Farydak

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea
• nausea
• vomiting
• decreased appetite

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Panobinostat is usually given in combination with other medicines. Follow your doctor's dosing instructions very carefully.

Panobinostat is given in a 21- day treatment cycle, and you may only need to take the medicine during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with panobinostat.

You may take panobinostat with or without food. Try to take the medicine at the same time on each scheduled day.

Take panobinostat with a full glass of water.

Do not open, crush or chew a panobinostat capsule. Swallow it whole. Do not use a broken capsule. The medicine from a broken capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

If you vomit after taking panobinostat, do not take another capsule. Take your next dose as scheduled.

Panobinostat can cause severe diarrhea. You may be given medicine to prevent diarrhea or other side effects while you are receiving panobinostat.

Panobinostat can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests.

Store the capsules in their original container at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you are less than 12 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Black Box Warnings

Severe diarrhea

• Severe diarrhea reported in 25% of patients
• Monitor for symptoms; institute antidiarrheal treatment
• Interrupt panobinostat dosing, and then reduce dose or discontinue

Severe cardiac toxicities

• Severe and fatal cardiac ischemic events reported, including severe arrhythmias and ECG changes
• Arrhythmias may be exacerbated by electrolyte abnormalities
• Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated

Contraindications

None

Cautions

Severe diarrhea reported in 25%, and diarrhea of any grade reported in 68% (compared with 42% in control arm in clinical trials); monitor hydration status and electrolyte blood levels at baseline and weekly (or more often as clinically required)

Fatal and serious hemorrhage reported

Causes myelosuppression, including severe thrombocytopenia, neutropenia, and anemia; obtain baseline CBC count and monitor weekly during treatment (or more often as clinically required)

Localized and systemic infections, including pneumonia, bacterial infections, invasive fungal infections, and viral infections, reported; severe infections occurred in 31% (including 10 deaths) compared with 24% (including 6 deaths) in the control arm of clinical trials

Hepatic dysfunction, primarily elevations in aminotransferases and total bilirubin, reported; monitor liver function prior to treatment and regularly during treatment

Can cause fetal harm when administered to a pregnant woman

Cardiac toxicities

• Severe and fatal cardiac ischemic events, as well as severe arrhythmias and ECG changes, reported
• Arrhythmias occurred in 12% of those receiving panobinostat compared with 5% of the control arm
• Do not initiate with history of recent MI or unstable angina ECG abnormalities such as ST-segment depression and T-wave abnormalities also occurred more frequently in patients receiving panobinostat compared with the control arm: 22% versus 4% and 40% versus 18%, respectively
• May prolong cardiac ventricular repolarization (QT interval); do not initiate if QTcF >450 msec or clinically significant baseline ST-segment or T-wave abnormalities
• Arrhythmias may be exacerbated by electrolyte abnormalities
• If the QTcF increases to ≥480 msec during treatment, interrupt treatment and correct any electrolyte abnormalities
• If QT prolongation does not resolve, permanently discontinue drug
• Obtain ECG at baseline and periodically during treatment as clinically indicated
• Monitor electrolytes during treatment and correct abnormalities as clinically indicated

Pregnancy

Perform pregnancy test in women of childbearing potential before initiating treatment

Advise females of reproductive potential to avoid becoming pregnant while taking panobinostat

Panobinostat was teratogenic in rats and rabbits

Advise sexually active females of reproductive potential to use effective contraception while taking panobinostat and for at least 3 months after last dose

Advise sexually active men to use condoms while on treatment and for 6 months after last dose

Lactation

Unknown if distributed in human breast milk

Because many drugs are excreted in human milk and because of the potential for serious adverse drug reactions in nursing infants, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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.

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

Substrate of CYP3A; inhibits CYP2D6, 2C19, and 3A4 (time-dependent) in vitro.1 Does not inhibit CYP1A2, 2C8, 2C9, or 2E in vitro; does not induce CYP1A1/2, 2B6, 2C8/9/19, or 3A.1

Substrate of P-glycoprotein (P-gp); does not inhibit or induce P-gp in vitro.1

Does not induce uridine diphosphate-glucuronosyl transferase (UGT) 1A1 in vitro.1

Inhibits organic anion transporter (OAT) 3, organic anion transporter protein (OATP) 1B1 and 1B3, and organic cation transporter (OCT) 1 and 2 in vitro; does not inhibit breast cancer resistance protein (BCRP) or OAT1.1 Does not induce multidrug resistance protein (MRP) 2 transporters.1

Drugs Affecting Hepatic Microsomal Enzymes

Potent CYP3A inhibitors: Possible increased panobinostat exposure;1 4 11 reduce initial panobinostat dose to 10 mg.1

Potent CYP3A inducers: Decreased panobinostat exposure is likely; avoid concomitant use.1

Drugs Metabolized by Hepatic Microsomal Enzymes

CYP2D6 substrates: Possible increased systemic exposure to the CYP2D6 substrate.1 4 Avoid concomitant use of panobinostat with sensitive CYP2D6 substrates or CYP2D6 substrates with a narrow therapeutic index.1 If concomitant use of panobinostat and CYP2D6 substrates cannot be avoided, frequently monitor patients for adverse reactions.1

CYP3A substrates: Possible increased systemic exposure to the CYP3A substrate; clinical relevance unknown.1 4

Drugs that Prolong QT Interval

Concomitant use with antiarrhythmics and other drugs known to prolong the QT interval not recommended.1 Manufacturer states that antiemetics that prolong the QT interval may be used concomitantly with frequent ECG monitoring.1

Drugs that Affect Gastric pH

Although aqueous solubility of panobinostat is pH dependent, simulations suggest changes in gastric pH will not substantially alter oral absorption.1 4

Specific Drugs and Foods

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Distribution of panobinostat is restricted. 8 (See Restricted Distribution under Dosage and Administration: General.)

In the U.S.

• Farydak

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Histone Deacetylase Inhibitor

Panobinostat is used in combination with bortezomib and dexamethasone to treat patients with multiple myeloma (plasma cell cancer) who have received at least 2 other treatments.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of panobinostat in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of panobinostat in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Atomoxetine
• Azithromycin
• Bedaquiline
• Boceprevir
• Buserelin
• Carbamazepine
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dextromethorphan
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Itraconazole
• Ivabradine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lopinavir
• Lumefantrine
• Mefloquine
• Methadone
• Metoprolol
• Metronidazole
• Mifepristone
• Mitotane
• Mizolastine
• Moxifloxacin
• Nafarelin
• Nebivolol
• Nefazodone
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Oxcarbazepine
• Paliperidone
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenytoin
• Pimavanserin
• Pipamperone
• Pitolisant
• Posaconazole
• Primidone
• Probucol
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice
• Pomegranate
• Starfruit

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Diarrhea or
• Electrolyte imbalance or
• Heart disease or
• Heart rhythm problems (eg arrhythmia, QT prolongation) or
• Liver disease (mild or moderate) or
• Neutropenia (low white blood cells) or
• Thrombocytopenia (low count of platelets)—Use with caution. May make these conditions worse.

• Angina (severe chest pain), unstable or
• Heart attack, recent
• Severe liver disease—Use is not recommended in patients with these conditions.

• Infection—May decrease your body's ability to fight infections.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Very bad and sometimes deadly infections have happened in patients who take Farydak. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Very bad and sometimes deadly bleeding problems have happened with this medicine. Talk with the doctor.
• If you are 65 or older, use Farydak with care. You could have more side effects.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 6 months after stopping this medicine. Use a condom.
• If you are a man and your sex partner gets pregnant while you take Farydak or within 6 months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• A pregnancy test will be done to show that you are NOT pregnant before starting this medicine. You will also need to have pregnancy tests done while taking Farydak (panobinostat). Talk with your doctor.
• Use birth control that you can trust to prevent pregnancy while taking this medicine and for 3 months after care ends.
• If you get pregnant while taking Farydak or within 3 months after your last dose, call your doctor right away.

The following adverse reactions are described in detail in other sections of the label:

• Diarrhea [see Warnings and Precautions (5.1)]
• Cardiac Toxicities [see Warnings and Precautions (5.2)]
• Hemorrhage [see Warnings and Precautions (5.3)]
• Myelosuppression [see Warnings and Precautions (5.4)]
• Infections [see Warnings and Precautions (5.5)]
• Hepatotoxicity [see Warnings and Precautions (5.6)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

     Clinical Trials Experience

The safety data reflect subject exposure to Farydak from a clinical trial, in which 758 subjects with relapsed multiple myeloma received Farydak in combination with bortezomib and dexamethasone or placebo in combination with bortezomib and dexamethasone (referred to as the control arm). The median duration of exposure to Farydak was 5 months with 16% of patients exposed to study treatment for ≥48 weeks.

Serious adverse events (SAEs) occurred in 60% of patients in the Farydak, bortezomib, and dexamethasone compared to 42% of patients in the control arm. The most frequent (≥5%) treatment-emergent SAEs reported for patients treated with Farydak were pneumonia (18%), diarrhea, (11%), thrombocytopenia (7%), fatigue (6%), and sepsis (6%).

Adverse reactions that led to discontinuation of Farydak occurred in 36% of patients. The most common adverse reactions leading to treatment discontinuations were diarrhea, fatigue, and pneumonia.

Deaths occurred in 8% of patients in the Farydak arm versus 5% on the control arm. The most frequent causes of death were infection and hemorrhage.

Table 4 summarizes the adverse reactions occurring in at least 10% of patients with ≥ 5% greater incidence in the Farydak arm, and Table 5 summarizes the treatment-emergent laboratory abnormalities.

Other Adverse Reactions

Other notable adverse drug reactions of Farydak not described above, which were either clinically significant, or occurred with a frequency less than 10% but had a frequency in the Farydak arm greater than 2% over the control arm in the multiple myeloma clinical trial are listed below:

Infections and infestations: hepatitis B.

Endocrine disorders: hypothyroidism.

Metabolism and nutrition disorders: hyperglycemia, dehydration, fluid retention, hyperuricemia, hypomagnesemia.

Nervous system disorders: dizziness, headache, syncope, tremor, dysgeusia.

Cardiac disorders: palpitations.

Vascular disorders: hypotension, hypertension, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders: cough, dyspnea, respiratory failure, rales, wheezing.

Gastrointestinal disorders: abdominal pain, dyspepsia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence, colitis, gastrointestinal pain.

Skin and subcutaneous disorders: skin lesions, rash, erythema.

Musculoskeletal and connective tissue disorders: joint swelling.

Renal and urinary disorders: renal failure, urinary incontinence.

General disorders and administration site conditions: chills.

Investigations: blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased.

Psychiatric disorders: insomnia.

Fatigue and Asthenia

Grade 1 to Grade 4 asthenic conditions (fatigue, malaise, asthenia, and lethargy) were reported in 60% of the patients in the Farydak arm compared to 42% of patients in the control arm. Grade ≥3 asthenic conditions were reported in 25% of the patients in the Farydak arm compared to 12% of patients in the control arm. Asthenic conditions led to treatment discontinuation in 6% of patients in the Farydak arm versus 3% of patients in the control arm.

The prespecified sub-group upon which the efficacy and safety of Farydak was based had a similar adverse reaction profile to the entire safety population of patients treated with Farydak, bortezomib, and dexamethasone.

Panobinostat is a CYP3A substrate and inhibits CYP2D6. Panobinostat is a P-glycoprotein (P-gp) transporter system substrate.

     Agents that May Increase Farydak Blood Concentrations

CYP3A Inhibitors: Coadministration of Farydak with a strong CYP3A inhibitor increased the Cmax and AUC of panobinostat by 62% and 73% respectively, compared to when Farydak was given alone [see Clinical Pharmacology (12.3)].

Reduce dose to 10 mg when coadministered with strong CYP3A inhibitors (e.g., boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) [see Dosage and Administration (2.5)]. Instruct patients to avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice because these foods are known to inhibit CYP3A enzymes.

     Agents that May Decrease Farydak Plasma Concentrations

CYP3A Inducers: Coadministration of Farydak with strong CYP3A inducers was not evaluated in vitro or in a clinical trial however, a reduction in panobinostat exposure is likely. An approximately 70% decrease in the systemic exposure of panobinostat in the presence of strong inducers of CYP3A was observed in simulations using mechanistic models. Therefore, the concomitant use of strong CYP3A inducers should be avoided [see Clinical Pharmacology (12.3)].

     Agents whose Plasma Concentrations May be Increased by Farydak

CYP2D6 Substrates: Farydak increased the median Cmax and AUC of a sensitive substrate of CYP2D6 by approximately 80% and 60%, respectively; however this was highly variable [see Clinical Pharmacology (12.3)]. Avoid coadministrating Farydak with sensitive CYP2D6 substrates (i.e., atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, and venlafaxine) or CYP2D6 substrates that have a narrow therapeutic index (i.e., thioridazine, pimozide). If concomitant use of CYP2D6 substrates is unavoidable, monitor patients frequently for adverse reactions.

     Drugs that Prolong QT interval

Concomitant use of anti-arrhythmic medicines (including, but not limited to amiodarone, disopyramide, procainamide, quinidine and sotalol) and other drugs that are known to prolong the QT interval (including, but not limited to chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil and pimozide) is not recommended. Anti-emetic drugs with known QT prolonging risk, such as dolasetron, ondansetron, and tropisetron can be used with frequent ECG monitoring [see Warnings and Precautions (5.2)].

You should not use Farydak if you are allergic to panobinostat.

To make sure Farydak is safe for you, tell your doctor if you have:

• heart disease, history of recent heart attack;

• a personal or family history of Long QT syndrome;

• liver disease;

• any type of infection;

• a bleeding or blood-clotting disorder;

• if you have been sick with diarrhea; or

• if you are dehydrated.

Do not use Farydak if you are pregnant.. It could harm the unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose. Call your doctor if you think you might be pregnant.

Use birth control to prevent pregnancy, whether you are a man or a woman. Men should use condoms while using Farydak and for at least 6 months after your last dose.

It is not known whether panobinostat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Farydak is not approved for use by anyone younger than 18 years old.

Other drugs may interact with panobinostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Common side effects of Farydak include: severe diarrhea, pneumonia, severe infection, severe neutropenia, cardiac arrhythmia, abnormal t waves on ecg, depression of st segment on ecg, diarrhea, neutropenia, and thrombocytopenia. Other side effects include: sepsis, and hemorrhage. See below for a comprehensive list of adverse effects.

Animal studies have revealed evidence of teratogenicity and maternal toxicity including death. Animal data also show this drug may impair male and female fertility. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use should be avoided as this drug can cause fetal harm. US FDA pregnancy category: Not Assigned Comments: -Pregnancy testing should be performed in females of reproductive potential prior to treatment initiation and intermittently during treatment. -Females of reproductive potential should avoid becoming pregnant and be advised to use effective contraception during treatment and for at least 3 months after the last dose. -Sexually active men should be advised to use condoms during treatment and for 6 months after last dose.

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

What are you taking this medication for?

Brand: Farydak

This drug comes in 21-day cycles. You may need to take Farydak for 8 cycles and then repeat for another 8 cycles.

• Typical dosage: One 20-mg capsule every other day, three times per week, during the first 2 weeks of each cycle. (This would be days 1, 3, 5, 8, 10, and 12).

Farydak has not been studied in children. It should not be used in people younger than 18 years.

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects, which can include heart problems, decreased blood cell counts, or stomach problems. If these side effects can’t be managed, your doctor may stop your treatment with this medication.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of Farydak from building up too much in your body.

People with previous severe side effects from Farydak: Your doctor may lower your dosage by 5 mg.

People with mild liver problems: Your doctor may prescribe one 15-mg capsule every other day, three times per week during the first 2 weeks of each cycle. (This would be on days 1, 3, 5, 8, 10, and 12.) You may need to take Farydak for 8 cycles and then repeat for another 8 cycles.

People with moderate liver problems: Your doctor may prescribe one 10-mg capsule every other day, three times per week during the first 2 weeks of each cycle. (This would be on days 1, 3, 5, 8, 10, and 12.) You may need to take Farydak for 8 cycles, and then repeat for another 8 cycles.

This drug can be taken with or without food. You should swallow the capsule whole with a cup of water

Take this drug at the time(s) recommended by your doctor

Don’t open, cut, crush, or chew capsules

Store this drug carefully

A prescription for this medication is refillable

Travel

Self-management

Clinical monitoring

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead

Hidden costs

Insurance

Are there any alternatives?