Treatment Name: Romidepsin (Istodax®)

Romidepsin (Istodax®) is a Chemotherapy Regimen for Lymphoma, T-Cell

How does romidepsin work?
Romidepsin is designed to either kill cancer cells, or slow growth of cancer cells by helping activate anti-cancer genes that have been turned off.

Goals of therapy:
Romidepsin is a chemotherapy drug given to shrink tumors and decrease symptoms of T-cell lymphoma. Romidepsin is not commonly given with the goal of cure.

Schedule

Romidepsin intravenous infusion is given over four hours on Days 1, 8, and 15
- No treatment is given on Day 22

Romidepsin is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, romidepsin may be given in the hospital if someone is too sick.

Romidepsin is repeated every 28 days. This is known as one cycle. Each cycle is repeated until the drug stops working or when intolerable side effects occur.

Click here for common starting doses.

Side Effects

In clinical studies, the most commonly reported side effects with romidepsin are shown here. Drug side effects sometimes have percentage ranges [example 51 – 54%] because they differed between clinical studies:

Nausea (51 - 54%)
Fatigue or muscle weakness (41 - 52%)
Low white blood cells (29 - 49%)
Increased bleeding risk [low platelets] (40 - 47%)
Anemia [low red blood cells] (21 - 40%)
Vomiting (19 - 34%)
Diarrhea (11 - 23%)
Altered taste (6 - 21%)
Fever (17 - 20%)
Infections (6 - 18%)
Headache (11 - 17%)
Constipation (8 - 15%)
Weight loss (8%)
Mouth sores (7%)
Stomach pain (6%)
Upset stomach (5%)
Trouble breathing (5%)
Fast heart beat (5%)
Chills (5%)
Water retention (2%)

Approximately 10% of patients discontinue romidepsin due to unacceptable side effects.

Side effect videos
Nausea and VomitingFatigue AnemiaDiarrheaConstipation

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and before each dose of romidepsin. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood potassium, blood magnesium, plus any you doctor may order.

How often is imaging needed?
Imaging may be checked before treatment and periodically during treatment to check for side effects and to see how you are responding to therapy. Imaging may include: electrocardiogram (ECG also known as "EKG"), computed tomography (CT) scan, or positron emission tomography (PET) scan.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue romidepsin as planned, or delay or switch therapy.

Questions to Ask Your...

A better understanding of your treatments will allow you to ask more questions of your healthcare team. We then hope that with the answers, you will get better results and have greater satisfaction with your care. Because we know it's not always easy to know what questions to ask, we've tried to make it easy for you!

Choose any healthcare provider below to see common questions that you may want to ask of this person. Then, either print each list to bring to your clinic visits, or copy the questions and send them as a message to your healthcare team through your electronic medical record.

Questions to ask your Doctor Nurse Pharmacist

Questions to ask your Nurse Doctor Pharmacist

Questions to ask your Pharmacist Doctor Nurse

ChemoExperts Tips

A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
Clinical trials may exist for T-cell lymphoma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Romidepsin (Istodax®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Romidepsin (Istodax®). Depending upon your income, they may be able to help cover the cost of:

Romidepsin

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Romidepsin (Istodax®) and are the best source to help you understand drug cost.

Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Romidepsin (Istodax®)

Individual Drug Label Information

Romidepsin (Istodax®)

Romidepsin is an intravenous infusion
Dosage adjustments may be required for low blood counts or severe side effects
May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions
May interact with grapefruit and grapefruit juice causing increased blood levels of romidepsin. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment
Avoid therapy with St. Johns Wort as it will decrease blood levels of romidepsin. This could decrease the effectiveness of romidepsin

General Romidepsin (Istodax) Side Effects

Can cause a rare but serious heart arrhythmia known as prolonged QTc interval. Electrocardiograms and blood electrolytes (potassium, magnesium, calcium) will be checked frequently
Serious infections can occur. Contact your doctor if you experience any signs of a possible illness
Can cause low red blood cells, white blood cells, and platelets
May cause fatigue and muscle weakness
Can cause an increase or decrease in in blood electrolytes
Click on the romidepsin (Istodax) package insert below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaFatigue ConstipationAnemia

See DailyMed package insert.

References

1. Coiffier B, Pro B, Prince HM, et al. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012;30:631-636.

2. Piekarz RL, Frye R, Prince HM, et al. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011;117:5827-5834.

Created: November 8, 2015 Updated: September 22, 2018

What is Lymphoma, T-Cell?

A disease of lymphocytes called T-lymphocytes, or "T-cells" that are found most commonly in the skin, spleen, blood, bone marrow, and/or lymph nodes. Peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) are the two main types of T-cell lymphoma; however, there are many different subtypes of PTCL and CTCL and all are very rare.

The exact cause of T-cell lymphomas is not known, but certain viral infections such as the Epstein-Barr Virus (EBV) and human T-cell leukemia virus have been associated with development of T-cell lymphomas. The stage of T-cell lymphoma can vary at diagnosis and throughout treatment. Stages of T-cell lymphoma include stage I, II, III, and IV. The effectiveness of the treatment may depend upon the stage and specific subtype at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common Starting Dose

Romidepsin 14 mg/m² intravenous infusion is given over 4 hours on days 1, 8, and 15
- No treatment is given on Day 22

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

2. Piekarz RL, Frye R, Prince HM, et al. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011;117:5827-5834.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status, 2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.