Gemtuzumab Side Effects
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.
For the Consumer
Applies to gemtuzumab: intravenous powder for solution
Along with its needed effects, gemtuzumab 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 gemtuzumab:More common
- Black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the stools or urine
- bluish color of the fingernails, lips, skin, palms, or nailbeds
- blurred vision
- burning or stinging of the skin
- chest pain
- convulsions (seizures)
- cough or hoarseness
- cracked lips
- decrease or increase in urine
- difficulty with swallowing
- dry mouth
- excessive sweating
- fast or slow heartbeat
- flushed, dry skin
- fruit-like breath odor
- headache, sudden and severe
- heavy, nonmenstrual vaginal bleeding
- inability to speak
- increased thirst or hunger
- irregular heartbeat
- large, flat, blue, or purplish patches in the skin
- lower back, joint, or side pain
- loss of appetite
- mood changes
- muscle pain or cramps
- muscle trembling or twitching
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain, difficulty, or burning while urinating
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pale skin
- persistent bleeding or oozing from puncture sites, mouth, or nose
- pinpoint red spots on the skin
- pounding in the ears
- rapid, shallow breathing
- rapid weight gain
- red or purplish patches or spots on the skin
- severe or continuing dull nervousness
- shortness of breath
- slurred speech
- small red or purple spots on the skin
- sore throat
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- swelling or inflammation of the mouth, face, fingers, feet, or lower legs
- swollen glands
- temporary blindness
- tightness in the chest
- tingling of the hands or feet
- troubled breathing, exertional
- unexplained nosebleeds
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- weakness in the arm or leg on one side of the body, sudden and severe
- yellow eyes or skin
Some side effects of gemtuzumab 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
- Acid or sour stomach
- difficulty with moving
- dry, red, hot, or irritated skin
- full or bloated feeling or pressure in the stomach
- lack or loss of strength
- muscle pain or stiffness
- pain, swelling, or redness in the joints
- runny, stuffy nose
- stomach discomfort upset
- swelling of the abdominal or stomach area
- trouble with sleeping
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%).
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 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 side effects have included nausea (70%), vomiting (63%), diarrhea (38%), stomatitis (32%), anorexia (29%), constipation (25%), dyspepsia (11%) and gastrointestinal hemorrhage.
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 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 side effects have included vaginal hemorrhage (12%) and hematuria (10%).
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 side effects including renal failure secondary to tumor lysis syndrome have been reported.
Cardiovascular side effects have included hypertension (20%), hypotension (20%), tachycardia (11%), and hemorrhage (10%).
Dermatologic side effects have included local reaction (25%), herpes simplex (22%), rash (22%), petechiae (20%), and peripheral edema (16%).
Nervous system side effects have included dizziness (15%), insomnia (15%), and depression (9%).
Musculoskeletal side effects have included arthralgia (8%).
Metabolic side effects have included hypokalemia (31%), increased lactic dehydrogenase (13%), and hypomagnesemia (10%).
Hypersensitivity side effects including anaphylaxis have been reported.
More about gemtuzumab
- Gemtuzumab ozogamicin
- Gemtuzumab Intravenous (Advanced Reading)
- Gemtuzumab ozogamicin Intravenous (Advanced Reading)
- Other brands: Mylotarg
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