Blinatumomab

Therapeutic indications

Blinatumomab is indicated for:

Relapsed or refractory B-cell precursor acute lymphoblastic leukaemia, CD19 positive

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

Blinatumomab is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

For patients weighting ≥45 kg 9 ug/day on Days 1-7 and 28 ug/day on Days 8-28, and for patients weighting <45 kg 5 ug/m²/day on Days 1-7 and 15 ug/m²/day on Days 8-28

B-precursor acute lymphoblastic leukaemia, Philadelphia chromosome negative, CD19 positive

Population group: only children (1 year - 12 years old)

Blinatumomab is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

For patients weighting ≥45 kg 9 ug/day on Days 1-7 and 28 ug/day on Days 8-28, and for patients weighting <45 kg 5 ug/m²/day on Days 1-7 and 15 ug/m²/day on Days 8-28

Minimal residual disease positive B-cell precursor ALL, Philadelphia chromosome-negative, CD19 positive

Population group: only adults (18 years old or older)

BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

28 ug/day for a 28-day treatment cycle followed by a 14-day treatment-free interval

High-risk first relapsed B-cell precursor ALL, Philadelphia chromosome-negative, CD19 positive

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old)

Blinatumomab is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

For patients weighting ≥45 kg 28 ug/day for 28 days and for patients weighting <45 kg 15 ug/m²/day for 28 days

Newly diagnosed B-cell precursor ALL, Philadelphia chromosome-negative, CD19 positive

Population group: only adults (18 years old or older)

Blinatumomab is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

For patients weighting ≥45 kg 28 ug/day and for patients weighting <45 kg 15 ug/m²/day for Days 1-28 followed by a 14 day treatment-free interval

Contraindications

Blinatumomab is contraindicated in the following cases:

Lactation

Lactation

< Previous: Overview

Next: Precautions >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈