Insomnia
    
    
15
    
0
 
Respiratory, thoracic, and mediastinal disorders

     Cough
     Dyspnea§
      ​
   
19
15
    
0
5
 
Skin and subcutaneous tissue disorders

     Rash¶
    
21
   
2
 
Vascular disorders

     Hypotension
     Hypertension
    
  
11
8
   

2
5
 

Additional important adverse reactions that did not meet the threshold criteria for inclusion in Table 2 were:

Blood and lymphatic system disorders: leukocytosis (2%), lymphopenia (1%)

Cardiac disorders: tachycardia (8%)

General disorders and administration site conditions: edema (5%)

Immune system disorders: cytokine storm (1%)

Investigations: decreased immunoglobulins (9%), increased blood bilirubin (8%), increased gamma-glutamyl-transferase (6%), increased liver enzymes (1%)

Metabolism and nutrition disorders: tumor lysis syndrome (4%), hypoalbuminemia (4%)

Nervous system disorders: encephalopathy (5%), paresthesia (5%), aphasia (4%), convulsion (2%), memory impairment (2%), cognitive disorder (1%), speech disorder (< 1%)

Psychiatric disorders: confusion (7%), disorientation (3%)

Vascular disorders: capillary leak syndrome (< 1%).

Hypersensitivity reactions related to BLINCYTO treatment were hypersensitivity (1%) and bronchospasm (< 1%).

6.2     Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The immunogenicity of BLINCYTO has been eva luated using either an electrochemiluminescence detection technology (ECL) or an enzyme-linked immunosorbent assay (ELISA) screening immunoassay for the detection of binding anti-blinatumomab antibodies. For patients whose sera tested positive in the screening immunoassay, an in vitro biological assay was performed to detect neutralizing antibodies.  

In clinical studies, less than 1% of patients treated with BLINCYTO tested positive for binding anti-blinatumomab antibodies. All patients who tested positive for binding antibodies also tested positive for neutralizing anti-blinatumomab antibodies.

Anti-blinatumomab antibody formation may affect pharmacokinetics of BLINCYTO. No association was seen between antibody development and development of adverse events. 

If formation of anti-blinatumomab antibodies with a clinically significant effect is suspected, contact Amgen at 1-800-77-AMGEN (1-800-772-6436) to discuss antibody testing.

The detection of anti-blinatumomab antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease