Gemtuzumab Ozogamicin

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

  1. anaphylactoid reactions
  2. anemia
  3. anorexia
  4. antibody formation
  5. ascites
  6. bleeding
  7. bleeding
  8. cardiotoxicity
  9. chills
  10. colitis
  11. constipation
  12. diarrhea
  13. elevated hepatic enzymes
  14. elevated hepatic enzymes
  15. fatigue
  16. fatigue
  17. fever
  18. fever
  19. headache
  20. headache
  21. hemorrhagic cystitis
  22. hepatomegaly
  23. hepatotoxicity
  24. hyperbilirubinemia
  25. hyperbilirubinemia
  26. hyperglycemia
  27. hypokalemia
  28. hyponatremia
  29. hypophosphatemia
  30. hypotension
  31. hypoxia
  32. infection
  33. infection
  34. infusion-related reactions
  35. intracranial bleeding
  36. nausea
  37. nausea
  38. nephrotoxicity
  39. neutropenia
  40. oral ulceration
  41. oral ulceration
  42. pulmonary edema
  43. rash
  44. rash
  45. sinus tachycardia
  46. sinusoidal obstruction syndrome (SOS)
  47. subdural hematoma
  48. thrombocytopenia
  49. veno-occlusive disease (VOD)
  50. vomiting
  51. 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
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