Applies to romidepsin: intravenous powder for solution, intravenous solution.

Serious side effects of Romidepsin

Along with its needed effects, romidepsin 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:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• bone pain
• chest pain
• chills
• confusion
• cough
• decreased urine output
• difficulty with breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fast or irregular heartbeat
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hoarseness
• increased hunger
• increased thirst
• increased urination
• joint pain, stiffness, or swelling
• loss of appetite
• lower back or side pain
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms or twitching
• nausea
• numbness or tingling in the hands, fingertips, feet, or lips
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps or pain
• sweating
• swelling of the face, ankles, feet, lower legs, or hands
• swollen glands
• tremor
• trouble breathing
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Other side effects of 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:

More common

• Change in taste
• constipation
• cracks in the skin
• diarrhea
• itching
• lack or loss of strength
• loss of heat from the body
• loss of taste
• red, swollen skin
• scaly skin
• weight loss

For Healthcare Professionals

Applies to romidepsin: intravenous powder for injection, intravenous solution.

Gastrointestinal

Very common (10% or more): Nausea (86%), vomiting (52%), constipation (40%), diarrhea (36%), abdominal pain (14%)

Common (1% to 10%): Stomatitis^[Ref]

General

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.^[Ref]

Hematologic

Very common (10% or more): Anemia (72%), neutropenia (66%), leukopenia (46%), thrombocytopenia (65%), lymphopenia (57%)^[Ref]

Cardiovascular

Very common (10% or more): ST-T wave changes on ECG (63%), hypotension (23%)

Common (1% to 10%): Tachycardia, supraventricular arrhythmia, ventricular arrhythmia, edema, deep vein thrombosis, chest pain

Frequency not reported: QT prolongation^[Ref]

Metabolic

Very common (10% or more): Anorexia (54%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), hyperuricemia (33%), hypomagnesemia (28%), hypermagnesemia (27%), hypophosphatemia (27%), hypokalemia (20%), weight loss (15%), hyponatremia (20%),

Common (1% to 10%): Dehydration, hypoalbuminemia, hyperuricemia, tumor lysis syndrome^[Ref]

Nervous system

Very common (10% or more): Dysgeusia (40%), headache (34%)

Common (1% to 10%): Syncope, dizziness^[Ref]

Hepatic

Very common (10% or more): AST elevations (28%), ALT elevations (22%)

Common (1% to 10%): Hyperbilirubinemia^[Ref]

Dermatologic

Very common (10% or more): Pruritus (31%), dermatitis/exfoliative dermatitis (27%)

Common (1% to 10%): Rash^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Immunologic

Very common (10% or more): Infections (54%)

Common (1% to 10%): Sepsis, upper respiratory infection, urinary tract infection, pneumonia, cellulitis, oral candidiasis, central line infection, catheter related infection

Other

Very common (10% or more): Asthenia/fatigue (77%), pyrexia (47%), chills (17%)

Common (1% to 10%): Febrile neutropenia

Respiratory

Very common (10% or more): Cough (21%), dyspnea (21%)

Common (1% to 10%): Pulmonary embolism, pneumonitis

Musculoskeletal

Common (1% to 10%): Muscle spasms, myalgia