Farydak

Package leaflet: Information for the patient

Farydak 10 mg hard capsules, 15 mg hard capsules, 20 mg hard capsules

panobinostat
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Farydak is and what it is used for
2. What you need to know before taking Farydak
3. How to take Farydak
4. Possible side effects
5. How to store Farydak
6. Contents of the pack and other information

1. What Farydak is and what it is used for

What Farydak is
Farydak is an antineoplastic medicinal product containing the active substance panobinostat, which belongs to
a group of medicines called pan-deacetylase inhibitors.
What Farydak is used for
Farydak is used for the treatment of adult patients with a rare type of blood cancer called
multiple myeloma. Multiple myeloma is a disease of plasma cells (a type of blood cell) that grow uncontrollably in the bone marrow.
Farydak blocks the growth of cancerous plasma cells and reduces the number of tumour cells.
Farydak is always used in combination with two other medicinal products: bortezomib and dexamethasone.
If you have any questions about how Farydak works or why it has been prescribed for you, please consult your doctor or pharmacist.

2. What you need to know before taking Farydak

Do not take Farydak:

• if you are allergic to panobinostat or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions
Follow all your doctor's instructions carefully.
Talk to your doctor or pharmacist before taking Farydak:

• if you have liver problems or a history of liver disease.
• if you have heart problems or irregular heartbeat, such as an irregular heart rhythm or a condition called long QT syndrome.
• if you have a bacterial, viral, or fungal infection.
• if you have gastrointestinal problems, such as diarrhoea, nausea, or vomiting.
• if you have blood clotting problems (coagulation disorder).

Immediately inform your doctor or pharmacist during treatment with Farydak:

• if you notice any signs of gastrointestinal problems.
• if you notice any signs of liver problems.
• if you notice any signs of infection.
• if you notice any signs of heart problems. A list of associated symptoms is provided in section 4, Possible side effects.

Your doctor may need to adjust the dose, temporarily interrupt, or completely stop treatment with Farydak if side effects occur.
Monitoring during treatment with Farydak
During treatment with Farydak, you will have regular blood tests. These are used to:

• check that your liver is working properly (by measuring blood levels of bilirubin and transaminases, which are substances produced by the liver).
• check the number of certain blood cells (white blood cells, red blood cells, platelets).
• check your electrolyte levels (such as potassium, magnesium, phosphate) in the body.
• check that your thyroid and pituitary gland are working properly (by measuring thyroid hormone levels in the blood).

Your heart rate will also be monitored using a device that measures the heart's electrical activity (called an ECG).
Children and adolescents
Farydak must not 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, as they may interact with Farydak.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• medicines used to treat infections, including fungal infections (such as ketoconazole, itraconazole, voriconazole, or posaconazole) and certain bacterial infections (such as antibiotics like clarithromycin or telithromycin). Medicines used to treat tuberculosis, such as rifabutin or rifampicin.
• medicines used to prevent epileptic seizures or convulsions (antiepileptics such as carbamazepine, perphenazine, phenobarbital, or phenytoin).
• medicines used to treat HIV, such as ritonavir or saquinavir.
• St John’s wort, a herbal medicine used to treat depression.
• medicines to prevent blood clotting called anticoagulants, such as warfarin or heparin.
• medicines used to treat cough, such as dextromethorphan.
• medicines used to treat irregular heartbeat, such as amiodarone, disopyramide, procainamide, quinidine, propafenone, or sotalol.
• medicines that may have an undesirable effect on the heart (called QT prolongation), such as chloroquine, halofantrine, methadone, moxifloxacin, bepridil, or pimozide.
• medicines used to treat high blood pressure, such as metoprolol or nebivolol.
• medicines used to treat serious mental health conditions, such as risperidone.
• medicines used to treat breast cancer, such as tamoxifen.
• medicines used to treat nausea and vomiting such as dolasetron, granisetron, ondansetron, or tropisetron; these may also have an undesirable effect on the heart (QT prolongation).
• atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).

These medicines should be used with caution or may need to be avoided during treatment with Farydak. If you are taking any of these medicines, your doctor may prescribe a different medicine during treatment with Farydak.
Ask your doctor or pharmacist if you are unsure whether a medicine you are taking is one of the medicines listed above.
During treatment with Farydak, you must also inform your doctor or pharmacist if you are prescribed another medicine that you have not previously taken.
Farydak with food and drink
You must not eat starfruit, pomegranate, or grapefruit, or drink pomegranate or grapefruit juice during treatment with Farydak, as they may increase the amount of medicine that enters your bloodstream.
Pregnancy and breastfeeding
Due to the potential risk of fetal death or malformation, Farydak must not be taken during:

• Pregnancy Farydak must not be taken during pregnancy unless the potential benefit to the mother outweighs the potential risk to the unborn child. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor. Your doctor will discuss with you the possible risks of taking Farydak during pregnancy.
• Breastfeeding You must not take Farydak if you are breastfeeding.

Contraception for women and men
Due to the potential risk of fetal death or malformation, the following contraceptive methods must be used during treatment with Farydak:

• For women taking Farydak If you are a sexually active woman, you must have a pregnancy test before starting treatment with Farydak and use a highly effective method of contraception during treatment with Farydak. You must continue using it for three months after stopping Farydak. Discuss with your doctor which method is best for you. If you use hormonal contraception, you must also use a barrier method of contraception (such as a condom or diaphragm).
• For men taking Farydak If you are a sexually active man, you must use a condom during treatment with Farydak. You must continue using it for six months after stopping Farydak. If your partner can become pregnant, she must use a highly effective method of contraception during your treatment and for six months afterwards. Inform your doctor immediately if your partner becomes pregnant while you are taking Farydak or within six months after treatment with Farydak.

Driving and using machines
Farydak may have a slight influence on the ability to drive and use machines. If you feel dizzy while taking this medicine, do not drive a vehicle or operate tools or machinery.

3. How to take Farydak

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
How much to take

• Farydak is taken over 21 days (2 consecutive weeks followed by 1 week off) – this is called a treatment cycle.
• Do not take the medicine every day.
• Based on your doctor's recommendation, the dose of Farydak is 20 mg, 15 mg, or 10 mg, taken once daily on Days 1, 3, 5, 8, 10, and 12 of the 21-day cycle.
• Do not take Farydak during Week 3.
• After Week 3, start a new cycle as indicated in Tables 1 and 2 below.
• Please refer to Table 1 for Cycles 1–8 and Table 2 for Cycles 9–16.

Table 1 Recommended treatment schedule for Farydak in combination with bortezomib and
dexamethasone (Cycles 1–8)
Cycles 1–8 Week 1 Week 2 Week 3
(3-week cycles) Days Days
Farydak 1 3 5 8 10 12 Rest
period
Bortezomib 1 4 8 11 Rest
period
Dexamethasone 1 2 4 5 8 9 11 12 Rest
period

Table 2 Recommended treatment schedule for Farydak in combination with bortezomib and
dexamethasone (Cycles 9–16)
Cycles 9–16 Week 1 Week 2 Week 3
(3-week cycles) Days Days
Farydak 1 3 5 8 10 12 Rest
period
Bortezomib 1 8 Rest
period
Dexamethasone 1 2 8 9 Rest
period

Your doctor will tell you exactly how many Farydak capsules you need to take. Do not change your dose without discussing it with your doctor.
Take Farydak once daily at the same time each day, but only on the scheduled days.
How to take the medicine

• Swallow the capsules whole with a glass of water.
• This medicine may be taken with or without food.
• Do not chew or crush the capsules.

If you vomit after swallowing the Farydak capsules, do not take another dose until your next scheduled dose.
How to use the Farydak blister pack

	One blister of Farydak = 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 out of its compartment on days 1, 3 and 5 of week 1 and on days 8, 10 and 12 of week 2.
	To help you keep track of your treatment schedule, on days when you do not take Farydak, including the rest period in week 3, scratch out the corresponding empty cavities with your fingernail.

How long to take Farydak
Continue taking Farydak for the entire duration prescribed by your doctor. This is a long-term treatment consisting of 16 cycles (48 weeks). Your doctor will monitor your condition to assess whether the treatment is working. If you have any questions about how long you should take Farydak, speak 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 the medicine, contact your doctor or go to hospital immediately. Take the pack and this leaflet with you. Medical treatment may be necessary.

If you forget to take Farydak

• If less than 12 hours have passed since you were supposed to take the medicine, take the missed dose as soon as you remember. Then continue taking the medicine as usual.
• If more than 12 hours have passed since you were supposed to take the medicine, do not take the missed dose. Then continue taking the medicine as usual.

Do not take a double dose to make up for a forgotten dose.
Never take a missed dose of Farydak on days when no Farydak dose is scheduled.
Inform your doctor about all the doses you have missed during each 21-day treatment cycle.
If you have any doubts about using this medicine, consult 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 can be serious.

STOP taking Farydak and seek immediate medical help if you experience any of the following:

• Difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin, with red rash or skin swellings (potential signs of an allergic reaction)
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (potential signs of nervous system problems such as bleeding or swelling in the skull and brain)
• Rapid breathing, feeling dizzy
• Sudden crushing chest pain, feeling of fatigue, irregular heartbeat (potential signs of a heart attack)
• Coughing up blood, blood dripping from the nose (signs of bleeding in the lungs)
• Vomiting blood, black or bloody stools, passing bright red blood through the anus, usually with or in stools (signs of gastrointestinal bleeding)
• Difficulty breathing with bluish discoloration around the mouth, which could lead to loss of consciousness (sign of severe lung problems)
• Fever, chest pain, increased heart rate, decreased blood pressure, shortness of breath or rapid breathing (signs of blood poisoning, also known as sepsis)
• Chest pain or discomfort, changes in heartbeat (faster or slower), palpitations, lightheadedness, fainting, dizziness, bluish lips, shortness of breath, swelling of lower limbs or skin (signs of heart problems)

Immediately inform your doctor or pharmacist if you notice any of the following side effects:

• Stomach or abdominal pain, nausea, diarrhoea, vomiting, black or bloody stools, constipation, heartburn, bloating or abdominal distension (signs of gastrointestinal problems)
• New or worsening symptoms such as cough, with or without mucus, fever, difficult or painful breathing, wheezing, chest pain when breathing, shortness of breath or difficulty breathing, pain or burning sensation when urinating, increased urge to urinate, blood in urine (signs of infection in the lungs or urinary tract)
• Fever, sore throat, or mouth ulcers due to infections (signs of low white blood cell count)
• Sudden bleeding or bruising under the skin (signs of low platelet levels in the blood)
• Diarrhoea, abdominal pain, fever (signs of inflammation of the colon)
• Feeling lightheaded, especially when standing up (a sign of low blood pressure)
• Feeling thirsty, reduced urine output, weight loss, dry flushed skin, irritability (signs of dehydration)
• Swelling of the ankles (sign of low albumin levels in the blood, known as hypoalbuminemia)
• Feeling tired, itching, yellowing of the skin and whites of the eyes, nausea or vomiting, loss of appetite, pain in the right side of the stomach, dark or brown urine, bleeding or bruising more than normal (signs of liver problems)
• Severely reduced urine output, swelling of the legs (signs of kidney problems)
• Muscle weakness, muscle spasms, unusual heartbeat (signs of changes in blood potassium levels)

Other possible side effects
If any of the following side effects become severe, inform your doctor or pharmacist.

Very common (may affect more than 1 in 10 people)

• Feeling tired (fatigue), pale skin. These could be signs of low red blood cell count.
• Decreased appetite or weight loss
• Difficulty falling asleep or staying asleep (insomnia)
• Headache
• Dizziness, tiredness or weakness
• Vomiting, nausea, stomach discomfort, indigestion
• Swelling of legs or arms
• Reduced levels of phosphate or sodium in the blood

Common (may affect up to 1 in 10 people)

• Rash with small fluid-filled blisters on red skin, mouth or gums (signs of a potentially severe viral infection)
• Inflamed ear, nosebleed or bleeding in the white part of the eye, bruising, inflamed skin due to infection (skin rash, red skin, also known as erythema)
• Abdominal pain, diarrhoea, bloating or abdominal distension (signs of inflammation of the inner lining of the stomach)
• Oral thrush (candida infection of the mouth)
• Feeling thirsty, increased urine production, increased appetite with weight loss (signs of high blood sugar levels)
• Rapid weight gain, swelling of hands, ankles, feet or face (signs of fluid retention)
• Reduced calcium levels in the blood, which sometimes causes cramps
• Uncontrollable tremor of the body
• Palpitations
• Lung sounds during breathing such as crackles, crepitations or rattling
• Dry, cracked lips
• Dry mouth or changes in taste sensation
• Flatulence
• Joint pain or inflammation
• Blood in urine (sign of kidney problem)
• Inability to control urine flow due to loss or weak bladder control
• Chills
• Weight gain, feeling tired, hair loss, muscle weakness, feeling cold (signs of reduced thyroid activity known as hypothyroidism)
• General feeling of being unwell
• Increased levels of uric acid in the blood
• Reduced magnesium levels in the blood
• Increased creatinine levels in the blood
• Increased blood levels of liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP)

Uncommon (may affect up to 1 in 100 people)

• Flat, pinpoint-sized red or purple spots under the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Farydak

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister.
• Do not store above 30°C.
• Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice any damage to the packaging or signs of tampering.
• Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Farydak contains

• The active substance of Farydak is panobinostat.
• Each Farydak 10 mg hard capsule contains panobinostat anhydrous lactose equivalent to 10 mg of panobinostat. The other components are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac.
• Each Farydak 15 mg hard capsule contains panobinostat anhydrous lactose equivalent to 15 mg of panobinostat. The other components are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac.
• Each Farydak 20 mg hard capsule contains panobinostat anhydrous lactose equivalent to 20 mg of panobinostat. The other components are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac.

Description of the appearance of Farydak and pack contents
Farydak 10 mg hard capsules are opaque light green capsules (15.6–16.2 mm), containing white to almost white powder, with circular black marking “LBH 10 mg” on the cap and two black circular bands on the body, supplied in blisters.
Farydak 15 mg hard capsules are opaque orange capsules (19.1–19.7 mm), containing white to almost white powder, with circular black marking “LBH 15 mg” on the cap and two black circular bands on the body, supplied in blisters.
Farydak 20 mg hard capsules are opaque red capsules (19.1–19.7 mm), containing white to almost white powder, with circular black marking “LBH 20 mg” on the cap and two black circular bands on the body, supplied in blisters.
The following packs are available: blister packs containing 6, 12 or 24 capsules.
Not all pack sizes may be marketed in your country.

Marketing Authorization Holder
pharmaand GmbH
Taborstrasse 1
1020 Wien
Austria

Manufacturer
Siegfried Barbera, S.L.
1 Ronda de Santa Maria, 158
08210 Barberà del Vallès
Barcelona, Spain

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu