Adverse Event Management: VOD/SOS

Veno-occlusive disease occurred more frequently with BESPONSA® than with standard chemotherapy1,2

In the INO-VATE ALL study, VOD/SOS* was reported in 23 patients (14%) treated with BESPONSA®:1,2

  • In 5 patients (3%) during or after BESPONSA® treatment without subsequent HSCT (occurring up to 56 days after last dose)1
  • There were no cases of VOD among patients in the standard chemotherapy group who did not proceed to HSCT1
  • In 18 patients (23%) who proceeded to subsequent HSCT (occurring 3–57 days after transplantation)1
    • 5 cases were fatal
  • There was 1 (1%) case of VOD after HSCT in the standard chemotherapy group2

In BESPONSA® patients who proceeded to HSCT, the highest risk  of VOD/SOS after transplantation was associated with:1

  • Use of a HSCT conditioning regimen containing two alkylating agents
  • Age ≥ 65 years
  • Serum bilirubin ≥ ULN prior to HSCT 

*Defined as the occurrence of two or more of the following events: hyperbilirubinaemia (> 34 μmol/L [> 2 mg/dL]); ascites or sudden weight gain (> 2.5%); painful hepatomegaly.1 
HSCT, haematopoietic stem cell transplantation; SOS, sinusoidal obstruction syndrome; ULN, upper limit of normal; VOD, veno-occlusive disease.

Other patient factors that appear to be associated with an increased risk of VOD/SOS after HSCT include:1

  • Prior HSCT
  • Age ≥ 55 years
  • History of liver disease and/or hepatitis before treatment
  • Later salvage lines
  • Greater number of treatment cycles

BESPONSA® is contraindicated in:1

  • Hypersensitivity to the active substance or to any of the excipients 
  • Patients who have experienced prior confirmed severe or ongoing VOD/SOS
  • Patients with serious ongoing hepatic liver disease (e.g. cirrhosis, nodular regenerative hyperplasia, or active hepatitis)

More information on VOD is available in the BESPONSA® Therapy Management Guide and from the EBMT published position statement (available online from: https://www.ncbi.nlm.nih.gov/pubmed/25798682)3

EBMT, European Society for Blood and Marrow Transplantation; HSCT, haematopoietic stem cell transplantation; SOS, sinusoidal obstruction syndrome; VOD, veno-occlusive disease.

Veno-occlusive disease recommendations4,5

ALT, alanine aminotransferase; AST, aspartate aminotransferase; EBMT, European Society for Blood and Marrow Transplantation; HSCT, haematopoietic stem cell transplantation; SOS, sinusoidal obstruction syndrome; VOD, veno-occlusive disease.

References:

  1. BESPONSA® SmPC Summary of Marketing Product Characteristics
  2. Kantarjian HM, et al. New Engl J Med. 2016;375:740-53.
  3. Mohty M, et al. Bone Marrow Transplant. 2015;50:781-9.
  4. Mohty M, et al. Bone Marrow Transplant. 2016;51:906-12. 
  5. Defitelio (defibrotide) SmPC 2016.

PP-INO-GBR-0133. May 2020

 

 

 

 

 

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Clinical Information

Prescribing information

BESPONSA® (inotuzumab ozogamicin) 1 mg powder for concentrate for solution for infusion

Legal category: Prescription only medicine. Cost: £8,048 per vial.

Click here to access the BESPONSA Summary of Product Characteristics hosted on Datapharm’s ‘electronic Medicines Compendium’.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Cytarabine 20 mg/mL and 100 mg/mL solution for infusion or injection

Legal category: Prescription only medicine. Basic NHS price: Cytarabine 100 mg/mL, supplied as single vials containing 100 mg/mL cytarabine in 10 mL (1 g), £39.00 or 20 mL (2 g), £77.50. Cytarabine 20 mg/mL supplied as vials containing 20 mg/mL cytarabine in 5 mL (100 mg) in packs of 5, £20.48 or 25 mL (500 mg) as single vials, £19.50. 
Click here to access the cytarabine 20 mg/mL and click here to access the cytarabine 100 mg/mL Summary of Product Characteristics hosted on Datapharm’s ‘electronic Medicines Compendium’.

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