What is Romidepsin?

Romidepsin injection is used to treat certain types of cancer of the white blood cells called cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). This medicine is used in a patient who has already been treated with other medicines.

Romidepsin interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Before you begin treatment with romidepsin, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.

This medicine is to be given only by or under the direct supervision of a doctor.

You will receive this medicine while you are in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of romidepsin injection in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of romidepsin injection in the elderly.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Atazanavir
• Boceprevir
• Cobicistat
• Lopinavir
• Nelfinavir
• Ritonavir
• Saquinavir
• Telaprevir
• Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Clarithromycin
• Conivaptan
• Dexamethasone
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Mitotane
• Nefazodone
• Phenytoin
• Posaconazole
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• Simeprevir
• St John's Wort
• Telithromycin
• Voriconazole

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Blood or bone marrow problems or
• Epstein Barr infection (mononucleosis), history of or
• Hepatitis B infection, history of or
• Leukopenia (low white blood cells) or
• Thrombocytopenia (low platelets)—Use with caution. May make these conditions worse.

• Congenital long QT syndrome (heart rhythm problem) or
• Heart or blood vessel disease or
• Heart rhythm problems, history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May make side effects become worse.

• Infection—May decrease your body's ability to fight an infection.

• Kidney disease, severe or
• Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using 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. These can occur during treatment and within 30 days after the last dose. Tell your doctor right away if you have a fever, cough, shortness of breath, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems.

This medicine may cause heart rhythm changes, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have fast, pounding, or uneven heartbeats, chest pain, or shortness of breath.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. 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.

Cancer medicines can cause nausea and/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.