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Gemtuzumab Side Effects

For the Consumer

Applies to gemtuzumab: parenteral powder for injection

Side effects include:

Abdominal pain, asthenia, back pain, chills, fever, headache, neutropenic fever, pain, sepsis, hemorrhage, hypertension, hypotension, tachycardia, anorexia, constipation, diarrhea, dyspepsia, liver function test abnormalities, nausea, stomatitis, vomiting, anemia, ecchymosis, leukopenia, petechiae, thrombocytopenia, bilirubinemia, hyperglycemia, hypocalcemia, hypokalemia, increased LDH, peripheral edema, dizziness, insomnia, increased cough, dyspnea, epistaxis, pharyngitis, pneumonia, herpes simplex, rash.

In clinical trials, overall mortality rate within 28 days of the last gemtuzumab ozogamicin dose was 14% in patients <60 years of age and 17% in those ≥60 years of age.

For Healthcare Professionals

Applies to gemtuzumab: intravenous powder for injection

Hematologic

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

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

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

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

Respiratory

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

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

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

Immunologic

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

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

Cardiovascular

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

Dermatologic

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

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

Metabolic

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

Hypersensitivity

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

References

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

Not all side effects for gemtuzumab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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