Note: This document contains side effect information about gemtuzumab. Some dosage forms listed on this page may not apply to the brand name Mylotarg.
Applies to gemtuzumab: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of gemtuzumab ozogamicin as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with gemtuzumab ozogamicin
Serious side effects of Mylotarg
Along with its needed effects, gemtuzumab (the active ingredient contained in Mylotarg) 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
- Bleeding gums
- blood in the urine or stools
- blurred vision
- bone pain
- chest pain
- chills
- confusion
- cough
- coughing up blood
- decreased urine output
- difficulty in breathing or swallowing
- dizziness, lightheadedness, or fainting
- dry mouth
- fast or irregular heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- hoarseness
- increased hunger
- increased menstrual flow or vaginal bleeding
- increased thirst
- increased urination
- irregular heartbeat
- loss of appetite
- loss of consciousness
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- paralysis
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- rapid, shallow breathing
- rash
- red or black, tarry stools
- red or dark brown urine
- seizures
- sore throat
- stomach pain and bloating
- sweating
- swelling of the face, ankles, or hands
- tightness in the chest
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Blue lips and fingernails
- coughing that sometimes produces a pink frothy sputum
- difficult, fast, noisy breathing
- fast, pounding, or irregular heartbeat or pulse
- increased sweating
- pale skin
- ulcers, sores, or white spots in the mouth
Incidence not known
- Stomach cramps
- watery or bloody diarrhea
Other side effects of Mylotarg
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
- Constipation
Less common
- Cracked lips
For Healthcare Professionals
Applies to gemtuzumab: intravenous powder for injection.
Hematologic
Very common (10% or more): Bleeding (25%), thrombocytopenia (24%), febrile neutropenia (18%)
Common (1% to 10%): Hemorrhage
Frequency not reported: Myelosuppression, anemia[Ref]
Other
Very common (10% or more): Fever (79%), fatigue (46%)
Common (1% to 10%): Pain
Frequency not reported: Chills[Ref]
Gastrointestinal
Very common (10% or more): Nausea (21%), vomiting (21%), constipation (21%), mucositis (21%)
Common (1% to 10%): Diarrhea
Postmarketing reports: Neutropenic colitis (sometimes fatal)[Ref]
Respiratory
Common (1% to 10%): Pneumonia, lung edema
Frequency not reported: Hypoxia, respiratory failure, dyspnea
Postmarketing reports: Fungal lung infections (including Pulmonary mycosis and Pneumocystis jirovecii pneumonia) (sometimes fatal), interstitial pneumonia (sometimes fatal)[Ref]
Hepatic
Very common (10% or more): Increased AST (40%), increased ALT (16%)
Common (1% to 10%): Veno-occlusive liver disease (VOD) (sometimes fatal), hyperbilirubinemia[Ref]
Genitourinary
Postmarketing reports: Hemorrhagic cystitis (sometimes fatal)
Genitourinary side effects have included vaginal hemorrhage (12%) and hematuria (10%)[Ref]
Immunologic
Very common (10% or more): Infection (44%), sepsis (32%)
Postmarketing reports: Bacterial infections (including Stenotrophomonas infection), potential for immunogenicity[Ref]
Renal
Frequency not reported: Renal failure secondary to tumor lysis syndrome[Ref]
Cardiovascular
Common (1% to 10%): Tachycardia
Frequency not reported: QT interval prolongation, hypotension[Ref]
Dermatologic
Very common (10% or more): Rash (16%)[Ref]
Nervous system
Very common (10% or more): Headache (19%)[Ref]
Metabolic
Very common (10% or more): Hypophosphatemia (64%), hypokalemia (57%), hyponatremia (44%), alkaline phosphatase increased (13%), aspartate aminotransferase increased (14%), alanine aminotransferase increased (10%)
Common (1% to 10%): Blood bilirubin increased[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity (including anaphylaxis)[Ref]
