Inotuzumab ozogamicin: Pediatric drug information

For additional information see "Inotuzumab ozogamicin: Drug information" and "Inotuzumab ozogamicin: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Hepatotoxicity, including veno-occlusive disease:

Hepatotoxicity, including fatal and life-threatening veno-occlusive disease (VOD) occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received inotuzumab ozogamicin. The risk of VOD was greater in patients who underwent hematopoietic stem cell transplant (HSCT) after inotuzumab ozogamicin treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ 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 inotuzumab ozogamicin included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of inotuzumab ozogamicin treatment cycles.

Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of inotuzumab ozogamicin. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice.

Increased risk of post-hematopoietic stem cell transplant non-relapse mortality:

There was higher post-HSCT non-relapse mortality rate in patients receiving inotuzumab ozogamicin, resulting in a higher Day 100 post-HSCT mortality rate.

Brand Names: US

Besponsa

Brand Names: Canada

Besponsa

Therapeutic Category

Antineoplastic Agent, Anti-CD22;
Antineoplastic Agent, Antibody Drug Conjugate;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Pediatric

Dosage guidance:

Safety: Premedication is recommended prior to inotuzumab ozogamicin infusion; premedications include a corticosteroid, an antipyretic, and an antihistamine.

Clinical considerations: Administer prophylactic anti-infectives and employ surveillance testing during and after treatment.

Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory, CD22 positive

Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory, CD22 positive:

Prior to the first dose, cytoreduction to a peripheral blast count of ≤10,000/mm³ with a combination of hydroxyurea, steroids, and/or vincristine is recommended for patients with circulating lymphoblasts.

Therapeutic indicators for dosing:

Complete remission (CR): Defined as <5% blasts in bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100,000/mm³ and ANC ≥1,000/mm³), and resolution of any extramedullary disease.

CR with incomplete hematologic recovery (CRi): Defined as <5% blasts in bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100,000/mm³ and/or ANC <1,000/mm³), and resolution of any extramedullary disease.

Children and Adolescents: IV:

**Dosing for Inotuzumab Ozogamicin in Children and Adolescents With Acute Lymphoblastic Leukemia**
	Day 1	Day 8^a	Day 15^a
^a Doses on days 8 and 15 may be varied by ±2 days (maintain a minimum of 6 days between doses).
Cycle 1 (21 days, 7 days treatment free)	0.8 mg/m²	0.5 mg/m²	0.5 mg/m²
Subsequent cycles (28 days)
Achieved CR or CRi	0.5 mg/m²	0.5 mg/m²	0.5 mg/m²
NOT achieved CR or CRi	0.8 mg/m²	0.5 mg/m²	0.5 mg/m²

Treatment duration: The recommended duration of treatment is 2 cycles for patients proceeding to hematopoietic cell transplant (HCT); may consider a third cycle in patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles. For patients not proceeding to HCT, may continue treatment for up to a maximum of 6 cycles.

Dosage adjustment for toxicity:

Children and Adolescents: IV:

Note: According to the prescribing information, if a dose is reduced due to toxicity, do not re-escalate the dose.

Doses within a treatment cycle (eg, day 8 and/or day 15 doses) do not need to be interrupted due to neutropenia or thrombocytopenia; however, dosing interruptions within a cycle are recommended for nonhematologic toxicities.

**Inotuzumab Ozogamicin Dosage Adjustments for Hematologic Toxicities in Children and Adolescents**
Criteria	Inotuzumab ozogamicin dose modification(s)
^a Platelet count used for dosage modification should be independent of transfusion.
If prior to inotuzumab ozogamicin treatment ANC was ≥1,000/mm³	If ANC decreases, then interrupt the next cycle of treatment until recovery of ANC to ≥1,000/mm³. Discontinue inotuzumab ozogamicin if low ANC persists for >28 days and is suspected to be related to inotuzumab ozogamicin.
If prior to inotuzumab ozogamicin treatment platelet count was ≥50,000/mm³ ^a	If platelet count decreases, then interrupt the next cycle of treatment until platelet count recovers to ≥50,000/mm³. Discontinue inotuzumab ozogamicin if low platelet count persists for >28 days and is suspected to be related to inotuzumab ozogamicin.
If prior to inotuzumab ozogamicin treatment ANC was <1,000/mm³ and/or platelet count was <50,000/mm³ ^a	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 ≥1,000/mm³ and platelet count recovers to ≥50,000/mm³, 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 inotuzumab ozogamicin-related toxicity).
Bleeding/Hemorrhage	May require dosing interruption, dose reduction, or permanent discontinuation.

**Inotuzumab Ozogamicin Dosage Adjustments Based on Duration of Dosing Interruption Due to Nonhematologic Toxicity in Children and Adolescents**
Duration of dose interruption due to toxicity	Inotuzumab ozogamicin dose modification(s)
<7 days (within a cycle)	Interrupt the next dose (maintain a minimum of 6 days between doses).
≥7 days	Omit the next dose within the cycle.
≥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 inotuzumab ozogamicin.
>28 days	Consider permanent discontinuation of inotuzumab ozogamicin.

**Inotuzumab Ozogamicin Dosage Adjustments for Nonhematologic Toxicities in Children and Adolescents**
Nonhematologic toxicity	Inotuzumab ozogamicin dose modification(s)
Infection (severe)	May require dosing interruption, dose reduction, or permanent discontinuation.
Other nonhematologic toxicity ≥ grade 2	Interrupt treatment until recovery to grade 1 or pretreatment grade levels prior to each dose.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children and Adolescents: IV:

CrCl 15 to 89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetics in this patient population are similar to those in patients with normal kidney function. Adult experience suggests dosage adjustment is not necessary (Ref).

End-stage kidney disease with or without hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, adult experience suggests no need for dosage adjustment is expected (Ref).

Dosing: Liver Impairment: Pediatric

Children and Adolescents: IV:

Baseline liver impairment:

Total bilirubin ≤1.5 times ULN and AST/ALT ≤2.5 times ULN: No initial dosage adjustment necessary.

Total bilirubin >1.5 times ULN and/or AST/ALT >2.5 times ULN: There are no dosage adjustments provided in the manufacturer's labeling; however, adult experience suggests no need for dosage adjustment is expected (Ref).

Acute hepatotoxicity during treatment:

Sinusoidal obstruction syndrome (also known as veno-occlusive disease [VOD]) or other severe liver toxicity: Discontinue permanently. Utilize standard medical management for severe VOD.

Total bilirubin >1.5 times ULN and AST/ALT >2.5 times ULN: Interrupt treatment until recovery of total bilirubin to ≤1.5 times ULN and AST/ALT to ≤2.5 times ULN prior to each dose unless due to Gilbert syndrome or hemolysis. Permanently discontinue treatment if total bilirubin does not recover to ≤1.5 times ULN or AST/ALT does not recover to ≤2.5 times ULN.

Dosing: Adult

(For additional information see "Inotuzumab ozogamicin: Drug information")

Dosage guidance:

Safety: Premedication is recommended prior to inotuzumab ozogamicin infusion; premedications include a corticosteroid, an antipyretic, and an antihistamine.

Clinical considerations: Administer prophylactic anti-infectives and employ surveillance testing during and after treatment.

Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory, CD22 positive

Acute lymphoblastic leukemia, B-cell precursor, relapsed or refractory, CD22 positive: Note: Prior to the first dose, cytoreduction to a peripheral blast count of ≤10,000/mm³ with a combination of hydroxyurea, steroids, and/or vincristine is recommended for patients with circulating lymphoblasts. Doses on days 8 and 15 may be varied by ±2 days (maintain a minimum of 6 days between doses). Complete remission (CR) is defined as <5% blasts in bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100,000/mm³ and ANC ≥1,000/mm³), and resolution of any extramedullary disease. CR with incomplete hematologic recovery (CRi) is defined as <5% blasts in bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100,000/mm³ and/or ANC <1,000/mm³), and resolution of any extramedullary disease.

Cycle 1: IV: 0.8 mg/m² on day 1 and 0.5 mg/m² on days 8 and 15 of a 21-day treatment cycle (total dose/cycle 1: 1.8 mg/m²); treatment cycle may be extended to 4 weeks if CR or CRi is achieved and/or to allow for recovery from toxicity (Ref).

Subsequent cycles:

Patients who achieve CR or CRi: IV: 0.5 mg/m² on days 1, 8 and 15 of a 28-day treatment cycle (total dose/cycle: 1.5 mg/m²) (Ref).

Patients who have NOT achieved CR or CRi: IV: 0.8 mg/m² on day 1 and 0.5 mg/m² on days 8 and 15 of a 28-day treatment cycle (total dose/cycle: 1.8 mg/m²); if CR or CRi is not achieved within 3 cycles, discontinue treatment (Ref).

Treatment duration: The recommended duration of treatment is 2 cycles for patients proceeding to hematopoietic cell transplant (HCT); may consider a third cycle in patients who do not achieve CR or CRi and minimal residual disease (MRD) negativity after 2 cycles. For patients not proceeding to HSCT, may continue treatment for up to a maximum of 6 cycles.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

End-stage kidney disease with or without hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, no need for dosage adjustment is expected (Ref).

Dosing: Liver Impairment: Adult

Hepatic impairment prior to treatment initiation:

Total bilirubin ≤1.5 times ULN and AST/ALT ≤2.5 times ULN: No initial dosage adjustment necessary.

Total bilirubin >1.5 times ULN and/or AST/ALT >2.5 times ULN: There are no dosage adjustments provided in the manufacturer's labeling; however, no need for dosage adjustment is expected (Ref).

Acute hepatotoxicity during treatment:

Sinusoidal obstruction syndrome (also known as veno-occlusive disease [VOD]) or other severe liver toxicity: Discontinue permanently. Utilize standard medical management for severe VOD.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Gastrointestinal: Abdominal pain (23%), constipation (16%), decreased appetite (12%), diarrhea (17%; grades ≥3: 1%), nausea (31%; grades ≥3: 2%), stomatitis (13%; grades ≥3: 2%), vomiting (15%; grades ≥3: 1%)

Hematologic & oncologic: Anemia (36%; grades ≥3%: 24%), febrile neutropenia (26%; grades ≥3: 26%), hemorrhage (33%; grades ≥3: 5%), leukopenia (35%; grades ≥3: 33%), lymphocytopenia (18%; grades ≥3: 16%), neutropenia (49%; grades 3/4: 20% to 27%), thrombocytopenia (51%; grades 3/4: 14% to 28%)

Hepatic: Hepatic sinusoidal obstruction syndrome (14%), hepatotoxicity (14%), hyperbilirubinemia (21%), increased gamma-glutamyl transferase (21%), increased serum alkaline phosphatase (13%), increased serum transaminases (26%; including serum alanine aminotransferase, increased serum aspartate aminotransferase)

Infection: Infection (48%; including bacterial infection, fungal infection, severe infection, viral infection)

Nervous system: Chills (11%), fatigue (35%), headache (28%)

Respiratory: Epistaxis (15%)

Miscellaneous: Fever (32%)

1% to 10%:

Cardiovascular: Prolonged QT interval on ECG (1%)

Endocrine & metabolic: Hyperuricemia (4%)

Gastrointestinal: Abdominal distention (6%), increased serum amylase (5%), increased serum lipase (9%)

Hematologic & oncologic: Pancytopenia (2%; including bone marrow failure, febrile bone marrow aplasia), tumor lysis syndrome (2%)

Hepatic: Ascites (4%)

Hypersensitivity: Infusion-related reaction (2%; including hypersensitivity reaction)

Immunologic: Antibody development (3%)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to inotuzumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Hematologic toxicity, including thrombocytopenia and neutropenia commonly occur (including grades 3 and 4). Neutropenic fever occurred in over one-fourth of patients; may be life-threatening. For patients who were in complete remission (CR) or CR with incomplete hematologic recovery (CRi) at the end of treatment, the time to platelet recovery (>50,000/mm³) was >45 days after the last dose in <10% of patients. Complications associated with myelosuppression (including infections and bleeding/hemorrhagic events) have been observed.

• Hemorrhage: Hemorrhagic events associated with thrombocytopenia have been reported, including grades 3 or 4 hemorrhagic events and one grade 5 (fatal) intra-abdominal hemorrhage. The most common hemorrhagic event was epistaxis. Hematoma and mouth hemorrhage were observed in some patient populations.

• Hepatotoxicity: Hepatotoxicity, including severe, life-threatening, and sometimes fatal sinusoidal obstructions syndrome (also referred to as veno-occlusive disease [VOD]) has occurred in patients with relapsed or refractory acute lymphoblastic leukemia who received inotuzumab ozogamicin. The risk of VOD was greater in patients who received a hematopoietic cell transplant (HCT) following inotuzumab ozogamicin treatment. The use of HCT conditioning regimens containing 2 alkylating agents (eg, busulfan in combination with other alkylating agents) and a total bilirubin level ≥ ULN before HCT were significantly associated with increasing the risk of VOD. Other risk factors for VOD associated with inotuzumab ozogamicin included ongoing or prior liver disease, prior HCT, increased age, later salvage lines, and a higher number of inotuzumab ozogamicin treatment cycles. Patients with a history of VOD or who have serious ongoing hepatic liver disease (eg, cirrhosis, idiopathic noncirrhotic portal hypertension [including nodular regenerative hyperplasia], active hepatitis) are at an increased risk for worsening of liver disease, including developing VOD, following inotuzumab ozogamicin therapy. VOD occurred up to 56 days after the last inotuzumab ozogamicin dose during treatment or during follow-up without an intervening HCT. For patients receiving HCT after inotuzumab ozogamicin, the median time to onset of VOD was 15 days (range: 3 to 57 days). Other hepatotoxicity events have been reported, including grades 3 and 4 AST, ALT, and total bilirubin elevations.

• Hypersensitivity: Hypersensitivity reactions have been reported.

• Infections: Infections, including serious infections (some life-threatening or fatal), were reported in nearly half of patients treated with inotuzumab ozogamicin. Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, have been reported; bacterial, viral, and fungal infections occurred.

• Infusion reactions: Grade 2 infusion related reactions were reported with inotuzumab ozogamicin administration in a small percentage of patients. Infusion reactions (eg, fever, chills, rash, dyspnea) usually occurred in cycle 1 shortly after the end of the infusion and resolved spontaneously or with medical management.

• QT prolongation: Increases in the corrected QT interval of ≥60 msec from baseline were observed in a small number of patients (including grade 2 prolongation in some patients). Use inotuzumab ozogamicin with caution in patients with a history of (or predisposition for) QTc prolongation, patients taking drugs known to prolong the QT interval, and/or in patients with electrolyte abnormalities.

Disease related concerns:

• Hematopoietic cell transplant: A higher post-HCT non-relapse mortality rate was observed in patients who received inotuzumab ozogamicin, resulting in a higher Day 100 post-HCT mortality rate. The most common causes of post-HCT non-relapse mortality included VOD and/or infection. Among patients with ongoing VOD, multiorgan failure or infection resulting in fatality occurred.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Besponsa: 0.9 mg (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Besponsa Intravenous)

0.9 mg (per each): $27,489.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Besponsa: 0.9 mg (1 ea) [contains polysorbate 80]

Prescribing and Access Restrictions

Available through specialty pharmacy distributors. Information and a distributor list is available from the manufacturer at 1-877-744-5675 or at https://besponsa.pfizerpro.com/how-to-order.

Administration: Pediatric

Note: Premedication with a corticosteroid, an antipyretic, and an antihistamine is recommended.

IV: Infuse over 1 hour; protect from light. If refrigerated, allow to reach room temperature for ~1 hour prior to administration. For syringe infusions, a syringe pump and micro-bore tubing must be used. An inline filter is not required during administration; 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). Do not mix or administer with other medications. Following infusion, flush infusion set with NS to ensure the complete dose is administered.

Infusion-related reactions: 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 corticosteroids and antihistamines. For severe or life-threatening infusion reactions, permanently discontinue treatment.

Administration: Adult

IV: Infuse over 1 hour (at a rate of 50 mL/hour). If refrigerated, allow to reach room temperature for ~1 hour prior to administration. Infuse at room temperature and protect from light during infusion. For syringe infusions, a syringe pump and micro-bore tubing must be used. An inline filter is not required during administration; 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). Do not mix or administer with other medications. Following infusion, flush infusion set with NS to ensure the complete dose is administered. For IV infusion only.

The maximum time from reconstitution to the end of the infusion should be ≤8 hours (including [if refrigerated] 1 hour to equilibrate to room temperature and 1 hour for infusion), with ≤4 hours between reconstitution and dilution.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Storage/Stability

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Store vials in original carton to protect from light. Protect from light following reconstitution and dilution for infusion and do not freeze. Reconstituted solutions may be used immediately or after being refrigerated for up to 4 hours. Solutions diluted for infusion may be used immediately or stored at room temperature at 20°C to 25°C (68°F to 77°F) or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 6 hours. If refrigerated, allow solutions diluted for infusion to reach room temperature for ~1 hour prior to administration. The maximum time from reconstitution to the end of the infusion should be ≤8 hours (including [if refrigerated] 1 hour to equilibrate to room temperature and 1 hour for infusion), with ≤4 hours between reconstitution and dilution.

Use

Treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) (FDA approved in ages ≥1 year and adults).

Medication Safety Issues

Sound-alike/look-alike issues:

Inotuzumab ozogamicin may be confused with gemtuzumab ozogamicin, ibritumomab

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Amisulpride (Oral): May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk C: Monitor

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Chloroquine: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Chloroquine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

Clofazimine: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Clofazimine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Dabrafenib: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Domperidone: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Encorafenib: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fluorouracil Products: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Gadobenate Dimeglumine: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Gadobenate Dimeglumine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Halofantrine: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Halofantrine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Haloperidol: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Levoketoconazole: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Levoketoconazole. Risk X: Avoid

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lofexidine: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Lofexidine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Midostaurin: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Midostaurin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Ondansetron: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Pentamidine (Systemic): QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Pentamidine (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pimozide: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Piperaquine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Probucol: QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of Probucol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

QT-prolonging Agents (Highest Risk): May increase QTc-prolonging effects of Inotuzumab Ozogamicin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification

QT-prolonging Antidepressants (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Antipsychotics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-Prolonging Inhalational Anesthetics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of QT-Prolonging Inhalational Anesthetics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Kinase Inhibitors (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Miscellaneous Agents (Moderate Risk): May increase QTc-prolonging effects of Inotuzumab Ozogamicin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Quinolone Antibiotics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may increase QTc-prolonging effects of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Moderate Risk). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Thioridazine: QT-prolonging Agents (Moderate Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Verify pregnancy status prior to therapy. Patients who could become pregnant should use effective contraception during therapy and for 8 months after the last dose. Effective contraception should also be used for 5 months after the last dose when treating patients with partners who could become pregnant.

Pregnancy Considerations

Based on the mechanism of action and information from animal reproduction studies, in utero exposure to inotuzumab ozogamicin may cause fetal harm.

Monitoring Parameters

Complete blood counts (prior to each dose), liver function tests including ALT, AST, total bilirubin, and alkaline phosphatase (prior to and following each dose); for patients who proceed to hematopoietic stem cell transplantation (HSCT), monitor liver function tests closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice; electrolytes (prior to treatment initiation, after initiation of any drug known to prolong QTc, and periodically as clinically indicated during treatment), pregnancy status (prior to treatment in females of reproductive potential). Obtain ECG (prior to treatment initiation, after initiation of any drug known to prolong QTc, and periodically as clinically indicated during treatment).

Monitor closely for signs and symptoms of veno-occlusive disease (VOD) (eg, hepatomegaly with or without pain, rapid weight gain, ascites); monitor for signs/symptoms of effects of myelosuppression (bleeding, hemorrhage, infection) during treatment; monitor closely during the infusion and for at least 1 hour after the end of the infusion for potential infusion reactions.

Mechanism of Action

Inotuzumab ozogamicin is a humanized CD22-directed monoclonal antibody-drug conjugate which is composed of the IgG4 kappa antibody inotuzumab (which is specific for human CD22), a calicheamicin component (a cytotoxic agent that causes double-stranded DNA breaks), and an acid-cleavable linker that covalently binds the calicheamicin to inotuzumab. After the antibody-drug conjugate binds to CD22, the CD22-conjugate complex is internalized, and releases calicheamicin. Calicheamicin binds to the minor groove of DNA to induce double strand cleavage and subsequent cell cycle arrest and apoptosis (Kantarjian 2016).

Pharmacokinetics (Adult Data Unless Noted)

Note: Body surface area was found to significantly affect disposition.

Distribution: ~12 L

Protein binding: Calicheamicin: ~97% bound to human plasma proteins

Metabolism: Calicheamicin: Primarily via nonenzymatic reduction

Half-life, elimination: 12.3 days

Excretion: Clearance (steady state): 0.0333 L/hour

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Besponsa;
(AR) Argentina: Besponsa;
(AT) Austria: Besponsa;
(AU) Australia: Besponsa;
(BE) Belgium: Besponsa;
(BG) Bulgaria: Besponsa;
(BR) Brazil: Besponsa;
(CH) Switzerland: Besponsa;
(CL) Chile: Besponsa;
(CO) Colombia: Besponsa;
(CZ) Czech Republic: Besponsa;
(DE) Germany: Besponsa;
(EE) Estonia: Besponsa;
(ES) Spain: Besponsa;
(FI) Finland: Besponsa;
(FR) France: Besponsa;
(GB) United Kingdom: Besponsa;
(GR) Greece: Besponsa;
(HK) Hong Kong: Besponsa;
(HU) Hungary: Besponsa;
(IE) Ireland: Besponsa;
(IN) India: Inonza;
(IT) Italy: Besponsa;
(JP) Japan: Besponsa;
(KR) Korea, Republic of: Besponsa;
(KW) Kuwait: Besponsa;
(LB) Lebanon: Besponsa;
(LT) Lithuania: Besponsa;
(NL) Netherlands: Besponsa;
(NO) Norway: Besponsa;
(NZ) New Zealand: Besponsa;
(PL) Poland: Besponsa;
(PR) Puerto Rico: Besponsa;
(PT) Portugal: Besponsa;
(RO) Romania: Besponsa;
(RU) Russian Federation: Besponsa | Bisponsa;
(SA) Saudi Arabia: Besponsa;
(SE) Sweden: Besponsa;
(SG) Singapore: Besponsa;
(SI) Slovenia: Besponsa;
(SK) Slovakia: Besponsa;
(TR) Turkey: Besponsa;
(TW) Taiwan: Besponsa

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Topic 145331 Version 16.0

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Inotuzumab ozogamicin: Pediatric drug information