Besponsa Side Effects

Generic name: inotuzumab ozogamicin

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 1, 2024.

Note: This document provides detailed information about Besponsa Side Effects associated with inotuzumab ozogamicin. Some dosage forms listed on this page may not apply specifically to the brand name Besponsa.

Applies to inotuzumab ozogamicin: intravenous powder for solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 8 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 5 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to inotuzumab ozogamicin: intravenous powder for injection.

Hematologic adverse events

• 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]

See also:

Frequently asked questions

• How does Besponsa work to treat Acute Lymphoblastic Leukemia (ALL)?

Further information

Besponsa side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer