Gemtuzumab Ozogamicin Brand Name– Mylotarg
What is Gemtuzumab Ozogamicin
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate. It is approved for the treatment of CD33-positive acute myelogenous leukemia (AML) as a single agent in adults with newly diagnosed AML and in patients aged 2 years and older with relapsed or refractory AML.
Gemtuzumab ozogamicin is also indicated in combination with other chemotherapy agents for the treatment of pediatric patients aged 1 month and older and adults with newly diagnosed AML.
The FDA approved gemtuzumab ozogamicin in May 2000 for the treatment of CD33-positive AML in first relapse in patients aged 60 years and older who were not considered candidates for cytotoxic chemotherapy.
However, it was removed from the market voluntarily by the manufacturer in June 2010 due to safety concerns and questions of clinical benefit.
The current FDA approval includes a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population
Indications
- acute myelogenous leukemia (AML)
For the treatment of acute myelogenous leukemia (AML)
NOTE: Gemtuzumab ozogamicin has been designated by the FDA as an orphan drug for the treatment of AML.
for the treatment of newly diagnosed, CD33-positive AML as a single agent
Side Effects
- anaphylactoid reactions
- anemia
- anorexia
- antibody formation
- ascites
- bleeding
- bleeding
- cardiotoxicity
- chills
- colitis
- constipation
- diarrhea
- elevated hepatic enzymes
- elevated hepatic enzymes
- fatigue
- fatigue
- fever
- fever
- headache
- headache
- hemorrhagic cystitis
- hepatomegaly
- hepatotoxicity
- hyperbilirubinemia
- hyperbilirubinemia
- hyperglycemia
- hypokalemia
- hyponatremia
- hypophosphatemia
- hypotension
- hypoxia
- infection
- infection
- infusion-related reactions
- intracranial bleeding
- nausea
- nausea
- nephrotoxicity
- neutropenia
- oral ulceration
- oral ulceration
- pulmonary edema
- rash
- rash
- sinus tachycardia
- sinusoidal obstruction syndrome (SOS)
- subdural hematoma
- thrombocytopenia
- veno-occlusive disease (VOD)
- vomiting
- weight gain
Monitoring Parameters
- CBC with differential
- LFTs
- pregnancy testing
- serum creatinine/BUN
- serum electrolytes
- serum uric acid
Contraindications
- apheresis
- AV block
- bleeding
- bone marrow suppression
- bradycardia
- breast-feeding
- cardiomyopathy
- celiac disease
- contraception requirements
- females
- fever
- gemtuzumab ozogamicin hypersensitivity
- geriatric
- heart failure
- hepatic disease
- hepatotoxicity
- human immunodeficiency virus (HIV) infection
- hyperparathyroidism
- hypocalcemia
- hypokalemia
- hypomagnesemia
- hypothermia
- hypothyroidism
- infection
- infertility
- infusion-related reactions
- long QT syndrome
- male-mediated teratogenicity
- myocardial infarction
- neutropenia
- pheochromocytoma
- pregnancy
- pregnancy testing
- QT prolongation
- reproductive risk
- rheumatoid arthritis
- sickle cell disease
- sinusoidal obstruction syndrome (SOS)
- sleep deprivation
- stroke
- systemic lupus erythematosus (SLE)
- thrombocytopenia
- tumor lysis syndrome (TLS)
- veno-occlusive disease (VOD)
Interactions
- Aclidinium; Formoterol
- Albuterol
- Albuterol; Ipratropium
- Alfuzosin
- Amiodarone
- Amitriptyline
- Amitriptyline; Chlordiazepoxide
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Anagrelide
- Apomorphine
- Arformoterol
- Aripiprazole
- Arsenic Trioxide
- Artemether; Lumefantrine
- Asenapine
- Atomoxetine
- Azithromycin
- Bedaquiline
- Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Budesonide; Formoterol
- Buprenorphine
- Buprenorphine; Naloxone
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Crizotinib
- Dasatinib
- Degarelix
- Desflurane
- Desipramine
- Deutetrabenazine
- Dextromethorphan; Promethazine
- Dextromethorphan; Quinidine
- Disopyramide
- Dofetilide
- Dolasetron
- Dolutegravir; Rilpivirine
- Donepezil
- Donepezil; Memantine
- Doxepin
- Dronedarone
- Droperidol
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Eliglustat
- Emtricitabine; Rilpivirine; Tenofovir alafenamide
- Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
- Encorafenib
- Enflurane
- Entrectinib
- Eribulin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Escitalopram
- Ezogabine
- Fingolimod
- Flecainide
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluphenazine
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Fluvoxamine
- Formoterol
- Formoterol; Mometasone
- Foscarnet
- Gemifloxacin
- Gilteritinib
- Glasdegib
- Glycopyrrolate; Formoterol
- Goserelin
- Granisetron
- Halogenated Anesthetics
- Haloperidol
- Halothane
- Histrelin
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Iloperidone
- Imipramine
- Indacaterol
- Indacaterol; Glycopyrrolate
- Isoflurane
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lapatinib
- Lefamulin
- Lenvatinib
- Leuprolide
- Leuprolide; Norethindrone
- Levalbuterol
- Levofloxacin
- Lithium
- Lofexidine
- Long-acting beta-agonists
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Macimorelin
- Maprotiline
- Mefloquine
- Meperidine; Promethazine
- Metaproterenol
- Methadone
- Metronidazole
- Midostaurin
- Mifepristone
- Mirtazapine
- Moxifloxacin
- Nilotinib
- Nortriptyline
- Octreotide
- Ofloxacin
- Olanzapine
- Olodaterol
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Ozanimod
- Palifermin
- Paliperidone
- Panobinostat
- Pasireotide
- Pazopanib
- Penicillamine
- Pentamidine
- Perphenazine
- Perphenazine; Amitriptyline
- Phenylephrine; Promethazine
- Pimavanserin
- Pimozide
- Pirbuterol
- Pitolisant
- Posaconazole
- Primaquine
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Ribociclib
- Ribociclib; Letrozole
- Rilpivirine
- Risperidone
- Romidepsin
- Salmeterol
- Saquinavir
- Selpercatinib
- Sertraline
- Sevoflurane
- Short-acting beta-agonists
- Siponimod
- Solifenacin
- Sorafenib
- Sotalol
- Sunitinib
- Tacrolimus
- Tamoxifen
- Telavancin
- Telithromycin
- Terbutaline
- Tetrabenazine
- Thioridazine
- Tiotropium; Olodaterol
- Tolterodine
- Toremifene
- Trazodone
- Triclabendazole
- Tricyclic antidepressants
- Trifluoperazine
- Trimipramine
- Triptorelin
- Tuberculin Purified Protein Derivative, PPD
- Umeclidinium; Vilanterol
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Voriconazole
- Vorinostat
- Ziprasidone