Istodax Side Effects

Generic name: romidepsin

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.

Some side effects of Istodax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to romidepsin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking romidepsin (the active ingredient contained in Istodax) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe nausea or vomiting;

• chest pain, fast or uneven heartbeats, feeling short of breath;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• low magnesium (depression, muscle cramps, feeling tired or irritable, severe or ongoing diarrhea);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

• pain or burning when you urinate; or

• worsening of CTCL skin symptoms.

Less serious side effects of romidepsin may include:

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• tired feeling; or

• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to romidepsin: intravenous powder for injection

Gastrointestinal

Gastrointestinal side effects including nausea (up to 86%), anorexia (up to 54%), vomiting (up to 52%), constipation (up to 39%), and diarrhea (up to 20%) have been reported.

General

General side effects including asthenia/fatigue (up to 77%), infections (up to 54%), and pyrexia (up to 23%) have been reported.

Hematologic

Hematologic side effects including anemia (up to 72%), thrombocytopenia (up to 65%), neutropenia (up to 57%), lymphopenia (up to 57%), hypoalbuminemia (up to 48%), and leukopenia (up to 46%) have been reported.

Cardiovascular

Cardiovascular side effects including electrocardiogram ST-T wave changes (up to 63%) and hypotension (up to 23%) have been reported.

Metabolic

Metabolic side effects including hypocalcemia (up to 52%), hyperglycemia (up to 51%), hyperuricemia (up to 33%), hypomagnesemia (up to 28%), hypermagnesemia (up to 27%), hypophosphatemia (up to 27%), hypokalemia (up to 20%), and hyponatremia (up to 20%) have been reported.

Nervous system

Nervous system side effects including dysgeusia (up to 40%) have been reported.

Hepatic

Hepatic side effects including increased aspartate aminotransferase (up to 28%) and increased alanine aminotransferase (up to 22%) have been reported.

Dermatologic

Dermatologic side effects including pruritus (up to 31%) and dermatitis/exfoliative dermatitis (up to 27%) have been reported.

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