WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES
Severe diarrhea occurred in 25% of FARYDAK treated patients. Monitor for symptoms, institute anti-diarrheal treatment...+
3-2-1 Dosing: 3 times a week, 2 weeks on, 1 week off1
Recommended starting dose of FARYDAK® (panobinostat) capsules is 20 mg orally per schedule below for up to 8 cycles1
FARYDAK should be taken on days 1, 3, and 5 in weeks 1 and 2 of a 21-day (3-week) cycle in all cycles of treatment. Dose interruption and/or reduction, or discontinuation of FARYDAK may be required based on individual tolerability.1
Starting dose modifications
Hepatic impairment: Reduce starting dose of FARYDAK to 15 mg in patients with mild hepatic impairment and 10 mg in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.
Coadministration with strong CYP3A4 inhibitors: Reduce starting dose of FARYDAK to 10 mg when coadministered with strong CYP3A4 inhibitors (eg, boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir)
No starting dose adjustment is required for patients with renal impairment
FARYDAK should be taken orally once on each scheduled day at about the same time, with or without food1
FARYDAK capsules should be swallowed whole with a cup of water. The capsules should not be opened, crushed, or chewed1
If a dose is missed, it can be taken up to 12 hours after the specified dose time1
If vomiting occurs, the patient should not repeat the dose, but should take the next usual scheduled dose1
Patients should avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice because these foods may increase blood concentrations of FARYDAK
Patients should avoid contact with the powder in FARYDAK capsules. If there is accidental contact, the area should be washed with soap and water; if powder gets in the eyes, they should be flushed with water
If dose reduction is required, FARYDAK should be reduced in increments of 5 mg (from 20 mg to 15 mg, or from 15 mg to 10 mg)1
- If the dosing of FARYDAK is reduced below 10 mg given 3 times per week, discontinue FARYDAK
- Keep the same treatment schedule (3-week treatment cycle) when reducing dose1
Dose and/or schedule modification of FARYDAK may be required based on toxicity. Management of adverse drug reactions may require treatment interruption and/or dose reductions. If dose reduction is required, the dose of FARYDAK should be reduced in increments of 5 mg (ie, from 20 mg to 15 mg, or from 15 mg to 10 mg). If the dosing of FARYDAK is reduced below 10 mg given 3 times per week, discontinue FARYDAK. Keep the same treatment schedule (3-week treatment cycle) when reducing dose. The table also lists bortezomib (BTZ) dose modification procedures from the clinical trials.
Dose Modifications for Most Common Toxicities1
Download a Dosing Guide
Keep the dosing schedule and dose modification guidelines on hand.
1. FARYDAK [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016.
FARYDAK® (panobinostat) capsules, 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.
IMPORTANT SAFETY INFORMATION