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HomeAboutDosingEfficacyAdult: Relapsed or
Refractory Patients
With Ph- or Ph+ ALLPediatric: Relapsed or
Refractory CD22-
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B-cell Precursor ALLSafetySafetyAdult SafetyPediatric SafetySavings & SupportSavings & SupportEventsMaterialsVideosPersonalized patient supportOrdering BESPONSANCCN Guidelines® Recommendations
Prescribing InformationIndicationPatient Site
Pediatric Safety Data

Safety Overview

Common (≥5%)
ARs

Lab
abnormalities

VOD & post-
HSCT NRM

Tab Number 5

BESPONSA has a BOXED WARNING for VOD and post-HSCT NRM1
  • Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA
  • A higher post-HSCT NRM rate occurred in patients receiving BESPONSA 
  • Additional warnings and precautions include myelosuppression, infusion-related reactions, QT interval prolongation, and embryo-fetal toxicity 
The most common serious adverse reactions (ARs) to BESPONSA in >2% of patients included infection, febrile neutropenia, VOD, hemorrhage, pyrexia, and multiorgan failure1
  • The most common ARs (≥20%), including laboratory abnormalities, were thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache
  • Permanent discontinuation of BESPONSA due to an adverse reaction occurred in 21% of patients. Adverse reactions that resulted in permanent discontinuation of BESPONSA in 2 or more patients included ALT increased and platelet count decreased
  • Dosage interruptions of BESPONSA due to an adverse reaction occurred in 11% of patients. Adverse reactions that required dosage interruption of BESPONSA in 6 patients included increased transaminases, febrile neutropenia, and headache
  • Fatal adverse reactions occurred in 8% of patients who received BESPONSA, including multiorgan failure, lung infection, sepsis, and encephalopathy
ReferencesALT=alanine aminotransferase; HSCT=hematopoietic stem cell transplant; NRM=non-relapse mortality; VOD=veno-occlusive disease.
Common (≥5%) adverse reactions (ARs)1
  • Safety was reported in 53 pediatric patients with a median age of 9 years old, 68% of whom were males
Adverse reactions (≥5%) in pediatric patients (N=53) with CD22-positive relapsed or refractory ALL in Study WI203581 (ITCC-059)1
Scroll left to view table
Body system BESPONSA monotherapy
(n=53)
Adverse reaction All grades, % Grades ≥3, %
General disorders and administration site conditions
Pyrexia 49 4
Edema* 19 0
Fatigue* 17 0
Pain 15 2
Chills 8 0
Blood and lymphatic system disorders
Anemia* 45 38
Febrile neutropenia 28 28
Gastrointestinal disorders
Vomiting 45 2
Nausea 32 0
Abdominal pain* 25 2
Constipation 19 2
Stomatitis* 17 6
Diarrhea 11 0
Infections and infestations
Infection† 43 23
Vascular disorders
Hemorrhage‡ 42 6
Hypotension 6 4
Nervous system disorders
Headache* 21 0
Skin and subcutaneous tissue disorders
Rash* 19 4
Pruritus 9 0
Hyperhidrosis 6 0
Musculoskeletal and connective tissue disorders
Pain in extremity 19 2
Back pain 6 0
Neck pain 6 0
Muscular weakness 6 0
Respiratory, thoracic, and mediastinal disorders
Cough 17 0
Dyspnea 8 2
Hypoxia 8 4
Hepatobiliary disorders
Veno-occlusive disease* 15 13
Hyperbilirubinemia* 9 8
Metabolism and nutrition disorders
Decreased appetite 11 4
Tumor lysis syndrome 11 11
Investigations
Weight increased 8 2
Injury, poisoning, and procedural complications
Infusion-related reaction§ 8 0
Cardiac disorders
Sinus tachycardia 6 2
Psychiatric disorders
Anxiety 6 0
ReferencesARs were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.1Includes other related terms.1Infection includes any reported preferred terms for system organ class infections and infestations resulting in the following preferred terms: Acinetobacter bacteremia, bacteremia, candida infection, cytomegalovirus infection, device-related infection, device-related sepsis, encephalitis, infectious enterocolitis, fungal infection, herpes virus infection, herpes zoster, influenza, kidney infection, mucosal infection, otitis media, paronychia, pneumonia, pneumonia fungal, respiratory tract infection, rhinitis, sepsis, sinusitis, skin infection, stoma site infection, upper respiratory tract infection, urinary tract inflammation, urinary tract infection, vaginal infection.1Hemorrhage includes any reported preferred terms for BESPONSA retrieved in the Standard MedDRA Query (narrow) for hemorrhage terms (excluding laboratory terms): catheter site hemorrhage, diarrhea hemorrhagic, epistaxis, gingival bleeding, hematemesis, hematoma, hematuria, hemoptysis, hemorrhage intracranial, hemorrhoidal hemorrhage, lip hemorrhage, mouth hemorrhage, oral blood blister, petechiae, purpura, thrombotic thrombocytopenic purpura, and upper gastrointestinal hemorrhage.1Infusion-related reaction includes the following preferred terms: infusion-related reaction and hypersensitivity.1ALL=acute lymphoblastic leukemia.References
Laboratory abnormalities1
  • Common (≥20%) grade 3/4 laboratory abnormalities with BESPONSA were platelet count decreased, neutrophil count decreased, white blood cell count decreased, hemoglobin decreased, lymphocyte count decreased, AST increased, ALT increased, and GGT increased
Scroll left to view table
 
Laboratory abnormality* BESPONSA
n All grades, % Grades ≥3/4, %
Hematology
Platelet count decreased 53 100 85
Neutrophil count decreased 53 98 96
White blood cell decreased 53 98 89
Hemoglobin decreased 53 96 42
Lymphocyte count decreased 52 87 73
Chemistry
AST increased 53 87 21
ALT increased 53 83 21
GGT increased 33 79 27
Blood bilirubin increased 53 30 9
ALP increased 58 23 0
Lipase increased 48 23 4
Serum amylase increased 49 14 0
ReferencesLaboratory abnormalities were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyltransferase.
Incidence of VOD in pediatric patients1
  • VOD occurred in 15% (8/53) of pediatric patients treated with single-agent BESPONSA
  • Among the 26 pediatric patients who underwent HSCT, VOD occurred in 19% (n=5) patients
​​​​Monitor closely for signs and symptoms of VOD, including elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. Due to the risk of VOD, for patients proceeding to HSCT, the recommended duration of treatment with BESPONSA is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles.VOD Post HSCT in pediatric patients1
  • For patients who proceed to HSCT, monitor liver tests at least weekly during the first month post-HSCT, then less frequently thereafter, according to standard medical practice
Monitor for toxicities post-HSCT, including signs and symptoms of infection and VOD.CR=complete remission; CRi=complete remission with incomplete hematologic recovery; HSCT=hematopoietic stem cell transplant; MRD=minimal residual disease; VOD=veno-occlusive disease.
ReferenceBESPONSA Prescribing Information. New York, NY: Pfizer Inc.​​​​​​
Safety

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PP-MCL-USA-0367
INDICATIONBESPONSA® (inotuzumab ozogamicin) is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Important Safety Information

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST–HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY (NRM):

  • Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment. The use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD
  • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles
  • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice
  • There was a higher post-HSCT NRM rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate

Hepatotoxicity, Including Hepatic VOD: In adult patients in the INO-VATE ALL trial, hepatotoxicity, including fatal and life-threatening VOD, occurred in 23/164 patients (14%) during or following treatment with BESPONSA or following subsequent HSCT. VOD was reported up to 56 days after the last dose during treatment or follow-up without an intervening HSCT. The median time from HSCT to onset of VOD was 15 days.

VOD occurred in 8/53 (15%) of pediatric patients treated with single agent BESPONSA. Among the 26 pediatric patients who underwent HSCT, VOD occurred in 5 (19%) patients.

Patients with prior VOD or serious ongoing liver disease are at an increased risk of worsening liver disease, including development of VOD, following treatment with BESPONSA. Monitor closely for signs and symptoms of VOD; these may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. For patients proceeding to HSCT, the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for patients who do not achieve a CR or CRi and MRD-negativity after 2 cycles. Monitor liver tests closely during the first month post HSCT, then less frequently thereafter, according to standard medical practice.

Grade 3/4 increases in aspartate aminotransferase, alanine aminotransferase, and total bilirubin occurred in 7/160 (4%), 7/161 (4%), and 8/161 (5%) adult patients, respectively. In a study of pediatric patients, liver test abnormalities occurred, with Grade 3/4 increases in AST, ALT, and blood bilirubin in 11/53 (21%), 11/53 (21%), and 5/53 (9%) of pediatric patients, respectively.

Increased Risk of Post-HSCT Non-Relapse Mortality (NRM): In adult patients in the INO-VATE ALL trial, there was a higher post-HSCT NRM rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate. The rate of post-HSCT NRM was 31/79 (39%) with BESPONSA and 8/35 (23%) with investigator’s choice of chemotherapy. In the BESPONSA arm, the most common causes of post-HSCT NRM included VOD and infections. In a study of pediatric patients, 26/53 patients (49%) had a follow-up HSCT. The post-HSCT NRM rate was 7/26 (27%). Monitor closely for toxicities post HSCT, including signs and symptoms of infection and VOD.

Myelosuppression: Myelosuppression, and severe, life-threatening, and fatal complications of myelosuppression, including hemorrhagic events and infections, have occurred with BESPONSA. In adult patients in the INO-VATE ALL trial, thrombocytopenia and neutropenia were reported in 83/164 patients (51%) and 81/164 patients (49%), respectively. Febrile neutropenia was reported in 43/164 adult patients (26%).

In a study of pediatric patients, Grade 3 or 4 thrombocytopenia occurred in 24/53 (45%) patients and grade 3 or 4 neutropenia in 21/53 (40%) patients. Infections occurred in 23/53 (43%) patients, and hemorrhage occurred in 22/53 (42%) patients. The most common types of hemorrhage were hematoma in 8/53 (15%), mouth hemorrhage in 6/53 (11%), and epistaxis in 6/53 (11%) patients.

Monitor complete blood counts prior to each dose of BESPONSA and monitor for signs and symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment, and provide appropriate management. As appropriate, administer prophylactic anti-infectives during and after treatment with BESPONSA. Dose interruption, dose reduction, or permanent discontinuation may be required.

Infusion-Related Reactions: Infusion-related reactions (all Grade 2) were reported in 4/164 adult patients (2%). In pediatric patients, infusion-related reactions occurred in 4/53 (8%) patients. Premedicate with a corticosteroid, an antipyretic, and an antihistamine prior to dosing. Monitor patients closely during and for at least 1 hour after the end of the infusion for the potential onset of infusion-related reactions, including symptoms such as fever, chills, rash, or breathing problems. Interrupt the infusion and institute appropriate medical management if an infusion-related reaction occurs. Depending on the severity, consider discontinuation of the infusion or administration of steroids and antihistamines. For severe or life-threatening infusion reactions, permanently discontinue BESPONSA.

QT Interval Prolongation: Increases in QT interval corrected for heart rate using Fridericia’s formula (QTcF) of ≥60 msec from baseline occurred in 4/162 adult patients (3%). In a study of pediatric patients, increases in QTcF of >60 msec from baseline occurred in 7/49 (14%) patients, and 3/52 (6%) of patients had QTcF values >500 msec. Administer BESPONSA with caution in patients who have a history of or predisposition to QTc prolongation, who are taking medicinal products that are known to prolong QT interval, and in patients who have electrolyte disturbances. Obtain electrocardiograms and electrolytes prior to treatment and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

Embryo-Fetal Toxicity: BESPONSA can cause embryo-fetal harm. Apprise pregnant women of the potential risk to the fetus. Advise males and females of reproductive potential to use effective contraception during BESPONSA treatment and for at least 5 and 8 months after the last dose, respectively. Advise women to contact their healthcare provider if they become pregnant or if pregnancy is suspected during treatment with BESPONSA.

Adverse Reactions: The most common (≥20%) adverse reactions in adult and pediatric patients, including laboratory abnormalities, are thrombocytopenia, pyrexia, neutropenia, infection, anemia, vomiting, leukopenia, hemorrhage, fatigue, nausea, febrile neutropenia, headache, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.

Nursing Mothers: Advise women against breastfeeding while receiving BESPONSA and for 2 months after the last dose.


Please see full Prescribing Information, including BOXED WARNING.

INDICATION BESPONSA® (inotuzumab ozogamicin) is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year of age and older.