Available Dosage Forms:
Pharmacologic Class: Histone Deacetylase Inhibitor
Romidepsin injection is used to treat a type of cancer of the white blood cells called cutaneous T-cell lymphoma (CTCL). romidepsin is used in patients with CTCL who have 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 by romidepsin, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Some unwanted effects may not be serious but may cause concern. Some of the unwanted effects do not occur until months or years after the medicine is used.
Before you begin treatment with romidepsin, you and your doctor should talk about the good romidepsin will do as well as the risks of using it.
romidepsin is available only with your doctor's prescription.
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 romidepsin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to romidepsin 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 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 in the elderly.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
Using romidepsin 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.
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.
The presence of other medical problems may affect the use of romidepsin. Make sure you tell your doctor if you have any other medical problems, especially:
You will receive romidepsin while you are in a hospital or cancer treatment center.
romidepsin is given through a needle placed in one of your veins. It is usually given on Day 1, Day 8, and Day 15 of a 28-day cycle treatment. This 3-day treatment is given again every 28 days until your body responds to the medicine. Each treatment usually takes about 4 hours.
It is very important that your doctor check your progress at regular visits to make sure romidepsin is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.
Using romidepsin 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:
romidepsin can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats; chest pain; or shortness of breath.
romidepsin may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g. condoms, a diaphragm, or a contraceptive foam or jelly) while using romidepsin.
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
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
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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