romidepsin
Romidepsin (Istodax) is a medication used to treat cutaneous T-cell lymphoma (CTCL), a rare type of blood cancer that mainly affects the skin. It's FDA approved for adults whose cancer has come back or hasn't improved after at least one previous treatment. Romidepsin (Istodax) is given as an intravenous (IV) infusion by a healthcare professional on certain days of a 28-day treatment cycle. Common side effects are nausea, tiredness, infections, and low blood cell counts.
What is Romidepsin (Istodax)?
What is Romidepsin (Istodax) used for?
- Cutaneous T-cell lymphoma (CTCL) in adults after at least one previous treatment stopped working
How Romidepsin (Istodax) works
Romidepsin (Istodax) is a histone deacetylase (HDAC) inhibitor. It works by blocking HDAC proteins, which normally help control which genes are turned on and off in your cells.
In some cancers, HDAC proteins allow cancer cells to grow and survive. By blocking these proteins, romidepsin (Istodax) helps slow or stop cancer cell growth and can cause cancer cells to die.
Drug facts
| Common Brands | Istodax |
|---|---|
| Drug Class | HDAC inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Romidepsin (Istodax)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Nausea (56%)
- Tiredness(53%)
- Infections (46%)
- Vomiting (34%)
- Loss of appetite (23%)
- Low magnesium levels (22%)
- Diarrhea (20%)
- Fever (20%)
Less Common Side Effects
- Low red blood cell counts
- Low platelet counts
- Taste changes
- Constipation
- Low white blood cells
- Low blood pressure
- Itching
- Low potassium levels
- Low calcium levels
Romidepsin (Istodax) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Low blood cell counts: unusual bleeding or bruising, tiredness
- Serious infections: fever, cough, shortness of breath, chest pain, burning with urination, flu-like symptoms, muscle aches, worsening skin problems
- Heart problems: abnormal heartbeat, lightheadedness, dizziness, chest pain, shortness of breath
- Tumor lysis syndrome: urinating less, dark urine, muscle cramps, racing heartbeat
The following Romidepsin (Istodax) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Change in taste
- Constipation
- Fatigue
- Loss of appetite
- Nausea
Pros and cons of Romidepsin (Istodax)
Pros
- Option for CTCL after at least one previous treatment has stopped working
- Given every week for 3 weeks followed by a week off
- Relieves itching for most people
Cons
- Must be given as an IV infusion
- Can cause low blood cell counts and raise risk for infections
- Requires frequent blood tests
Pharmacist tips for Romidepsin (Istodax)
- Keep all of your appointments while receiving romidepsin (Istodax). Your oncology care team will check your blood counts and electrolyte levels to make sure it's safe to continue treatment.
- Nausea and vomiting are common with romidepsin (Istodax). You'll receive medications before each infusion to help prevent these side effects, and your oncologist might prescribe additional medication to take at home if needed.
- Tell your oncology care team about all the medications, vitamins, supplements, herbal products, and foods you use before starting romidepsin (Istodax). Some products can interact with the medication and raise your risk of side effects.
- Contact your oncology care team right away if you develop a fever of 100.4°F or higher while receiving romidepsin (Istodax). This medication can raise your risk of serious infections, and a fever might be the first sign.
- Romidepsin (Istodax) might affect your ability to have children. Tell your oncologist before starting treatment if you plan to have children in the future.
- Pregnancy: Romidepsin (Istodax) can harm an unborn baby. If you can become pregnant or you’re a man with a partner who can become pregnant, use effective birth control during treatment and for 1 month after your last dose. Tell your oncologist right away if you or your partner becomes pregnant.
- Breastfeeding: Don't breastfeed while taking romidepsin (Istodax) or for 1 week after your last dose. It's not known whether the medication passes into breast milk.
Risks and warnings for Romidepsin (Istodax)
Romidepsin (Istodax) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Low blood cell counts
Romidepsin (Istodax) can lower your white blood cells, red blood cells, and platelets. This can raise your risk of infection, bleeding, and anemia (low red blood cells). Your oncology care team will check your blood counts regularly during treatment. Tell your care team right away if you have a fever, unusual bleeding or bruising, severe tiredness, or shortness of breath.
Infections
- Risk factors: Cancer involving the bone marrow | Previous treatment with certain anticancer medications | History of hepatitis B or Epstein-Barr infections
Romidepsin (Istodax) can raise your risk of serious bacterial, viral, and fungal infections. Contact your oncology care team right away if you develop a fever, chills, muscle aches, severe tiredness, or other signs of infection. If you develop a serious infection, your treatment might be paused or stopped while the infection is treated.
If you've had hepatitis B (HBV) or Epstein-Barr virus (EBV) in the past, these viruses can become active again during treatment with romidepsin (Istodax). Your oncologist might test you for these viruses before you start treatment and prescribe medication to help prevent them from coming back if needed.
Abnormal heart rhythm
- Risk factors: History of heart rhythm problems | History of heart problems | Taking medications that affect heart rhythm
Romidepsin (Istodax) can affect your heart rhythm and rarely cause QT prolongation, a change in your heart's electrical activity that can be serious or life-threatening. Your risk is higher if you have certain heart conditions, low electrolyte levels, or take other medications that can also cause QT prolongation.
Before and during treatment, your oncology care team may check your heart with an electrocardiogram (ECG) and monitor your electrolyte levels. Tell your care team right away if you have a fast or irregular heartbeat, dizziness, fainting, or chest pain.
Tumor lysis syndrome
- Risk factors: Advanced-stage cancer | High tumor burden
Although rare, treatment with romidepsin (Istodax) can cause tumor lysis syndrome (TLS), a serious condition that happens when cancer cells break down too quickly. This can damage your kidneys or cause dangerous heart rhythm problems.
Your oncology care team will check your blood tests regularly for signs of TLS. They may also recommend drinking plenty of fluids, give you IV fluids, or prescribe medication to treat the condition. Contact your care team right away if you urinate less than usual, have dark urine, muscle cramps, or a fast or racing heartbeat.
Harm to unborn babies
Before starting treatment with romidepsin (Istodax), let your oncologist know if you’re pregnant or planning to become pregnant. Romidepsin (Istodax) hasn’t been studied in human pregnancy, but it’s possible that the medication can cause harm to the unborn baby based on findings from animal studies.
If you’re able to become pregnant, your oncology care team will have you take a pregnancy test before starting treatment. They’ll also ask you to use effective birth control while taking this medication and for at least 1 month after your last dose. If you’re male and have a partner who’s able to become pregnant, you should also use effective methods to prevent pregnancy while on this medication and for at least 1 month after the last dose.
Romidepsin (Istodax) dosage
Typical dosage for Romidepsin (Istodax)
Your oncology care team will calculate your dose based on your body surface area (BSA), which accounts for your height and weight.
The typical dose is 14 mg/m² given as an intravenous (IV) infusion on days 1, 8, and 15 of a 28-day treatment cycle. This means you'll receive treatment once a week for 3 weeks, followed by 1 week without treatment before starting the next cycle.
Your dose might differ if you have liver problems or develop side effects during treatment.
