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Gemtuzumab Side Effects

For the Consumer

Applies to gemtuzumab: parenteral powder for injection

Side effects include:

The most common adverse reactions (greater than 15%) were hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased AST, increased ALT, rash, and mucositis.

For Healthcare Professionals

Applies to gemtuzumab: intravenous powder for injection


Hematologic side effects have included severe myelosuppression which is the major toxicity associated with gemtuzumab. During the treatment phase, grade 3 or 4 thrombocytopenia (99% ), neutropenia (98%), anemia (47%), and bleeding (15%) have been reported. Ecchymosis (13%) has also been reported. Treatment emergent adverse events have included epistaxis (3%), cerebral hemorrhage (2%), disseminated intravascular coagulation (2%), intracranial hemorrhage (2%), and hematuria (1%).[Ref]


General side effects have included fever (85%), chills (73%), asthenia (44%), abdominal pain (37%), headache (35%), sepsis (25%), neutropenic fever (21%), pain (21%), back pain (9%), and enlarged abdomen (9%).[Ref]


Other side effects have included acute infusion related chills (62%), fever (61%), nausea (38%), vomiting (32%), headache (12%), hypotension (11%), hypertension (6%), hypoxia (6%), dyspnea (4%), and hyperglycemia (2%).[Ref]

Acute infusion related events generally occur after the end of the two hour infusion and resolve after two to four hours with supportive therapy of acetaminophen, diphenhydramine, and intravenous fluids.[Ref]


Gastrointestinal side effects have included nausea (70%), vomiting (63%), diarrhea (38%), stomatitis (32%), anorexia (29%), constipation (25%), dyspepsia (11%) and gastrointestinal hemorrhage.[Ref]


Respiratory side effects have included dyspnea (32%), epistaxis (31%), increased cough (20%), pharyngitis (14%), pulmonary physical findings (including rales and changes in breath sounds) (11%), pneumonia (10%), and rhinitis (10%). Severe respiratory events leading to death, including dyspnea, pulmonary hemorrhage, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency, hypoxia, and acute respiratory distress syndrome have been reported infrequently.[Ref]


Hepatic side effects have included grade 3 or 4 hyperbilirubinemia (23%), AST abnormalities (17%), ALT abnormalities (9%), concurrent elevations of transaminases (grade 3 to 4) and bilirubin, sinusoidal obstruction syndrome, and hepatic veno-occlusive disease (including fatalities).[Ref]

Hepatic effects are transient and generally reversible.

Sinusoidal obstruction syndrome was characterized by portal hypertension, jaundice, and elevated serum AST levels.[Ref]


Genitourinary side effects have included vaginal hemorrhage (12%) and hematuria (10%).[Ref]


Immunologic side effects have been reported. During the treatment phase, Grade 3 or 4 infections (28%) including opportunistic infections have been reported. Grade 3 or 4 infection related treatment emergent adverse events included sepsis (16%) and pneumonia (7%). Herpes simplex infection (22%) has also been reported.[Ref]


Renal side effects including renal failure secondary to tumor lysis syndrome have been reported.[Ref]


Cardiovascular side effects have included hypertension (20%), hypotension (20%), tachycardia (11%), and hemorrhage (10%).[Ref]


Dermatologic side effects have included local reaction (25%), herpes simplex (22%), rash (22%), petechiae (20%), and peripheral edema (16%).[Ref]

Nervous system

Nervous system side effects have included dizziness (15%), insomnia (15%), and depression (9%).[Ref]


Musculoskeletal side effects have included arthralgia (8%).[Ref]


Metabolic side effects have included hypokalemia (31%), increased lactic dehydrogenase (13%), and hypomagnesemia (10%).[Ref]


Hypersensitivity side effects including anaphylaxis have been reported.[Ref]


1. "Product Information. Mylotarg (gemtuzumab)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

2. Tack DK, Letendre L, Kamath PS, Tefferi A "Development of hepatic veno-occlusive disease after Mylotarg infusion for relapsed acute myeloid leukemia." Bone Marrow Transplant 28 (2001): 895-7

Some side effects of gemtuzumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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