Applies to tagraxofusp: intravenous solution.

Serious side effects of Tagraxofusp

Along with its needed effects, tagraxofusp 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 tagraxofusp:

More common

• Black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• chills
• confusion
• cough
• decrease or increase in the amount of urine
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• itching skin
• lower back or side pain
• nausea
• nervousness
• nosebleed
• painful or difficult urination
• pale skin
• pounding in the ears
• rapid weight gain
• slow heartbeat
• small red or purple spots on the skin
• sore throat
• stomach pain
• sweating
• tightness in the chest
• tingling of the hands or feet
• troubled breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Other side effects of Tagraxofusp

Some side effects of tagraxofusp 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

• Anxiety
• arm, back, or leg pain
• constipation
• decreased appetite
• diarrhea
• mouth or throat pain
• nausea
• trouble sleeping
• vomiting

For Healthcare Professionals

Applies to tagraxofusp: intravenous solution.

Hematologic

Very common (10% or more): Decreased platelets (67%), decreased hemoglobin (60%), decreased neutrophils (37%)^[Ref]

Hypersensitivity

Very common (10% or more): Hypersensitivity (46%)^[Ref]

Immunologic

Frequency not reported: Immunogenicity^[Ref]

Metabolic

Very common (10% or more): Increased glucose (67%), decreased calcium (57%), decreased sodium (50%), decreased potassium (39%), decreased phosphate (30%), increased alkaline phosphatase (26%), decreased appetite (24%), increased potassium (21%), decreased magnesium (14%), decreased glucose (11%), increased sodium (10%)^[Ref]

Psychiatric

Very common (10% or more): Insomnia (17%), anxiety (15%), confusion (11%)^[Ref]

Hepatic

Very common (10% or more): Elevated liver enzymes (Grade 1 or 2 in 48%, Grade 3 in 36%, Grade 4 in 4%) (88%), ALT increase (82%), AST increase (79%)^[Ref]

Respiratory

Very common (10% or more): Dyspnea (19%), cough (14%), epistaxis (14%), oropharyngeal pain (12%)^[Ref]

Other

Very common (10% or more): Fatigue (45%), peripheral edema (43%), pyrexia (43%), weight increase (31%), chills (29%)^[Ref]

General

-The most common laboratory abnormalities (incidence 50% or greater) are decreases in albumin, platelets, hemoglobin, calcium, and sodium and increases in glucose, ALT, and AST.

-The most common adverse reactions (incidence 30% or greater) are capillary leak syndrome (CSL), nausea, fatigue, peripheral edema, pyrexia, and weight increase.^[Ref]

Nervous system

Very common (10% or more): Headache (29%), dizziness (20%)^[Ref]

Renal

Very common (10% or more): Hematuria (10%), decreased creatinine (27%)^[Ref]

Cardiovascular

Very common (10% or more): Capillary leak syndrome (55%), hypotension (29%), tachycardia (17%), hypertension (15%)^[Ref]

Dermatologic

Very common (10% or more): Petechiae (10%), pruritus (10%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (49%), constipation (23%), vomiting (21%), diarrhea (20%)^[Ref]