Panobinostat

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Panobinostat Brand Name– FARYDAK

What is Panobinostat

Panobinostat is a histone deacetylase (HDAC) inhibitor that works by blocking the enzymatic activity of HDAC causing increased acetylation of histone proteins leading to transcriptional activation.

The accumulation of acetylated histones and other proteins resulted in cell cycle arrest and/or apoptosis of some transformed cells in vitro.

Panobinostat is indicated in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.

At a median follow-up time of 6.47 months (interquartile range, 1.81 to 13.47 months), the median progression-free survival (PFS) time was significantly improved in patients with relapsed or relapsed and refractory multiple myeloma who received panobinostat, bortezomib, and dexamethasone (11.99 months) compared with placebo, bortezomib, and dexamethasone (8.08 months; hazard ratio (HR) = 0.63; 95% CI, 0.52 to 0.76; p < 0.0001) in a multinational, double-blind, randomized, phase III trial (the PANORAMA1 trial; n = 768).

The overall survival (OS) time was not significantly improved in the panobinostat arm compared with placebo arm (33.64 months vs. 30.39 months; HR = 0.87; 95% CI, 0.69 to 1.1); however, OS data are not mature.

Panobinostat (Farydak) was approved by the FDA in February 2015. It was an accelerated approval based on PFS data; however, continued approval may be dependent upon verification and description of clinical benefit in confirmatory trials.

Indications

  • cutaneous T-cell lymphoma (CTCL)
  • multiple myeloma

For the treatment of multiple myeloma in patients who have received at least 2 prior therapies (including bortezomib and an immunomodulatory agent), in combination with bortezomib and dexamethasone

NOTE: Panobinostat has been designated as an orphan drug by the FDA.

Side Effects

  1. abdominal pain
  2. anemia
  3. anemia
  4. anorexia
  5. anorexia
  6. asthenia
  7. asthenia
  8. atrial fibrillation
  9. atrial flutter
  10. atrial tachycardia
  11. bleeding
  12. bradycardia
  13. cardiac arrest
  14. cardiotoxicity
  15. cheilitis
  16. chills
  17. colitis
  18. cough
  19. dehydration
  20. diarrhea
  21. diarrhea
  22. dizziness
  23. dysgeusia
  24. dyspepsia
  25. dyspnea
  26. elevated hepatic enzymes
  27. erythema
  28. fatigue
  29. fatigue
  30. fever
  31. fever
  32. flatulence
  33. fluid retention
  34. gastritis
  35. GI bleeding
  36. headache
  37. hepatitis
  38. hyperbilirubinemia
  39. hyperbilirubinemia
  40. hyperglycemia
  41. hypermagnesemia
  42. hypermagnesemia
  43. hyperphosphatemia
  44. hyperphosphatemia
  45. hypertension
  46. hyperuricemia
  47. hypoalbuminemia
  48. hypoalbuminemia
  49. hypocalcemia
  50. hypocalcemia
  51. hypokalemia
  52. hypokalemia
  53. hypomagnesemia
  54. hyponatremia
  55. hyponatremia
  56. hypophosphatemia
  57. hypophosphatemia
  58. hypotension
  59. hypothyroidism
  60. infection
  61. insomnia
  62. lethargy
  63. lethargy
  64. leukopenia
  65. leukopenia
  66. lymphopenia
  67. lymphopenia
  68. malaise
  69. malaise
  70. nausea
  71. nausea
  72. neutropenia
  73. neutropenia
  74. orthostatic hypotension
  75. palpitations
  76. peripheral edema
  77. peripheral edema
  78. QT prolongation
  79. rash
  80. renal failure (unspecified)
  81. respiratory arrest
  82. sinus tachycardia
  83. skin ulcer
  84. supraventricular tachycardia (SVT)
  85. supraventricular tachycardia (SVT)
  86. syncope
  87. thrombocytopenia
  88. thrombocytopenia
  89. tremor
  90. urinary incontinence
  91. ventricular tachycardia
  92. vomiting
  93. vomiting
  94. weight loss
  95. weight loss
  96. wheezing
  97. xerostomia

Monitoring Parameters

  • CBC with differential
  • ECG
  • LFTs
  • pregnancy testing
  • serum electrolytes

Contraindications

  • anemia
  • angina
  • apheresis
  • AV block
  • bleeding
  • bradycardia
  • breast-feeding
  • cardiac arrhythmias
  • cardiomyopathy
  • cardiotoxicity
  • celiac disease
  • children
  • contraception requirements
  • dehydration
  • diarrhea
  • electrolyte imbalance
  • females
  • fever
  • fungal infection
  • geriatric
  • GI bleeding
  • heart failure
  • hepatic disease
  • human immunodeficiency virus (HIV) infection
  • hyperparathyroidism
  • hypocalcemia
  • hypokalemia
  • hypomagnesemia
  • hypothermia
  • hypothyroidism
  • infants
  • infection
  • infertility
  • long QT syndrome
  • male-mediated teratogenicity
  • myocardial infarction
  • nausea/vomiting
  • neonates
  • neutropenia
  • pheochromocytoma
  • pregnancy
  • pregnancy testing
  • pulmonary bleeding
  • QT prolongation
  • reproductive risk
  • rheumatoid arthritis
  • sickle cell disease
  • sleep deprivation
  • stroke
  • systemic lupus erythematosus (SLE)
  • thrombocytopenia
  • viral infection

Interactions

  • Acetaminophen; Butalbital; Caffeine; Codeine
  • Acetaminophen; Caffeine; Dihydrocodeine
  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
  • Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
  • Acetaminophen; Codeine
  • Acetaminophen; Dextromethorphan
  • Acetaminophen; Dextromethorphan; Doxylamine
  • Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine
  • Acetaminophen; Dextromethorphan; Phenylephrine
  • Acetaminophen; Dextromethorphan; Pseudoephedrine
  • Acetaminophen; Hydrocodone
  • Acetaminophen; Tramadol
  • Aclidinium; Formoterol
  • Albuterol
  • Albuterol; Ipratropium
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Amitriptyline; Chlordiazepoxide
  • Amoxicillin; Clarithromycin; Lansoprazole
  • Amoxicillin; Clarithromycin; Omeprazole
  • Anagrelide
  • Apalutamide
  • Apomorphine
  • Aprepitant, Fosaprepitant
  • Arformoterol
  • Aripiprazole
  • Arsenic Trioxide
  • Artemether; Lumefantrine
  • Asenapine
  • Aspirin, ASA; Butalbital; Caffeine; Codeine
  • Aspirin, ASA; Caffeine; Dihydrocodeine
  • Aspirin, ASA; Carisoprodol; Codeine
  • Atazanavir; Cobicistat
  • Atomoxetine
  • Atropine; Hyoscyamine; Phenobarbital; Scopolamine
  • Azithromycin
  • Bedaquiline
  • Belladonna Alkaloids; Ergotamine; Phenobarbital
  • Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
  • Bismuth Subsalicylate; Metronidazole; Tetracycline
  • Boceprevir
  • Brexpiprazole
  • Brompheniramine; Dextromethorphan; Guaifenesin
  • Brompheniramine; Dextromethorphan; Phenylephrine
  • Brompheniramine; Guaifenesin; Hydrocodone
  • Brompheniramine; Hydrocodone; Pseudoephedrine
  • Budesonide; Formoterol
  • Buprenorphine
  • Buprenorphine; Naloxone
  • Carbamazepine
  • Carbinoxamine; Dextromethorphan; Pseudoephedrine
  • Carbinoxamine; Hydrocodone; Phenylephrine
  • Carbinoxamine; Hydrocodone; Pseudoephedrine
  • Ceritinib
  • Chloroquine
  • Chlorpheniramine; Codeine
  • Chlorpheniramine; Dextromethorphan
  • Chlorpheniramine; Dextromethorphan; Phenylephrine
  • Chlorpheniramine; Dihydrocodeine; Phenylephrine
  • Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
  • Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
  • Chlorpheniramine; Hydrocodone
  • Chlorpheniramine; Hydrocodone; Phenylephrine
  • Chlorpheniramine; Hydrocodone; Pseudoephedrine
  • Chlorpromazine
  • Ciprofloxacin
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Codeine
  • Codeine; Guaifenesin
  • Codeine; Phenylephrine; Promethazine
  • Codeine; Promethazine
  • Conivaptan
  • Crizotinib
  • Daclatasvir
  • Darunavir; Cobicistat
  • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
  • Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
  • Dasatinib
  • Degarelix
  • Desflurane
  • Desipramine
  • Deutetrabenazine
  • Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
  • Dextromethorphan
  • Dextromethorphan; Diphenhydramine; Phenylephrine
  • Dextromethorphan; Guaifenesin
  • Dextromethorphan; Guaifenesin; Phenylephrine
  • Dextromethorphan; Guaifenesin; Potassium Guaiacolsulfonate
  • Dextromethorphan; Guaifenesin; Pseudoephedrine
  • Dextromethorphan; Promethazine
  • Dextromethorphan; Quinidine
  • Dihydrocodeine; Guaifenesin; Pseudoephedrine
  • Diphenhydramine; Hydrocodone; Phenylephrine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Dolutegravir; Rilpivirine
  • Doxepin
  • Dronedarone
  • Droperidol
  • Efavirenz
  • Efavirenz; Emtricitabine; Tenofovir
  • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
  • Elbasvir; Grazoprevir
  • 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
  • Fluticasone; Salmeterol
  • Fluticasone; Umeclidinium; Vilanterol
  • Fluticasone; Vilanterol
  • Fluvoxamine
  • Formoterol
  • Formoterol; Mometasone
  • Fosamprenavir
  • Foscarnet
  • Fosphenytoin
  • Fostemsavir
  • Gefitinib
  • Gemifloxacin
  • Gemtuzumab Ozogamicin
  • Gilteritinib
  • Glasdegib
  • Glecaprevir; Pibrentasvir
  • Glycopyrrolate; Formoterol
  • Goserelin
  • Granisetron
  • grapefruit juice
  • Guaifenesin; Hydrocodone
  • Guaifenesin; Hydrocodone; Pseudoephedrine
  • Halogenated Anesthetics
  • Haloperidol
  • Halothane
  • Histrelin
  • Homatropine; Hydrocodone
  • Hydrochlorothiazide, HCTZ; Metoprolol
  • Hydrocodone
  • Hydrocodone; Ibuprofen
  • Hydrocodone; Phenylephrine
  • Hydrocodone; Potassium Guaiacolsulfonate
  • Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
  • Hydrocodone; Pseudoephedrine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indacaterol
  • Indacaterol; Glycopyrrolate
  • Indinavir
  • Inotuzumab Ozogamicin
  • Isoflurane
  • 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
  • Macimorelin
  • Maprotiline
  • Mefloquine
  • Meperidine; Promethazine
  • Metaproterenol
  • Methadone
  • Metoprolol
  • Metronidazole
  • Mexiletine
  • Midostaurin
  • Mifepristone
  • Mirtazapine
  • Mitotane
  • Nebivolol
  • Nebivolol; Valsartan
  • Nefazodone
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Olodaterol
  • Ombitasvir; Paritaprevir; Ritonavir
  • Omeprazole; Amoxicillin; Rifabutin
  • Ondansetron
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Ozanimod
  • Palifermin
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Penicillamine
  • Pentamidine
  • Perphenazine
  • Perphenazine; Amitriptyline
  • Phenobarbital
  • Phenylephrine; Promethazine
  • Phenytoin
  • Pimavanserin
  • Pimozide
  • Pirbuterol
  • Pitolisant
  • Posaconazole
  • Primidone
  • Procainamide
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Ribociclib; Letrozole
  • Rifabutin
  • Rifapentine
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Romidepsin
  • Salmeterol
  • Sapropterin
  • Saquinavir
  • Selpercatinib
  • Sertraline
  • Sevoflurane
  • Short-acting beta-agonists
  • Siponimod
  • Sofosbuvir; Velpatasvir; Voxilaprevir
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St. John’s Wort, Hypericum perforatum
  • Sunitinib
  • Tacrolimus
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Telotristat Ethyl
  • Terbutaline
  • Tetrabenazine
  • Thioridazine
  • Tiotropium; Olodaterol
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Triclabendazole
  • Trimipramine
  • Triptorelin
  • Tuberculin Purified Protein Derivative, PPD
  • Tucatinib
  • Umeclidinium; Vilanterol
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Voriconazole
  • Vorinostat
  • Ziprasidone
  • Zonisamide

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