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Romidepsin

(roe-muh-dep-sin)

Trade/other name(s): Istodax®, depsipeptide, FK228

Why would this drug be used?

Romidepsin is used to treat peripheral T-cell lymphoma, as well as a type of skin cancer known as cutaneous T-cell lymphoma (CTCL), usually after other treatments have been tried. It is also being studied for use against several other types of cancer.

How does this drug work?

Romidepsin is a type of anti-cancer drug known as a histone deacetylase (HDAC) inhibitor. It is thought to work by blocking enzymes in cells called histone deacetylases. Cancer cells sometimes have too many of these enzymes, which stop the cells from making proteins needed to keep them from growing and dividing too fast.

By blocking these HDAC enzymes, romidepsin allows the cells to make these important proteins, which may cause cancer cells to stop growing or to die.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any heart problems, including an abnormal or fast heart rhythm, or a condition called prolonged QT syndrome. This drug can slow down the heart's electrical impulses and may make the problems worse (see “Precautions” below).
  • If you have problems with the amount of magnesium or potassium in your blood. These minerals can affect the rhythm of the heart.
  • If you are having nausea, vomiting, or diarrhea. This drug may make these symptoms worse (see “Precautions” below).
  • If you have any other medical conditions such as liver disease (including hepatitis), kidney disease, high blood pressure, diabetes, gout, or infections. You may need closer monitoring of these conditions while being treated.
  • If you are using some type of birth control (contraceptive) containing estrogen, such as birth control pills, patches, or implants. This drug may reduce the effectiveness of these contraceptives.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. This drug may cause problems with the fetus if taken at the time of conception or during pregnancy (see “Precautions” below).
  • If you are breast-feeding. It is not known whether this drug passes into breast milk. If it does, it may affect the baby. If you are nursing, talk to your doctor about whether to stop breast-feeding or stop taking this drug.
  • If you think you might want to have children in the future. This drug may affect your fertility. Talk with your doctor about the possible risk with this drug and options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs or other treatments

This drug can interact with many other drugs, so it is very important to tell your doctor about all drugs, vitamins, or dietary supplements you are taking.

This drug should be used with caution in people who take warfarin (Coumadin) or other "blood-thinning" drugs, as it may increase the time it takes for blood to clot and raise the risk of bleeding.

Other drugs may affect the amount of romidepsin in the body (which could make it less effective or cause dangerous side effects), or they may be affected by romidepsin. These include:

  • Drugs to treat tuberculosis (TB)
  • Drugs to treat bacterial infections (antibiotics)
  • Drugs to treat fungal infections (antifungals)
  • Drugs to treat HIV infection or AIDS
  • Drugs to treat seizures (anti-epileptics)
  • Drugs to treat depression (antidepressants), including St. John's wort
  • Drugs to treat abnormal heart rhythms
  • Dexamethasone (a corticosteroid)

Check with your doctor, nurse, or pharmacist about these or any other medicines, herbs, and supplements you are taking, and whether alcohol can cause problems with this medicine.

No other serious interactions with drugs are known at this time. But this does not necessarily mean that none exist.

Interactions with foods

Grapefruit and grapefruit juice can sometimes interact with drugs like those listed above. Check with your doctor, nurse, or pharmacist about whether consuming grapefruit or grapefruit juice may be a problem if you are taking this drug.

No other interactions with food are known at this time.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Romidepsin is given as an infusion into a vein (IV), usually over 4 hours. The dose is based on your body size.

It is usually given once a week for 3 weeks, followed by a week without treatment. This 4-week cycle is continued as long as you are being helped by the drug and the side effects aren't too severe. If you have serious side effects, your doctor may need to reduce the dose, delay the next treatment, or stop treatment with this drug altogether.

Precautions

This drug may affect your heart rhythm, which in some cases can cause serious problems. Your doctor may get tests of your heart rhythm (EKGs) before and during treatment. He or she will likely test your blood during treatment for certain minerals that can affect your heart rhythm. Tell your doctor or nurse right away if you have a slow or irregular heartbeat, chest pain, shortness of breath, or if you feel dizzy or lightheaded.

You may have nausea, vomiting and/or diarrhea while taking this drug. Your doctor may prescribe medicines to help prevent these side effects that you can take at home. It is important to have these medicines on hand and to take them as prescribed by your doctor. Report any vomiting or diarrhea to your doctor or nurse.

Your doctor will likely test your blood frequently throughout your treatment, looking for possible effects of the drug on blood counts and blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether.

This drug may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Speak with your doctor before taking any drugs or supplements that might affect your body's ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising or bleeding, such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting a serious infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever, unexplained pain, chills, pain when passing urine, new cough, or bringing up sputum.

This drug may lower your red blood cell count. If this occurs, it is usually a few weeks to months after starting treatment. A low red blood cell count (known as anemia) can cause shortness of breath, or make you to feel weak or tired all the time. Your doctor may give you medicines to help prevent or treat this condition, or you may need to get blood transfusions.

This drug can cause the rapid killing of tumor cells, which in some cases has led to a serious imbalance of electrolytes (salts and minerals) in the blood, and even kidney damage within the first 3 days of treatment. This condition is known as tumor lysis syndrome. It is more likely if you have a large number of cancer cells in the body, such as at the beginning of treatment. If your doctor feels you might be at risk, he or she will give you medicines and/or fluids to help prevent it.

This drug should not be taken if you are pregnant. This drug might cause problems with the fetus if taken at the time of conception or during pregnancy. Women who could become pregnant need to use effective birth control during treatment and for some time afterward. Check with your doctor about what kinds of birth control can be used with this medicine. Tell your doctor right away if you think you might be pregnant.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.

Common

  • Feeling tired or weak
  • Nausea/vomiting*
  • Loss of appetite
  • Changes in how foods taste
  • Lowered white blood cell count*
  • Lowered blood platelet count with increased risk of bleeding*
  • Lowered red blood cell count (anemia)*
  • Changes in blood levels of magnesium or other minerals
  • Infections
  • Increased blood sugar levels
  • Rash or itchy skin
  • Diarrhea*
  • Constipation

Less common

  • Fever, chills
  • Low blood pressure
  • Abnormal blood tests that suggest that the drug is affecting the liver (your doctor will discuss the importance of this finding, if any.)
  • Changes electric impulses of the heart (seen on EKG)*

Rare

  • Headache
  • Swelling in the hands or feet
  • Infection in the blood
  • Abnormal heart rhythm*
  • Death from infection in the blood or lungs*

*See "Precautions" section for more detailed information.

There are other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2009.

Disclaimer: This information may not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 08/21/2013
Last Revised: 08/21/2013