Midostaurin Brand Name– Rydapt
What is Midostaurin
Midostaurin is an oral tyrosine kinase inhibitor that inhibits mutant FLT3 (ITD and TKD) and D816V mutant KIT.
Midostaurin is indicated for the treatment of adult patients with newly diagnosed, FLT3 mutation-positive acute myeloid leukemia (AML) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
It is also indicated as single-agent therapy for the treatment of aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia.
Midostaurin is approved for use with a diagnostic test, the LeukoStrat CDx FLT3 Mutation Assay; this test is used to detect the FLT3 mutation in patients with AML.
Fatal cases of interstitial lung disease and pneumonitis have been reported; patients should be monitored for signs and symptoms of pulmonary toxicity.
Indications
- acute myelogenous leukemia (AML)
- systemic mastocytosis
For the treatment of acute myelogenous leukemia (AML)
NOTE: The FDA has designated midostaurin as an orphan drug for the treatment of AML.
What are the side effects of Midostaurin?
- Abdominal pain
- Anaphylactic shock
- Anemia
- Angina
- Angioedema
- Arthralgia
- Asthenia
- Back pain
- Bone pain
- Bronchospasm
- Chest pain (unspecified)
- Chills
- Colitis
- Constipation
- Cough
- Cystitis
- diarrhea
- Diarrhea
- Dizziness
- Dyspepsia
- Dyspnea
- Edema
- Elevated hepatic enzymes
- Epistaxis
- Erythema multiforme
- Fatigue
- Fever
- Flushing
- Gastritis
- GI bleeding
- Headache
- Heart failure
- Hematoma
- Hemorrhoids
- Hyperamylasemia
- Hyperbilirubinemia
- Hypercalcemia
- Hyperglycemia
- Hyperhidrosis
- Hyperkalemia
- Hypernatremia
- Hypertension
- Hyperuricemia
- Hypoalbuminemia
- Hypocalcemia
- Hypokalemia
- Hypomagnesemia
- Hyponatremia
- Hypophosphatemia
- Hypotension
- Infection
- Insomnia
- Leukopenia
- Lymphopenia
- Maculopapular rash
- Musculoskeletal pain
- Myocardial infarction
- Nausea
- Nephrotoxicity
- Neutropenia
- Pericardial effusion
- Peripheral edema
- Petechiae
- Pharyngitis
- Pleural effusion
- Pneumonitis
- Prolonged bleeding time
- Pulmonary edema
- QT prolongation
- Rash
- Renal failure (unspecified)
- Sinusitis
- Stomatitis
- Thrombocytopenia
- Thrombosis
- Tremor
- Vertigo
- Vomiting
- Weight gain
- Xerosis
Monitoring Parameters
- CBC with differential
- Pregnancy testing
Contraindications
- Anemia
- Apheresis
- AV block
- Bradycardia
- Breast-feeding
- Cardiomyopathy
- Celiac disease
- Contraception requirements
- Females
- Fever
- Geriatric
- heart failure
- History of angioedema
- Human immunodeficiency virus (HIV) infection
- Hyperparathyroidism
- Hypocalcemia
- Hypokalemia
- Hypomagnesemia
- Hypothermia
- Hypothyroidism
- Infertility
- Long QT syndrome
- Male-mediated teratogenicity
- Myocardial infarction
- Nausea/vomiting
- Neutropenia
- Pheochromocytoma
- Pneumonitis
- Pregnancy
- Pregnancy testing
- Pulmonary toxicity
- QT prolongation
- Reproductive risk
- Rheumatoid arthritis
- Sickle cell disease
- Sleep deprivation
- Stroke
- Systemic lupus erythematosus (SLE)
- Thrombocytopenia
Interactions
- Aclidinium; Formoterol
- Albuterol
- Albuterol; Ipratropium
- Alfuzosin
- Amiodarone
- Amitriptyline
- Amitriptyline; Chlordiazepoxide
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Anagrelide
- Apalutamide
- Apomorphine
- Arformoterol
- Aripiprazole
- Arsenic Trioxide
- Artemether; Lumefantrine
- Asenapine
- Atazanavir
- Atazanavir; Cobicistat
- Atomoxetine
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Azithromycin
- Bedaquiline
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Brigatinib
- Budesonide; Formoterol
- Buprenorphine
- Buprenorphine; Naloxone
- Carbamazepine
- Ceritinib
- Chloramphenicol
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobicistat
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Conivaptan
- Crizotinib
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Dasatinib
- Degarelix
- Delavirdine
- Desflurane
- Desipramine
- Deutetrabenazine
- Dextromethorphan; Promethazine
- Dextromethorphan; Quinidine
- Diltiazem
- Disopyramide
- Dofetilide
- Dolasetron
- Dolutegravir; Rilpivirine
- Donepezil
- Donepezil; Memantine
- Doxepin
- Dronedarone
- Droperidol
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Eliglustat
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Emtricitabine; Rilpivirine; Tenofovir alafenamide
- Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
- Encorafenib
- Enflurane
- Entrectinib
- Enzalutamide
- Eribulin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Escitalopram
- Ezogabine
- Fingolimod
- Flecainide
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluphenazine
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Fluvoxamine
- Formoterol
- Formoterol; Mometasone
- Fosamprenavir
- Foscarnet
- Fosphenytoin
- Fostemsavir
- Gemifloxacin
- Gemtuzumab Ozogamicin
- Gilteritinib
- Glasdegib
- Glycopyrrolate; Formoterol
- Goserelin
- Granisetron
- grapefruit juice
- Halogenated Anesthetics
- Haloperidol
- Halothane
- Histrelin
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Idelalisib
- Iloperidone
- Imipramine
- Indacaterol
- Indacaterol; Glycopyrrolate
- Indinavir
- Inotuzumab Ozogamicin
- Isoflurane
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lapatinib
- Lefamulin
- Lenvatinib
- Letermovir
- Leuprolide
- Leuprolide; Norethindrone
- Levalbuterol
- Levofloxacin
- Lithium
- Lofexidine
- Long-acting beta-agonists
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Lumacaftor; Ivacaftor
- Lumacaftor; Ivacaftor
- Macimorelin
- Maprotiline
- Mefloquine
- Meperidine; Promethazine
- Metaproterenol
- Methadone
- Metronidazole
- Mifepristone
- Mirtazapine
- Mitotane
- Moxifloxacin
- Nefazodone
- Nelfinavir
- Nilotinib
- Nortriptyline
- Octreotide
- Ofloxacin
- Olanzapine
- Olodaterol
- Ombitasvir; Paritaprevir; Ritonavir
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Ozanimod
- Palifermin
- Paliperidone
- Panobinostat
- Pasireotide
- Pazopanib
- Penicillamine
- Pentamidine
- Perphenazine
- Perphenazine; Amitriptyline
- Phenobarbital
- Phenylephrine; Promethazine
- Phenytoin
- Pimavanserin
- Pimozide
- Pirbuterol
- Pitolisant
- Posaconazole
- Primaquine
- Primidone
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Ribociclib
- Ribociclib; Letrozole
- Rifampin
- Rilpivirine
- Risperidone
- Ritonavir
- Romidepsin
- Salmeterol
- Saquinavir
- Selpercatinib
- Sertraline
- Sevoflurane
- Short-acting beta-agonists
- Siponimod
- Solifenacin
- Sorafenib
- Sotalol
- St. John’s Wort, Hypericum perforatum
- Sunitinib
- Tacrolimus
- Tamoxifen
- Telavancin
- Telithromycin
- Terbutaline
- Tetrabenazine
- Thioridazine
- Tiotropium; Olodaterol
- Tipranavir
- Tolterodine
- Toremifene
- Trazodone
- Triclabendazole
- Tricyclic antidepressants
- Trifluoperazine
- Trimipramine
- Triptorelin
- Tuberculin Purified Protein Derivative, PPD
- Tucatinib
- Umeclidinium; Vilanterol
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Voriconazole
- Vorinostat
- Ziprasidone
