Class: Biological Therapy

Generic Name: Panobinostat

Trade Name: Farydak®

For which conditions is this drug approved? Farydak® is approved for use, in combination with Velcade® (bortezomib) and dexamethasone, in people with multiple myeloma after they’ve had at least two other types of treatment.

What is the mechanism of action? Farydak is an agent known as a histone deacetylase inhibitor. It works by blocking the activity of the histone deacetylase enzyme, which is involved the growth and spread of cancer cells.

How is Farydak typically given (administered)? Farydak is given as a capsule.

How are patients typically monitored? Patients taking Farydak typically have blood counts checked regularly to watch for low blood cell and platelet counts. They will also have liver function and electrolyte levels monitored—both are done with a blood test—and an electrocardiogram before and during treatment to check heart health.

What are the common (occur in 30% or more of patients) side effects of treatment with Farydak?

• Diarrhea
• Nausea
• Fatigue
• Low platelet count (thrombocytopenia)
• Anemia
• Low count of neutrophils, a type of white blood cell that helps fight infections (neutropenia)
• Low levels of white blood cells

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Farydak?

• Irregular heartbeat (arrhythmia)
• Vomiting
• Peripheral edema
• Fever
• Weight decreased
• Decreased appetite

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Keep a list of all the medicines you take and show your healthcare provider and pharmacist when you get a new medicine.
• Tell your doctor if you have any of the following: diarrhea; heart problems; a history of bleeding problems; an infection (you should not take Farydak if you have an infection); or liver problems.
• Take Farydak exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much Farydak to take and when to take it (one time on each scheduled day at about the same time). Farydak can be taken with or without food.
• Do not change your dose or stop taking Farydak without first talking with your healthcare provider.
• Swallow Farydak capsules whole with a cup of water. Do not open, crush, or chew them.
• If you accidentally get powder from a Farydak capsule on your skin, wash the area with soap and water. Flush your eyes with water if you get the powder in your eyes.
• If you miss a dose of Farydak, take it as soon possible—up to 12 hours after the time the dose should have been taken.
• If you vomit after taking Farydak, do not take another capsule. Stay on your dosing schedule and take your next dose as usual.
• If you take too much Farydak, call your healthcare provider.

Are there any special precautions patients should be aware of before starting treatment?

• Tell your doctor if you are pregnant or plan to become pregnant. Farydak can harm your unborn baby, so you should not become pregnant during treatment with Farydak. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
• Women who are able to become pregnant should use effective birth control during treatment with Farydak and for one month after the last dose.
• Men who are sexually active should use a condom during treatment with Farydak and for three months after the last dose.
• Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Farydak will pass into your breast milk. You and your healthcare provider should decide if you will take Farydak or breastfeed—you should not do both.
• 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.

When should patients notify their physician?

Tell your doctor if you have:

• Unusual bleeding or bruising under your skin (signs of low platelet count)
• Feel weak tired, look pale, or feel short of breath (signs of low red blood cell count, or anemia)
• Have any signs of infection, including: fever, sweats, chills, flu-like symptoms, cough, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body, or feel very tired
• Have any signs of liver problems, including: feeling tired or weak, loss of appetite, dark or amber colored urine, upper abdominal (stomach) pain, yellowing of your skin or whites of your eyes

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.