• 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%.

Contraindicated in:

• Hypersensitivity
• Severe renal impairment (CCr <30 mL/min)
• 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)
• 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, SEIZURES, weakness.

Resp: cough, dyspnea.

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

Drug-Drug:

• May suppress activity of CYP450 drug-metabolizing enzymes (especially first 9 days of first cycle and first two days of second cycle), careful monitoring of drugs that are substrates of CYP450, 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.
• 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.

• 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 ≥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 <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 ≥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 <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.

Blincyto

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

• Depletion of B-cells, including malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: T-cell engagers

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)

• 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 cytokine release syndrome (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 wks before and during, 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 and for at least 48 hrs after last dose and to notify health care professional immediately if pregnancy is planned or suspected. Monitor the infant’s B lymphocytes before initiation of live virus vaccination due to the potential for B-cell lymphocytopenia 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.

bli-ni-TOO-moe-mab

NDC Code^*

• 55513- Amgen Inc
  • 55513-160- BLINCYTO
    • 55513-160-01- 1 KIT in 1 PACKAGE (55513-160-01) * 10.6 mL in 1 VIAL (55513-155-01) * 3.088 mL in 1 VIAL (55513-150-01)