Applies to inotuzumab ozogamicin: intravenous powder for solution.

Serious side effects

Along with its needed effects, inotuzumab ozogamicin 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

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]