FARYDAK® (PANOBINOSTAT) CAPSULES IS A MULTIPLE MYELOMA TREATMENT THAT WORKS AT THE DNA LEVEL

  • FARYDAK is taken in combination with Velcade® (bortezomib) and dexamethasone
  • FARYDAK is in a class of multiple myeloma medicines that offer a different way to attack myeloma cells
    • FARYDAK can cause serious side effects, including diarrhea, heart problems, and bleeding
  • FARYDAK works at the DNA level to help slow the growth of multiple myeloma cells

FARYDAK REGIMENa SLOWED THE PROGRESSION OF MULTIPLE MYELOMA IN THE CLINICAL TRIAL

  • In patients who had multiple myeloma and had already tried at least 2 other types of treatment, including Velcade and an IMiD such as Revlimid

Median number of months without progression (or worsening) of multiple myeloma was longer with FARYDAK/Velcade/dexamethasone than with placebo/Velcade/dexamethasoneb,c

  • The median duration of follow-up was 29 months

aFARYDAK/Velcade/dexamethsone.

bIn patients taking FARYDAK, multiple myeloma did not get worse for a median of 10.6 months. Median means that for half the patients it was longer than 10.6 months and for half the patients it was shorter than 10.6 months. This does not mean that the disease has gone away.

cIn the clinical trial, patients with relapsed multiple myeloma who had already had 1 to 3 prior treatments received either a combination of FARYDAK/Velcade/dexamethasone (n=387) or a combination of placebo (a pill with no medicine in it)/Velcade/dexamethasone (n=381). The maximum duration of treatment was 48 weeks. Approval was based on the subset of patients (n=193) who had tried at least 2 other types of treatment because the benefit, weighed against the risk, appeared to be greater for this subset of patients than for the overall trial set. The data on this page are from this subset.

THE MAJORITY OF PATIENTS RESPONDED TO TREATMENT WITH THE FARYDAK REGIMENa IN THE CLINICAL TRIAL

Overall response rate was higher with FARYDAK as part of the treatment regimena,c,d

dOverall response rate is the percent of patients who had a reduction in certain signs of multiple myeloma. This does not mean that the disease has gone away.

FARYDAK can cause serious side effects in some people. Serious side effects associated with FARYDAK include diarrhea, heart problems, and bleeding.

Your doctor will do regular tests before and during treatment to check the levels of fluid and electrolytes in your blood, platelet counts, and an electrocardiogram (ECG).

Velcade is a registered trademark of Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd.

Revlimid is a registered trademark of Celgene Corporation.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDER BEFORE TAKING FARYDAK® (PANOBINOSTAT) CAPSULES?

Before you take FARYDAK, tell your health care provider about all your medical conditions, including if you have:

  • Diarrhea
  • Heart problems
  • A history of bleeding problems
  • An infection. You should not take FARYDAK if you have an infection
  • Liver problems

If you are pregnant or plan to become pregnant:

  • FARYDAK can harm your unborn baby. You should not become pregnant during treatment with FARYDAK
  • If you become pregnant while taking FARYDAK, or think you may be pregnant, tell your health care provider right away
    • Females who are able to become pregnant should use effective birth control during treatment with FARYDAK and for at least 3 months after the last dose of FARYDAK
    • Males who are sexually active should use a condom during treatment with FARYDAK and for at least 6 months after the last dose of FARYDAK

If you are breastfeeding or plan to breastfeed:

  • It is not known if FARYDAK will pass into your breast milk. You and your health care provider should decide if you will take FARYDAK or breastfeed. You should not do both.

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your health care provider and pharmacist when you get a new medicine.

There are side effects associated with FARYDAK. Serious side effects occurred in patients taking FARYDAK, Velcade, and dexamethasone. The most frequent were pneumonia, diarrhea, low platelet counts, fatigue, and sepsis. The most common side effects leading to treatment discontinuations were diarrhea, fatigue, and pneumonia. The most common side effects of FARYDAK include tiredness, nausea, swelling in your arms or legs, decreased appetite, fever, and vomiting.

These are not all of the possible side effects of FARYDAK. For a complete listing, see the Medication Guide or speak to your health care provider.

Learn more about managing some of the most serious and common side effects:

  • Diarrhea
  • Heart problems
  • Low blood cell counts and infection
  • Fatigue
  • Diarrhea can be defined as frequent, loose, or watery bowel movements
  • Diarrhea can happen at any point during your treatment
    • Diarrhea may begin soon after you start treatment

To learn more about diarrhea, click here.

  • FARYDAK can cause severe heart problems that can lead to death
  • Your risk of heart problems may be increased if you have a condition called “long QT syndrome” or other heart problems
  • Your doctor will do blood tests to check your electrolytes, and do an electrocardiogram (ECG) test before and during treatment with FARYDAK

To learn more about heart problems, click here.

  • FARYDAK can cause severe bleeding which can lead to death
  • It may take you longer than usual to stop bleeding while you are taking FARYDAK
  • Your health care provider will check your platelet counts before you start FARYDAK and during your treatment with FARYDAK

To learn more about possible bleeding, click here.

Low blood cell counts are common with FARYDAK and can be severe.

  • Low platelet count (thrombocytopenia) can cause unusual bleeding or bruising under your skin
    • You could experience severe bleeding
    • It may take you longer than usual to stop bleeding
  • Low white blood cell count (neutropenia) can cause you to get infections
  • Low red blood cell count (anemia) may make you feel weak, tired, or you may tire easily, become pale, or feel short of breath
  • Your health care provider will do blood tests to monitor your blood cell counts before you start treatment with FARYDAK, and will continue to do regular blood tests periodically while you are on treatment

To learn more about possible low blood cell counts, click here.

  • There is an increased risk of infection while taking FARYDAK.

To learn more about possible infection, click here.

Liver problems (hepatotoxicity)

  • Your health care provider should do blood tests to check your liver before you start taking FARYDAK and if you have symptoms of liver problems while you take FARYDAK
  • The most common side effects of FARYDAK include tiredness, nausea, swelling in your arms or legs, decreased appetite, fever, and vomiting
  • Tell your health care provider if you have any side effect that bothers you or that does not go away

To learn more about possible liver problems, click here.

Fatigue may be a challenging side effect of FARYDAK.

  • Tell your health care team if you experience fatigue that is affecting your ability to do routine daily activities
    • Your health care team can help you identify things, in addition to treatment with FARYDAK, that may contribute to fatigue. Some of these, such as having a low red blood cell count (anemia), being in pain, taking certain medicines, or having trouble sleeping, are treatable

To learn more about possible fatigue problems, click here.

3-2-1 DOSING: 3 TIMES A WEEK, 2 WEEKS ON, 1 WEEK OFF

Dosing Schedule

RECOMMENDED DOSING FROM FARYDAK FULL PRESCRIBING INFORMATION

Take FARYDAK and your other medicines exactly as your health care provider tells you to take them.

  • FARYDAK is a capsule taken by mouth every other day for 3 doses per week in weeks 1 and 2 of your 21-day (3-week) treatment cycle
  • Velcade is an injection that is scheduled by your health care provider
  • Dexamethasone is an oral tablet taken on a full stomach as prescribed by your health care provider

PATIENT BROCHURE

A comprehensive brochure detailing how FARYDAK works, dosing schedule, clinical trial results, and the management of possible side effects.

Download

TREATMENT DIARY & THERAPY TRACKER

This spiral-bound treatment journal and calendar helps you organize important information, keep track of when to take your medications, and record topics for discussion with your doctor.

Download

Financial Assistance

SECURA CARE PATIENT SUPPORT PROGRAM offers help with insurance verification and patient support programs. To access Secura Care, please call:

844-9SECURA [(844) 973-2872]

Monday to Friday 10:00 AM to 7:00 PM ET

The Patient Support Program includes:

  • The Co-Pay Program offers quick and easy access to co-pay assistance for FARYDAK.
  • With the Co-Pay Program, eligible, commercially insured patients pay no more than $5 per month up to an annual maximum of $25,000 per calendar year. Find out eligibility for the Co-Pay Program by calling Secura Care.
  • The Patient Assistance Program is available to support low-income and uninsured patients. Please contact Secura Careā„¢ to understand if you qualify.
See if you're eligible

INDICATION AND IMPORTANT SAFETY INFORMATION

What is FARYDAK® (panobinostat) capsules?

FARYDAK is a prescription medicine used, in combination with bortezomib and dexamethasone, to treat adults with a type of cancer called multiple myeloma after at least 2 other types of treatment have been tried.

It is not known if FARYDAK is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What you should know about FARYDAK

FARYDAK can cause serious side effects.

  • Diarrhea is common with FARYDAK, and can be severe. Tell your doctor right away if you have stomach cramps, loose stools, diarrhea, or if you feel like you are becoming dehydrated. Taking or using stool softeners or laxative medicines may worsen diarrhea; talk to your doctor before taking or using these medicines. Your doctor will regularly check the levels of fluid and electrolytes in your blood during treatment
  • FARYDAK can cause severe heart problems, which can lead to death. Your risk of heart problems may be increased if you have a condition called "long QT syndrome," or other heart problems. Call your doctor and get emergency medical help right away if you experience chest pain, faster or slower heartbeat, heart racing, lightheadedness or feeling faint, dizziness, have blue lips, shortness of breath, or swelling in your legs
  • FARYDAK can cause severe bleeding, which can lead to death. It may take you longer than usual to stop bleeding.
    Tell your doctor right away if you get any of the following signs of bleeding:
    • blood in your stools or black stools that look like tar
    • pink or brown urine
    • unexpected bleeding, or bleeding that is severe or that you cannot control
    • vomit blood or vomit looks like coffee grounds
    • cough up blood or blood clots
    • increased bruising
    • feeling dizzy or weak
    • confusion
    • change in your speech
    • headache that lasts a long time

Before you take FARYDAK, tell your doctor about all your medical conditions, including if you:

  • have diarrhea, heart problems, a history of bleeding problems, an infection, or liver problems. You should not take FARYDAK if you have an infection
  • are pregnant or plan to become pregnant. FARYDAK can harm your unborn baby. You should not become pregnant during treatment with FARYDAK
  • are breastfeeding or plan to breastfeed. It is not known if FARYDAK will pass into your breast milk. You and your health care provider should decide if you will take FARYDAK or breastfeed. You should not do both
  • Females who are able to become pregnant should use effective birth control during treatment with FARYDAK, and for at least 3 months after the last dose of FARYDAK. Males who are sexually active should use a condom during treatment with FARYDAK, and for at least 6 months after the last dose of FARYDAK

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to take FARYDAK

  • Take FARYDAK exactly as your doctor tells you, including how much FARYDAK to take and when to take it
  • Your doctor may change your dose, or stop treatment temporarily, if you have side effects. Do not change your dose, or stop taking FARYDAK, without first talking with your doctor
  • Take FARYDAK once on each scheduled day at about the same time
  • FARYDAK can be taken with or without food, and should be swallowed whole with a cup of water. Do not open, crush, or chew FARYDAK
  • If you miss a dose of FARYDAK, take it as soon as possible up to 12 hours after your scheduled dose
  • If you vomit after taking FARYDAK, do not take another capsule. Stay on your schedule, and take your next dose as usual
  • If you take too much FARYDAK, call your doctor
  • 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

FARYDAK may cause serious side effects.

  • See “What you should know about FARYDAK”
  • Low blood cell counts are common with FARYDAK, and can be severe. Your doctor will check your blood counts before you start FARYDAK, and during your treatment with FARYDAK
    • Low platelet count (thrombocytopenia) can cause unusual bleeding or bruising under your skin
    • Low white cell count (neutropenia) can cause you to get infections
    • Low red blood cell count (anemia) may make you feel weak, tired, or you may get tired easily, you look pale, or you feel short of breath
  • Infection risk is increased while taking FARYDAK. Contact your doctor right away if you have a fever or have any signs of an infection including sweats or chills, cough, flu-like symptoms, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body, or are feeling very tired
  • Your doctor should do blood tests to check your liver before you start taking FARYDAK, and if you have symptoms of liver problems while taking FARYDAK. Call your doctor right away if you feel tired or weak, lose your appetite, have dark urine, upper stomach pain, or yellowing of your skin or the white of your eyes

The most common side effects of FARYDAK include tiredness, nausea, swelling in your arms or legs, decreased appetite, fever, and vomiting. 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 FARYDAK. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for FARYDAK® (panobinostat) capsules.

Patient Support Line
844-9SECURA
[(844) 973-2872]
Monday to Friday 10:00 AM to 7:00 PM ET

Important Safety Information, including Boxed WARNING: What you should know about FARYDAK. FARYDAK can cause serious side effects.

  • Diarrhea is common with FARYDAK, and can be severe. Tell your doctor right away if you have stomach cramps, loose stools, dia ... See More

Approved Use:

FARYDAK is used in combination with 2 other medications, to treat adults with a type of cancer called multiple myeloma after at least 2 other types of treatment have been tried. It is not known if FARYDAK is safe and effective in children.

Read Full Important Safety Information and Approved Use