Farydak

Farydak is a prescription medication used to treat multiple myeloma. Farydak belongs to a group of drugs called HDAC inhibitors. These work by slowing the over-development of plasma cells in multiple myeloma patients or causing these dangerous cells to die.

This medication is available as an oral capsule and is usually taken once every other day during the first 2 weeks of a 3-week chemotherapy cycle. Treatment should be continued for 8 cycles. Do not crush, chew, or open the capsules. Swallow Farydak capsules whole.

Common side effects of Farydak include diarrhea, nausea, swelling of the extremities, fever, and vomiting. Farydak can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Farydak affects you.

Farydak is a prescription medication used to treat multiple myeloma. Farydak should be used in combination with bortezomib, a type of chemotherapy, and dexamethasone, an anti-inflammatory medication.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Farydak. See the “Farydak Precautions” section.

Common side effects of Farydak include the following:

• diarrhea
• tiredness
• nausea
• swelling in the arms or legs
• decreased appetite
• fever
• vomiting
• weakness
• changes in blood counts
• low potassium
• low sodium in the blood (hyponatremia)

This is not a complete list of Farydak side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• atomoxetine (Strattera)
• bepredil (Vascor)
• boceprevir (Victrelis)
• chloroquine
• clarithromycin (Biaxin)
• conivaptan (Vaprisol)
• desipramine (Norpramin)
• dextromethorphan (Delsym)
• dolasetron(Anzemet)
• halofantrine (Halfan)
• indinavir (Crixivan)
• itraconazole (Onmel, Sporanox)
• ketoconazole (Nizoral)
• lopinavir/ritonavir (Kaletra)
• methadone (Methadose, Diskets)
• metoprolol (Lopressor)
• moxifloxacin (Vigamox, Avelox, Moxeza)
• nebivolol (Bystolic)
• nefazadone (Serzone)
• nelfinavir (Viracept)
• ondansetron (Zupenz, Zofran)
• perphenazine
• pimozide (Orap)
• posaconazole (Noxafil)
• ritonavir (Norvir, in Kaletra)
• saquinavir (Fortovase, Invirase)
• telaprevir (Incivek)
• telithromycin (Ketek)
• thioridazine
• tolterodine (Detrol)
• tropisetron (Navoban)
• venlafaxine (Effexor)
• voriconazole (Vfend)

This is not a complete list of Farydak drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Farydak including the following:

• Hemorrhage, including gastrointestinal and pulmonary bleeding
• Liver toxicity and abnormal liver function
• Embryo and fetal toxicity

Farydak can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Farydak affects you.

Do not take Farydak if you are:

• allergic to Farydak or to any of its ingredients

Grapefruit and grapefruit juice, star fruit, and pomegranates and pomegranate juice may interact with Farydak and lead to potentially dangerous effects. Discuss the use of these fruits and fruit products with your doctor.

Before taking Farydak, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Farydak or to any of its ingredients
• have liver disease
• have heart disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Farydak can cause fetal harm if administered to pregnant women. Women should perform a pregnancy test before beginning Farydak and intermittently during treatment to confirm that they are not pregnant. Females should avoid becoming pregnant while taking Farydak and for at least 1 month after the last dose of Farydak. Males should avoid use condoms while taking Farydak and for up to 3 months after the last dose of Farydak.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Farydak crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Farydak.

Take Farydak exactly as prescribed.

This medication is available as an oral capsule and is usually taken once every other day during the first 2 weeks of a 3-week chemotherapy cycle. Treatment should be continued for 8 cycles.

Do not crush, chew, or open the capsules. Swallow Farydak capsules whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Farydak at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose of Farydak for the treatment of multiple myeloma is 20 mg every other day for 3 doses per week during weeks 1 and 2 of a 3-week chemotherapy cycle. Treatment may be continued for up to 8 cycles.

If you take too much Farydak, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Farydak is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Farydak at room temperature. Store it in the original blister pack to protect it from light.
• Ask your doctor or pharmacist on special handling of Farydak.
• Keep this and all medication out of the reach of children.

WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES

Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dose or discontinue FARYDAK.

Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.