Important note: Before prescribing, consult the full prescribing information of FARYDAK. FARYDAK is administered in combination with bortezomib (BTZ) and dexamethasone (Dex). BTZ and Dex prescribing information should be consulted prior starting the combination treatment.
Presentation: Hard gelatin capsules containing 10 mg, 15 mg and 20 mg panobinostat.
Indications: FARYDAK, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma, who have received at least 2 prior regimens including bortezomib and immunomodulatory agent.
Adults: ♦The recommended starting dose of FARYDAK is 20 mg, taken orally once a day, on days 1, 3, 5, 8, 10 and 12, of a 21 days cycle. Patients should be treated initially for eight cycles. It is recommended that patients with clinical benefit continue the treatment for eight additional cycles. The total duration of treatment is up to 16 cycles (48 weeks). ♦FARYDAK capsules can be taken with or without food. ♦Treatment dose and/or schedule modification may be required based on individual safety and tolerability. If dose reduction is required, the dose should be reduced by decrements of 5 mg daily. ♦Dose reduced at 10 mg when concomitant administration with strong CYP3A inhibitor.
Children (below the age of 18 years): ♦No studies have been performed and there is no relevant use of FARYDAK in pediatric patients below the age of 18.
Special patient populations: ♦Renal impairment: Mild to severe: no adjustments necessary. End stage renal disease or patients on dialysis: not studied. ♦Hepatic impairment: Mild: starting dose 15 mg. Moderate: starting dose 10 mg. Severe: not studied. Caution should be exercized in patients with hepatic impairment, with close clinical monitoring for adverse events. ♦Elderly patients: Patients ≥65 years: no starting dose adjustment is required. Patients >75 years: consider starting dose at 15 mg and if tolerated escalate to 20 mg in the second cycle. It is recommended to more frequently monitor patients over 65 years of age especially for thrombocytopenia and gastrointestinal toxicities.
Warnings and precautions: ♦Decrease in blood cell count: Complete blood count must be performed before initiating therapy with FARYDAK and during treatment. The platelet count should be ≥100 x 109/L before initiation of treatment and prior to initiating any cycle of treatment, and the absolute neutrophil count should be ≥1.0 x 109/L prior to initiation of treatment. ♦Hemorrhage: Physicians and patients should be aware of the increased risk of thrombocytopenia and the potential for hemorrhage, especially in patients with coagulation disorders, receiving chronic anticoagulation therapy ♦Infection: Physicians and patients should be aware of the increased risk of infections. FARYDAK treatment should not be initiated in patients with active infections. Treat pre-existing infections prior to starting treatment with FARYDAK. During treatment, monitor patients for signs and symptoms of infections; if a diagnosis of infection is made, institute an appropriate anti-infective treatment promptly and consider interruption or discontinuation of FARYDAK. ♦Gastrointestinal disorders: Fluid and electrolyte blood levels, especially potassium, magnesium and phosphate, should be monitored periodically during therapy and corrected as clinically indicated to prevent potential dehydration and electrolyte disturbances. ♦Prophylactic anti-emetics should be administered at the discretion of the physician and in accordance with local medical practice. At the first sign of abdominal cramping, loose stools, or onset of diarrhea, it is recommended that the patient be treated with anti-diarrheal medication. ♦Electrocardiographic changes: Appropriate monitoring of electrolytes (e. g. potassium, magnesium, and phosphate) and ECG should be performed at baseline and periodically during treatment. FARYDAK should be used with caution in patients who already have or who are at significant risk of developing QTc prolongation. This includes patients: with long QT syndrome, with uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia. Concomitant administration of medications that are known to cause QTc prolongation is not recommended. ♦Hepatotoxicity: Liver function should be monitored prior treatment and regularly during treatment. If abnormal liver function tests are observed, dose adjustments may be considered and the patient should be followed until values return to normal or pre- treatment levels. ♦Strong CYP3A4 inducers: May reduce the efficacy of panobinostat, concomitant use should be avoided. ♦Elderly population: Monitor patients over 65 years of age more frequently. Consider dose adjustment for patient ≥75 years.
Pregnancy, lactation and females and males of reproductive potential: ♦Pregnancy: FARYDAK should be used during pregnancy only if the expected benefits outweigh the potential risks to the fetus. ♦Lactation: A decision should be made whether to abstain from breast-feeding or abstain from using FARYDAK treatment taking into account the importance of FARYDAK to the mother. ♦Females and males of reproductive potential: Sexually-active females of reproductive potential should have a pregnancy test prior to the initiation of treatment and should be advised to use an effective method of contraception during treatment with FARYDAK and for 3 months after the last dose of FARYDAK. Sexually active men must use condoms while on treatment and for 6 months after. Female partners of sexually active treated men should also use an effective contraceptive method during treatment and for 6 months after their male partner has stopped taking FARYDAK. Based on non-clinical findings, male fertility may be compromised by treatment with FARYDAK.
Adverse reactions: ♦Very common (≥10%): Pneumonia, upper respiratory tract infection, insomnia, headache, dizziness, hypotension, dyspnea, cough, diarrhea, vomiting, abdominal pain, nausea, dyspepsia, fatigue, asthenia, edema peripheral, pyrexia, weight decreased, decreased appetite. ♦Common (1 to 10%): Septic shock, sepsis, gastrointestinal hemorrhage, hematochezia, clostridium difficile colitis, renal failure, hematuria, urinary tract infection, viral infection, oral herpes, otitis media, cellulitis, gastroenteritis, lower respiratory infection, candidiasis, hypothyroidism, hyperglycemia, dehydration, hypoalbuminemia, fluid retention, hyperuricemia, hypocalcemia, hypomagnesemia, hemorrhage intracranial, syncope, tremor, dysgeusia, conjunctival hemorrhage, atrial fibrillation, bradycardia, sinus tachycardia, tachycardia, palpitation, orthostatic hypotension, hypertension, hematoma, respiratory failure, rales, wheezing, epistaxis, gastritis, cheilitis, abdominal distension, dry mouth, flatulence, hepatic function abnormal, skin lesions, rash, erythema, joint swelling, urinary incontinence, chills, malaise, blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased, electrocardiogram QT prolonged. ♦Uncommon (0.1 to 1%): Shock hemorrhagic, hematemesis, pneumonia fungal, hepatitis B, aspergillosis, myocardial infarction, pulmonary hemorrhage, hemoptysis, colitis, gastrointestinal pain, petechie.
Laboratory abnormalities: ♦Very common (≥10%): Thrombocytopenia, neutropenia, lymphopenia, leukopenia, anemia, hypokalemia, hypophosphatemia, hyponatremia, hyperbilirubinemia, SGPT Alanine transaminase (ALT) increased, SGOT Aspartate transaminase (AST) increased, blood creatinine increased.
Interactions: ♦Consider dose reduction of FARYDAK when used with strong CYP3Ainhibitors, including but not limited to ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole, and nefazodone. ♦Star fruit, pomegranates or pomegranate juice, grapefruit or grapefruit juice should be avoided. ♦Avoid co-administration of sensitive CYP2D6 substrates (including but not limited to atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine and venlafaxine) or CYP2D6 substrates that have a narrow therapeutic index (including, but not limited to thioridazine and pimozide). If concomitant use is unavoidable, monitor patients frequently for adverse reactions. ♦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) are not recommended
Packs and prices: Country-specific.
Legal classification: Country-specific.
Farydak 10 mg hard capsules
Farydak 15 mg hard capsules
Farydak 20 mg hard capsules
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Farydak is and what it is used for
What Farydak is
Farydak is an anti-cancer medicine that contains the active substance panobinostat, which belongs to a group of medicines called pan-deacetylase inhibitors.
What Farydak is used for
Farydak is used to treat adult patients with a rare type of blood cancer called multiple myeloma. Multiple myeloma is a disorder of plasma cells (a type of blood cell) that grow out of control in the bone marrow.
Farydak blocks the growth of cancerous plasma cells and reduces the number of cancer cells.
Farydak is always used together with two other medicines: bortezomib and dexamethasone.
If you have any questions about how Farydak works or why you have been given it, ask your doctor or pharmacist.
2. What you need to know before you take Farydak
Do not take Farydak:
Warnings and precautions
Follow all your doctor’s instructions carefully.
Talk to your doctor or pharmacist before taking Farydak:
Tell your doctor or pharmacist straight away during treatment with Farydak:
The list of associated symptoms is provided in section 4, Possible side effects.
Your doctor may need to change your dose, temporarily stop or completely stop your treatment with Farydak in case you experience side effects.
Monitoring during your treatment with Farydak
You will have regular blood tests during treatment with Farydak. These are to:
Your heart rate will also be checked using a machine that measures the electrical activity of the heart (called an ECG).
Children and adolescents
Farydak is not to be used in children or adolescents under 18 years of age.
Other medicines and Farydak
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, such as vitamins or herbal supplements, because they might interact with Farydak.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
These medicines should be used with care or may need to be avoided during your treatment with Farydak. If you are taking any of these medicines, your doctor might prescribe a different medicine for you during your treatment with Farydak.
Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
During Farydak treatment, you should also tell your doctor or your pharmacist if you are prescribed another medicine that you have not already been taking.
Farydak with food and drink
You should not eat star fruit, pomegranate or grapefruit or drink pomegranate or grapefruit juice during your treatment with Farydak, as they may increase the amount of the medicine that passes into your blood.
Pregnancy and breast-feeding
Due to the potential risk of death or malformation to the foetus, Farydak should not be taken during:
Farydak should not be taken during pregnancy, unless the potential benefit to the mother is greater than the potential risk to the baby. If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice. Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
You should not take Farydak if you are breast-feeding.
Contraception for women and men
Due to the potential risk of death or malformation to the foetus, you should use the following methods of contraception while taking Farydak:
If you are a sexually active woman, you must use a highly effective method of contraception during treatment with Farydak. You must also use this for three months after you have stopped taking Farydak. Your doctor will discuss with you which is the best method for you to use. If you use a hormonal contraceptive you must also use a barrier method of contraception (such as condom or diaphragm) in addition.
If you are a sexually active man, you should use condoms during treatment with Farydak. You should also do this for six months after you have stopped taking Farydak. If your partner is able to become pregnant she should also use a highly effective method of contraception during your treatment and for three months after. Tell your doctor straight away if your partner becomes pregnant while you are taking Farydak or during the three months following your treatment with Farydak.
Driving and using machines
Farydak may have a minor influence on the ability to drive and use machines. If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
3. How to take Farydak
Always take this medicine exactly as your doctor has told you. Check with your doctor or your pharmacist if you are not sure.
How much to take
Please refer to Table 1 for cycles 1 to 8 and Table 2 for cycles 9-16.
Table 1 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 1-8)
Table 2 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 9-16).
Your doctor will tell you exactly how many capsules of Farydak you need to take. Do not change the dose without talking to your doctor.
Take Farydak once a day at the same time each day only on the scheduled days.
Taking this medicine
If you have to vomit after you swallow the Farydak capsules, do not take any more capsules until your next scheduled dose.
How to use the Farydak blister
One Farydak blister = 3 weeks = 1 cycle
The days of the cycle are numbered on the blister.
Take Farydak on days 1, 3 and 5 and on days 8, 10 and 12.
Push the Farydak capsule through the pocket on days 1, 3 and 5 of week 1 and days 8, 10 and 12 of week 2.
On days when you do not have to take Farydak, including the rest period in week 3, scratch the relevant empty cavities with your finger nail to help you keep track of your medication schedule.
How long to take Farydak
Keep taking Farydak for as long as your doctor tells you. This is a long-term treatment with 16 cycles (48 weeks). Your doctor will monitor your condition to see if the treatment is working. If you have questions about how long to take Farydak, talk to your doctor or pharmacist.
If you take more Farydak than you should
If you accidentally take more capsules than you should, or if someone else accidentally takes your medicine, talk to a doctor or go to a hospital straight away. Take the pack and this leaflet with you. You may need medical treatment.
If you forget to take Farydak
Do not take a double dose to make up for a forgotten dose.
Never take a missed dose of Farydak on one of the “off” days when no Farydak dose is planned.
Tell your doctor about all the doses that you have missed during any 21-day cycle of treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be serious
STOP taking Farydak and seek medical help immediately if you experience any of the following:
Tell a doctor or a pharmacist straight away if you notice any of these side effects:
Other possible side effects
If any of the side effects below becomes severe, tell your doctor, or your pharmacist.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Farydak
6. Contents of the pack and other information
What Farydak contains
What Farydak looks like and contents of the pack
Farydak 10 mg hard capsules are light green opaque capsules (15.6–16.2 mm) containing white to almost white powder, with radial marking “LBH 10 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Farydak 15 mg hard capsules are orange opaque capsules (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 15 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
Farydak 20 mg hard capsules are red opaque capsules (19.1–19.7 mm) containing white to almost white powder, with radial marking “LBH 20 mg” in black ink on the cap and two radial bands in black ink on the body, provided in blisters.
The following pack sizes are available: blister packs containing 6, 12 or 24 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
Manufacturer Novartis Pharma GmbH