Romidepsin belongs to the group of cancer-fighting medications known as antineoplastics. It is used to treat people with peripheral T-cell lymphoma (PTCL) that has either been treated and has returned, or is not responding to other medications and for whom transplant is not an option.

Romidepsin causes the death of cancer cells by interfering with the genetic material DNA, which is necessary for reproduction and growth of cells.

Romidepsin has been granted a notice of compliance with conditions (NOC/c) by Health Canada. This means that Health Canada has approved this medication to be marketed based on promising evidence of effectiveness, but additional results of studies are needed to verify its effectiveness. An NOC/c is used to allow access to products that are used to treat or prevent serious, life-threatening, or severely debilitating illness.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual dose of this medication is based on body size. The doctor will calculate the dose based on body surface area, which takes into account a person's height and weight.

Romidepsin is usually injected into a vein through a site on your skin that has been specially prepared for this purpose. The dose is given over 4 hours, on days 1, 8 and 15 of a 28-day cycle.

Very careful handling of this medication is required. Romidepsin should only be given by health care professionals familiar with the use of chemotherapy medications used to treat cancer. It is always given under the direct supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive romidepsin, contact your doctor as soon as possible to reschedule your appointment.

Each single-use vial of sterile, lyophilized powder contains 11 mg of romidepsin. Nonmedicinal ingredients: povidone, USP. Diluent: Each single-use vial containing 2.4 mL of sterile, clear solution contains propylene glycol, USP and dehydrated alcohol, USP.

Do not use this medication if you are allergic to romidepsin or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste
• constipation
• diarrhea
• dizziness
• dry skin
• headache
• itchiness
• loss of appetite
• muscle spasms
• nausea
• night sweats
• rash
• runny nose
• tiredness
• trouble sleeping
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety
• fever
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg), or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• stomach, mouth, joint, limb, or back pain
• swelling of mouth or legs

Stop taking the medication and seek immediate medical attention if any of the following occur:

• irregular or increased heartbeat
• symptoms of tumour lysis syndrome (e.g., decreased urination, severe muscle weakness, changed heart rhythm, seizures)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, arsenic trioxide, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with romidepsin. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Anemia: Romidepsin may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Romidepsin may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: Romidepsin may cause drowsiness or fatigue, affecting the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Fertility: Romidepsin can cause changes to sperm production and changes to the ovaries. These changes may be permanent, resulting in decreased fertility. Speak to your doctor about preserving fertility before starting to take this medication if you have concerns about these changes.

Infection: As well as killing cancer cells, romidepsin can reduce the number of cells that fight infection in the body (white blood cells). Serious and sometimes fatal infections such as blood infections (sepsis) and pneumonia have occurred with the use of romidepsin. If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Tumour lysis syndrome: Romidepsin, like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: This medication is expected to cause harm and possibly death to an unborn fetus and should not be used during pregnancy, based on the way that it works to treat cancer. If you become pregnant while taking this medication, contact your doctor immediately. People who could become pregnant who are taking romidepsin should use an effective method of birth control such as condoms during treatment and for 8 weeks after stopping the medication. Romidepsin is likely to decrease the effectiveness of birth control pills and should not be used as the only form of birth control.

It is not known if romidepsin is present in the semen of individuals taking this medication. It is important for those who are taking romidepsin to use appropriate birth control, such as condoms, to avoid exposing their partner to the medication during treatment and for 1 month after finishing treatment.

Breast-feeding: It is not known if romidepsin passes into breast milk. Because there is a high likelihood of causing harm to a nursing infant if this medication does pass into breast milk, it is advisable that either breast-feeding be stopped or the medication not used. Talk to your doctor about the risks and benefits of breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

For a full list of interactions, use the Drug Interaction Checker available on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.