Gemtuzumab Side Effects

Brand Names: Mylotarg

Please note - some side effects for Gemtuzumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Gemtuzumab - for the Consumer

Gemtuzumab Ozogamicin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Gemtuzumab Ozogamicin:

Back pain; constipation; cough; diarrhea; dizziness; fatigue; headache; indigestion; joint pain; loss of appetite; mouth sores; nausea; pain or inflammation at the injection site; runny nose; sleeplessness; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in amount or frequency of urine; chest pain; dark urine; depression; fast or irregular heart rate; fever, chills, or sore throat; increased thirst; one-sided weakness; pink or red-colored urine; right-sided stomach pain; seizure; severe dizziness; severe headache; shortness of breath; slurred speech; stomach swelling; sudden weight gain; swelling of the arms, legs, or feet; unusual bleeding or bruising (eg, nosebleed, red or purple spots under the skin, unusual vaginal bleeding); vision changes; yellowing of the eyes or skin.

Side Effects by Body System

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%).

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%).

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%).

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.

Gastrointestinal

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

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.

Hepatic

Hepatic effects are transient and generally reversible.

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

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).

Genitourinary

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

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.

Renal

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

Cardiovascular

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

Dermatologic

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

Nervous system

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

Musculoskeletal

Musculoskeletal side effects have included arthralgia (8%).

Metabolic

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

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

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