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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.
  • Headache.
  • 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

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]

References

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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