Blincyto

[Common name] Blinatumomab

[Drug name] Blincyto

[English name] Blincyto

[Target] CD19 CD3

[Main ingredient]

A BLINCYTO The 35 mg single-use vial contains a sterile, preservative-free, white to off-white lyophilized powder and an IV solution stabilizer. The 10 mL single-use glass vial contains a sterile, preservative-free, colorless to slightly yellow, clear solution.

[Drug Properties]

For injection: 35mcg lyophilized powder for reconstitution in a single-use vial.

[Usage and Dosage]

1. A single course of treatment consists of 4 weeks of continuous intravenous infusion followed by 2 weeks of free interval treatment.

2. For patients weighing at least 45 kg, in Cycle 1, administer BLINCYTO at 9mcg/day on days 1–7 and 28mcg/day on days 8–28. For subsequent courses of treatment, administer BLINCYTO at 28 mcg/day on Days 1–28.

[Indications]

BLINCYTO is a CD19-specific CD3 T-cell adapter indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

[Adverse Reactions]

The most common adverse reactions (≥ 20%) are fever, headache, peripheral edema, febrile neutropenia, nausea, hypokalemia, tremor, rash, and constipation.

[Precautions]

(1) Infection: Monitor the patient’s signs or symptoms and treat appropriately.

(2) Effects on the ability to drive and use machinery: Advise patients to avoid driving and engaging in hazardous occupations or activities such as operating heavy or potentially hazardous machinery while taking BLINCYTO.

[Contraindications]

Known hypersensitivity to blinatumomab or to any component of the product dosage form.

[Pharmacology and Toxicology]

Blinatumomab is a bispecific CD19 CD3 T-cell adapter that binds to CD19 expressed on the surface of B-lineage derived cells and CD3 expressed on the surface of T cells. Endogenous T cells are activated by ligation of CD3 on the T-cell receptor (TCR) complex with CD19 on benign and malignant B cells. Blinatumomab mediates the formation of synapses between T cells and tumor cells, the upregulation of cell adhesion molecules, the production of cytolytic proteins, the release of inflammatory cytokines, and the proliferation of T cells, leading to the redirection of CD19+ cells to lysis.

[Drug for pregnant women and breastfeeding]

It is not known whether blinatumomab is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from blinatumomab, the decision whether to discontinue breastfeeding or discontinue the drug should be made, taking into account the importance of the drug to the mother.

【Overdose】

Overdoses have been observed, including one case in a patient who received the recommended therapeutic dose of BLINCYTO delivered over a short period of time. Adverse reactions resulting from overdose are consistent with recommended therapeutic doses and include pyrexia, tremor, and headache. In the event of overdose, interrupt the infusion, monitor the patient for signs of toxicity, and provide supportive care [see Warnings and Precautions. Consider starting BLINCYTO at the correct dose and no earlier than 12 hours after interruption of infusion when all toxicities have resolved.

【Storage】

Store BLINCYTO and IV Solution Stabilizer vials in the original packaging in the refrigerator at 2°C to 8°C (36°F to 46°F) and protect from light until use. Do not freeze. Store and transport IV bags prepared for infusion of solutions containing BLINCYTO at 2°C to 8°C (36°F to 46°F). Shipping packaging has been certified to maintain contents at 2°C to 8°C (36°F to 46°F). Do not freeze.