Besponsa Side Effects
Generic Name: inotuzumab ozogamicin
Note: This document contains side effect information about inotuzumab ozogamicin. Some of the dosage forms listed on this page may not apply to the brand name Besponsa.
For the Consumer
Applies to inotuzumab ozogamicin: intravenous solution reconstituted
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Feeling very tired or weak.
- Dizziness or passing out.
- A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling tired or weak.
- Upset stomach or throwing up.
- Belly pain.
- Not hungry.
- Loose stools (diarrhea).
- Hard stools (constipation).
- Mouth irritation or mouth sores.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to inotuzumab ozogamicin: intravenous powder for injection
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]
Common (1% to 10%): Hypersensitivity[Ref]
Very common (10% or more): Infection (48%) (28% of which were Grade 3 or higher)
Frequency not reported: Immunogenicity[Ref]
Common (1% to 10%): Infusion related reaction[Ref]
Frequency not reported: Muscle hemorrhage[Ref]
Frequency not reported: Conjunctival hemorrhage, eyelid bleeding[Ref]
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]
Very common (10% or more): Vaginal hemorrhage (10%)
Frequency not reported: Menorrhagia, hematuria[Ref]
Very common (10% or more): Hyperbilirubinemia (21%), transaminases increased (26%), gamma-glutamyltransferase increased (21%), alkaline phosphatase increased (13%)[Ref]
Frequency not reported: Epistaxis[Ref]
Very common (10% or more): Fatigue (35%), pyrexia (32%), chills (11%)
Frequency not reported: Hemotympanum[Ref]
Very common (10% or more): Headache (28%)[Ref]
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]
Frequency not reported: Ecchymosis, hemorrhage subcutaneous, mesenteric hemorrhage, petechiae, post-procedural hematoma[Ref]
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]
1. "Product Information. Besponsa (inotuzumab ozogamicin)." Wyeth Laboratories, Philadelphia, PA.
Some side effects of Besponsa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
More about Besponsa (inotuzumab ozogamicin)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Español
- 0 Reviews – Add your own review/rating
- Drug class: miscellaneous antineoplastics
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