WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES
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1 INDICATION FARYDAK (panbinstat) capsules, a histne deacetylase inhibitr, in cmbinatin with brtezmib and dexamethasne, is indicated fr the treatment f patients with multiple myelma wh have received at least 2 prir regimens, including brtezmib and an immunmdulatry agent. This indicatin is apprved under accelerated apprval based n prgressin-free survival. Cntinued apprval fr this indicatin may be cntingent upn verificatin and descriptin f clinical benefit in cnfirmatry trials. IMPORTANT SAFETY INFORMATION WARNING: FATAL AND SERIOUS TOXICITIES: SEVERE DIARRHEA AND CARDIAC TOXICITIES Severe diarrhea ccurred in 25% f FARYDAK treated patients. Mnitr fr symptms, institute anti-diarrheal treatment, interrupt FARYDAK and then reduce dse r discntinue FARYDAK. Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have ccurred in patients receiving FARYDAK. Arrhythmias may be exacerbated by electrlyte abnrmalities. Obtain ECG and electrlytes at baseline and peridically during treatment as clinically indicated. Diarrhea Severe diarrhea ccurred in 25% f patients treated with FARYDAK. Diarrhea f any grade ccurred in 68% f patients treated with FARYDAK cmpared with 42% f patients in the cntrl arm. Diarrhea can ccur at any time. Ensure patients have antidiarrheal medicatins n hand, and initiate antidiarrheal medicatin at the nset f diarrhea Mnitr hydratin status and electrlyte bld levels at baseline, and weekly (r mre ften as clinically indicated) during therapy, and crrect t prevent dehydratin and electrlyte disturbances Interrupt FARYDAK at the nset f mderate diarrhea (4-6 stls/day) Fr life-threatening diarrhea (grade 4), permanently discntinue FARYDAK and brtezmib Fr severe diarrhea ( 7 stls/day), r IV fluids r hspitalizatin required (grade 3), interrupt FARYDAK and brtezmib until reslved and restart bth at reduced dses Fr mderate diarrhea (4-6 stls/day, grade 2), interrupt FARYDAK until reslved and restart at same dse. Cnsider interruptin f brtezmib until reslved and restart at same dse Cardiac Txicities Arrhythmias ccurred in 12% f patients treated with FARYDAK cmpared with 5% f patients in the cntrl arm. Cardiac ischemic events ccurred in 4% f patients treated with FARYDAK cmpared with 1% f patients in the cntrl arm 1
2 D nt initiate FARYDAK treatment in patients with histry f recent mycardial infarctin r unstable angina ECG abnrmalities such as ST-segment depressin and T-wave abnrmalities ccurred mre frequently in patients receiving FARYDAK cmpared with the cntrl arm: 22% vs 4% and 40% vs 18%, respectively FARYDAK may prlng QT interval. D nt initiate treatment with FARYDAK in patients with a QTcF >450 msec r clinically significant baseline ST-segment r T-wave abnrmalities Arrhythmias may be exacerbated by electrlyte abnrmalities. If during treatment with FARYDAK the QTcF increases t 480 msec, interrupt treatment. Crrect any electrlyte abnrmalities. If QT prlngatin des nt reslve, permanently discntinue treatment. Obtain ECG at baseline and peridically during treatment. Mnitr electrlytes during treatment with FARYDAK, and crrect abnrmalities as clinically indicated Hemrrhage Fatal and serius cases f gastrintestinal and pulmnary hemrrhage ccurred In the phase 3 registratin trial, 5 patients receiving FARYDAK, cmpared with 1 patient in the cntrl arm, died due t a hemrrhagic event. All 5 patients had grade 3 thrmbcytpenia at the time f the event Grade 3/4 hemrrhage was reprted in 4% f patients treated with FARYDAK and 2% f patients in the cntrl arm Mnitr platelet cunts and transfuse as needed Myelsuppressin FARYDAK causes myelsuppressin, including severe thrmbcytpenia, neutrpenia, and anemia. Obtain a baseline CBC, and mnitr the CBC weekly during treatment (r mre ften if clinically indicated r in patients >65 years f age) Thrmbcytpenia In the phase 3 registratin trial, 67% f patients treated with FARYDAK develped Grade 3/4 thrmbcytpenia cmpared with 31% in the cntrl arm Thrmbcytpenia led t treatment interruptin and/r dse mdificatin in 31% f patients receiving FARYDAK Fr patients receiving FARYDAK, 33% required platelet transfusin Fr patients with platelet cunt <50 x 10 9 /L with bleeding (grade 3) r <25 x 10 9 /L (grade 4) Interrupt FARYDAK therapy and mnitr platelets at least weekly until 50 x 10 9 /L, and restart at reduced dse Interrupt brtezmib until thrmbcytpenia reslves 50 x 10 9 /L If nly 1 dse f brtezmib was mitted prir t crrectin t these levels, restart brtezmib at same dse 2
3 If 2 dses were mitted cnsecutively, r within the same cycle, restart at a reduced dse Fr patients with platelet cunt <50 x 10 9 /L (grade 3), maintain FARYDAK and brtezmib dses and mnitr platelet cunts at least weekly Fr patients with severe thrmbcytpenia, cnsider platelet transfusins Discntinue FARYDAK if thrmbcytpenia des nt imprve despite the recmmended treatment mdificatins r if repeated platelet transfusins are required Neutrpenia Severe neutrpenia ccurred in 34% f patients treated with FARYDAK cmpared with 11% f patients in the cntrl arm Neutrpenia led t treatment interruptin and/r dse mdificatin in 10% f patients receiving FARYDAK Use f granulcyte-clny stimulating factr (G-CSF) was 13% in patients treated with FARYDAK Fr patients with ANC <0.5 x 10 9 /L (grade 4) Interrupt FARYDAK and brtezmib therapy until ANC is 1.0 x 10 9 /L. Restart FARYDAK at reduced dse If nly 1 dse f brtezmib was mitted prir t crrectin t these levels, restart at same dse. If 2 dses f brtezmib were mitted cnsecutively, r within the same cycle, restart at reduced dse Fr patients with ANC <1.0 x 10 9 /L (grade 3) and febrile neutrpenia (any grade) Interrupt FARYDAK and brtezmib therapy until febrile neutrpenia is reslved and ANC >1.0 x 10 9 /L Restart FARYDAK at reduced dse If nly 1 dse f brtezmib was mitted prir t crrectin t these levels, restart at same dse. If 2 dses f brtezmib were mitted cnsecutively, r within the same cycle, restart at reduced dse Fr patients with 2 ccurrences f ANC between x 10 9 /L (grade 3) Interrupt FARYDAK therapy until ANC 1.0 x 10 9 /L, and restart at same dse Maintain brtezmib dse Fr patients with ANC between x 10 9 /L (grade 3) Maintain FARYDAK and brtezmib dses Fr grade 3 r 4 neutrpenia, cnsider dse reductin and/r the use f grwth factrs Discntinue FARYDAK if neutrpenia des nt imprve despite dse mdificatins, CSF, r in case f severe infectin Anemia Fr patients with hemglbin <8 g/dl (grade 3), interrupt FARYDAK until hemglbin 10 g/dl. Restart at reduced dse Infectins Severe infectins ccurred in 31% f patients (including 10 deaths) treated with FARYDAK cmpared with 24% f patients (including 6 deaths) in the cntrl arm FARYDAK treatment shuld nt be initiated in patients with active infectins 3
4 Mnitr patients fr signs and symptms f infectins during treatment; if a diagnsis f infectin is made, institute apprpriate anti-infective treatment prmptly and cnsider interruptin r discntinuatin f FARYDAK Hepattxicity Hepatic dysfunctin, primarily elevatins in amintransferases and ttal bilirubin, ccurred in patients treated with FARYDAK Mnitr liver functin prir t and regularly during treatment. If abnrmal liver functin tests are bserved, cnsider dse adjustments. Fllw patient until values return t nrmal r pretreatment levels Avid use in patients with severe hepatic impairment Reduce the starting dse f FARYDAK t 15 mg r 10 mg in patients with mild r mderate hepatic impairment, respectively Embry-Fetal Txicity FARYDAK can cause fetal harm when administered t a pregnant wman If FARYDAK is used during pregnancy, r if the patient becmes pregnant while taking FARYDAK, the patient shuld be apprised f the ptential hazard t the fetus Advise females f reprductive ptential t avid becming pregnant while taking FARYDAK Advise sexually active females f reprductive ptential t use effective cntraceptin while taking FARYDAK, and fr at least 3 mnths after the last dse f FARYDAK Advise sexually active men t use cndms while n treatment, and fr at least 6 mnths after their last dse f FARYDAK Drug Interactins Reduce dse t 10 mg when cadministered with strng CYP3A inhibitrs. Instruct patients t avid star fruit, pmegranate r pmegranate juice, and grapefruit r grapefruit juice Avid the cncmitant use f strng CYP3A inducers Avid cadministratin with sensitive CYP2D6 substrates r CYP2D6 substrates that have a narrw therapeutic index. If cncmitant use f CYP2D6 substrates is unavidable, mnitr patients frequently fr adverse reactins Cncmitant use f antiarrhythmic medicines, and ther drugs that are knwn t prlng the QT interval, is nt recmmended. Antiemetic drugs with knwn QT-prlnging risk can be used with frequent ECG mnitring 4
5 Adverse Reactins The mst cmmn adverse reactins (incidence f at least 20%) in clinical studies are diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia, and vmiting The mst cmmn nnhematlgic labratry abnrmalities (incidence 40%) are hypcalcemia, hypphsphatemia, hypalbuminemia, hypkalemia, hypnatremia, and increased creatinine. The mst cmmn hematlgic labratry abnrmalities (incidence 60%) are thrmbcytpenia, lymphpenia, leukpenia, neutrpenia, and anemia Serius adverse events (SAEs) ccurred in 60% f patients in the FARYDAK arm. The mst frequent ( 5%) treatment-emergent SAEs reprted fr patients treated with FARYDAK were pneumnia, diarrhea, thrmbcytpenia, fatigue, and sepsis Please see full Prescribing Infrmatin, including Bxed WARNING, fr FARYDAK (panbinstat) capsules. 5
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