farydak

Farydak (panobinostat) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Farydak is used in combination with other drugs to treat multiple myeloma. It is usually given after other cancer medicines have been tried without success.

Farydak was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, the medicine slowed progression of the disease. However, it has not been shown that Farydak can improve symptoms or lengthen survival time.

Important information

Farydak can cause severe diarrhea. Tell your doctor if you have diarrhea with stomach cramps or if you get dehydrated (extreme thirst, decreased urination, sweating or hot and dry skin).

Farydak can also cause serious or fatal heart problems. Get emergency medical help if you have chest pain, fast or slow heartbeats, dizziness or fainting, swelling in your legs, or shortness of breath.

While using this medicine, you will need frequent medical tests.

Before taking this medicine

You should not use Farydak if you are allergic to panobinostat.

To make sure Farydak is safe for you, tell your doctor if you have:

• heart disease, history of recent heart attack;

• a personal or family history of Long QT syndrome;

• liver disease;

• any type of infection;

• a bleeding or blood-clotting disorder;

• if you have been sick with diarrhea; or

• if you are dehydrated.

Do not use Farydak if you are pregnant.. It could harm the unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while you are using this medicine and for at least 1 month after your treatment ends. Call your doctor if you think you might be pregnant.

Use birth control to prevent pregnancy, whether you are a man or a woman. Men should use condoms while using Farydak and for at least 3 months after treatment ends.

It is not known whether panobinostat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Farydak is not approved for use by anyone younger than 18 years old.

How should I take Farydak?

Take Farydak capsules exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Farydak is usually given in combination with other medicines. Follow your doctor"s dosing instructions very carefully.

Farydak is given in a 21- day treatment cycle, and you may only need to take the medicine during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with panobinostat.

You may take Farydak with or without food. Try to take the medicine at the same time on each scheduled day.

Take the capsule with a full glass of water.

Do not open, crush or chew a capsule. Swallow it whole. Do not use a broken capsule. The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

If you vomit after taking Farydak, do not take another capsule. Take your next dose as scheduled.

Farydak can cause severe diarrhea. You may be given medicine to prevent diarrhea or other side effects while you are receiving panobinostat.

Farydak can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests.

Store the capsules in their original container at room temperature away from moisture, heat, and light.

Farydak dosing information

Usual Adult Dose of Farydak for Multiple Myeloma:

-Initial dose: 20 mg orally once every other day for 3 doses per week (on Days 1, 3, 5, 8, 10, 12) in Weeks 1 and 2 of each 21-day cycle for up to 8 cycles

-Duration of therapy: Up to 16 cycles (48 weeks)

Comments:
-Consider continuing treatment of this drug for an additional 8 cycles (16 cycles total) for patients with clinical benefit who do not experience unresolved severe or medically significant toxicity.
-This drug is administered in combination with bortezomib and dexamethasone. Consult manufacturer product information for the recommended dosing for these two drugs.

Use: Treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent

What happens if I miss a dose?

If you are less than 12 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Farydak?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Certain foods may interact with panobinostat and lead to unwanted side effects. Avoid eating star fruit, pomegranate and grapefruit products while taking Farydak.

Farydak side effects

Get emergency medical help if you have signs of an allergic reaction to Farydak: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Farydak can cause serious or fatal heart problems. Get emergency medical help if you have chest pain, fast or slow heartbeats, dizziness or fainting, swelling in your legs, or shortness of breath.

Call your doctor at once if you have:

• severe or ongoing vomiting or diarrhea;

• pink or brown urine;

• easy bruising or bleeding, bleeding that will not stop;

• low blood cell counts - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, feeling tired or short of breath;

• signs of an electrolyte imbalance - confusion, headache, slurred speech, increased thirst or urination, leg cramps, constipation, fluttering in your chest, numbness or tingling, muscle weakness, loss of coordination, feeling unsteady;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Farydak side effects may include:

• nausea, vomiting, loss of appetite;

• diarrhea;

• fever;

• swelling in your arms or legs;

• tired feeling; or

• low blood cell counts.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Farydak?

Other drugs may interact with panobinostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.