Farydak®

Generic Name: Panobinostat

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

Drug Type:

Farydak ® is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Farydak® is classified as a "Histone Deacetylase (HDAC) Inhibitor". For more detail, see How Farydak® Works below.

What Farydak Is Used For:

Farydak ®, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.

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 Farydak Is Given:

• Farydak ® is a pill, taken by mouth. It is taken orally, once every other day for 3 doses per week (on Days 1, 3, 5, 8, 10, and 12) of Weeks 1 and 2 of each 21 day cycle for 8 cycles. It can be taken with or without food. Your doctor may alter this dosing schedule depending upon side effects from this treatment.
• Take Farydak® exactly as prescribed. Take 1 time on each scheduled day at about the same time.
• Swallow Farydak® capsules whole with a full glass of water. Do not crush, dissolve or open capsules.
• Do not change your dose or stop Farydak® unless your health care provider tells you to.
• If you miss a dose, take it as soon as you remember. If your next dose is within 12 hours, skip the missed dose and take the next dose at your regular time.
• If vomiting occurs, you should not repeat the dose but take the next usual scheduled dose.
• Do not take more than 1 dose of Farydak® at one time. Call your health care provider right away if you take too much.
• Avoid skin contact with the powder in the Farydak® capsules. If you accidently get powder from the Farydak® capsule on your skin, wash the area with soap and water. If you accidentally get the powder in your eyes, flush your eyes with water.
• Avoid eating star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice while taking Farydak®. These foods may affect the amount of Farydak® in your blood.

The amount of Farydak ® that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects:

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

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

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

• Low platelet count (thrombocytopenia)
• Low white blood cells: Lymphopenia, neutropenia
• Diarrhea
• Low calcium
• Low albumin
• Low phosphorus
• Low hemaglobin
• Fatigue
• Low potassium
• Low sodium
• Blood creatinine increased
• Nausea

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

• Swelling
• High phosphorus
• Decreased appetite
• High magnesium
• Fever
• Vomiting
• High bilirubin
• Arrhythmia
• Weight loss

A rare, but serious side effect of Farydak® is severe diarrhea. You should notify your health care provider immediately if you develop uncontrollable diarrhea.

Severe cardiac ischemic events, severe arrhythmias, and ECG changes have occurred.

This list includes common and less common side effects for those taking Farydak ®. Farydak® side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But 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 and go to the emergency room, day or night, if you should experience any of the following symptoms:

· Fever of 100.4° F (38°C or higher, chills)

· Chest pain

· Sudden onset of shortness of breath

· Severe bleeding

· Severe diarrhea

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:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period).
• Diarrhea (4-6 episodes in a 24-hour period).
• Unusual bleeding or bruising.
• Loss of appetite.
• Dark, tea-colored urine.
• Upper abdominal pain.
• Yellowing of your skins or the whites of your eyes.
• Black or tarry stools, or blood in your stools.
• Blood in the urine.
• Pain or burning with urination.
• Extreme fatigue (unable to carry on self-care activities).
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decreased amount of urine, or dizziness (particularly with standing).
• Signs of infection (sweats, cough, flu-like symptoms, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body)

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

Precautions:

• Before starting Farydak® treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Farydak®.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting Farydak®. Pregnancy category D ( Farydak® 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 Farydak®. Use effective contraception while takingFarydak® and for at least 1 month after the last dose of Farydak®. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking Farydak®.

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.
• 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.
• Avoid sun exposure. Wear SPF 30 (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:

You will be checked regularly by your doctor while you are taking Farydak®, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Farydak 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.

Farydak ® is a Histone Deacetylase (HDAC) Inhibitor. Histone Deacetylase is an enzyme that is normally present in the cells. In some cancer cells, there is an overexpression of HDACs. It is believed that inhibition of the HDAC activity causes cell cycle arrest and cell death. Farydak® works by inhibiting the activity of enzymes, known as histone deacetylases (HDACs). This process may slow the over-development of plasma cells in multiple myeloma patients or cause cancer cells to die. Farydak® shows more cytotoxicity towards tumor cells compared to normal cells. It works best when combined with drugs like bortezomib (Velcade).

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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