Romidepsin, Intravenous Route

Cancer treatment Romidepsin is administered intravenously in a hospital setting and is suitable for adult patients who have already undergone other treatments.

Overview

Romidepsin is a cancer treatment used to treat cutaneous T-Cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). This group of cancers affect the immune system and appear as skin rashes first. The drug is designed for patients who have already been treated with at least one other medicine, which could have been administered either orally or by injection.

Romidepsin works by blocking certain enzymes in the body in order to slow down the growth of cancer cells so that they can then be destroyed by the body. It also affects the growth of other normal cells in the body, which can lead to unwanted effects. Doctors will discuss these potential effects with you in detail so that you can understand the risks and weigh them against the benefits. You should keep your doctor updated about all the symptoms and side effects that you experience while undergoing treatment with romidepsin.

In the US, romidepsin is known under the brand name Istodax. It is only available with a doctor’s prescription and should be administered under the supervision of a doctor. It is administered intravenously, which means it is injected directly into the vein and into the blood stream.

Conditions Treated

  • T-Cell lymphoma (CTCL)
  • Peripheral T-cell lymphoma (PTCL)

Type of Medicine

  • Histone deacetylase (HDAC) inhibitors

Side Effects

It is normal for romidepsin to cause some unwanted effects as well as its wanted, beneficial effects. Some of these effects are mild and don’t necessarily need medical attention, while others are serious and may mean that treatment has to be discontinued. You should update your doctor at each appointment on all the side effects that you experience.

The following side effects don’t always require medical attention unless they become very severe or persistent:

  • Changed sense of taste
  • Nausea
  • Vomiting
  • Constipation
  • Diarrhea
  • Itching

The following side effects can be serious and should be reported to a doctor immediately:

  • Unusual tiredness or weakness
  • Pale skin
  • Rash
  • Peeling or blistering skin
  • Worsening skin problems
  • Abnormal or easy bruising or bleeding
  • Irregular heartbeat
  • Chest pain
  • Shortness of breath
  • Fever, cough or flu-like symptoms
  • Burning sensation during urination
  • Muscle aches

There may be other side effects associated with romidepsin not listed here. If you experience any other unpleasant effects report them to your doctor or to the FDA.

Dosage

Romidepsin is administered intravenously, over a four-hour period, multiple times within a 28-day cycle. Usually, the drug is given on days 1, 8 and 15. The 28-day cycle is repeated for as long as the medication continues to have successful effects and does not cause serious or severe side effects.

A doctor or nurse will usually administer the medicine. In cases where a nurse administers it, they will be under the supervision of a doctor and following the doctor’s dosing instructions. If you experience unpleasant side effects while undergoing treatment with romidepsin, report them to your doctor. In cases where serious or severe side effects occur, your doctor may reduce your dose temporarily or permanently, or stop the treatment temporarily or permanently.

Interactions

Your doctor should know about all the medicines you currently take, including prescribed drugs and those purchased over the counter. They should also know about the herbal supplements and vitamins you are taking. This is because romidepsin can interact with a wide range of other drugs and:

  • Become less effective
  • Make other medicines less effective
  • Increase the risk of side effects
  • Cause other complications

It is particularly important that your doctor knows of the medicines you take which fall within the following categories:

  • Abnormal heartbeat medicines
  • Antibiotics (for treatment of bacterial infections)
  • Antifungals (for treatment of fungal infections)
  • Antidepressants
  • Anti-seizure medicines (for treatment of epilepsy)
  • Blood thinning medicines
  • HIV or AIDS treatments
  • Tuberculosis (TB) treatments

You should also tell your doctor or dentist that you are undergoing romidepsin therapy before you have surgery. This is because some of the medicines used during surgery may interact with romidepsin.

It may be helpful to write a list of all the medicines you take so that you can take these to each doctor’s appointment. A list like this may also be helpful should you ever need to be admitted to an emergency room.

The following medications are not recommended for concurrent use with romidepsin. Your doctor will either change some of the medicines you’re currently taking or decide not to treat you with romidepsin.

  • Atazanavir (Reyataz)
  • Boceprevir (Victrelis)
  • Cobicistat (Tybost)
  • Lopinavir (Kaletra)
  • Nelfinavir (Viracept)
  • Ritonavir (Norvir)
  • Saquinavir (Invirase, Fortovase)
  • Telaprevir (Incivek)
  • Tipranavir (Aptivus)

The following medications are not recommended for concurrent use with romidepsin, but in some instances both medicines may be required. Your doctor may adjust the dosage of your current medicines or they might give you new instructions as to how to take existing medicines, such as taking it at a different time of day. Always follow your doctor’s instructions closely.

  • Carbamazepine (Carbatrol, Epitol, Equetro, TEGretol)
  • Clarithromycin (Biaxin)
  • Conivaptan (Vaprisol)
  • Dexamethasone (Baycadron, Dexamethasone Intensol, DexPak)
  • Eliglustat (Cerdelga)
  • Enzalutamide (Xtandi)
  • Fosphenytoin (Cerebyx)
  • Idelalisib (Zydelig)
  • Indinavir (Crixivan)
  • Itraconazole (Onmel, Sporanox)
  • Ketoconazole (Nizoral)
  • Mitotane (Lysodren)
  • Nefazodone (Serzone)
  • Phenytoin (Dilantin, Phenytek)
  • Posaconazole (Noxafil)
  • Primidone (Mysoline)
  • Rifabutin (Mycobutin)
  • Rifampin (Rifadin, Rimactane)
  • Rifapentine (Priftin)
  • Simeprevir (Olysio)
  • St. John's Wort
  • Telithromycin (Ketek)
  • Voriconazole (VFEND)

Grapefruit

Grapefruit and grapefruit juice may interact with romidepsin. Talk to your doctor to check if it is safe to consume grapefruit or grapefruit juice while undergoing this treatment.

Warnings

Concurrent medical conditions

Make sure your doctor knows your full medical history and is aware of all the medical conditions you currently have. Romidepsin may not be suitable for patients with certain medical conditions, so it’s very important that you notify them of all ailments, no matter how minor.

Romidepsin is used with caution in patients with the following conditions because the drug may worsen them:

  • Anemia
  • Bone marrow or blood problems
  • Mononucleosis (Epstein Barr infection), or a history of it
  • Hepatitis B infection, or a history of it
  • Leukopenia (low white blood cell counts)
  • Thrombocytopenia (low blood platelet counts)

The following conditions could increase the risk or severity of side effects associated with romidepsin, and the drug is used with caution in patients with a history of them:

  • Congenital long QT syndrome (a condition which affects heart rhythm)
  • Other heart rhythm problems
  • Heart disease
  • Blood vessel disease
  • Hypokalemia (low blood potassium levels)
  • Hypomagnesemia (low blood magnesium levels)

Decreased liver and kidney function

Patients with severe kidney disease or moderate to severe liver disease may not be able to undergo treatment with romidepsin. This is because the drug will be processed by the body at a much slower rate, which means it will stay in the body longer and increase the risk of serious side effects. Doctors may reduce the dosage of the drug to account for this, or they may avoid treating you with romidepsin altogether depending on the severity of your kidney or liver disease.

Nausea, vomiting and diarrhea

Romidepsin can cause nausea, vomiting and diarrhea. These side effects aren’t usually a problem unless they become prolonged, as they could cause dehydration and subsequent complications. Tell your doctor if you have been suffering from nausea, vomiting or diarrhea before starting treatment with romidepsin, since the medicine could worsen these problems and cause serious health problems.

Increased risk of serious infection

Romidepsin can reduce the body’s ability to fight off infection. This means that patients are more susceptible to infection and more likely to suffer serious, life-threatening infection. It is very important that you report all signs of infection to your doctor as soon as possible, which include:

  • Fever
  • Cough
  • Flu-like symptoms
  • Shortness of breath
  • Chest pain
  • Muscle aches
  • Burning urination (indicative of bladder or urinary tract infection)
  • Worsening skin problems

Infection can occur at any point during treatment with romidepsin and for up to 30 days afterwards. You are at an increased risk of infection if you’ve had chemotherapy in the past.

Risk of TLS

Tumor Lysis Syndrome (TLS) is a serious condition in which metabolic abnormalities occur due to large amounts of cancer cells being destroyed and releasing their contents into the bloodstream. You should drink lots of fluids during the first 3 days of each romidepsin dose. Your doctor may prescribe additional medicines to prevent or treat TLS, and they may perform additional blood tests to check for the syndrome.

Pediatric use

There is not enough evidence available to determine the safety and efficacy of romidepsin in patients under the age of 18. Doctors may still prescribe the drug if they believe it will be a beneficial treatment. They may administer lower doses than those typically given to adult patients.

Pregnancy and breastfeeding

Romidepsin is an FDA pregnancy category D drug, which means it should be avoided during pregnancy. Animal studies have shown that it poses serious risks to the fetus. There is also some evidence of fetal risk in human pregnancies. For this reason, the drug should be avoided unless its benefits warrant its use despite potential risks.

Tell your doctor if you become pregnant while undergoing romidepsin treatment. Your doctor will advise you to avoid trying to become pregnant while taking this medicine, and may recommend that you use birth control. You should not use hormonal contraceptives since romidepsin may stop them from working as they should. Examples of hormonal contraceptives include:

  • Pills
  • Patches
  • Rings
  • Implants
  • Injections

It isn’t known whether romidepsin is excreted into human milk and what effects it could have on a nursing infant, but it is assumed that it could be harmful. Nursing mothers should decide to either discontinue breastfeeding or avoid the use of romidepsin. Your doctor will be able to help you make this decision by discussing the benefits and values of the drug to you.

Keep all appointments

It’s very important that you attend all appointments at the laboratory, hospital or with your doctor. You need to adhere to the dosing cycle to ensure the drug has the best chance of working correctly. Plus, your doctor will want to assess you regularly to see how well the drug is working for you, and they will order lab tests frequently. If you cannot make a planned appointment, try to reschedule as soon as possible.

Storage

Since romidepsin is administered by medical professionals in a hospital environment, you will not be required to store it at home. You should, however, retain all information leaflets about the drug which will be provided to you by your doctor. This information will outline the key side effects and warnings associated with the drug which you may need to refer back to while undergoing treatment. If there is any information you do not understand, ask your doctor for advice.

Summary

Romidepsin is a cancer treatment which is typically used in patients with cutaneous or peripheral T-cell lymphoma who have already undergone treatments with other medicines. It slows down the growth of cancer cells so that the body can destroy them. In the US, it is known as Istodax and it is only available with a doctor’s prescription.

This drug is administered intravenously, which means it is diluted into a solution and injected directly into a vein over the course of four hours. This means that it has to be given in a hospital setting either by a doctor or a nurse. Usually, patients will have the injections three times every 28 days, usually on days 1, 8 and 15. Cycles are repeated for as long as the medicine is effective and doesn’t cause serious side effects.

Since romidepsin destroys cancer cells, it can also kill normal cells in the process. This means that it can cause unwanted side effects. Many patients will experience nausea, vomiting, diarrhea or constipation, itching and changed sense of taste, but these don’t usually require treatment unless they become prolonged.

Romidepsin can make the body less capable of fighting infection, and patients are at an increased risk of serious infection throughout romidepsin therapy and for 30 days afterwards. Look out for signs of infection and report them to your doctor immediately. Symptoms include fever, flu-like symptoms, persistent cough, muscle aches, burning urination, worsening skin problems, chest pain and shortness of breath.

This drug is not suitable for use during pregnancy due to serious risks to the fetus. Tell your doctor if you become pregnant while taking romidepsin. Avoid pregnancy by using birth control, but do not rely on hormonal birth control since romidepsin can make it less effective. Breastfeeding should also be avoided when taking romidepsin. People with liver or kidney disease, problem blood cells or platelets, heart rhythm problems, low magnesium or potassium levels, or heart or blood vessel disease also may not be able to take romidepsin.

 

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Last Reviewed:
January 30, 2018
Last Updated:
January 27, 2018
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