Description
Romidepsin injection is used to treat a certain type of cancer of the white blood cells called cutaneous T-cell lymphoma (CTCL) in patients who have received at least 1 previous treatment.
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 receiving it.
This medicine is to be given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
Before Using
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:
Allergies
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of romidepsin injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
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.
Drug Interactions
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.
- Apalutamide
- Carbamazepine
- Clarithromycin
- Conivaptan
- Enzalutamide
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ketoconazole
- Lumacaftor
- Mitotane
- Nefazodone
- Phenytoin
- Posaconazole
- Rifampin
- St John's Wort
- Telithromycin
- Voriconazole
Other Interactions
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
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 (low red blood cells) or
- Blood or bone marrow problems or
- Epstein Barr infection (mononucleosis), history of or
- Hepatitis B infection, history of or
- Kidney disease or
- Leukopenia (low number of white blood cells) or
- Thrombocytopenia (low number of 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—Use with caution. May make side effects become worse.
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood)—Use with caution. These conditions must be corrected first before receiving this medicine.
- Infection—May decrease your body's ability to fight an infection.
- Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.
This medicine is usually given on days 1, 8, and 15 of a 28-day cycle of treatment. Each treatment takes at least 4 hours.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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.
Side Effects
Along with its needed effects, a medicine 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:
More common
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- bone pain
- chest pain
- chills
- confusion
- cough
- decreased urine output
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- fast or irregular heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- hoarseness
- increased hunger
- increased thirst
- increased urination
- joint pain, stiffness, or swelling
- loss of appetite
- lower back or side pain
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms or twitching
- nausea
- numbness or tingling in the hands, fingertips, feet, or lips
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- seizures
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach cramps or pain
- sweating
- swelling of the face, ankles, feet, lower legs, or hands
- swollen glands
- tremor
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Some side effects 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:
More common
- Change in taste
- constipation
- cracks in the skin
- diarrhea
- itching
- lack or loss of strength
- loss of heat from the body
- loss of taste
- red, swollen skin
- scaly skin
- weight loss
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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