ROMIDEPSIN

(ROE mi DEP sin) Brand: Istodax

What is the most significant information I must know about romidepsin?

• Till you receive romidepsin, speak your doctor if you have an electrolyte imbalance, a private or family history of "Long QT syndrome," heart malady, kidney malady, or liver disease.

• Do not receive romidepsin if you are pregnant. It could harm the unborn child. Use effective birth control, and speak your doctor if you become pregnant during treatment.

• Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective satis to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking romidepsin.

• You will need regular medical trials to be certain this medicine is not causing deleterious effects. Do not miss any follow-up visits to your doctor.

• Call your doctor if you have a serious side effect such as severe nausea or vomiting, chest pain, quick or uneven heartbeats, feeling short of breath, fever, chills, flu symptoms, pale skin, light bruising or bleeding, muscle cramps, confusion, pain or burning when you urinate, or worsening of your CTCL skin symptoms.

What is romidepsin?

• Romidepsin blocks determined enzymes in the body and interferes with the growth of tumor cells.

• Romidepsin is used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or CTCL).

• Romidepsin is generally given after another medications have been tried without successful treatment of symptoms.

• Romidepsin may also be used for another purposes not listed in this medicine guide.

What must I discuss with my health care provider till receiving romidepsin?

• You must not use this medicine if you are allergic to it.

• If you have any of these another conditions, you may need a doze adjustment or particular trials to safely receive this medication:

· an electrolyte imbalance (such as tall or low levels of potassium or magnesium in your blood);

· a private or family history of "Long QT syndrome";

· heart disease;

· kidney malady; or

· liver disease.

• FDA pregnancy category D. Romidepsin can reason harm to an unborn child or reason birth defects. Before you receive romidepsin, speak your doctor if you are pregnant. Use an effective form of birth control, and speak your doctor if you become pregnant during treatment.

• Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective satis to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking romidepsin.

• It is not known whether romidepsin passes into breast milk or if it could harm a nursing child. Do not receive this medicine without telling your doctor if you are breast-feeding a baby.

How is romidepsin given?

• Romidepsin is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medication should be given slowly through an IV infusion, and can take up to 4 hours to complete.

• Romidepsin is generally given each 7 days for 3 weeks. This treatment cycle may be repeated 28 days after your first doze. Your doctor will determine how long to treat you with romidepsin.

• Romidepsin can lower the blood cells that help your body fight infections. This can create it easier for you to bleed from an injury or get sick from being near others who are ill.

• To be certain your blood cells do not get too low, your blood will need to be tested on a regular basis. Your heart course may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these trials. Do not miss any scheduled visits to your doctor.

What happens if I miss a dose?

• Call your doctor for instructions if you miss an appointment for your romidepsin injection.

What happens if I overdose?

• Search abnormal medical attention if you think you have used too many of this medicine.

• Symptoms of a romidepsin overdose are not known.

What must I avoid while receiving romidepsin?

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of romidepsin?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have a serious side effect such as:

· severe nausea or vomiting;

· chest pain, quick or uneven heartbeats, feeling short of breath;

· fever, chills, body aches, flu symptoms, sores in your mouth and throat;

· pale skin, feeling light-headed, rapid heart course, trouble concentrating;

· light bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

· low magnesium (depression, muscle cramps, feeling weary or irritable, severe or ongoing diarrhea);

· low potassium (confusion, uneven heart course, extreme thirst, heighten urination, leg discomfort, muscle weakness or limp feeling);

· pain or burning when you urinate; or

· worsening of CTCL skin symptoms.

• Smaller serious side effects may include:

· nausea, vomiting, loss of appetite;

· diarrhea, constipation;

· weary feeling; or

· mild itching.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect romidepsin?

• Much drugs can interact with romidepsin. Adown is just a partial list. Speak your doctor if you are using:

· dexamethasone (Decadron, Hexadrol);

· isoniazid (for treating tuberculosis);

· St. John's wort;

· an antibiotic such as clarithromycin (Biaxin), erythromycin (Ery-Tab, Erythrocin), levofloxacin (Levaquin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), telithromycin (Ketek);

· antifungal medicine such as itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend);

· an antidepressant such as amitriptylline (Elavil, Vanatrip), nefazodone;

· anti-malaria medication;

· a barbiturate such as phenobarbital (Solfoton);

· a blood thinner such as warfarin (Coumadin);

· heart or blood pressure medicine such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan);

· heart rhythm medication such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), quinidine (Quinidex, Quin-Release Quin-G), and others;

· HIV or AIDS medications such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);

· medicines used to prevent organ transplant rejection;

· medication to prevent or treat nausea and vomiting, such as droperidol (Inapsine) or ondansetron (Zofran);

· medicines to treat a psychiatric mess, such as clozapine (FazaClo, Clozaril), haloperidol (Haldol), or pimozide (Orap);

· migraine headache medication such as sumatriptan (Imitrex) or zolmitriptan (Zomig);

· narcotic medicine such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose); or

· seizure medicine such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.

• There are much another medicines that can interact with romidepsin. Speak your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start using a new medicine without telling your doctor. Hold a list of all the medicines you use and show this list to any doctor or another healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about romidepsin.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.