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FARYDAK
Overview
What is FARYDAK?
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 CHNO•CHO (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.
What does FARYDAK look like?
What are the available doses of FARYDAK?
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) ()
What should I talk to my health care provider before I take FARYDAK?
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. ()
How should I use FARYDAK?
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.
The recommended starting dose of FARYDAK is 20 mg, taken orally once every other day for 3 doses per week in Weeks 1 and 2 of each 21-day cycle for up to 8 cycles. Consider continuing treatment for an additional 8 cycles for patients with clinical benefit who do not experience unresolved severe or medically significant toxicity. The total duration of treatment may be up to 16 cycles (48 weeks). FARYDAK is administered in combination with bortezomib and dexamethasone as shown in Table 1 and Table 2.
The recommended dose of bortezomib is 1.3 mg/m given as an injection. The recommended dose of dexamethasone is 20 mg taken orally per scheduled day, on a full stomach.
What interacts with FARYDAK?
Sorry No Records found
What are the warnings of FARYDAK?
Sorry No Records found
What are the precautions of FARYDAK?
Sorry No Records found
What are the side effects of FARYDAK?
Sorry No records found
What should I look out for while using FARYDAK?
None
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)
What might happen if I take too much FARYDAK?
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.
How should I store and handle FARYDAK?
Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Storage and HandlingStore at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store blister pack in original carton to protect from light. FARYDAK capsules should not be opened, crushed, or chewed. Direct contact of the powder in FARYDAK capsules with the skin or mucous membranes should be avoided. If such contact occurs wash thoroughly. Personnel should avoid exposure to crushed and/or broken capsules.FARYDAK is a cytotoxic drug. Follow special handling and disposal procedures .Product: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLEProduct: 71335-0091NDC: 71335-0091-7 90 CAPSULE in a BOTTLENDC: 71335-0091-5 120 CAPSULE in a BOTTLENDC: 71335-0091-8 14 CAPSULE in a BOTTLENDC: 71335-0091-2 20 CAPSULE in a BOTTLENDC: 71335-0091-9 40 CAPSULE in a BOTTLENDC: 71335-0091-3 100 CAPSULE in a BOTTLENDC: 71335-0091-6 60 CAPSULE in a BOTTLENDC: 71335-0091-1 30 CAPSULE in a BOTTLENDC: 71335-0091-4 15 CAPSULE in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
FARYDAK is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations. HDACs catalyze the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. Inhibition of HDAC activity results in increased acetylation of histone proteins, an epigenetic alteration that results in a relaxing of chromatin, leading to transcriptional activation. In vitro, panobinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells. Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat. Panobinostat shows more cytotoxicity towards tumor cells compared to normal cells.
Non-Clinical Toxicology
NoneSevere 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)
Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies.
Severe diarrhea occurred in 25% of patients treated with FARYDAK . Diarrhea of any grade occurred in 68% of patients treated with FARYDAK compared to 42% of patients in the control arm. Diarrhea can occur at any time. Monitor patient hydration status and electrolyte blood levels, including potassium, magnesium and phosphate, at baseline and weekly (or more frequently as clinically indicated) during therapy and correct to prevent dehydration and electrolyte disturbances. Initiate anti-diarrheal medication at the onset of diarrhea. Interrupt FARYDAK at the onset of moderate diarrhea (4 to 6 stools per day) . Ensure that patients initiating therapy with FARYDAK have anti-diarrheal medications on hand.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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