Besponsa Side Effects

Generic name: inotuzumab ozogamicin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2023.

Note: This document contains side effect information about inotuzumab ozogamicin. Some dosage forms listed on this page may not apply to the brand name Besponsa.

Applies to inotuzumab ozogamicin: intravenous powder for solution.

Warning

Intravenous route (Powder for Solution)

Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received inotuzumab ozogamicin.A higher post-HSCT non-relapse mortality rate occurred in patients receiving inotuzumab ozogamicin.

Serious side effects of Besponsa

Along with its needed effects, inotuzumab ozogamicin (the active ingredient contained in Besponsa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking inotuzumab ozogamicin:

More common

Black, tarry stools
bleeding gums
blood in the urine or stools
chest pain
chills
cough or hoarseness
coughing up blood
difficulty in breathing or swallowing
dizziness
fever
headache
increased menstrual flow or vaginal bleeding
lower back or side pain
nosebleeds
painful or difficult urination
pale skin
paralysis
pinpoint red spots on the skin
prolonged bleeding from cuts
red or dark brown urine
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
yellow eyes or skin

Other side effects of Besponsa

Some side effects of inotuzumab ozogamicin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation
decreased appetite
diarrhea
nausea
stomach pain
swelling or inflammation of the mouth
vomiting

For Healthcare Professionals

Applies to inotuzumab ozogamicin: intravenous powder for injection.

Hematologic

Very common (10% or more): Thrombocytopenia (51%) (42% of which were Grade 3 or higher), neutropenia (49%) (48% of which were Grade 3 or higher), anemia (36%) (24% of which were Grade 3 or higher), leukopenia (35%) (33% of which were Grade 3 or higher), febrile neutropenia (26%) (all of which were Grade 3 or higher), lymphopenia (18%) (16% of which were Grade 3 of higher)

Common (1% to 10%): Pancytopenia (e.g., bone marrow failure, febrile bone marrow aplasia, pancytopenia)^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity^[Ref]

Immunologic

Very common (10% or more): Infection (48%) (28% of which were Grade 3 or higher)

Frequency not reported: Immunogenicity^[Ref]

Local

Common (1% to 10%): Infusion related reaction^[Ref]

Musculoskeletal

Frequency not reported: Muscle hemorrhage^[Ref]

Ocular

Frequency not reported: Conjunctival hemorrhage, eyelid bleeding^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (12%)

Common (1% to 10%): Lipase increased, amylase increased, hyperuricemia

Uncommon (0.1% to 1%): Tumor lysis syndrome^[Ref]

Genitourinary

Very common (10% or more): Vaginal hemorrhage (10%)

Frequency not reported: Menorrhagia, hematuria^[Ref]

Hepatic

Very common (10% or more): Hyperbilirubinemia (21%), transaminases increased (26%), gamma-glutamyltransferase increased (21%), alkaline phosphatase increased (13%)^[Ref]

Respiratory

Frequency not reported: Epistaxis^[Ref]

Other

Very common (10% or more): Fatigue (35%), pyrexia (32%), chills (11%)

Frequency not reported: Hemotympanum^[Ref]

Nervous system

Very common (10% or more): Headache (28%)^[Ref]

Cardiovascular

Very common (10% or more): Hemorrhage (33%) (5% of which were Grade 3 or higher)

Common (1% to 10%): QT prolonged

Frequency not reported: Intracranial hemorrhage, subdural hematoma^[Ref]

Dermatologic

Frequency not reported: Ecchymosis, hemorrhage subcutaneous, mesenteric hemorrhage, petechiae, post-procedural hematoma^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (31%), abdominal pain (23%), diarrhea (17%), constipation (17%), vomiting (15%), stomatitis (13%)

Common (1% to 10%): Abdominal distention, ascites

Frequency not reported: GI hemorrhage, hemorrhagic gastritis, gingival bleeding, hematemesis, hematochezia, hemorrhoidal hemorrhage, intraabdominal hemorrhage, lip hemorrhage, upper/lower GI hemorrhage, mouth hemorrhage, oral mucosa hematoma, rectal hemorrhage^[Ref]