Blincyto

About Blinatumomab

• Blinatumomab, granted accelerated approval by the US Food and Drug Administration in December 2014, is marketed as Blincyto. 
• Blinatumomab belongs to the class of constructed monoclonal antibodies known as bi-specific T-cell engagers (BiTEs). 
• Utilized as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia (ALL), Blincyto is a bispecific CD19-directed CD3 T-cell engager indicated for adults and children.
•  Its applications include the treatment of B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on accelerated approval contingent upon MRD response rate and hematological relapse-free survival. Furthermore, it is employed for relapsed or refractory B-cell precursor ALL. 
• The therapeutic action of Blinatumomab is selectively directed at tumor cells by specifically targeting the CD19 antigen on B cells, demonstrating its innovative approach in cancer treatment. The marketing authorization hinged on outcomes from ongoing clinical trials at the time of its accelerated approval.

Strength

35 mcg of lyophilized powder in a single-dose vial for Reconstitution.

Recommended Dosage

• The course of blinatumomab consists of 2 cycles for induction followed by 3 or 4 more cycles for continued therapy for consolidation.
• One cycle of induction or consolidation includes 28 days of continuous intravenous infusion, then a 14-day treatment-free interval, taking 42 days.
• One cycle of continued therapy includes 28 days of continuous intravenous infusion followed by a 56-day treatment-free interval of 84 days. Hospitalizing the patient for the first 9 days of the first cycle and the first 2 days of the second cycle is recommended.
• Premedicate with the patient with dexametha.

Warnings and Precautions

• Monitor the patient for signs and symptoms and treat them appropriately.
• Cytokine Release Syndrome (CRS) can be a life-threatening or fatal issue that occurs in patients receiving blinatumomab.
• Interrupt or discontinue blinatumomab as recommended when the symptoms are seen.

• Neurological toxicities, which may be severe, life-threatening, or fatal, occurred in patients medicating on blinatumomab.
• Interrupt or discontinue blinatumomab as recommended.

• Ability to Drive and Use Machines can be affected: Advise patients to avoid driving and engaging in hazardous activities, including operating heavy or potentially dangerous machinery while medicating with blinatumomab.
• Pancreatitis: Evaluation of patients who develop signs and symptoms of pancreatitis should be done. Management of pancreatitis may require temporary interruption or stopping of blinatumomab.
• Errors in preparation and administration: Follow instructions strictly for preparation and administration. (including admixing) There is a risk of serious Adverse Reactions in Pediatric Patients due to blinatumomab.
• Alcohol Preservative: Use blinatumomab prepared with preservative-free saline for patients weighing less than 22 kg.

Common blinatumomab side-effects

• Bacterial and pathogen infections.
• Pyrexia
• Headache
• Infusion-related reactions
• Anemia,
• Febrile neutropenia
• Thrombocytopenia
• Neutropenia

Use in specific population 

• Before commencing Blincyto treatment, it is imperative to assess the pregnancy status of females of reproductive potential. Due to the potential for fetal harm, including B-cell lymphocytopenia, when administered to pregnant women, caution is advised. 
• Due to unknown effects on breastfeeding and potential adverse reactions, including B-cell lymphocytopenia, patients are strongly advised not to breastfeed during and at least 48 hours after Blincyto treatment.
• Additionally, females of reproductive potential should employ effective contraception throughout the course of treatment and for at least 48 hours following the last dose of Blincyto. This precautionary measure aims to mitigate potential risks associated with Blincyto and ensure the well-being of both mothers and infants.

Storage and handling

Store between 36°F to 46°F

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