Farydak 15 mg capsule

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Medication name

Generic name:
Panobinostat - oral

Pronunciation
(PAN-oh-BIN-oh-stat)

Brand name(s)
Farydak

Warning

Panobinostat can cause diarrhea which may become very severe. Tell your doctor right away if you get diarrhea or have abdominal/stomach pain or cramping. Your doctor may need to prescribe medication to stop the diarrhea or stop panobinostat until your diarrhea gets better. Talk to your doctor for more details.

Panobinostat can cause very serious (possibly fatal) heart problems (such as heart attack, irregular heartbeat). Your risk of irregular heartbeat may be increased due to high or low blood mineral levels. Your doctor will monitor your medical and laboratory tests very closely while you are taking this medication. Get medical help right away if you have any signs of heart problems, including: chest/jaw/left arm pain, fast/slow//irregular heartbeat, severe dizziness, fainting (see also Precautions section).

Uses

Panobinostat is used to treat multiple myeloma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

How to use

Read the Medication Guide provided by your pharmacist before you start taking panobinostat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor. It is usually taken once every other day for 3 doses each week for the first 2 weeks, then stopped for 1 week. This is one cycle of treatment. Continue taking the medication this way as directed by your doctor. Swallow the capsules whole with a cup of water. Do not crush, chew, or open the capsules. If you vomit after taking the medication, do not take another dose of the medication that day. Take the next dose at the usual time.

Avoid getting the powder in the capsule onto your skin or into your eyes. If the powder does get onto the skin, wash the area with water and soap. If the powder gets into the eyes, flush the eyes with plenty of water.

The dosage is based on your medical condition, laboratory tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may stop your medication for a while if you get any side effects. Talk to your doctor for more details.

Avoid eating grapefruit, star fruit, or pomegranate or drinking grapefruit or pomegranate juice while using this medication unless your doctor or pharmacist says you may do so safely. These fruits can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time on the days you are scheduled to take the medication. It may help to mark your calendar with a reminder.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the powder from the capsules.

Side effects

See also Warning section.

Nausea, vomiting, tiredness, loss of appetite, diarrhea, weight loss, swelling hands/ankles/feet, or weakness may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration) and/or blood minerals. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

Panobinostat may rarely cause serious liver disease. Tell your doctor right away if you have any symptoms of liver damage, including:

  • persistent nausea/vomiting
  • yellowing eyes/skin
  • dark urine

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. These effects may be fatal. Tell your doctor right away if you develop any of the following symptoms:

  • unusual tiredness
  • pale skin
  • signs of infection (such as fever, chills, persistent sore throat, cough, shortness of breath)
  • easy bruising/bleeding
  • pink/bloody urine
  • black/bloody stools
  • vomit that contains blood or looks like coffee grounds
  • coughing up blood

Get medical help right away if you have any very serious signs of bleeding, including:

  • severe/persistent headache
  • trouble speaking
  • confusion

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking panobinostat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease
  • heart disease (such as chest pain, heart attack)
  • current/recent infection
  • frequent diarrhea
  • bleeding problems
  • blood disorders

Panobinostat may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using panobinostat, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

  • certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
  • family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using panobinostat safely.

Panobinostat can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially diarrhea, decreased bone marrow function, and QT prolongation (see above).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Before you start treatment and during treatment with this medication, your doctor should direct you to have a pregnancy test. Women of childbearing age should use reliable forms of birth control during treatment and for at least 3 month after the last dose of panobinostat. Men using this medication should use condoms while on treatment and for at least 6 months after the last dose of panobinostat. Consult your doctor for more details. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor right away.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of panobinostat from your body, which may affect how panobinostat works. Examples include carbamazepine, phenytoin, rifamycins (such as rifampin), St. John's wort, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting/diarrhea, easy bruising/bleeding.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, ECG, blood mineral levels, liver function) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

Missed dose

If you miss a dose, take it as soon as you remember if it is within 12 hours of your scheduled dose. If it is more than 12 hours after your scheduled dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in blister pack at room temperature away from light and moisture. Keep the blister pack in the original carton to protect from light. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised January 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.