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 Description

BLINCYTO (blinatumomab) is a CD19-directed bispecific CD3 T cell adaptor that can bind to CD19 (expressed on cells of B lineage origin) and CD3 (expressed on T cells). BLINCYTO is produced in Chinese hamster ovary cells. It is composed of 504 amino acids and has a molecular weight of approximately 54 kilodaltons.

Each package of BLINCYTO contains 1 vial of BLINCYTO and 1 vial of IV solution stabilizer.

BLINCYTO is provided in a single-dose vial as a sterile, preservative-free white to off-white lyophilized powder for intravenous administration. Each BLINCYTO single-dose vial contains 35 mcg of blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg) and hydrogen Sodium oxide adjusts the pH to 7.0. After reconstitution with 3 mL of preservative-free sterile water for injection (USP), the resulting concentration is 12.5 mcg/mL blinatumomab.

The IV solution stabilizer is provided in a single-dose vial as a sterile, preservative-free, colorless to pale yellow clear solution. Each IV solution stabilizer single-dose vial contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide adjusted to pH 7.0 and injection Use water.

Indications and dosage

Indications

MRD positive B cell precursor ALL

BLINCYTO is suitable for the first or second complete remission of B-cell precursor acute lymphoblastic leukemia (ALL) in adults or children with minimum residual disease (MRD) greater than or equal to 0.1%.

This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval of this indication may depend on the verification and description of clinical benefits in confirmatory trials.

Relapsed or refractory B cell precursor ALL

BLINCYTO is suitable for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

Dosage and administration

Treatment of MRD-positive B cell precursor ALL

Dose adjustment for adverse reactions

If the interruption time after the adverse reaction does not exceed 7 days, the same cycle should be continued until a total of 28 days of infusion, including the number of days before and after the interruption of the cycle. If the interruption time due to adverse reactions exceeds 7 days, please start a new cycle.

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It is very important to strictly follow the preparation (including mixing) and dosing instructions provided in this section to minimize medication errors (including overdose and overdose) [see Warnings and Precautions].

BLINCYTO can be injected in 24 hours (without preservatives), 48 hours (without preservatives) or 7 days (with preservatives). For the duration of the infusion, the choice between these options should be considered by the attending healthcare provider, depending on the frequency of infusion bag replacement and the weight of the patient. It is not recommended for patients weighing less than 22 kg to take BLINCYTO as a 7-day infusion.

To prepare, rebuild and manage BLINCYTO:

For 24-hour or 48-hour infusion, please refer to the preparation and administration section of BLINCYTO for 24 hour or 48 hour infusion.

For information on the use of bacteriostatic 0.9% sodium chloride injection USP (with 0.9% benzyl alcohol) for 7-day infusion, please refer to BLINCYTO for 7-day infusion using bacteriostatic 0.9% sodium chloride injection USP (preservative) Preparation and administration part. This option is suitable for patients weighing 22 kg or more. It is not recommended for patients weighing less than 22 kg.

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