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Note: This document contains side effect information about romidepsin. Some of the dosage forms listed on this page may not apply to the brand name Istodax.
Applies to romidepsin: intravenous powder for solution
Along with its needed effects, romidepsin (the active ingredient contained in Istodax) 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 romidepsin:
Some side effects of romidepsin 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:
Applies to romidepsin: intravenous powder for injection
Very common (10% or more): Nausea (up to 86%), vomiting (up to 52%), constipation (up to 40%), diarrhea (up to 36%), abdominal pain (up to 14%)
Common (1% to 10%): Stomatitis
The most commonly reported adverse events included neutropenia, lymphopenia, thrombocytopenia, infections, nausea, fatigue, vomiting, anorexia, anemia, and ECG T-wave changes.
The most commonly reported events leading to discontinuation included infection, fatigue, dyspnea, QT prolongation, and hypomagnesemia.
Very common (10% or more): Anemia (up to 72%), neutropenia (up to 66%), leukopenia (up to 46%), thrombocytopenia (up to 65%), lymphopenia (up to 57%)
Very common (10% or more): ST-T wave changes on ECG (up to 63%); Hypotension (up to 23%)
Common (1% to 10%): Tachycardia, supraventricular arrhythmia, ventricular arrhythmia, edema, deep vein thrombosis, chest pain
Frequency not reported: QT prolongation
Very common (10% or more): Anorexia (up to 54%), hypocalcemia (up to 52%), hyperglycemia (up to 51%), hypoalbuminemia (up to 48%), hyperuricemia (up to 33%), hypomagnesemia (up to 28%), hypermagnesemia (up to 27%), hypophosphatemia (up to 27%), hypokalemia (up to 20%), weight loss (up to 15%), hyponatremia (up to 20%),
Common (1% to 10%): Dehydration, hypoalbuminemia, hyperuricemia, tumor lysis syndrome
Very common (10% or more): Dysgeusia (up to 40%), headache (up to 34%)
Common (1% to 10%): Syncope, dizziness
Very common (10% or more): AST elevations (up to 28%), ALT elevations (up to 22%)
Common (1% to 10%): Hyperbilirubinemia
Very common (10% or more): Pruritus (up to 31%), dermatitis/exfoliative dermatitis (up to 27%)
Common (1% to 10%): Rash
Common (1% to 10%): Hypersensitivity
Very common (10% or more): Infections (up to 54%)
Common (1% to 10%): Sepsis, upper respiratory infection, urinary tract infection, pneumonia, cellulitis, oral candidiasis, central line infection, catheter related infection
Very common (10% or more): Asthenia/fatigue (up to 77%), pyrexia (up to 47%), chills (up to 17%)
Common (1% to 10%): Febrile neutropenia
Very common (10% or more): Cough (up to 21%), dyspnea (up to 21%)
Common (1% to 10%): Pulmonary embolism, pneumonitis
Common (1% to 10%): Muscle spasms, myalgia