Romidepsin Intravenous

In the U.S.

• Istodax

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Histone Deacetylase Inhibitor

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). romidepsin is used in a patient who has 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, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Before you begin treatment with romidepsin, you and your doctor should talk about the benefits of romidepsin as well as the risks of using it.

romidepsin is to be given only by or under the direct supervision of a doctor.

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:

Allergies

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.

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

Breast Feeding

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.

Interactions with Medicines

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 romidepsin, 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 romidepsin 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 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.

• Carbamazepine
• Clarithromycin
• Conivaptan
• Dexamethasone
• Eliglustat
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Mitotane
• Nefazodone
• Phenytoin
• Posaconazole
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• Simeprevir
• St John's Wort
• Telithromycin
• Voriconazole

Interactions with Food/Tobacco/Alcohol

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 romidepsin 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 romidepsin, 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 romidepsin. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Blood or bone marrow problems or
• Epstein Barr infection (mononucleosis), history of or
• Hepatitis B infection, history of or
• Leukopenia (low white blood cells) or
• Thrombocytopenia (low platelets)—Use with caution. May make these conditions worse.

• Congenital long QT syndrome (heart rhythm problem) or
• Heart or blood vessel disease or
• Heart rhythm problems, history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use with caution. May make side effects become worse.

• Infection—May decrease your body's ability to fight an infection.

• Kidney disease, severe or
• Liver disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), current/recent infection.

This drug may make you tired. Alcohol or marijuana can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Romidepsin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using romidepsin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using romidepsin safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Romidepsin can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. See also Drug Interactions section.

It is unknown if this drug passes into breast milk and may harm nursing infants. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

See also Precautions section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: disulfiram, "blood thinners" (such as warfarin).

Other medications can affect the removal of romidepsin from your body, thereby affecting how romidepsin works. These drugs include azole antifungals (such as itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (such as clarithromycin), HIV drugs (such as ritonavir), nefazodone, rifamycins (such as rifabutin, rifampin), St. John's wort, and some drugs used to treat seizures (such as carbamazepine), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Many drugs besides romidepsin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as complete blood count, potassium/magnesium blood levels, EKG, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all regular medical and laboratory appointments.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.