Generic Name: Romidepsin

Istodax® is the trade name for the generic drug Romidepsin. In some cases, health care professionals may use the generic name Romidepsin when referring to the trade drug name, Istodax®.

Drug Type :

Istodax® is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Istodax® is classified as a "Histone Deacetylase Inhibitor"-for more detail, see "How this drug works," below).

What Istodax® Is Used For:

• Istodax® is used to treat cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL).

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Istodax® Is Given:

• As an infusion into the vein (intravenous, IV) over 4 hours.
• It is usually given on days 1, 8, and 15 of a 28-day cycle.
• The cycle may be repeated as long as the medication is working and is not causing severe side effects.
• The amount of Istodax® that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. The actual dose is based on your body size as well. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of Istodax®:

• Most people will not experience all of the Istodax® side effects listed.
• Istodax® side effects are often predictable in terms of their onset, duration, and severity.
• Istodax® side effects are almost always reversible and will go away after therapy is complete.
• There is no relationship between the presence or severity of Istodax® side effects and the effectiveness of the medication.
• Istodax® side effects may be quite manageable. There are many options to minimize or prevent them.

The following Istodax® side effects are common (occurring in greater than 30%) for patients taking Istodax®:

• Nausea
• Fatigue
• Infection
• Vomiting
• Diarrhea
• Fever
• High blood sugar
• Taste changes (this most often goes back to normal)
• Constipation
• Anemia
• Poor appetite
• Itching
• Low platelet count (Thrombocytopenia)
• Low white blood cells
• Low calcium levels
• Low albumin levels
• High uric acid

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Istodax®:

• Low blood pressure
• Cough
• Headache
• Abdominal pain
• Low potassium
• Weight loss
• Skin inflammation (redness/peeling)
• Shortness of breath
• Increased liver enzymes
• Chills
• Magnesium imbalance
• Low phosphate levels
• Low sodium

Not all side effects are listed above. Some that are rare (occurring in less than about 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° or higher, chills)
• Irregular or fast heartbeat

Always inform your health care provider if you experience any unusual symptoms.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Diarrhea (4-6 episodes in a 24-hour period)
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness
• Skin or the whites of your eyes turn yellow
• Urine turns dark or brown (tea color)
• Decreased appetite
• Pain on the right side of your stomach
• Bleed or bruise more easily than normal
• Any skin change, irritation, itching or rash
• Extreme fatigue (unable to carry on self-care activities)
• Muscle weakness
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely
• Signs of infection. These include a fever of 100.4°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
• Trouble breathing.
• Very bad dizziness or passing out.
• Change in thinking clearly and with logic.
• Very bad headache.
• A big weight loss.
• Not able to pass urine.
• Any rash.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Istodax® treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Talk with your doctor before using products that have aspirin, blood thinners, garlic, ginseng, ginkgo, ibuprofen or like products, pain drugs, or vitamin E.
• Do not eat grapefruit or grapefruit juice as it may affect the levels of Istodax® in your system.
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking Istodax®.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting Istodax®. Pregnancy category D (Istodax® may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Do not conceive a child (get pregnant) while taking Istodax®. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking Istodax®.
• Istodax® can cause elevated INR levels in patients taking warfarin (coumadin) and these levels should be monitored closely.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely
• Do not take St John's wort with this drug. This drug may not work as well.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bath daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your doctor or nurse before scheduling dental appointments or procedures.
• Ask your doctor or nurse before you, or someone you live with, has any vaccinations
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals. Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help
• For constipation, drinking more liquids, working out, or adding fiber to your diet may help. Talk with your doctor about a stool softener or laxative.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
• For flu-like symptoms, keep warm with blankets and drink plenty of liquids. There are medications that can help reduce the discomfort caused by chills.
• Acetaminophen or ibuprofen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.

Monitoring and Testing:

Lab work to check blood counts, liver/kidney functions and electrolytes will be checked regularly by your health care provider while you are taking Istodax®, to monitor side effects and check your response to therapy.

How Istodax® Works:

Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition. Cancerous cells lose this ability. Cancer cells no longer have the normal checks and balances in place that control and limit cell division. The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).

The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).

Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific. Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific. The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.

Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur. The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different parts of the body.

Istodax® belongs to a class of drugs called histone deacetylase (HDAC) inhibitors. HDACs are enzymes that control histones, which are important proteins in the formulation of DNA. Istodax® blocks HDACs so histones cannot be used properly. This interferes with the genetic makeup of cancer cells, leading to cell death.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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