Romidepsin Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 11, 2024.

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

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are woman who can get pregnant, your doctor will give you a pregnancy test within 7 days before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, IUD, spermicide) along with your pills. Women should use an effective form of birth control during treatment and for at least 1 month after the last dose. Men should use an effective form of birth control during treatment and for at least 1 month after the last dose to prevent pregnancy in a sexual partner. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Romidepsin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You may get infections more easily while using this medicine. Tell your doctor right away if you have a fever, cough, burning sensation on urination, flu-like symptoms, muscle aches, or worsening skin problems.

This medicine may cause heart rhythm changes, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Tell your doctor right away if you have a fast, pounding, or uneven heartbeat, chest pain, or trouble breathing.

This medicine may cause a serious called tumor lysis syndrome. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Some men and women receiving this medicine have become infertile (unable to have children). If you plan to have children, talk with your doctor before receiving this medicine.

Cancer medicines can cause nausea or vomiting even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

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:

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:

For healthcare professionals

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

General adverse events

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]

Gastrointestinal

• Very common (10% or more): Nausea (86%), vomiting (52%), constipation (40%), diarrhea (36%), abdominal pain (14%)
• Common (1% to 10%): Stomatitis^[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^[Ref]

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

See also:

Further information

Romidepsin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer