Farydak 15 mg capsule

Generic name:
Panobinostat - oral

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

Brand name(s)
Farydak

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 lab 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).

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

This drug has been withdrawn from the US market due to problems with effectiveness.

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. Keep 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, lab 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. 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.

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 last or get worse, tell your doctor or pharmacist promptly.

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

Vomiting/diarrhea that doesn't stop may result in dehydration. 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:

• nausea/vomiting that doesn't stop
• 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 sore throat that doesn't go away, fever, chills, 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:

• headache that is severe or doesn't go away
• 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.

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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using panobinostat before having any immunizations/vaccinations. 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).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using panobinostat. Panobinostat may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for at least 3 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for at least 6 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

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, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

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.

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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea/vomiting/diarrhea, easy bruising/bleeding.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, ECG, blood mineral levels, liver function) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

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

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.

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).

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.