Managing Side Effects of FARYDAK
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FARYDAK (panobinostat) capsules 10mg/15mg/20mg

Important Safety Information, Including Boxed WARNING

What is the most important safety information to know about FARYDAK? FARYDAK can cause serious diarrhea and heart problems

Black box warning

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
  • have heart problems
  • have a history of bleeding problems
  • have an infection. You should not take FARYDAK if you have an infection
  • have liver problems
  • 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
  • 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.

WHAT YOU SHOULD KNOW ABOUT MANAGING POSSIBLE SIDE EFFECTS

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.

Tell your health care provider if you have any side effect that bothers you or that does not go away. Do not change your dose or stop taking FARYDAK without first talking with your health care provider.

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

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

WHAT YOU SHOULD KNOW ABOUT MANAGING DIARRHEA

Intestine Icon Intestine Icon

Diarrhea is common with FARYDAK and can be severe

  • 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
BE PROACTIVE!

Talk to your health care provider at the first sign of diarrhea and before starting any antidiarrheal medicine

  • Tell your health care provider right away if you have abdominal (stomach) cramps, loose stool, diarrhea, or if you feel like you are becoming dehydrated
  • Taking or using stool softeners or laxative medicines may worsen diarrhea. Talk to your health care provider before taking or using these medicines
  • Your health care provider may recommend an antidiarrheal medicine such as Ioperamide to help manage your diarrhea. Talk to your doctor or pharmacist to find out what brands contain this medicine and the potential side effects
  • Your health care provider may advise you to begin the antidiarrheal medicine at the first sign of abdominal cramps, a poorly formed or loose stool, or as soon as you are having bowel movements more frequently than normal
  • Tell your health care provider if your diarrhea gets worse even though you’re taking loperamide
8 Glasses Icon 8 Glasses Icon

Watch what you eat and drink when you have diarrhea

  • Diarrhea can cause you to lose more fluid than you’re taking in so it’s important to stay hydrated. Drink at least 8 glasses of clear liquids per day (such as water, broth, or sports drinks)
  • Eat frequent small meals and easily digestible foods such as rice, applesauce, and toast
  • Discontinue any lactose-containing products, alcohol, laxatives and/or stool softeners
  • Talk to your doctor before making any changes to your diet
Stethoscope Icon Stethoscope Icon

Your health care team will monitor your condition frequently during treatment

Your health care provider may:

  • Do regular tests to monitor the levels of fluid and electrolytes (such as potassium and magnesium) in your blood to help ensure that you are properly hydrated
  • Lower your dose or have you skip 1 or more doses of FARYDAK
    • If your diarrhea does not improve with the use of Ioperamide, or a change in dose, treatment with FARYDAK may need to be stopped

WHAT YOU SHOULD KNOW ABOUT POSSIBLE HEART PROBLEMS

Heart Icon Heart Icon

Heart problems

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.

BE PROACTIVE!

Call your doctor and get emergency help right away if you have any of the following symptoms of heart problems:

  • chest pain
  • faster or slower heart beat
  • palpitations (feel like your heart is racing)
  • feel lightheaded or faint
  • dizziness
  • blue-colored lips
  • shortness of breath
  • swelling in your legs

WHAT YOU SHOULD KNOW ABOUT POSSIBLE BLEEDING

bleeding icon bleeding icon

Bleeding

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.

BE PROACTIVE!

Tell your health care provider right away if you get any of the following signs of bleeding:

  • blood in your stools or black stools (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

WHAT YOU SHOULD KNOW ABOUT LOW BLOOD CELL COUNTS

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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
BE PROACTIVE!

It is important that you call your health care provider immediately if you:

    • Show signs of bleeding
    • blood in your stools or black stools (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
  • Have a fever and/or show any signs of infection
    • cough up blood or blood clots
    • increased bruising
    • feeling dizzy or weak
    • confusion
    • change in your speech
    • headache that lasts a long time

WHAT YOU SHOULD KNOW ABOUT INFECTION

Infection icon Infection icon

There is an increased risk of infection while taking FARYDAK.

BE PROACTIVE!

Contact your health care provider right away if you have a fever or have any signs of an infection:

  • 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
  • feeling very tired

WHAT YOU SHOULD KNOW ABOUT POSSIBLE LIVER PROBLEMS

liver icon liver icon

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.

BE PROACTIVE!

Call your health care provider right away if you have the following symptoms of liver problems:

  • Feel tired or weak
  • Loss of appetite
  • Dark amber colored urine
  • Upper abdominal (stomach) pain
  • 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 health care provider if you have any side effect that bothers you or that does not go away.

WHAT YOU SHOULD KNOW ABOUT FATIGUE

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Fatigue may be a challenging side effect of FARYDAK® (panobinostat) capsules

  • 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
BE PROACTIVE!

Talk to your health care team and follow these guidelines, which may help manage your fatigue

  • Save your energy. Don’t try to do everything. Do the things that are the most important to you
  • Distract yourself with music, reading, or relaxing with friends or family
  • Limit nap time to less than 1 hour so it won’t interfere with the quality of your nighttime sleep
  • Talk to your health care provider about the amount of exercise that’s right for you and try to exercise for a short time every day

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.

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;

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.