Istodax

The usual dose of Istodax (Romidepsin) is based on body size. The doctor will calculate the dose based on body surface area, which takes into account a person's height and weight.

Istodax (Romidepsin) is usually injected into a vein through a site on your skin that has been specially prepared for this purpose. The dose is given over 4 hours, on days 1, 8 and 15 of a 28 day cycle.

Very careful handling of Istodax (Romidepsin) is required. Istodax (Romidepsin) should only be given by health care professionals familiar with the use of chemotherapy medications used to treat cancer. It is always given under the direct supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important Istodax (Romidepsin) be given exactly as recommended by your doctor. If you miss an appointment to receive Istodax (Romidepsin), contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each single-use vial of sterile, lyophilized powder contains 10 mg of Istodax (Romidepsin). Nonmedicinal ingredients: povidone, USP. Diluent: Each single-use vial containing 2 mL of sterile, clear solution contains propylene glycol, USP and dehydrated alcohol, USP.

Do not use Istodax (Romidepsin) if you are allergic to Istodax (Romidepsin) or any ingredients of the medication.

There may be an interaction between Istodax (Romidepsin) and any of the following:

• 5-ASA medications (e.g., Mesalamine, Olsalazine, Sulfasalazine)
• Amiodarone
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., pentobarbital, Phenobarbital)
• Baricitinib
• BCG intravesical
• birth control pills (oral contraceptives)
• Bosentan
• Carbamazepine
• Carvedilol
• Cobicistat
• corticosteroids (high doses; Dexamethasone, Hydrocortisone, Methylprednisolone)
• Cyclosporine
• Dabrafenib
• Deferasirox
• Denosumab
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Domperidone
• Dronedarone
• echinacea
• Elagolix
• Eliglustat
• Enzalutamide
• Fingolimod
• Flecainide
• Flibanserin
• formoterol
• Hepatitis C antivirals (e.g., glecaprevir and pibrentasvir, ledipasvir, velpatasvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• laxatives
• Leflunomide
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• mefloquine
• Methadone
• mifepristone
• Mitotane
• Modafinil
• Natalizumab
• Nilotinib
• Ocrelizumab
• Ozanimod
• Phenytoin
• Pimecrolimus
• Primaquine
• primidone
• procainamide
• Propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifabutin
• rifampin
• Roflumilast
• St. John's wort
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• siltuximab
• siponimod
• sotalol
• tacrolimus
• Tocilizumab
• Tofacitinib
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• upadacitinib
• vaccines
• verapamil
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Istodax (Romidepsin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Istodax (Romidepsin).

Abnormal heart rhythms: Istodax (Romidepsin) can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, probucol, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Istodax (Romidepsin). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Istodax (Romidepsin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Istodax (Romidepsin), and whether any special monitoring is needed.

Anemia: Istodax (Romidepsin) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Istodax (Romidepsin) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: Istodax (Romidepsin) may cause drowsiness or fatigue, affecting the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Istodax (Romidepsin) affects you.

Fertility: Istodax (Romidepsin) can cause changes to sperm production and changes to the ovaries. These changes may be permanent, resulting in decreased fertility. Speak to your doctor about preserving fertility before starting to take Istodax (Romidepsin) if you have concerns about these changes.

Infection: As well as killing cancer cells, Istodax (Romidepsin) can reduce the number of cells that fight infection in the body (white blood cells). Serious and sometimes fatal infections such as blood infections (sepsis) and pneumonia have occurred with the use of Istodax (Romidepsin). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: Liver disease or reduced liver function may cause Istodax (Romidepsin) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Istodax (Romidepsin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Istodax (Romidepsin), and whether any special monitoring is needed.

Tumour lysis syndrome: Istodax (Romidepsin), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: Istodax (Romidepsin) is expected to cause harm and possibly death to an unborn fetus and should not be used during pregnancy, based on the way that it works to treat cancer. If you become pregnant while taking Istodax (Romidepsin), contact your doctor immediately. Women who could become pregnant who are taking Istodax (Romidepsin) should use an effective method of birth control such as condoms during treatment and for 8 weeks after stopping the medication. Istodax (Romidepsin) is likely to decrease the effectiveness of birth control pills and should not be used as the only form of birth control.

It is not known if Istodax (Romidepsin) is present in the semen of a male taking Istodax (Romidepsin). It is important for men who are taking Istodax (Romidepsin) to use appropriate birth control, such as condoms, to avoid exposing their partner to the medication during treatment and for 1 month after finishing treatment.

Breast-feeding: It is not known if Istodax (Romidepsin) passes into breast milk. Because there is a high likelihood of causing harm to a nursing infant if Istodax (Romidepsin) does pass into breast milk, it is advisable that either breast-feeding be stopped or the medication not used. Talk to your doctor about the risks and benefits of breast-feeding.

Children: The safety and effectiveness of using Istodax (Romidepsin) have not been established for children.