Applies to moxetumomab pasudotox: intravenous powder for solution.

Serious side effects

Along with its needed effects, moxetumomab pasudotox 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 moxetumomab pasudotox:

More common

• Back pain
• black, tarry stools
• blood in the urine
• blurred vision
• bone pain
• chest pain or tightness
• chills
• confusion
• cough
• dizziness
• drowsiness
• dry mouth
• fast or irregular heartbeat
• feeling of warmth
• fever
• headache
• increased or decreased urination
• increased thirst
• joint pain, stiffness, or swelling
• loss of appetite
• loss of consciousness
• lower back, side, or stomach pain
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain
• muscle spasms (tetany) or twitching seizures
• nausea
• nervousness
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• slow or fast heartbeat
• sore throat
• stomach cramps or pain
• swelling of the face, fingers, feet, lower legs, or ankles
• trembling
• tremor
• troubled breathing
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Less common

• Chest discomfort
• stomach bloating

Other side effects

Some side effects of moxetumomab pasudotox 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
• diarrhea
• dry eye

Less common

• Blindness
• bloody eye
• burning, dry, or itching eyes
• decreased vision
• discharge, excessive tearing
• discomfort, pain, or swelling of the eye or around the eye
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

For Healthcare Professionals

Applies to moxetumomab pasudotox: intravenous powder for injection.

Hematologic

Very common (10% or more): Hemoglobin decreased (43%), neutrophil count decreased (41%), platelet count decreased (21%), anemia (21%)

Common (1% to 10%): Hemolytic uremic syndrome^[Ref]

Immunologic

Frequency not reported: Immunogenicity^[Ref]

Local

Very common (10% or more): Infusion related reactions (e.g., chills, cough, dizziness, dyspnea, feeling hot, flushing, headache, hypertension, hypotension, infusion related reaction, myalgia, nausea, pyrexia, sinus tachycardia, tachycardia, vomiting, wheezing) (50%)^[Ref]

Musculoskeletal

Very common (10% or more): Hypoalbuminemia (64%), fluid retention (63%), electrolyte abnormalities (57%), hypocalcemia (54%), hypophosphatemia (53%), hyponatremia (41%), peripheral edema (39%), hypokalemia (25%), hypomagnesemia (21%), hyperuricemia (21%)

Common (1% to 10%): Weight gain, localized edema, fluid overload, fluid retention^[Ref]

Ocular

Common (1% to 10%): Blurred vision, dry eye, cataracts, ocular discomfort and/or pain, ocular swelling/periorbital edema, conjunctivitis, conjunctival hemorrhage, ocular discharge^[Ref]

Hepatic

Very common (10% or more): ALT increased (65%), AST increased (55%), blood bilirubin increased (30%), GGT increased (25%)^[Ref]

Respiratory

Very common (10% or more): Cough, dyspnea, wheezing

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

Other

Very common (10% or more): Fatigue (34%), pyrexia (31%), alkaline phosphatase increased (20%), chills, feeling hot^[Ref]

Nervous system

Very common (10% or more): Headache (33%), dizziness^[Ref]

Renal

Very common (10% or more): Renal toxicity (e.g., acute kidney injury, renal impairment, renal failure, increased serum creatinine, proteinuria) (26%)^[Ref]

Cardiovascular

Very common (10% or more): Capillary leak syndrome (34%), flushing, hypertension, hypotension, sinus tachycardia, tachycardia

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

Dermatologic

Very common (10% or more): Facial edema (14%), abdominal distention (13%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (35%), constipation (23%), diarrhea (21%), vomiting

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