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BESPONSA is the first and only FDA-approved CD22-directed antibody-drug conjugate
indicated for the treatment of adults with relapsed or refractory B-cell precursor ALL.1,2

Access & Support

Access & support

At Pfizer Oncology Together, we’re committed to helping your patients get the Pfizer Oncology medication you’ve prescribed. Our support services also go beyond financial assistance and treatment information, focusing on individual patient needs.

Support that's personalized for your patients

For live, personalized support, call 1-877-744-5675 (Monday-Friday 8 AM to 8 PM ET) or

Visit PfizerOncologyTogether.com to learn more

Access & reimbursement support

Pfizer Oncology Together is here to offer access and reimbursement support. We can assist with:

  • Benefits verification
  • Prior authorization
  • Appeals
  • Billing and coding for IV products
  • Ordering BESPONSA

Patient financial assistance

Pfizer Oncology Together can help patients identify financial support resources—regardless of their insurance coverage. Some options include co-pay assistance, help with finding coverage, support from independent charitable foundations,a and medication for free or at a savings.b

aThese foundations exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations.

bFor eligible patients through the Pfizer Patient Assistance Program, which is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.

Product & patient support

Pfizer Oncology Together supports your patients throughout their treatment with BESPONSA. Our certified oncology nursing staff is available to:

  • Answer your questions regarding BESPONSA
  • Support patients through setting-of-care transitions
  • Connect patients to social and logistical support servicesc

cSome services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.

Speak with an experienced, certified Oncology Nurse

1-877-744-5675

Monday-Friday, 8 AM to 8 PM ET

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Dosing & Administration

Dosing & administration

BESPONSA should be administered by 1-hour IV infusion on Days 1, 8, and 15 of each 3- to 4-week cycle

Before starting BESPONSA1

Premedicate before each dose

  • Premedication with a corticosteroid, antipyretic, and antihistamine is recommended prior to each dose

Cytoreduction

  • For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count of ≤10,000/mm3 is recommended prior to the first dose of Cycle 1
Download the Dosing and Administration Brochure for more information
Starting BESPONSA1

The first cycle of BESPONSA is 21 days in length, while Cycles 2-6 are each 28 days in length. Cycle 1 may be extended to 28 days for patients achieving CR/CRi or if recovery from toxicity is needed.

dosing table 1dosing table 2
dosing table 1dosing table 2

CR=complete remission; CRi=complete remission with incomplete hematologic recovery.

a+/- 2 days (maintain minimum of 6 days between doses).

bDose is based on the patient’s body surface area (m2).

cFor patients who achieve a CR/CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (ie, 7-day treatment-free interval starting on Day 21).

dCR is defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100 × 109/L and absolute neutrophil counts [ANC] ≥1 × 109/L) and resolution of any extramedullary disease.

eCRi is defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100 × 109/L and/or ANC <1 × 109/L) and resolution of any extramedullary disease.

f7-day treatment-free interval starting on Day 21.

Treatment duration1

The recommended number of cycles of BESPONSA will vary depending on both response to treatment and plans for further therapeutic intervention with HSCT.

dosing table 3
dosing table 3

HSCT=hematopoietic stem cell transplant; MRD=minimal residual disease.

Patients who do not achieve CR/CRi within 3 cycles should discontinue treatment.

Administering BESPONSA1,2

BESPONSA should be administered by IV infusion over 1 hour

dosing table 4
dosing table 4

gWith ≤4 hours between reconstitution and dilution.

  • BESPONSA is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration
  • Do not freeze the reconstituted or diluted BESPONSA solution
  • Do not mix or administer BESPONSA as an infusion with other medicinal products

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.

How BESPONSA is supplied1

BESPONSA is supplied as a white to off-white lyophilized powder in a single-dose vial for reconstitution and dilution

  • Each carton (NDC 0008‐0100‐01) contains one single‑dose vial
  • Each vial delivers 0.9 mg of BESPONSA
  • Reconstitute each vial with 4 mL of Sterile Water for Injection, USP, to obtain a concentration of 0.25 mg/mL of BESPONSA that delivers 3.6 mL (0.9 mg)
Download the Dosing and Administration Brochure for more information
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INDICATION and IMPORTANT SAFETY INFORMATION

BESPONSA 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 non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate

Hepatotoxicity, Including Hepatic VOD: 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.

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%) patients, respectively.

Increased Risk of Post-HSCT Non-Relapse Mortality (NRM): 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. 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. Thrombocytopenia and neutropenia were reported in 83/164 patients (51%) and 81/164 patients (49%), respectively. Febrile neutropenia was reported in 43/164 patients (26%).

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 patients (2%). Premedicate with a corticosteroid, antipyretic, and 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 of ≥60 msec from baseline were measured in 4/162 patients (3%). 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 with 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 observed with BESPONSA were thrombocytopenia, neutropenia, infection, anemia, leukopenia, fatigue, hemorrhage, pyrexia, nausea, headache, febrile neutropenia, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia. The most common (≥2%) serious adverse reactions were infection, febrile neutropenia, hemorrhage, abdominal pain, pyrexia, VOD, and fatigue.

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.

References: 1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc. 2. National Cancer Institute. Drugs approved for leukemia. http://www.cancer.gov/about-cancer/treatment/drugs/leukemia. Updated May 19, 2017. Accessed July 17, 2017. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia. Version 1.2018. © National Comprehensive Cancer Network, Inc. 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.

References: 1. BESPONSA Prescribing Information. New York, NY: Pfizer Inc. 2. Data on file. Pfizer Inc, New York, NY.