Panobinostat (Farydak)

Trade Name : FARYDAK

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 10 mg/1

PANOBINOSTAT LACTATE Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Panobinostat (Farydak) which is also known as FARYDAK and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 10 mg/1 per ml. Read more

Panobinostat (Farydak) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

No data

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. (5.1)
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. (5.2)
WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES
See full prescribing information for complete boxed warning.

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. ()

FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression free survival . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
FARYDAK, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. This indication is approved under accelerated approval based on progression free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. ()

No data

20 mg, taken orally once every other day for 3 doses per week (on Days 1, 3, 5, 8, 10, and 12) of Weeks 1 and 2 of each 21-day cycle for 8 cycles ()
Consider continuing treatment for an additional 8 cycles for patients with clinical benefit, unless they have unresolved severe or medically significant toxicity ()

Capsules: 10 mg, 15 mg, and 20 mg panobinostat (equivalent to 12.58 mg, 18.86 mg, and 25.15 mg respectively of panobinostat lactate)
10 mg: Size #3 light green opaque capsule, radial markings on cap with black ink u201cLBH 10 mgu201d and two radial bands with black ink on body, containing white to almost white powder.
15 mg: Size #1 orange opaque capsule, radial markings on cap with black ink u201cLBH 15 mgu201d and two radial bands with black ink on body, containing white to almost white powder.
20 mg: Size #1 red opaque capsule, radial markings on cap with black ink u201cLBH 20 mgu201d and two radial bands with black ink on body, containing white to almost white powder.
Capsules: 10 mg, 15 mg, and 20 mg panobinostat (equivalent to 12.58 mg, 18.86 mg, and 25.15 mg respectively of panobinostat lactate) ()

Nonentttttt
None ()

No data

Hemorrhage: Fatal and serious cases of gastrointestinal and pulmonary hemorrhage. Monitor platelet counts and transfuse as needed. ()
Hepatotoxicity: Monitor hepatic enzymes and adjust dosage if abnormal liver function tests are observed during FARYDAK therapy. ()
Embryo-Fetal Toxicity: can cause fetal harm. Advise women of the potential hazard to the fetus and to avoid pregnancy while taking FARYDAK. ()

The following adverse reactions are described in detail in other sections of the label:
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.
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 u226548 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 (u22655%) 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 u2265 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:
Endocrine disorders:
Metabolism and nutrition disorders:
Nervous system disorders:
Cardiac disorders:
Vascular disorders:
Respiratory, thoracic and mediastinal disorders:
Gastrointestinal disorders:
Skin and subcutaneous disorders:
Musculoskeletal and connective tissue disorders:
Renal and urinary disorders:
General disorders and administration site conditions:
Investigations:
Psychiatric disorders:
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 u22653 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.
The most common adverse reactions (incidence of at least 20%) in clinical studies are diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia, and vomiting. ()n
The most common non-hematologic laboratory abnormalities (incidence u226540%) are hypophosphatemia, hypokalemia, hyponatremia, and increased creatinine. The most common hematologic laboratory abnormalities (incidence u226560%) are thrombocytopenia, lymphopenia, leukopenia, neutropenia, and anemia. ()

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

Strong CYP3A4 inhibitors: Reduce FARYDAK dose. ()
Strong CYP3A4 inducers: Avoid concomitant use with FARYDAK. ()
Sensitive CYP2D6 substrates: Avoid concomitant use with FARYDAK. ()
Anti-arrhythmic drugs/QT-prolonging drugs: Avoid concomitant use. ()

Hepatic Impairment: Hepatic impairment can increase panobinostat exposure. Reduce FARYDAK dose in patients with mild or moderate hepatic impairment. Avoid use in patients with severe hepatic impairment. ()n n

There is limited experience with overdosage. Expect exaggeration of adverse reactions observed during the clinical trial, including hematologic and gastrointestinal reactions such as thrombocytopenia, pancytopenia, diarrhea, nausea, vomiting and anorexia. Monitor cardiac status including ECGs, and assess and correct electrolytes. Consider platelet transfusions for thrombocytopenic bleeding. It is not known if FARYDAK is dialyzable.

FARYDAK (panobinostat lactate) is a histone deacetylase inhibitor.
The chemical name of panobinostat lactate is 2-Hydroxypropanoic acid, compd. with 2-(E)-N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2-propenamide (1:1).
The structural formula is:
Panobinostat lactate anhydrous is a white to slightly yellowish or brownish powder. The molecular formula is CHNOu2022CHO (lactate); its molecular weight is 439.51 (as a lactate), equivalent to 349.43 (free base). Panobinostat lactate anhydrous is light sensitive. Panobinostat lactate anhydrous is both chemically and thermodynamically a stable crystalline form with no polymorphic behavior. Panobinostat free base is not chiral and shows no specific optical rotation. Panobinostat lactate anhydrous is slightly soluble in water. Solubility of panobinostat lactate anhydrous is pH-dependent, with the highest solubility in buffer pH 3.0 (citrate).
FARYDAK capsules contain 10 mg, 15 mg, or 20 mg panobinostat free base (equivalent to 12.58 mg, 18.86 mg, and 25.15 mg respectively of panobinostat lactate). The inactive ingredients are magnesium stearate, mannitol, microcrystalline cellulose and pregelatinized starch. The capsules contain gelatin, FD&C Blue 1 (10 mg capsules), yellow iron oxide (10 mg and 15 mg capsules), red iron oxide (15 mg and 20 mg capsules) and titanium dioxide.

No data

No data

No data

1. OSHA Hazardous Drugs. n

No data

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Dosing and Administration
Instruct patients to take FARYDAK exactly as prescribed and not to change their dose or to stop taking FARYDAK unless they are told to do so by their healthcare provider. If a patient misses a dose, advise them to take their dose as soon possible and up to 12 hours after the specified dose time. If vomiting occurs advise the patient not to repeat the dose, but to take the next usual prescribed dose on schedule.
Cardiac Toxicity/Electrocardiographic Changes
Inform patients to report chest pain or discomfort, changes in heart beat (fast or slow), palpitations, lightheadedness, fainting, dizziness, blue discoloration of lips, shortness of breath, and swelling of lower limbs or skin as these may be warning signs of a heart problem.
Bleeding Risk
Inform patients that FARYDAK is associated with thrombocytopenia. Advise patients to contact their healthcare provider right away if they experience any signs of bleeding and inform patients that it might take longer than usual for them to stop bleeding. Advise patients of the need to monitor blood chemistry and hematology prior to the start of FARYDAK therapy and periodically thereafter.
Infections
Inform patients of the risk of neutropenia and severe and life-threatening infections. Instruct patients to contact their physician immediately if they develop a fever and/or any exhibit any signs of infection.
Gastrointestinal Toxicities
Inform patients that FARYDAK can cause severe nausea, vomiting and diarrhea which may require medication for treatment. Advise patients to contact their physician at the start of diarrhea, for persistent vomiting, or signs of dehydration. Inform patients to consult with their physicians prior to using medications with laxative properties.
Pregnancy
Inform patients that FARYDAK can cause fetal harm. Advise women of reproductive potential to avoid pregnancy while taking FARYDAK. Advise women of reproductive potential to use effective contraception while taking FARYDAK and for at least 3 months after the last dose of the drug.
Advise sexually active men to use condoms while receiving FARYDAK and for at least 6 months following the last dose of the drug.
Lactation
Advise women not to breastfeed while taking FARYDAK.
Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
u00a9 Novartis
T2016-49June 2016

No data

PRINCIPAL DISPLAY PANEL
NDC 0078-0650-06
6 capsules
FARYDAKn
(panobinostat)
capsules
10 mg
equivalent to 12.58 mg of panobinostat lactate
Swallow Whole with Water and Do Not Open, Crush or Chew.
Store blister pack in original carton to protect from light.
ATTENTION: Dispense with enclosed Medication Guide
Rx only

PRINCIPAL DISPLAY PANEL
NDC 0078-0651-06
6 capsules
FARYDAKn
(panobinostat)
capsules
15 mg
equivalent to 18.86 mg of panobinostat lactate
Swallow Whole with Water and Do Not Open, Crush or Chew.
Store blister pack in original carton to protect from light.
ATTENTION: Dispense with enclosed Medication Guide
Rx only

PRINCIPAL DISPLAY PANEL
NDC 0078-0652-06
6 capsules
FARYDAKn
(panobinostat)
capsules
20 mg
equivalent to 25.15 mg of panobinostat lactate
Swallow Whole with Water and Do Not Open, Crush or Chew.
Store blister pack in original carton to protect from light.
ATTENTION: Dispense with enclosed Medication Guide
Rx only

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Panobinostat (Farydak)

Trade Name : FARYDAK

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Panobinostat (Farydak)

Trade Name : FARYDAK

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?