Genetic Implications:
Pronunciation:
bli-ni-too-moe-mab
Trade Name(s)
Ther. Class.
Pharm. Class.
T-cell engagers
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 Effect(s):
Depletion of B-cells, including malignant ones.
Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Metabolism and Excretion: Catabolized into small peptides and amino acids.
Half-life: 2.11 hr.
TIME/ACTION PROFILE (depletion of B-cells)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
IV | rapid | unknown | persists during treatment free interval |
Contraindicated in:
Use Cautiously in:
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
Metabolic: ↓ 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
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Drug-Drug
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.
Lyophilized powder for injection: 35 mcg/vial (IV solution stabilizer provided with package)
Monitor for signs and symptoms of cytokine release syndrome (CRS) (pyrexia, fever, headache, nausea, asthenia, hypotension, ↑ AST, ↑ ALT, ↑ bilirubin, disseminated intravascular coagulation [DIC]) during and following infusion. Median time to onset was 2 days after start of infusion and to resolution was 5 days. May be similar to infusion reactions. If symptoms are Grade 3, hold blinatumomab until resolved and administer dexamethasone 8 mg for patients ≥45 kg or 5 mg/m2 for patients <45 kg, every 8 hrs IV or PO for up to 3 days, then taper over 4 days. Restart at 9 mcg/day for patients ≥45 kg and 5 mcg/m2 /day for patients <45 kg. Escalate to 28 mcg/day for patients ≥45 kg and 15 mcg/m2 /day in patients <45 kg, after 7 days if toxicity does not recur. If Grade 4 symptoms occur, discontinue blinatumomab permanently and administer dexamethasone as for Grade 3 CRS.
Monitor for signs and symptoms of neurological toxicity (encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion, disorientation, loss of balance and coordination) during therapy. Discontinue blinatumomab permanently if more than 1 seizure occurs. If Grade 3 symptoms occur, hold blinatumomab until no more than Grade 1 (mild) and for at least 3 days, then restart blinatumomab at 9 mcg/day for patients ≥45 kg and 5 mcg/m2 /day for patients <45 kg. Escalate dose to 28 mcg/day for patients ≥45 kg and 15 mcg/m2 /day in patients <45 kg after 7 days if toxicity does not recur. If toxicity occurred at 9 mcg/day for patients ≥45 kg and 5 mcg/m2 /day for patients <45 kg or takes >7 days to resolve, discontinue blinatumomab permanently. If Grade 4 symptoms occur, discontinue blinatumomab permanently.
Assess for signs and symptoms of infection (fever, chills, sepsis, pneumonia, bacteremia, opportunistic infections, catheter site infections) during therapy. Treat with anti-infectives as needed.
Monitor for signs and symptoms of tumor lysis syndrome (abdominal pain and distension, dysuria, oliguria, flank pain, hematuria, anorexia, vomiting, cramps, seizures, spasms, altered consciousness) during therapy. May use prophylactic nontoxic cytoreduction and on-treatment hydration. May require temporary interruption or discontinuation.
Monitor for signs and symptoms of pancreatitis (severe and persistent stomach pain, with or without nausea and vomiting) during therapy.
Lab Test Considerations:
Monitor CBC periodically during therapy. May cause neutropenia. Interrupt therapy if neutropenia is prolonged.
Patient must be hospitalized for first 9 days of first cycle and first 2 days of second cycle. For other cycles, supervision by health care professional is recommended.
Do not flush line, especially when changing bags or at completion of infusion; may result in excess or overdose. To prime IV tubing, use only the solution in the bag containing the FINAL prepared blinatumomab solution. Do not prime with 0.9% NaCl. Aseptically add 270 mL of 0.9% NaCl to polyolefin, DEHP-free PVC, or ethyl vinyl acetate (EVA) infusion bags/pump cassettes. Use polyolefin, DEHP-free PVC, or EVA intravenous tubing sets.
Infuse via programmable, lockable, non-elastomeric infusion pump with an alarm. Infuse 240 mL over 24 or 48 hr based on pharmacy label, at a rate of 10 mL/hr for 24 hr or 5 mL/hr for 48 hr. Use tubing that is sterile, non-pyrogenic, low protein-binding, with a 0.2 micron in-line filter. Ensure tubing is compatible with infusion pump. If using a multilumen catheter, infuse blinatumomab through a dedicated lumen.
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.
Depletion of B-cells, including malignant ones.