BESPONSA™ Dosage and Administration

(inotuzumab ozogamicin)

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

•
Pre-medicate before each dose [see Dosage and Administration (2.2)].
•
Administer by intravenous infusion only.
•
For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.
•
For subsequent cycles:
•
In patients who achieve a CR or CRi, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration.
OR
•
In patients who do not achieve a CR or CRi, the recommended total dose of BESPONSA is 1.8 mg/m2 per cycle given as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment.
•
For patients proceeding to hematopoietic stem cell transplant (HSCT), the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for those patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles [see Warnings and Precautions (5.1)].
•
For patients not proceeding to HSCT, additional cycles of treatment, up to a maximum of 6 cycles, may be administered.

Table 1 shows the recommended dosing regimens.

Table 1. Dosing Regimen for Cycle 1 and Subsequent Cycles Depending on Response to Treatment
Abbreviations: CR=complete remission; CRi=complete remission with incomplete hematologic recovery.
*
+/- 2 days (maintain minimum of 6 days between doses).
†
Dose is based on the patient's body surface area (m2).
‡
For patients who achieve a CR or a CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e., 7-day treatment-free interval starting on Day 21).
§
CR 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.
CRi 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.
#
7-day treatment-free interval starting on Day 21.

Day 1

Day 8*

Day 15*

Dosing regimen for Cycle 1

All patients:

  Dose†

0.8 mg/m2

0.5 mg/m2

0.5 mg/m2

  Cycle length

21 days‡

Dosing regimen for subsequent cycles depending on response to treatment

Patients who have achieved a CR§ or CRi:

  Dose†

0.5 mg/m2

0.5 mg/m2

0.5 mg/m2

  Cycle length

28 days#

Patients who have not achieved a CR§ or CRi:

  Dose†

0.8 mg/m2

0.5 mg/m2

0.5 mg/m2

  Cycle length

28 days#

2.2 Recommended Pre-medications and Cytoreduction

•
Premedication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing. Patients should be observed during and for at least 1 hour after the end of infusion for symptoms of infusion related reactions [see Warnings and Precautions (5.4)].
•
For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count of less than or equal to 10,000/mm3 is recommended prior to the first dose.

2.3 Dosage Modifications for Adverse Reactions

Modify the dose of BESPONSA for toxicities (see Tables 2–4). BESPONSA doses within a treatment cycle (i.e., Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-hematologic toxicities. If the dose is reduced due to BESPONSA-related toxicity, the dose must not be re-escalated.

Table 2. BESPONSA Dosage Modifications for Hematologic Toxicities [see Warnings and Precautions (5.3)]

CriteriaBESPONSA Dosage Modification(s)
Abbreviation: ANC=absolute neutrophil count.
*
Platelet count used for dosing should be independent of blood transfusion.

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. Discontinue BESPONSA if low ANC persists for greater than 28 days and is suspected to be related to BESPONSA.

If prior to BESPONSA treatment platelet count was greater than or equal to 50 × 109/L*

If platelet count decreases, then interrupt the next cycle of treatment until platelet count recovers to greater than or equal to 50 × 109/L*. Discontinue BESPONSA if low platelet count persists for greater than 28 days and is suspected to be related to BESPONSA.

If prior to BESPONSA treatment ANC was less than 1 × 109/L and/or platelet count was less than 50 × 109/L*

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/L*, 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).
Table 3. BESPONSA Dosage Modifications for Non-hematologic Toxicities
Non-hematologic ToxicityDosage Modification(s)
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=veno‑occlusive disease.
*
Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.

VOD or other severe liver toxicity

Permanently discontinue treatment [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.4)].

Non-hematologic toxicity greater than or equal to Grade 2*

Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.

Table 4. BESPONSA Dosage Modifications Depending on Duration of Dosing Interruption Due to Non-Hematologic Toxicity Toxicities
Duration of Dose Interruption Due to ToxicityDosage 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.

2.4 Instructions for Reconstitution, Dilution, and Administration

Protect the reconstituted and diluted BESPONSA solutions from light. Do not freeze the reconstituted or diluted solution.

The maximum time from reconstitution through the end of administration should be less than or equal to 8 hours, with less than or equal to 4 hours between reconstitution and dilution.

Reconstitution:

•
BESPONSA is a hazardous drug. Follow applicable special handling and disposal procedures.1
•
Calculate the dose (mg) and number of vial(s) of BESPONSA required.
•
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).
•
Gently swirl the vial to aid dissolution. DO NOT SHAKE.
•
Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution should be clear to opalescent, colorless to slightly yellow, and essentially free of visible foreign matter.
•
See Table 6 for storage times and conditions for the reconstituted solution.

Dilution:

•
Withdraw the required volume of the reconstituted solution from the vial(s) needed to obtain the appropriate dose according to the patient’s body surface area. Discard any unused reconstituted BESPONSA solution left in the vial.
•
Dilute the reconstituted BESPONSA solution in 0.9% Sodium Chloride Injection, USP, in the appropriate infusion container per Table 5:
Table 5. Infusion Container Information

Infusion Bag Administration

Syringe Administration

•
For calculated doses greater than or equal to 0.5 mg
•
Ensure a final prepared concentration of 0.01 mg/mL to 0.1 mg/mL in a total volume of 50 mL
•
For calculated doses less than 0.5 mg
•
Ensure a final prepared concentration of 0.025 mg/mL to 0.1 mg/mL in a total volume between 2 mL to 50 mL
•
Gently invert the infusion container to mix the diluted solution. DO NOT SHAKE.
•
PROTECT FROM LIGHT.
•
See Table 6 for storage times and conditions for the diluted solution.

Administration:

•
See Table 6 for storage times and conditions for prior to and during administration of the diluted solution.
•
For syringe infusions, a syringe pump and micro-bore IV tubing must be used.
•
Filtration of the diluted solution is not required. However, if the diluted solution is filtered, polyethersulfone (PES)-, polyvinylidene fluoride (PVDF),- or hydrophilic polysulfone (HPS) -based filters are recommended. Do not use filters made of nylon or mixed cellulose ester (MCE).
•
Infuse the diluted solution as an intravenous infusion over one hour. Flush the intravenous infusion line with 0.9% Sodium Chloride Injection, USP, to ensure the complete dose is administered.

Do not mix BESPONSA or administer as an infusion with other medicinal products.

Table 6 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA.

Table 6. Storage Times and Conditions for Reconstituted and Diluted BESPONSA Solution
*
Maximum time from reconstitution through end of administration less than or equal to 8 hours with less than or equal to 4 hours between reconstitution and dilution.

Storage Time and Conditions*

Reconstituted Solution

•
BESPONSA contains no bacteriostatic preservatives. Use reconstituted solution immediately or store refrigerated at (2°C-8°C; 36°F-46°F) for up to 4 hours.
•
PROTECT FROM LIGHT. DO NOT FREEZE.

Diluted Solution

•
Use diluted solution immediately or store at room temperature (20°C-25°C; 68°F-77°F) or refrigerated (2°C-8°C; 36°F-46°F) for up to 6 hours.
•
If the diluted solution is refrigerated (2°C-8°C; 36°F-46°F), allow it to equilibrate at room temperature (20°C-25°C; 68°F-77°F) for approximately 1 hour prior to administration.
•
Administer diluted solution within 8 hours of reconstitution including the 1 hour equilibration and 1 hour infusion.
•
PROTECT FROM LIGHT. DO NOT FREEZE.

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Dosage and Administration

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

•
Pre-medicate before each dose [see Dosage and Administration (2.2)].
•
Administer by intravenous infusion only.
•
For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.
•
For subsequent cycles:
•
In patients who achieve a CR or CRi, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration.
OR
•
In patients who do not achieve a CR or CRi, the recommended total dose of BESPONSA is 1.8 mg/m2 per cycle given as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment.
•
For patients proceeding to hematopoietic stem cell transplant (HSCT), the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for those patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles [see Warnings and Precautions (5.1)].
•
For patients not proceeding to HSCT, additional cycles of treatment, up to a maximum of 6 cycles, may be administered.

Table 1 shows the recommended dosing regimens.

Table 1. Dosing Regimen for Cycle 1 and Subsequent Cycles Depending on Response to Treatment
Abbreviations: CR=complete remission; CRi=complete remission with incomplete hematologic recovery.
*
+/- 2 days (maintain minimum of 6 days between doses).
†
Dose is based on the patient's body surface area (m2).
‡
For patients who achieve a CR or a CRi, and/or to allow for recovery from toxicity, the cycle length may be extended up to 28 days (i.e., 7-day treatment-free interval starting on Day 21).
§
CR 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.
CRi 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.
#
7-day treatment-free interval starting on Day 21.

Day 1

Day 8*

Day 15*

Dosing regimen for Cycle 1

All patients:

  Dose†

0.8 mg/m2

0.5 mg/m2

0.5 mg/m2

  Cycle length

21 days‡

Dosing regimen for subsequent cycles depending on response to treatment

Patients who have achieved a CR§ or CRi:

  Dose†

0.5 mg/m2

0.5 mg/m2

0.5 mg/m2

  Cycle length

28 days#

Patients who have not achieved a CR§ or CRi:

  Dose†

0.8 mg/m2

0.5 mg/m2

0.5 mg/m2

  Cycle length

28 days#

2.2 Recommended Pre-medications and Cytoreduction

•
Premedication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing. Patients should be observed during and for at least 1 hour after the end of infusion for symptoms of infusion related reactions [see Warnings and Precautions (5.4)].
•
For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids, and/or vincristine to a peripheral blast count of less than or equal to 10,000/mm3 is recommended prior to the first dose.

2.3 Dosage Modifications for Adverse Reactions

Modify the dose of BESPONSA for toxicities (see Tables 2–4). BESPONSA doses within a treatment cycle (i.e., Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-hematologic toxicities. If the dose is reduced due to BESPONSA-related toxicity, the dose must not be re-escalated.

Table 2. BESPONSA Dosage Modifications for Hematologic Toxicities [see Warnings and Precautions (5.3)]

CriteriaBESPONSA Dosage Modification(s)
Abbreviation: ANC=absolute neutrophil count.
*
Platelet count used for dosing should be independent of blood transfusion.

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. Discontinue BESPONSA if low ANC persists for greater than 28 days and is suspected to be related to BESPONSA.

If prior to BESPONSA treatment platelet count was greater than or equal to 50 × 109/L*

If platelet count decreases, then interrupt the next cycle of treatment until platelet count recovers to greater than or equal to 50 × 109/L*. Discontinue BESPONSA if low platelet count persists for greater than 28 days and is suspected to be related to BESPONSA.

If prior to BESPONSA treatment ANC was less than 1 × 109/L and/or platelet count was less than 50 × 109/L*

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/L*, 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).
Table 3. BESPONSA Dosage Modifications for Non-hematologic Toxicities
Non-hematologic ToxicityDosage Modification(s)
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD=veno‑occlusive disease.
*
Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.

VOD or other severe liver toxicity

Permanently discontinue treatment [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.1)].

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 [see Warnings and Precautions (5.4)].

Non-hematologic toxicity greater than or equal to Grade 2*

Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.

Table 4. BESPONSA Dosage Modifications Depending on Duration of Dosing Interruption Due to Non-Hematologic Toxicity Toxicities
Duration of Dose Interruption Due to ToxicityDosage 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.

2.4 Instructions for Reconstitution, Dilution, and Administration

Protect the reconstituted and diluted BESPONSA solutions from light. Do not freeze the reconstituted or diluted solution.

The maximum time from reconstitution through the end of administration should be less than or equal to 8 hours, with less than or equal to 4 hours between reconstitution and dilution.

Reconstitution:

•
BESPONSA is a hazardous drug. Follow applicable special handling and disposal procedures.1
•
Calculate the dose (mg) and number of vial(s) of BESPONSA required.
•
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).
•
Gently swirl the vial to aid dissolution. DO NOT SHAKE.
•
Inspect the reconstituted solution for particulates and discoloration. The reconstituted solution should be clear to opalescent, colorless to slightly yellow, and essentially free of visible foreign matter.
•
See Table 6 for storage times and conditions for the reconstituted solution.

Dilution:

•
Withdraw the required volume of the reconstituted solution from the vial(s) needed to obtain the appropriate dose according to the patient’s body surface area. Discard any unused reconstituted BESPONSA solution left in the vial.
•
Dilute the reconstituted BESPONSA solution in 0.9% Sodium Chloride Injection, USP, in the appropriate infusion container per Table 5:
Table 5. Infusion Container Information

Infusion Bag Administration

Syringe Administration

•
For calculated doses greater than or equal to 0.5 mg
•
Ensure a final prepared concentration of 0.01 mg/mL to 0.1 mg/mL in a total volume of 50 mL
•
For calculated doses less than 0.5 mg
•
Ensure a final prepared concentration of 0.025 mg/mL to 0.1 mg/mL in a total volume between 2 mL to 50 mL
•
Gently invert the infusion container to mix the diluted solution. DO NOT SHAKE.
•
PROTECT FROM LIGHT.
•
See Table 6 for storage times and conditions for the diluted solution.

Administration:

•
See Table 6 for storage times and conditions for prior to and during administration of the diluted solution.
•
For syringe infusions, a syringe pump and micro-bore IV tubing must be used.
•
Filtration of the diluted solution is not required. However, if the diluted solution is filtered, polyethersulfone (PES)-, polyvinylidene fluoride (PVDF),- or hydrophilic polysulfone (HPS) -based filters are recommended. Do not use filters made of nylon or mixed cellulose ester (MCE).
•
Infuse the diluted solution as an intravenous infusion over one hour. Flush the intravenous infusion line with 0.9% Sodium Chloride Injection, USP, to ensure the complete dose is administered.

Do not mix BESPONSA or administer as an infusion with other medicinal products.

Table 6 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA.

Table 6. Storage Times and Conditions for Reconstituted and Diluted BESPONSA Solution
*
Maximum time from reconstitution through end of administration less than or equal to 8 hours with less than or equal to 4 hours between reconstitution and dilution.

Storage Time and Conditions*

Reconstituted Solution

•
BESPONSA contains no bacteriostatic preservatives. Use reconstituted solution immediately or store refrigerated at (2°C-8°C; 36°F-46°F) for up to 4 hours.
•
PROTECT FROM LIGHT. DO NOT FREEZE.

Diluted Solution

•
Use diluted solution immediately or store at room temperature (20°C-25°C; 68°F-77°F) or refrigerated (2°C-8°C; 36°F-46°F) for up to 6 hours.
•
If the diluted solution is refrigerated (2°C-8°C; 36°F-46°F), allow it to equilibrate at room temperature (20°C-25°C; 68°F-77°F) for approximately 1 hour prior to administration.
•
Administer diluted solution within 8 hours of reconstitution including the 1 hour equilibration and 1 hour infusion.
•
PROTECT FROM LIGHT. DO NOT FREEZE.
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