Important Safety Information | FARYDAK® (panobinostat) capsules
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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

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.