e, ketoconazole, lopinavir/ritonavir, others); see Adults. Avoid star fruit, pomegranate or grapefruit juice. Avoid concomitant strong CYP3A inducers. Avoid concomitant sensitive CYP2D6 substrates (eg, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine) or substrates with narrow therapeutic index (eg, thioridazine, pimozide); if unavoidable, monitor frequently. Concomitant antiarrhythmics or QT prolonging drugs: not recommended. Antiemetics that prolong QT interval (eg, dolasetron, ondansetron, tropisetron): monitor ECG frequently.
Adverse Reaction(s)
Diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia, vomiting, electrolyte imbalance, increased creatinine, thrombocytopenia, lymphopenia, leukopenia, neutropenia, anemia.
How Supplied:
Blister packs—6
LAST UPDATED:
6/12/2015
containing white to off-white powder.
FARYDAK capsules are packaged in PVC/PCTFE blister packs.
10 mg blister packs containing 6 capsules………………………….……..NDC 0078-0650-06
15 mg blister packs containing 6 capsules ………………………….…….NDC 0078-0651-06
20 mg blister packs containing 6 capsules ………………………….…….NDC 0078-0652-06
3) Storage and Handling:
Store 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 [see References].
New Drugs Online Report for panobinostat
Information
Generic Name: panobinostat
Trade Name: Farydak
Synonym: LBH 589, LBH589
Entry Type: New molecular entity
Development and Regulatory status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Sep 15: Approved in EU. EMA based its decision on a study of 147 patients in a subgroup of a PIII trial that found a Farydak/bortezomib/steroid combination added an average of 7.8 months to patients´ survival vs. 4.7 months for bortezomib and a steroid alone [22].
07/09/2015 10:27:10
Jun 15: EU positive opinion for use in combination with bortezomib and dexamethasone, for treatment of adults with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent [21].
26/06/2015 12:18:27
Feb 15: US FDA approves panobinostat for use with bortezomib and dexamethasone in pts who have received at least two prior standard therapies. It carries a boxed warning alerting pts and doctors that severe diarrhoea and severe and fatal cardiac events, arrhythmias and electrocardiogram changes, have been observed [20].
24 |
