue permanently
  • Grade 4: Discontinue permanently

Other clinically relevant adverse reactions

  • Grade 3: Withhold until ≤Grade 1 (mild), then restart at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg); escalate to 28 mcg/day (≥45 kg) or 15 mcg/m²/day (<45 kg) after 7 days if the toxicity does not recur; if the toxicity takes >14 days to resolve, discontinue permanently
  • Grade 4: Consider discontinuing permanently

Renal impairment

  • Baseline CrCl ≥30 mL/min: No dose reduction required
  • CrCl <30 mL/min or on hemodialysis: No information available

Hepatic impairment

  • No formal pharmacokinetic studies conducted

Dosing Considerations

Hospitalization

  • Relapsed or refractory B-cell precursor ALL
    • Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle
    • For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for ≥4 hr), supervision by a healthcare professional or hospitalization is recommended
  • MRD-positive B-cell precursor ALL
    • Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle
    • For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for ≥4 hr), supervision by a healthcare professional or hospitalization is recommended

Accelerated approval

  • MRD-positive B cell precursor ALL approved under accelerated approval based on MRD response rate and hematological relapse-free survival
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials

Diffuse Large B-cell Lymphoma (Orphan)

Orphan designation for treatment of diffuse large B-cell lymphoma (DLBCL)

Sponsor

  • Amgen Inc; 1 Amgen Center Drive; Thousand Oaks, California 91320

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 35mcg/vial
more...

Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Indicated for Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Induction and consolidation: Allow for 2 week treatment-free interval between cycles (total 42 days)

Continued therapy: Allow for 8 week treatment-free interval between cycles (total 84 days)

A treatment course consists of up to 2 cycles for induction followed by 3 additional cycles for consolidation treatment and up to 4 additional cycles of continued therapy

≥45 kg

  • Induction
    • Cycle 1: 9 mcg/day continuous IV infusion on Days 1-7, THEN 28 mcg/day on Days 8-28 of a 42-day cycle
    • Cycle 2: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle
  • Consolidation
    • Cycle 3-5: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle
  • Continued therapy
    • Cycle 6-9: 28 mcg/day continuous IV infusion on Days 1-28 of an 84-day cycle

<45 kg (BSA-based dose)

  • Induction
    • Cycle 1: 5 mcg/m²/day (not to exceed 9 mcg/day) continuous IV infusion on Days 1-7, THEN 15 mcg/m²/day (not to exceed 28 mcg/day) on Days 8-28 of a 42-day cycle 
    • Cycle 2: 15 mcg/m²/day (not to exceed 28 mcg/day) on Days 1-28 of a 42-day cycle
  • Consolidation
    • Cycle 3-5: 15 mcg/m²/day (not to exceed 28 mcg/day) on Days 1-28 of a 42-day cycle 
  • Continued therapy
    • Cycle 6-9: 15 mcg/m²/day (not to exceed 28 mcg/day) on Days 1-28 of an 84-day cycle 

Premedication

  • Dexamethasone 5 mg/m² (maximum 20 mg) IV 1 hr prior to the first dose of each cycle, prior to a step dose (eg, Cycle 1 day 8), or when restarting an infusion after an interruption of ≥4 hr in the first cycle

Minimal Residual Disease-positive B-cell Precursor Acute Lymphoblastic Leukemia

See also Dosage Modifications and Administration

Indicated for B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) ≥0.1%

A treatment course consists of 1 cycle for induction followed by up to 3 additional cycles for consolidation

Induction and consolidation: Allow for 2 week treatment-free interval between cycles (total 42 days)

≥45 kg (fixed dose)

  • Induction
    • Cycle 1: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle
  • Consolidation
    • Cycle 2-4: 28 mcg/day continuous IV infusion on Days 1-28 of a 42-day cycle

<45 kg (BSA-based dose)

  • Induction
    • Cycle 1: 15 mcg/m²/day continuous IV infusion on Days 1-28 of a 42-day cycle; not to exceed 28 mcg/day
  • Consolidation
    • Cycle 2-4: 15 mcg/m²/day continuous IV infusion on Days 1-28 of a 42-day cycle; not to exceed 28 mcg/day

Premedication

  • Premedicate with prednisone 100 mg IV or equivalent (eg, dexamethasone 16 mg) 1 hr before first dose in each cycle and when restarting an infusion after an interruption of ≥4 hr

Dosage Modifications

If the interruption after an adverse event is ≤7 days, continue the same cycle to a total of 28 days of infusion, inclusive of days before and after the interruption in that cycle

If an interruption due to an adverse event is >7 days, start a new cycle

Cytokine release syndrome (CRS)

  • Grade 3: Withhold until resolved, then restart at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg); escalate to 28 mcg/day (≥45 kg) or 15 mcg/m²/day (<45 kg) after 7 days if the toxicity does not recur
  • Grade 4: Discontinue permanently

Neurological toxicity

  • Seizure: Discontinue permanently if >1 seizure occurs
  • Grade 3: Withhold until ≤Grade 1 (mild) for at least 3 days, then restart at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg); escalate to 28 mcg/day (≥45 kg) or 15 mcg/m²/day (<45 kg) after 7 days if the toxicity does not recur; if the toxicity occurred at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg), or if the toxicity takes >7 days to resolve, discontinue permanently
  • Grade 4: Discontinue permanently

Other clinically relevant adverse reactions

  • Grade 3: Withhold until ≤Grade 1 (mild), then restart at 9 mcg/day (≥45 kg) or 5 mcg/m²/day (<45 kg); escalate to 28 mcg/day (≥45 kg) or 15 mcg/m²/day (<45 kg) after 7 days if the toxicity does not recur; if the toxicity takes >14 days to resolve, discontinue permanently
  • Grade 4: Consider discontinuing permanently

Renal impairment

  • Baseline CrCl ≥30 mL/min: No dose reduction required
  • CrCl <30 mL/min or on hemodialysis: No information available

Hepatic impairment

  • No formal pharmacokinetic studies conducted

Dosing Considerations

Hospitalization

  • Relapsed or refractory B-cell precursor ALL
    • Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle
    • For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for ≥4 hr), supervision by a healthcare professional or hospitalization is recommended
  • MRD-positive B-cell precursor ALL
    • Hospitalization is recommended for the first 3 days of the first cycle and the first 2 days of the second cycle
    • For all subsequent cycle starts and reinitiation (eg, if treatment is interrupted for ≥4 hr), supervision by a healthcare professional or hospitalization is recommended

Accelerated approval

  • MRD-positive B cell precursor ALL approved under accelerated approval based on MRD response rate and hematological relapse-free survival
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials
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Interactions

Interaction Checker

and blinatumomab

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      Serious - Use Alternative

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            Adverse Effects

            >10%

            Pyrexia (55-91%)

            Infusion related reaction (30-77%)

            Other pathogen infections (28-39%)

            Headache (23-36%)

            Tremor (31%)

            Neutropenia (16-31%)

            Chills (15-28%)

            Febrile neutropenia (25%)

            Nausea (25%)

            Peripheral edema (25%)

            Hypokalemia (23%)

            Thrombocytopenia (10-21%)

            Tremor (20%)

            Constipation (20%)

            Diarrhea (20%)

            Bacterial infections (19%)

            Cough (13-19%)

            Insomnia (15-18%)

            Decreased immunoglobulins (18%)

            Fatigue (17%)

            Rash (12-16%)

            Dyspnea (15%)

            Abdominal pain (15%)

            Neutropenia, Grade 3 or more (15%)

            Hypertransaminasemia (9-15%)

            Dizziness (10-14%)

            Back pain (12-14%)

            Leukopenia (9-14%)

            Hypotension (14%)

            Bacterial infectious disorders (14%)

            Cytokine release syndrome (14%)

            Arrhythmia (12-14%)

            Vomiting (13%)

            Viral infections (11-13%)

            Pain in extremity (12%)

            Hypomagnesemia (12%)

            Increased ALT (12%)

            Aphasia (12%)

            Increased AST (11%)

            Bone pain (11%)

            Hyperglycemia (11%)

            Increased weight (11%)

            Chest pain (11%)

            Cytokine release syndrome (11%)

            Hypotension (11%)

            1-10%

            Fungal infections (10%)

            Arthralgias (10%)

            Decreased appetite (10%)

            Increased weight (10%)

            Encephalopathy (10%)

            Leukopenia, Grade 3 or more (9%)

            Pneumonia (9%)

            Hypertension (8%)

            Sepsis (7%)

            Hypophosphatemia (6%)

            Infusion-related reaction, Grade 3 or more (3-5%)

            Decreased immunoglobulins, Grade 3 or more (5%)

            Headache, Grade 3 or more (4%)

            Tremor, Grade 3 or more (4%)

            Encephalopathy, Grade 3 or more (4%)

            Arrhythmia, Grade 3 or more (2%)

            Rash, Grade 3 or more (1%)

            Postmarketing Reports

            Stomach pain

            Fatal pancreatitis

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            Warnings

            Black Box Warnings

            Cytokine release syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving blinatumomab; interrupt or discontinue depending on severity (see Dosage Modifications)

            Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients receiving blinatumomab; interrupt or discontinue depending on severity (see Dosage Modifications)

            Contraindications

            Hypersensitivity to blinatumomab or any components of product formulation

            Cautions

            Cytokine release syndrome (CRS), which may be life-threatening or fatal, has been observed and may be clinically indistinguishable from infusion reactions; serious adverse events that may be associated with CRS included pyrexia, headache, nausea, asthenia, hypotension, increased ALT, increased AST, and increased total bilirubin; monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), and total blood bilirubin prior to start of and during treatment (see Black Box Warnings)

            Neurological toxicities have occurred in ~65% of patients; median time to first event was within the first 2 weeks of treatment and majority of events resolved; ≥Grade 3 (severe, life-threatening, or fatal) neurological toxicities occurred in ~13% of patients and included encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders

            Serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections were observed in approximately 25% of patients, some of which were life-threatening or fatal

            Tumor lysis syndrome may be life-threatening or fatal; appropriate prophylactic measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used for prevention: may require either temporary interruption or discontinuation

            Neutropenia and febrile neutropenia, including life-threatening cases, observed; monitor WBC and absolute neutrophil counts during infusion; interrupt if prolonged neutropenia occurs

            Owing to the potential for neurologic events, including seizures, patients are at risk for loss of consciousness; advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery during treatment

            Transient elevation of liver enzymes reported; interrupt if the transaminases rise to >5 xULN or if bilirubin rises to >3 xULN

            Leukoencephalopathy observed confirmed by cranial MRI, especially in patients with prior treatment with cranial irradiation and antileukemic chemotherapy (high dose methotrexate, IT cytarabine); clinical significance of this is unknown

            Preparation and administration errors have occurred; follow instructions for preparation (including admixing) and administration strictly to minimize medication errors

            Potential for immunogenicity (as with all therapeutic proteins)

            Safety of immunization with live viral vaccines during or following therapy not studied; vaccination with live virus vaccines not recommended for at least 2 weeks prior to start of treatment, during treatment, and until immune recovery following last cycle of blinatumomab

            Fatal pancreatitis reported in combination with dexamethasone in clinical trials and post-marketing setting; evaluate patients who develop signs and symptoms of pancreatitis; management of pancreatitis may require either temporary interruption or discontinuation of blinatumomab and dexamethasone

            Benzyl alcohol preservative may cause serious adverse reactions (eg, gasping syndrome) in pediatrics; gasping syndrome is CNS depression, metabolic acidosis, and gasping respirations; consider total benzyl alcohol metabolic load contains 7.4 mg of benzyl alcohol; minimum benzyl alcohol amount which adverse reactions occur is unknown

            Possible drug interactions

            • No formal drug interaction studies have been conducted Initiation of blinatumomab treatment causes transient release of cytokines that may suppress CYP450 enzymes
            • The highest drug-drug interaction risk is during the first 9 days of the first cycle and the first 2 days of the second cycle in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index
            • In these patients, monitor for toxicity (eg, warfarin) or drug concentrations (eg, cyclosporine)
            • Adjust the dose of the concomitant drug as needed
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            Pregnancy & Lactation

            Pregnancy

            Based on mechanism of action, therapy may cause fetal harm when administered to pregnant woman; verify pregnancy status of females of reproductive potential prior to initiating treatment

            Due to potential for B-cell lymphocytopenia in infants following exposure to blinatumomab in-utero, monitor infant’s B lymphocytes before the initiation of live virus vaccination

            Advise females of reproductive potential to use effective contraception during treatment and for at least 48 hr after the last dose of blinatumomab

            Lactation

            There is no information regarding presence of blinatumomab in human milk, effects on breastfed infant, or effects on milk production; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from therapy, including B-cell lymphocytopenia, advise patients not to breastfeed during and for at least 48 hr after ending therapy

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Bispecific CD19-directed CD3 T-cell engager that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells

            Activates endogenous T-cells by connecting CD3 in the T-cell receptor (TCR) complex with CD19 on benign and malignant B cells

            Blinatumomab mediates the formation of a synapse between the T-cell and the tumor cell, up-regulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells, which result in redirected lysis of CD19+ cells

            Absorption

            Steady-state achieved within a day of continuous IV infusion

            Peak plasma concentration at steady-state: 228 pg/mL (9 mcg/day); 616 pg/mL (28 mcg/day)

            Distribution

            Vd: 4.35 L

            Metabolism

            Metabolic pathway has not been characterized

            Like other protein therapeutics, it is expected to be degraded into small peptides and amino acids via catabolic pathways

            Elimination

            Half-life: 2.1 hr

            Clearance: 3.11 L/hr

            Excretion: Negligible amounts in urine (all doses)

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            Administration

            IV Incompatibility

            Any products containing with di-ethylhexylphthalate (DEHP)

            IV Preparation

            Reconstituting vial

            • Using a 5-mL syringe, reconstitute 1 vial using 3 mL of preservative-free sterile water for injection
            • Do not reconstitute vial with IV solution stabilizer
            • Direct sterile water for injection toward the side of the vial during reconstitution
            • Gently swirl contents to avoid excess foaming
            • Reconstituted solution should be clear to slightly opalescent; do not use if solution is cloudy or has precipitated
            • Do not shake

            IV admixture

            • For 24 hr or 48 hr infusion (preservative free)
              • Specific admixing instructions are provided for each dose and infusion time
              • Aseptically add 270 mL of 0.9% NaCl to an empty bag; transfer 5.5 mL IV solution stabilizer to saline solution; see prescribing information for specific instructions for preparation
            • For 7 day infusion (preservative containing)
              • Specific admixing instructions are provided for each dose and infusion time
              • Aseptically add 90 mL of bacteriostatic 0.9% NaCl to an empty bag; transfer 2.2 mL IV solution stabilizer to saline solution
              • Aseptically transfer reconstituted blinatumomab and 0.9% NaCl to diluted solution; final volume should be 110 mL; see prescribing information for specific instructions for preparation

            IV Administration

            Prime the IV line only with the prepared solution for infusion

            Do not prime with 0.9% NaCl

            Administer as a continuous IV infusion at a constant flow rate using an infusion pump; the pump should be programmable, lockable, non-elastomeric, and have an alarm

            Premedication

            • Adults (MRD-positive B-cell percussor ALL): Prednisone 100 mg IV or equivalent (eg, dexamethasone 16 mg) 1 hr prior to the first dose in each cycle and when restarting an infusion after an interruption of ≥4 hr
            • Adults (relapsed/refractory B-cell precursor ALL): Dexamethasone 20 mg IV1 hr prior to the first dose of each cycle, prior to a step dose (eg, Cycle 1 Day 8), and when restarting an infusion after an interruption of ≥4 hr
            • Pediatric patients: Dexamethasone 5 mg/m² (not to exceed 20 mg/dose) IV prior to the first dose in the first cycle and when restarting an infusion after an interruption of ≥4 hr in the first cycle

            For 24 hr or 48 hr infusion

            • Infusion bags should be infused over 24 hr or 48 hr (see preparation)
            • Infuse the total 240 mL solution according to the instructions on the pharmacy label on the bag at one of the following constant infusion rates:
            • Infusion rate of 10 mL/hr for a duration of 24 hr, OR
            • Infusion rate of 5 mL/hr for a duration of 48 hr

            For 7 day infusion

            • Not recommended for patients weighing ≤22kg
            • Infusion rate of 0.6 mL/hr for a duration of 7 days

            All infusions must be administered using IV tubing that contains a sterile, nonpyrogenic, low protein-binding, 0.2 micron in-line filter

            Infuse through a dedicated lumen

            At the end of the infusion, any unused solution in the IV bag and IV lines should be disposed of in accordance with local requirements

            Do NOT flush line

            • Do not flush the infusion line, especially when changing infusion bags
            • Flushing when changing bags or at completion of infusion can result in excess dosage

            Storage

            Protect from light

            Unopened vial

            • Store drug and IV solution stabilizer vials in the original package refrigerated at 2-8°C (36-46°F) and protect from light until time of use
            • Do not freeze

            Reconstituted vial

            • Room temperature 23- 27°C (73-81°F): 4 hr
            • Refrigerated 2-8°C (36-46°F): 24 hr

            Prepared IV bag (preservative-free)

            • Room temperature 23-27°C (73-81°F):48 hr (includes infusion time)
            • Refrigerated 2-8°C (36-46°F): 8 days

            Prepared IV bag (with preservative)

            • Room temperature 23-27°C (73-81°F):7 days (includes infusion time)
            • Refrigerated 2-8°C (36-46°F): 14 days
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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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.