For US residents only.

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 Works at the DNA Level

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

The median patient on Farydak went almost twice as long progression free compared to placebo

 

FARYDAK/Velcade/dexamethsone.

In 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.

In 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 regimen a,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, lnc., 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

 

  • FARYDAK® (panobinostat) capsules are taken by mouth
    • FARYDAK should be swallowed whole with a cup of water. Do not open, crush, or chew

 

  • FARYDAK can be taken with or without food; dexamethasone must be taken with food

 

 

  • FARYDAK is taken in combination with 2 other medications: Velcade and dexamethasone

 

 

  • Take FARYDAK 1 time on each of your scheduled FARYDAK days at about the same time

 

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

 

  • If you miss a dose of FARYDAK, it can be taken up to 12 hours later

 

  • Avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice when taking FARYDAK. These foods may affect the amount of FARYDAK in your blood

 

  • If you vomit after taking FARYDAK, do not take another dose. Take your next dose on the usual scheduled day

 

  • Avoid contact with the powder in the FARYDAK capsules. If you accidentally get powder from the FARYDAK capsule on your skin, wash the area with soap and water. If you accidentally get powder from the FARYDAK capsule in your eyes, flush your eyes with water

 

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

FARYDAK® (PANOBINOSTAT) CAPSULES IS PART OF A COMPREHENSIVE CO-PAY SUPPORT PROGRAM OFFERED BY NOVARTIS ONCOLOGY

Limitations apply. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full terms and conditions, visit www.CoPay.NovartisOncology.com or call 1‑877‑577‑7756.

 

WITH FARYDAK, WE'RE COMMITTED TO SUPPORTING YOU BY OFFERING CO-PAY ASSISTANCE

You may be eligible for immediate co-pay savings on your next prescription: 

  • Commercially insured patients pay $25 per month
  • Novartis will pay the remaining co-pay, up to $15,000 per calendar year

 

Click here to see if you are eligible, or call 1-877-577-7756

See if you're eligible

Terms and Conditions

This offer is valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash payments, where product is not covered by patient's commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. The card is the property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke, or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. This offer expires on December 31, 2017. Additional Terms and Conditions may apply.

 

Patient Instructions

Present this offer and your insurance card along with a valid prescription at any participating pharmacy or through mail order. Patients with commercial insurance are responsible for $25 for a 30-day supply and Novartis pays up to $15,000 per calendar year. If patient reaches the maximum annual cap per calendar year of $15,000, patient will be responsible for the difference. This offer expires on December 31, 2017. Patient questions should be directed to: 1‑877‑577‑7756.

 

When you use this offer, you are certifying that you understand the program rules, regulations, and terms and conditions, and that you will disclose and report the use of this offer as may be required by your insurer. You are not eligible if prescriptions are paid by any federal or state program, or where prohibited by law; and you will otherwise comply with the terms and conditions above.

 

Support for you

 

Patient Assistance Now Oncology (PANO) assists with all aspects of access, from insurance verification, to information about financial assistance, to a supportive call center.

 

To learn more, call 1‑800‑282‑7630.