Istodax

Istodax is a prescription medication used to treat T-cell lymphoma affecting the skin when other treatments have not be successful. Istodax belongs to a group of drugs called histone deacetylase inhibitors. This medication works by interfering with the growth of tumor cells.

This medication comes in an injectable form. It is given directly into a vein (IV) by a healthcare provider every 7 days for 3 weeks.

Common side effects include nausea, vomiting, diarrhea, loss of appetite, and tiredness. Do not drive or operate heavy machinery until you know how Istodax affects you.

Istodax is a prescription medicine used to treat people with a type of cancer called cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) after at least one other type of medicine by mouth or injection has been tried.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Celgene Corporation

• Gloucester Pharmaceuticals, Inc.

Serious side effects have been reported with Istodax. See the “Istodax Precautions” section.

Common side effects of Istodax include:

• nausea, vomiting, diarrhea
• loss of appetite
• tiredness

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Istodax. For more information, ask your doctor or pharmacist.

Ask your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements and any recent changes in medications.

Some medicines may affect how Istodaxworks, or Istodax may affect how your other medicines work. Especially tell your doctor if you take or use:

• warfarin sodium (Coumadin, Jantoven) or any other blood thinner medicine. Ask your doctor if you are not sure if you are taking a blood thinner. Your doctor may want to test your blood more often.
• a medicine to treat abnormal heart beats
• St. John's Wort (Hypericum perforatum)
• Dexamethasone (a steroid)
• Medicine for:
  • tuberculosis (TB)
  • seizures (epilepsy)
  • bacterial infections (antibiotics)
  • fungal infections (antifungals)
  • HIV (AIDS)
  • depression

Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

Serious side effects have been reported with Istodax including the following:

• Low blood cell counts: Your doctor will regularly do blood tests to check your blood counts.
  • Low platelets: can cause unusual bleeding, or bruising under the skin. Talk to your doctor right away if this happens.
  • Low red blood cells: may make you feel tired and you may get tired easily. You may look pale, and feel short of breath. Tell your doctor if you have these symptoms.
  • Low white blood cells: can cause you to get infections, which may be serious.
• Serious Infections. Patients receiving Istodax can develop serious infections that can sometimes lead to death. These infections can happen during treatment and within 30 days after treatment with Istodax. Your risk of infection may be higher if you have had chemotherapy in the past. Tell your doctor right away if you have any of these symptoms of infection:

• fever
• cough
• shortness of breath with or without chest pain
• burning with urination
• flu like symptoms
• muscle aches
• worsening skin problems

• Changes in your heartbeat. Your doctor may check your heart by doing an ECG (electrocardiogram) and your potassium and magnesium levels in your blood before you start your Istodax treatment. Tell your doctor if you feel an abnormal heart beat, feel dizzy or faint, have chest pain or shortness of breath. These may be symptoms related to QT prolongation and ST segment changes.
• Tumor Lysis Syndrome (TLS). TLS is a problem of the rapid breakdown of cancer cells that can happen during your treatment with Istodax. Your doctor may do blood tests to check for TLS and may give you medicine to prevent or treat TLS.

Istodax can cause drowsiness. Do not drive or operate heavy machinery until you know how Istodax affects you.

Do not take Istodax if you:

• are allergic to Istodax or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Istodax, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Istodax, tell your doctor if you:

• have any heart problems, including an irregular or fast heartbeat, or a condition called QT prolongation.
• have kidney problems
• have liver problems
• have problems with the amount of potassium or magnesium in your blood
• have nausea, vomiting, or diarrhea
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements and any recent changes in medications.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.  It is not known if Istodax passes into your breast milk. You and your doctor should decide if you will receive Istodax or breastfeed. Talk to your doctor about the best way to feed your baby while you are being treated with Istodax.

• Istodax will be given to you by your doctor or nurse as an intravenous (IV) injection into your vein usually over 4 hours.
• Istodax is usually given on Day 1, Day 8, and Day 15 of a 28 day cycle of treatment.
• Your doctor will decide how long you will receive treatment with Istodax.
• Your doctor will check your blood cell counts and other blood tests regularly during your treatment with Istodax to check for side effects of Istodax. Your doctor may decide to do other tests to check your health as needed.
• Your doctor may stop your treatment, change when you get your treatment, or change the dose of your treatment if you have certain side effects while taking Istodax.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The dose is 14 mg/m2 is given intot the vein (IV) over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Repeat cycles every 28 days.

Since this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Istodax injection.