MIMS Monthly Up­date

Septem­ber 2017

Pharmacy Daily - - NEWS -

New Prod­ucts

Kanuma (se­be­li­pase alfa rce) is a re­com­bi­nant hu­man lyso­so­mal acid li­pase (rhLAL). Lyso­so­mal acid li­pase de­fi­ciency (LAL-D) is a rare dis­ease as­so­ci­ated with sig­nif­i­cant mor­bid­ity and mor­tal­ity af­fect­ing in­di­vid­u­als from in­fancy through to adult­hood. Treat­ment with se­be­li­pase alfa rce re­stores LAL en­zyme ac­tiv­ity in LAL-D cells, en­abling hy­drol­y­sis of cholesteryl es­ters and triglyc­erides in the lyso­some. Kanuma (se­be­li­pase alfa rce) is in­di­cated for long-term en­zyme re­place­ment ther­apy in pa­tients of all ages with LAL-D. Kanuma is con­traindi­cated in pa­tients with a life-threat­en­ing hy­per­sen­si­tiv­ity (ana­phy­lac­tic reaction) to egg. Kanuma so­lu­tion for in­fu­sion 20 mg in 10 mL is sup­plied as a sin­gle use vial, pack of 1.

Lon­surf (tri­fluri­dine/ tipiracil (hy­drochlo­ride)) is com­prised of an an­ti­neo­plas­tic thymi­dine based nu­cle­o­side ana­logue, tri­fluri­dine, and the thymi­dine phos­pho­ry­lase (TPase) in­hibitor, tipiracil hy­drochlo­ride, at a mo­lar ra­tio 1:0.5. Tri­fluri­dine/ tipiracil hy­drochlo­ride demon­strated an­ti­tu­mor ac­tiv­ity against both 5-flu­o­rouracil (5-FU) sen­si­tive and re­sis­tant col­orec­tal cancer cell lines in non­clin­i­cal stud­ies. Lon­surf is in­di­cated for the treat­ment of adults with metastatic col­orec­tal cancer (mCRC) who have been pre­vi­ously treated with, or are not con­sid­ered can­di­dates for flu­o­ropy­rim­i­dine, ox­ali­platin and irinote­can based chemo­ther­a­pies, anti-VEGF agents, and anti-EGFR agents. Lon­surf 15/6.14 (tri­fluri­dine 15 mg and tipiracil (hy­drochlo­ride) 6.14 mg)) and Lon­surf 20/8.19 (tri­fluri­dine 20 mg and tipiracil (hy­drochlo­ride) 8.19 mg) tablets are avail­able in a pack of 20.

Ocre­vus (ocre­lizumab) is a re­com­bi­nant hu­man­ised anti-CD20 mon­o­clonal an­ti­body that se­lec­tively tar­gets CD20-ex­press­ing B-cells. The pre­cise mech­a­nisms through which ocre­lizumab ex­erts its ther­a­peu­tic clin­i­cal ef­fects in mul­ti­ple scle­ro­sis (MS) are not fully elu­ci­dated but is pre­sumed to in­volve im­munomod­u­la­tion through the re­duc­tion in the num­ber and func­tion of CD20-ex­press­ing B-cells. Ocre­vus is in­di­cated for the treat­ment of re­laps­ing forms of mul­ti­ple scle­ro­sis (RMS) to de­lay the pro­gres­sion of phys­i­cal dis­abil­ity and to re­duce the fre­quency of re­lapse; treat­ment of pri­mary pro­gres­sive mul­ti­ple scle­ro­sis (PPMS) to de­lay the pro­gres­sion of phys­i­cal dis­abil­ity. Ocre­vus con­cen­trate for so­lu­tion for in­fu­sion 300 mg in 10 mL is sup­plied in a 15 mL vial, pack of 1.

Phe­bu­rane (sodium phenyl­bu­tyrate) is an am­mo­nia scav­enger. Phe­bu­rane is in­di­cated for the man­age­ment of hy­per­am­mon­aemia as­so­ci­ated with urea cy­cle dis­or­ders. Phe­bu­rane should be used with di­etary pro­tein re­stric­tion and, in some cases, di­etary sup­ple­ments. Phe­bu­rane is con­traindi­cated with preg­nancy and breast­feed­ing. Phe­bu­rane is avail­able in a bot­tle con­tain­ing sodium phenyl­bu­tyrate 84 g in 174 g of gran­ules (sodium phenyl­bu­tyrate 483 mg/gram of gran­ules).

Urorec (silo­dosin) is a se­lec­tive an­tag­o­nist of α1A-adrenore­cep­tors pri­mar­ily lo­cated in the hu­man prostate, blad­der base, blad­der neck, pro­static cap­sule and pro­static ure­thra. Smooth mus­cle re­lax­ation causes an im­prove­ment of both stor­age (ir­ri­ta­tive) and void­ing (ob­struc­tive) symp­toms (lower uri­nary tract symp­toms (LUTS)) as­so­ci­ated with be­nign pro­static hy­per­pla­sia. Urorec is in­di­cated for the re­lief of LUTS as­so­ci­ated with be­nign pro­static hy­per­pla­sia in adult men. Urorec 8 mg cap­sules are avail­able in a pack of 30.

New In­di­ca­tions

Op­divo (nivolumab) is now in­di­cated as monother­apy for the treat­ment of re­cur­rent or metastatic squa­mous cell cancer of the head and neck in adults pro­gress­ing on or af­ter plat­inum based ther­apy.

Ozur­dex (dex­am­etha­sone) in­trav­it­real im­plant is now in­di­cated for the treat­ment of mac­u­lar oedema due to branch reti­nal vein oc­clu­sion (BRVO) or cen­tral reti­nal vein oc­clu­sion (CRVO); non­in­fec­tious uveitis af­fect­ing the pos­te­rior seg­ment of the eye.

New Con­traindi­ca­tions

Dak­tarin Oral Gel (mi­cona­zole) is now con­traindi­cated in com­bi­na­tion with CYP2C9 sub­strate coumarin an­ti­co­ag­u­lants such as war­farin.

El­troxin (levothy­rox­ine sodium) is now con­traindi­cated with acute my­ocardi­tis and acute pan­car­di­tis.

Neoti­ga­son (ac­itretin) is highly ter­ato­genic and must not be used by pa­tients who in­tend to be­come preg­nant within 3 years af­ter ces­sa­tion of ther­apy.

Trilep­tal (ox­car­bazepine) is now con­traindi­cated with known hy­per­sen­si­tiv­ity to es­li­car­bazepine.

Vic­trelis (bo­cepre­vir) is now con­traindi­cated in com­bi­na­tion with lurasi­done.

This list is a sum­mary of only some of the changes that have oc­curred over the last month. Be­fore pre­scrib­ing, al­ways re­fer to the full prod­uct in­for­ma­tion.

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