blinatumomab

High Alert

Relapsed or refractory CD-19 positive, B-cell precursor acute lymphoblastic leukemia (ALL).
CD-19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease ≥0.1%.
CD-19 positive Philadelphia chromosome-negative B-cell precursor ALL in the consolidation phase of multiphase chemotherapy.

Contraindicated in:

Hypersensitivity;
Severe renal impairment;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: ↑risk of potentially fatal “gasping syndrome” in very low-birth-weight neonates born weighing <1500 g and early preterm neonates (born less than 34-wk gestational age); safety and effectiveness not established in children <1 mo;
Geri: ↑risk of neurologic toxicity in older adults.

CV: chest pain, hypotension, peripheral edema, hypertension, tachycardia

Derm: rash

Endo: hyperglycemia

F and E: hypokalemia, hypomagnesemia, hypophosphatemia

GI: abdominal pain, constipation, diarrhea, pancreatitis, vomiting, ↑liver enzymes, hypoalbuminemia

Hemat: anemia, neutropenia, leukocytosis, lymphopenia, thrombocytopenia

Metab: ↓appetite

MS: arthralgia, back pain, bone pain, extremity pain

Neuro: altered consciousness, balance disorder, confusion, coordination disorder, disorientation, dizziness, encephalopathy, fatigue, headache, insomnia, speech disorders, tremor, aphasia, cognitive disorder, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), SEIZURES, weakness

Resp: cough, dyspnea

Misc: chills, cytokine release syndrome (CRS), fever, infection , HYPERSENSITIVITY REACTIONS, infusion reactions, TUMOR LYSIS SYNDROME

Drug-drug:

May suppress activity of CYP450 drug-metabolizing enzymes (especially first 9 days of 1st cycle and first 1 days of 2nd cycle); careful monitoring of CYP450 substrates, including cyclosporine and warfarin, is recommended.
May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines; do not administer live vaccines for ≥2 wk before starting therapy, during therapy, and until immune system recovers after completion of therapy.

Lyophilized powder for injection: 35 mcg/vial (IV solution stabilizer provided with package)

Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Treatment course consists of up to 2 cycles for induction followed by 3 additional cycles for consolidation and up to 4 additional cycles of continued therapy.
IV (Adults and Children ≥1 mo and ≥45 kg): Induction cycle 1: 9 mcg/day as a continuous infusion for days 1–7, followed by 28 mcg/day as a continuous infusion for days 8–28, followed by a 2-wk treatment-free interval. Induction cycle 2: 28 mcg/day as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval. Consolidation cycles 3–5: 28 mcg/day as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval. Continued therapy cycles 6–9: 28 mcg/day as a continuous infusion for days 1–28, followed by an 8-wk treatment-free interval.
IV (Adults and Children ≥1 mo and <45 kg): Induction cycle 1: 5 mcg/m²/day (not to exceed 9 mcg/day) as a continuous infusion for days 1–7, followed by 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 8–28, followed by a 2-wk treatment-free interval. Induction cycle 2: 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval. Consolidation cycles 3–5: 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval. Continued therapy cycles 6–9: 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 1–28, followed by an 8-wk treatment-free interval.

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

Treatment course consists of 1 cycle for induction followed by up to 3 additional cycles for consolidation.
IV (Adults and Children ≥1 mo and ≥45 kg): Induction cycle 1: 28 mcg/day as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval. Consolidation cycles 2–4: 28 mcg/day as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval.
IV (Adults and Children ≥1 mo and <45 kg): Induction cycle 1: 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval. Consolidation cycles 2–4: 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval.

B-Cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase

IV (Adults and Children ≥1 mo and ≥45 kg): 28 mcg/day as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval.
IV (Adults and Children ≥1 mo and <45 kg): 15 mcg/m²/day (not to exceed 28 mcg/day) as a continuous infusion for days 1–28, followed by a 2-wk treatment-free interval.

Acts as a T-cell engager, binding to and activating T-cells binding them to tumor cells resulting in facilitated lysis of malignant cells.

Therapeutic effects:

Depletion of B-cells, including malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: T-cell engagers, monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Catabolized into small peptides and amino acids.

Half-Life: 2.11 hr.

(depletion of B-cells)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unknown	persists during treatment free interval

Explain schedule for blinatumomab administration. Instruct patient to read Medication Guide before starting therapy and before each cycle in case of changes.
Instruct patient in how to keep area around IV catheter clean to reduce infections. Advise patient not to change settings of infusion pump.
May cause seizures and loss of consciousness. Caution patient to avoid driving or other activities requiring alertness until response from medication is known.
Advise patient to notify health care professional immediately if signs and symptoms of CRS (fever, tiredness or weakness, dizziness, headache, low BP, nausea, vomiting, chills, facial swelling, wheezing or difficulty breathing, rash) or neurological problems (seizures, difficulty speaking or slurred speech, loss of consciousness, confusion, disorientation, loss of balance) occur or if side effects occur that are bothersome or persistent.
Caution patient to avoid receiving live vaccines for 2 wk before and during therapy and until immune recovery following last cycle of blinatumomab therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during therapy and for at least 48 hr after last dose and to notify health care professional immediately if pregnancy is planned or suspected. Monitor infant’s B lymphocytes before initiation of live-virus vaccination due to the potential for B-cell lymphopenia in infants following blinatumomab exposure in utero. Monitor neonates receiving blinatumomab (with preservative) for new or worsening metabolic acidosis. The minimum amount of benzyl alcohol at which serious adverse reactions may occur in neonates is not known. The 7-day bag (with preservative) contains 7.4 mg of benzyl alcohol per mL.

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Indications ⬇

Contraind./Precautions ⬆ ⬇

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Interactions ⬆ ⬇

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US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆