Farydak (Panobinostat)
Pan-deacetylase (HDAC) inhibitor for relapsed multiple myeloma
Quick Facts about Farydak
Key Takeaways about Farydak
- Combination therapy only: Farydak must always be used together with bortezomib and dexamethasone – never as a standalone treatment
- Intermittent dosing schedule: Taken only on specific days (days 1, 3, 5, 8, 10, 12) of each 21-day cycle, not daily
- Regular monitoring essential: Blood tests for liver function, blood counts, electrolytes, and thyroid function are required throughout treatment
- Severe diarrhea risk: Diarrhea is a very common side effect that may require dose adjustment or treatment interruption
- Cardiac monitoring needed: Farydak can cause QT prolongation; ECG monitoring is performed during treatment
What Is Farydak and What Is It Used For?
Farydak (panobinostat) is a targeted cancer therapy that belongs to a class of medicines called pan-deacetylase inhibitors. It is used in combination with bortezomib and dexamethasone to treat adults with relapsed or refractory multiple myeloma – a rare type of blood cancer affecting plasma cells in the bone marrow.
Multiple myeloma is a cancer in which abnormal plasma cells – a type of white blood cell – multiply uncontrollably in the bone marrow. These malignant plasma cells produce abnormal antibodies and crowd out healthy blood-forming cells, leading to bone damage, anemia, kidney problems, and immune deficiency. Multiple myeloma is the second most common blood cancer worldwide, with approximately 176,000 new cases diagnosed annually according to the World Health Organization (WHO).
Farydak works by blocking enzymes called histone deacetylases (HDACs). These enzymes play a key role in gene regulation by modifying histone proteins around which DNA is wound. When HDACs are inhibited, the acetylation of both histone and non-histone proteins increases, leading to changes in gene expression that ultimately cause cancer cell death (apoptosis) and stop tumour growth. This epigenetic mechanism of action is distinct from other myeloma therapies and provides an additional way to attack cancer cells.
The approval of panobinostat was based on the PANORAMA clinical trial program, which demonstrated that adding Farydak to bortezomib and dexamethasone significantly improved progression-free survival in patients with relapsed or refractory multiple myeloma compared with bortezomib and dexamethasone alone. The European Medicines Agency (EMA) granted conditional marketing authorization for Farydak based on these results.
Farydak is specifically indicated for patients who have received at least two prior treatment regimens, including bortezomib and an immunomodulatory agent. It is not indicated for use in treatment-naive patients or as monotherapy. The triple combination approach leverages the synergistic effects of these three different mechanisms of action to provide maximum anti-myeloma activity.
Farydak does not cure multiple myeloma but can help control the disease and extend the time before it progresses. Treatment decisions should be made in close consultation with an oncologist or hematologist experienced in managing multiple myeloma.
What Should You Know Before Taking Farydak?
Before starting Farydak, your doctor must evaluate your liver function, heart health, blood counts, and current medications. Farydak is contraindicated during breastfeeding and in those allergic to panobinostat. Effective contraception is mandatory for both men and women during treatment and for a period after discontinuation.
Contraindications
You must not take Farydak if you are allergic to panobinostat or any of the other ingredients in the capsule. An allergic reaction may include difficulty breathing, swelling of the face or throat, or a severe skin rash. Additionally, Farydak must not be used if you are breastfeeding, as it may pass into breast milk and harm the nursing infant.
Warnings and Precautions
Before and during treatment with Farydak, it is essential that you inform your healthcare provider about all your medical conditions. Particular caution is warranted in the following situations:
- Liver problems: If you have a history of liver disease or impaired liver function, your doctor may need to adjust the dose, as panobinostat is metabolized by the liver. Regular liver function tests (bilirubin and transaminase levels) will be performed throughout treatment.
- Heart conditions: Farydak can affect the heart rhythm, particularly by prolonging the QT interval on ECG. If you have a history of irregular heartbeat, long QT syndrome, or other cardiac conditions, this medication requires careful monitoring. ECG testing will be performed regularly during treatment.
- Active infections: If you have any bacterial, viral, or fungal infection, your doctor needs to know before starting treatment. Farydak can reduce your immune cells, making you more susceptible to infections. Signs of infection include fever, chills, sore throat, or painful urination.
- Gastrointestinal problems: Diarrhea is one of the most common and potentially serious side effects of Farydak. If you have pre-existing gastrointestinal conditions, your doctor should assess the risks carefully. Anti-diarrheal medications should be available from the start of treatment.
- Bleeding disorders: If you have problems with blood clotting (coagulation disorders), inform your doctor. Farydak can lower platelet counts, which may increase the risk of bleeding.
Monitoring During Treatment
Regular blood tests will be taken throughout your treatment with Farydak. These tests are essential to monitor for potential complications and include:
- Liver function: Measurement of bilirubin and transaminase levels to detect any liver damage
- Complete blood count: Monitoring of white blood cells, red blood cells, and platelets. Low counts may require dose adjustment or treatment pause
- Electrolytes: Levels of potassium, magnesium, and phosphate, which are important for heart function and can be affected by diarrhea
- Thyroid function: Thyroid hormone levels, as Farydak may affect thyroid and pituitary gland function
- ECG: Regular electrocardiogram testing to monitor for QT prolongation and other cardiac rhythm abnormalities
Pregnancy and Breastfeeding
Farydak can cause serious harm to an unborn baby, including birth defects and fetal death. Therefore, strict precautions regarding pregnancy must be followed:
For women: A pregnancy test must be performed before starting treatment. Women of childbearing potential must use a highly effective method of contraception during treatment and for at least three months after the last dose. If a hormonal contraceptive is used, a barrier method (such as condoms or a diaphragm) must also be used. If pregnancy occurs during treatment, inform your doctor immediately.
For men: Men must use condoms during treatment and for six months after the last dose. If your partner is of childbearing potential, she should also use a highly effective method of contraception. If your partner becomes pregnant during your treatment or within six months after your last dose, inform your doctor immediately.
Breastfeeding: You must not breastfeed while taking Farydak. It is not known whether panobinostat passes into breast milk, but due to the potential for serious adverse effects in a nursing infant, breastfeeding is contraindicated.
Farydak may have a minor effect on your ability to drive or operate machinery. If you experience dizziness while taking this medicine, you should not drive or use any tools or machines until the symptoms resolve.
How Does Farydak Interact with Other Drugs?
Farydak has significant drug interactions, particularly with strong CYP3A4 inhibitors and inducers, QT-prolonging medications, and CYP2D6 substrates. Always inform your healthcare provider about all medicines you are taking, including over-the-counter drugs, vitamins, and herbal supplements.
Panobinostat is primarily metabolized by the CYP3A4 enzyme system and, to a lesser extent, by CYP2D6. It also inhibits CYP2D6. These metabolic pathways mean that many other drugs can either increase or decrease panobinostat levels in the blood, or that panobinostat can affect the levels of other medications. Additionally, because Farydak can prolong the QT interval, combining it with other QT-prolonging drugs increases the risk of potentially dangerous heart rhythm disturbances.
Major Interactions
| Drug / Drug Class | Type of Interaction | Clinical Consequence |
|---|---|---|
| Ketoconazole, itraconazole, voriconazole, posaconazole | Strong CYP3A4 inhibitors | Significantly increases panobinostat blood levels; dose reduction may be required |
| Clarithromycin, telithromycin | Strong CYP3A4 inhibitors (antibiotics) | Increased panobinostat exposure; use with caution or consider alternatives |
| Ritonavir, saquinavir | Strong CYP3A4 inhibitors (HIV antivirals) | Increased panobinostat levels; dose adjustment needed |
| Rifampicin, rifabutin | Strong CYP3A4 inducers | Significantly decreases panobinostat blood levels; reduced efficacy |
| Carbamazepine, phenobarbital, phenytoin | Strong CYP3A4 inducers (antiepileptics) | Reduced panobinostat efficacy; avoid concurrent use |
| Amiodarone, disopyramide, procainamide, quinidine, sotalol | QT-prolonging antiarrhythmics | Increased risk of life-threatening cardiac arrhythmias |
| Warfarin, heparin | Anticoagulants | Altered anticoagulant effect; close INR monitoring required |
Other Notable Interactions
| Drug / Drug Class | Type of Interaction | Clinical Consequence |
|---|---|---|
| Metoprolol, nebivolol | CYP2D6 substrates (beta-blockers) | Panobinostat may increase beta-blocker levels; monitor for low blood pressure and slow heart rate |
| Tamoxifen | CYP2D6 substrate (breast cancer drug) | Panobinostat may alter tamoxifen metabolism; use caution |
| Dextromethorphan | CYP2D6 substrate (cough suppressant) | Increased dextromethorphan levels; caution advised |
| Risperidone | CYP2D6 substrate (antipsychotic) | Increased risperidone levels; monitor for adverse effects |
| Atomoxetine | CYP2D6 substrate (ADHD medication) | Increased atomoxetine levels; caution required |
| Ondansetron, granisetron, dolasetron | Antiemetics with QT-prolonging potential | Additive QT prolongation risk; ECG monitoring recommended |
| St. John's Wort (Hypericum) | CYP3A4 inducer (herbal supplement) | May reduce panobinostat effectiveness; avoid concurrent use |
Do not eat starfruit (carambola), pomegranate, or grapefruit, and do not drink pomegranate or grapefruit juice during treatment with Farydak. These foods can inhibit CYP3A4 enzymes and increase the amount of panobinostat in your blood, potentially leading to more severe side effects.
What Is the Correct Dosage of Farydak?
The recommended starting dose of Farydak is 20 mg taken orally once daily on days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. The capsules are swallowed whole with water and can be taken with or without food. Treatment continues for up to 16 cycles (48 weeks), depending on clinical response and tolerability.
Farydak follows an intermittent dosing schedule within each 21-day treatment cycle. The medication is taken during the first two weeks of each cycle, with the third week being a rest period. This schedule allows the body to recover between dosing periods and helps manage side effects. Your doctor will determine the exact dose based on your individual circumstances.
Adults – Standard Dosing
The treatment protocol for Farydak differs between the initial cycles (1–8) and subsequent cycles (9–16). During cycles 1 through 8, Farydak is administered alongside both bortezomib (given as an injection) and dexamethasone. From cycle 9 onward, bortezomib is typically given less frequently while Farydak and dexamethasone continue on the same schedule.
Cycles 1–8 (Weeks 1–24)
Farydak: 20 mg orally on days 1, 3, 5, 8, 10, and 12. No dosing during week 3 (days 13–21).
Bortezomib: Given by injection on days 1, 4, 8, and 11.
Dexamethasone: 20 mg orally on days of and after bortezomib injection.
Cycles 9–16 (Weeks 25–48)
Farydak: 20 mg orally on days 1, 3, 5, 8, 10, and 12. No dosing during week 3.
Bortezomib: Given by injection on days 1 and 8 (reduced frequency).
Dexamethasone: 20 mg orally on days of and after bortezomib injection.
Dose modifications may be required based on individual tolerability. Your doctor may reduce the dose from 20 mg to 15 mg or 10 mg, or may temporarily interrupt treatment, depending on the severity of side effects. The three available capsule strengths (10 mg, 15 mg, and 20 mg) facilitate dose adjustments.
Children and Adolescents
Farydak is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of panobinostat have not been established in this age group. Multiple myeloma is extremely rare in the pediatric population.
Elderly Patients
No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to certain side effects, particularly cardiac events, dehydration from diarrhea, and bone marrow suppression. Close monitoring is especially important in this population, and dose reductions may be made more frequently.
Missed Dose
If you forget to take a dose of Farydak:
- Less than 12 hours late: Take the missed dose as soon as you remember, then continue with your regular schedule
- More than 12 hours late: Skip the missed dose entirely and take your next dose at the regularly scheduled time
- Never take a double dose to make up for a missed dose
- Never take a missed dose on a day when Farydak is not scheduled according to your treatment plan
- Tell your doctor about any missed doses during each treatment cycle
Overdose
If you accidentally take more capsules than prescribed, or if someone else accidentally takes your medication, contact your doctor or go to a hospital emergency department immediately. Bring the medication packaging and this information with you. There is no specific antidote for panobinostat overdose, and treatment is supportive, addressing symptoms as they arise.
Swallow the capsules whole with a glass of water. Do not chew or crush the capsules. Farydak can be taken with or without food. Take the medicine at the same time each day on the scheduled dosing days. If you vomit after swallowing the capsules, do not take additional capsules until the next scheduled dose.
What Are the Side Effects of Farydak?
Like all cancer medicines, Farydak can cause side effects, although not everyone experiences them. The most common side effects include diarrhea, fatigue, nausea, decreased appetite, and low blood cell counts. Some side effects can be serious and require immediate medical attention.
Side effects of Farydak can range from mild to severe. Many side effects are manageable with supportive care and dose adjustments. Your healthcare team will monitor you closely and may modify your treatment based on the side effects you experience. It is crucial to report any new or worsening symptoms to your doctor promptly.
Difficulty breathing or swallowing, facial swelling, severe headache, sudden weakness or paralysis, chest pain with a pressing sensation, blood in vomit or stool, signs of severe infection (high fever, rapid breathing, low blood pressure), or irregular heartbeat with dizziness or fainting. These may be signs of serious, life-threatening complications.
Very Common
- Diarrhea, nausea, vomiting, indigestion
- Fatigue, weakness, pallor (signs of low red blood cells / anemia)
- Decreased appetite, weight loss
- Difficulty sleeping (insomnia)
- Headache, dizziness
- Swollen legs or arms (peripheral edema)
- Low phosphate or sodium levels in the blood
Common
- Viral infections (e.g., herpes simplex with fluid-filled blisters)
- Ear infection, nosebleed, bleeding in the white of the eye, bruising
- Abdominal pain, bloating, inflamed stomach lining
- Oral thrush (fungal mouth infection)
- High blood sugar, rapid weight gain, fluid retention
- Low calcium in the blood, uncontrollable body trembling
- Palpitations, crackles or rattling in the lungs
- Dry mouth, altered taste, chapped and cracked lips
- Flatulence, joint pain or inflammation
- Blood in urine, loss of bladder control
- Chills, weight gain, hypothyroidism
- Elevated uric acid, creatinine, liver enzymes (ALT, AST, alkaline phosphatase)
- Low magnesium levels
Uncommon
- Petechiae (red or purple flat pinpoint-sized spots under the skin)
Serious but Less Common Events
- Severe gastrointestinal bleeding (bloody vomit, black or bloody stool)
- Pulmonary hemorrhage (coughing up blood)
- Sepsis (blood infection with fever, rapid breathing, low blood pressure)
- Colitis (inflammation of the large intestine with abdominal pain and fever)
- Cardiac events (heart attack, severe arrhythmias)
- Hepatotoxicity (severe liver damage with jaundice, dark urine)
- Renal failure (severely decreased urine output, swollen legs)
If you experience any side effects, including those not listed here, talk to your doctor or pharmacist. Your healthcare team can help manage side effects and determine whether your dose needs to be adjusted. Reporting side effects also contributes to ongoing safety monitoring of this medicine.
How Should You Store Farydak?
Store Farydak at or below 30°C (86°F) in the original packaging to protect from moisture. Keep the medicine out of the sight and reach of children and do not use it after the expiry date printed on the carton and blister pack.
Proper storage of Farydak is important to maintain its effectiveness and safety. Follow these guidelines:
- Temperature: Store at or below 30°C (86°F). Do not freeze
- Moisture protection: Keep the capsules in the original blister packaging until you are ready to take them. The packaging is designed to protect the medicine from moisture
- Light protection: Store in the original carton
- Child safety: Keep out of the sight and reach of children at all times
- Expiry date: Do not use Farydak after the expiry date (marked as EXP) on the carton and blister pack. The expiry date refers to the last day of that month
- Damaged packaging: Do not use the medicine if the packaging is damaged or shows signs of tampering
- Disposal: Do not dispose of medicines through wastewater or household waste. Ask your pharmacist about proper disposal of medicines you no longer need. These measures help protect the environment
What Does Farydak Contain?
The active substance in Farydak is panobinostat (as panobinostat lactate anhydrate). Each capsule contains either 10 mg, 15 mg, or 20 mg of panobinostat. The capsules also contain several inactive ingredients that form the capsule shell and its markings.
The complete composition of each capsule strength is as follows:
| Component | 10 mg Capsule | 15 mg Capsule | 20 mg Capsule |
|---|---|---|---|
| Active substance | Panobinostat 10 mg | Panobinostat 15 mg | Panobinostat 20 mg |
| Core excipients | Magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch | ||
| Capsule shell | Gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172) | Gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) | Gelatin, titanium dioxide (E171), red iron oxide (E172) |
| Printing ink | Black iron oxide (E172), propylene glycol (E1520), shellac | ||
| Capsule colour | Light green, opaque | Orange, opaque | Red, opaque |
| Imprint | LBH 10 mg | LBH 15 mg | LBH 20 mg |
| Pack sizes | 6, 12, or 24 capsules per blister pack | ||
Each capsule contains a white to off-white powder. The capsules measure approximately 15.6–16.2 mm (10 mg) or 19.1–19.7 mm (15 mg and 20 mg) in length. Each capsule has two black bands printed on the lower portion of the shell. The three different colours help distinguish between the strengths: light green for 10 mg, orange for 15 mg, and red for 20 mg.
The marketing authorization holder is pharmaand GmbH, Taborstrasse 1, 1020 Vienna, Austria. The capsules are manufactured by Siegfried Barbera, S.L. in Barcelona, Spain. Additional information about Farydak is available on the European Medicines Agency website.
Frequently Asked Questions about Farydak
References
- European Medicines Agency (EMA). Farydak (panobinostat) – Summary of Product Characteristics. Last updated 2023. Available at: www.ema.europa.eu
- San-Miguel JF, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial (PANORAMA 1). Lancet Oncol. 2014;15(11):1195-1206. doi:10.1016/S1470-2045(14)70440-1
- Richardson PG, Hungria VT, Yoon SS, et al. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment (PANORAMA 1). Blood. 2016;127(6):713-721. doi:10.1182/blood-2015-09-665018
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 2.2025. Available at: www.nccn.org
- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd edition. Geneva: WHO; 2023.
- Laubach JP, Moreau P, San-Miguel JF, Richardson PG. Panobinostat for the treatment of multiple myeloma. Clin Cancer Res. 2015;21(21):4767-4773. doi:10.1158/1078-0432.CCR-15-0530
- Rajkumar SV, Kumar S. Multiple myeloma current treatment algorithms. Blood Cancer J. 2020;10(9):94. doi:10.1038/s41408-020-00359-2
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