This site is intended only for healthcare professionals resident in the Republic of Ireland

Search

Menu

Close

Sign in or RegisterLog out
Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up

Menu

Close

EfficacyEfficacyKey Take AwaysHospitalisation DataSafetySafetyAdverse Event Management: VOD/SOSSelected Adverse ReactionsDosingDosing and Dose ModificationsAdministrationSupport and ResourcesPublications
Method of administration and Dose ModificationsBesponsa is administered through a 1-hour IV infusion that can be provided in an outpatient setting 1,2

BESPONSA is administered three times per 3- to 4-week cycle†, over 1 hour on Days 1, 8, and 15, for 1–6 cycles1

Cycle Numbers
  • For patients proceeding to HSCT:1
    The recommended duration of treatment is 2 cycles
    A third cycle may be considered for patients who do not achieve CR/CRi and MRD negativity after 2 cycles
  • For patients not proceeding to HSCT:1
    ​​​​​​​A maximum of 6 cycles may be administered
  • Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
BESPONSA Dosing RegimenBESPONSA is administered as a 1-hour infusion in 21- or 28-day cycles.1± 2 days (maintain a minimum of 6 days between doses);1The first cycle of BESPONSA is 21 days, and Cycles 2-6 are each 28 days. Cycle 1 may be extended to 28 days for patients achieving CR/CRi or if recovery from toxicity is needed;17-day treatment-free interval starting on Day 21.7-day treatment-free interval starting on day 21.CR=complete remission; CRi=complete remission with incomplete hematologic recovery of peripheral blood counts; EBMT=European Society for Blood and Marrow Transplantation; ESMO=European Society for Medical Oncology; NCCN=National Comprehensive Cancer Network.Dose modifications for haematological toxicities at the start of a treatment cycle (Day 1)1

BESPONSA is administered as a 1-hour infusion in 21- or 28-day cycles

Scroll left to view table
Criteria BESPONSA Dose Modification(s) 
If prior to BESPONSA treatment ANC was greater than or equal to 1 × 109/L If ANC decreases, then interrupt the next cycle of treatment until recovery of ANC to greater than or equal to 1 × 109/L.
If prior to BESPONSA treatment 
platelet count was greater than or equal to 50 × 109/La		 If platelet count decreases, then interrupt the next cycle of treatment until platelet count recovers to greater than or equal to 50 × 109/La.
If prior to BESPONSA treatment ANC was less than 1 × 109/L and/or platelet count was less than 50 x 109/La







 		 If ANC or platelet count decreases, then interrupt the next cycle of treatment until at least one of the following occurs: 
  • ANC and platelet counts recover to at least baseline levels for the prior cycle, or 
  • ANC recovers to greater than or equal to 1 × 109/L and platelet count recovers to greater than or equal to 50 × 109/La, or 
  • Stable or improved disease (based on most recent bone marrow assessment) and the ANC and platelet count decrease is considered to be due to the underlying disease (not considered to be BESPONSA-related toxicity).
BESPONSA Dose Modifications for Hematologic Toxicities1

ANC=absolute neutrophil count.
a Platelet count used for dosing should be independent of blood transfusion.BESPONSA Dose Modifications for Non-haematologic Toxicities at any time during treatment1
Scroll left to view table
Non-haematological toxicity    Dose Modification(s) 
VOD or other severe liver toxicity  Permanently discontinue treatment. 
Total bilirubin greater than 1.5 × ULN and AST/ALT greater than 2.5 × ULN




  		 Interrupt dosing until recovery of total bilirubin to less than or equal to 1.5 × ULN and AST/ALT to less than or equal to 2.5 × ULN prior to each dose unless due to Gilbert’s syndrome or hemolysis. Permanently discontinue treatment if total bilirubin does not recover to less than or equal to 1.5 × ULN or AST/ALT does not recover to less than or equal to 2.5 × ULN. 
Infusion related reaction 





 		 Interrupt the infusion and institute appropriate medical management. Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines. For severe or life-threatening infusion reactions, permanently discontinue treatment.
Non-haematological toxicity greater than or equal to Grade 2a

 		 Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose. 
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=veno-occlusive disease.
 
a Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.BESPONSA Dose Modifications Depending on Duration of Dosing Interruption Due to Toxicity1
Scroll left to view table
Duration of Dose Interruption Due to Toxicity  Dose Modification(s) 
 
Less than 7 days (within a cycle)  Interrupt the next dose (maintain a minimum of 6 days between doses). 
Greater than or equal to 7 days  Omit the next dose within the cycle. 
Greater than or equal to 14 days Once adequate recovery is achieved, decrease the total dose by 25% for the subsequent cycle. If further dose modification is required, then reduce the number of doses to 2 per cycle for subsequent cycles. If a 25% decrease in the total dose followed by a decrease to 2 doses per cycle is not tolerated, then permanently discontinue treatment. 
Greater than 28 days  Consider permanent discontinuation of treatment. 
References:BESPONSA Summary of Product CharacteristicsMarks DI, et al. Cancer Med. 2019;8(13):5959-5968.
ALL=acute lymphoblastic leukemia; CR=complete remission; CRi=complete remission with incomplete hematologic recovery of peripheral blood counts; HSCT=hematopoietic stem cell transplantation; MRD=measurable residual disease; R/R=relapsed/refractory; RWE=real-world evidence; SmPC=Summary of Product Characteristics.
Dosing Besponsa Prescribing Information Visit Loading

Legal Category: S1A
Further information is available upon request

PP-INO-IRL-0113 January 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit https://www.medicines.ie

 

This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002. Directors: D. Mangone (Managing), O. Gavan, D. Kennedy. Company Secretary: M.Byrne.  

 

Copyright © 2024 Pfizer Limited. All rights reserved.
 

PP-UNP-IRL-0784. June 2024
For Healthcare Professionals in the Republic of Ireland *

The information on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland and contains promotional content.

I confirm that I am a healthcare professional* resident in the Republic of Ireland.

If you select 'No', you will be redirected to Pfizer.ie, where you will be able to access information on Pfizer Healthcare Ireland.

*The IPHA Code definition of a healthcare professional is a person of any of the following classes: (i) Registered medical practitioners (ii) Registered dentists (iii) Registered pharmacists (iv) Registered nurses

Terms of use

PP-UNP-IRL-0784. June 2024

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.


PP-UNP-IRL-0784. June 2024