Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Istodax

Descriptions


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 patients with CTCL and PTCL 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 benefits this medicine will do as well as the risks of using 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:

  • 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.

Pregnancy

Information about this romidepsin-intravenous-route
Pregnancy Category Explanation
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.

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.

  • Abiraterone Acetate
  • Amiodarone
  • Aprepitant
  • Azithromycin
  • Bosutinib
  • Captopril
  • Carbamazepine
  • Carvedilol
  • Clarithromycin
  • Conivaptan
  • Crizotinib
  • Cyclosporine
  • Dexamethasone
  • Diltiazem
  • Dronedarone
  • Enzalutamide
  • Erythromycin
  • Felodipine
  • Fosaprepitant
  • Fosphenytoin
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lomitapide
  • Mitotane
  • Nefazodone
  • Nilotinib
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Posaconazole
  • Primidone
  • Quercetin
  • Quinidine
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Simeprevir
  • St John's Wort
  • Telithromycin
  • Ticagrelor
  • Tocophersolan
  • 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. 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

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:

  • Blood or bone marrow problems (e.g., anemia, leukopenia, thrombocytopenia) or
  • Heart or blood vessel disease or
  • Heart rhythm problems (e.g., congenital long QT syndrome), or history of or
  • Mineral imbalance (e.g., magnesium, potassium imbalance)—Use with caution. May make these conditions worse.
  • Infection—May decrease your body's ability to fight infection.
  • Kidney disease, severe or
  • Liver disease, moderate and severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

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. 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.

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.

Precautions

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 (including pneumonia and sepsis) more easily while using this medicine. These can occur during treatment and within 30 days after treatment. Tell your doctor right away if you have a fever, cough, shortness of breath with or without chest pain, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems.

This medicine 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 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; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Cancer medicines can cause nausea and/or vomiting in most people, sometimes 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 (e.g., 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

  1. Abdominal or stomach cramps or pain
  2. black, tarry stools
  3. bleeding gums
  4. blood in the urine or stools
  5. blurred vision
  6. bone pain
  7. chest pain
  8. chills
  9. coma
  10. confusion
  11. convulsions
  12. cough or hoarseness
  13. decreased urine output
  14. difficulty with breathing
  15. dizziness
  16. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  17. drowsiness
  18. dry mouth
  19. fast or irregular heartbeat
  20. fever
  21. flushed, dry skin
  22. fruit-like breath odor
  23. headache
  24. increased hunger
  25. increased thirst
  26. increased urination
  27. joint pain, stiffness, or swelling
  28. loss of appetite
  29. lower back or side pain
  30. mood or mental changes
  31. muscle cramps in the hands, arms, feet, legs, or face
  32. muscle pain
  33. muscle spasms (tetany) or twitching seizures
  34. nausea or vomiting
  35. numbness or tingling in the hands, fingertips, feet, or lips
  36. painful or difficult urination
  37. pale skin
  38. pinpoint red spots on the skin
  39. shortness of breath
  40. sore throat
  41. sores, ulcers, or white spots on the lips or in the mouth
  42. sweating
  43. swelling of the face, ankles, feet, lower legs, or hands
  44. swollen glands
  45. trembling
  46. tremor
  47. troubled breathing
  48. troubled breathing with exertion
  49. unexplained weight loss
  50. unusual bleeding or bruising
  51. unusual tiredness or weakness

Less common

  1. Fainting
  2. fast, pounding, or irregular heartbeat or pulse
  3. swelling

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

  1. Change in taste
  2. constipation
  3. cracks in the skin
  4. diarrhea
  5. itching skin
  6. lack or loss of strength
  7. loss of appetite
  8. loss of heat from the body
  9. loss of taste
  10. red, swollen skin
  11. scaly skin
  12. 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.