Romidepsin, Injection

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KEY POINTS

• This medicine is given by IV to treat cutaneous and peripheral T-cell lymphomas.
• People receiving this medicine can develop serious infections that may cause death. These infections can happen during treatment and within 30 days after treatment.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: romidepsin, injection; Istodax

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat cutaneous and peripheral T-cell lymphomas when other anticancer medicines are not effective.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Gout
• Heart problems
• Kidney or liver problems
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with the amount of magnesium or potassium in your blood

This medicine may make you sterile (unable to have children) whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Hormonal birth control may be less effective while you are taking this medicine. Talk with your provider about this. Do not breast-feed while you are receiving this medicine.

How do I use it?

This medicine is given by IV infusions (slow drip through a needle into a large vein) by your healthcare provider. The infusions are usually given over 4 hours. Your healthcare provider will determine how long you will need this treatment. Keep all appointments for these infusions.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Follow your provider’s instructions about how much liquid to drink while you are receiving this medicine.

People receiving this medicine can develop serious infections that may cause death. These infections can happen during treatment and within 30 days after treatment. Your risk of infection may be higher if you have had chemotherapy in the past. Tell your healthcare provider right away if you have any of these symptoms of infection:

• Fever
• Burning with urination
• Cough or shortness of breath
• Muscle aches
• Worsening skin problems

Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

Do not drink alcohol or take aspirin while receiving this medicine. It may increase the risk of bleeding. Report any unusual bruising or bleeding to your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chills, fever, shortness of breath, cough, sore throat, severe weakness or tiredness, mouth sores, unusual bruising or bleeding, chest pain, irregular or fast heartbeat, fainting, dizziness, burning on urination or trouble urinating, swelling in your arms or legs or any unusual swelling, severe nausea or vomiting, severe diarrhea, mouth sores, muscle aches, worsening of skin problems.

Other: Nausea; vomiting; constipation; loss of appetite; diarrhea; tiredness; weakness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider before receiving:

• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, and sotalol (Betapace, Sorine)
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Oravig), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni) and sofosbuvir (Sovaldi)
• Artemether/lumefantrine (Coartem)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), imatinib (Gleevec), nilotinib (Tasigna), procarbazine (Matulane), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Dextromethorphan/quinidine (Nuedexta)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Genvoya, Stribild), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings (Talk to your healthcare provider if you need birth control.)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), granisetron (Sancuso), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Quinine
• St. John’s wort
• Vaccines
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.