CRIT­I­CAL UP­DATE

Panadol (Chil­dren) Liq­uid For­mu­la­tions - Please be in­formed of a crit­i­cal cor­rec­tion in the Dosage sec­tion of Panadol (Chil­dren) Liq­uid For­mu­la­tions…

Pharmacy Daily - - News -

New Prod­ucts

Ben­ral­izumab (rch) (Fasenra) is a hu­man­ised mon­o­clonal an­ti­body se­lec­tive for the al­pha sub­unit of the hu­man in­ter­leukin-5 re­cep­tor (IL5Rα). The IL-5 re­cep­tor is specif­i­cally ex­pressed on the sur­face of eosinophils and ba­sophils. Ben­ral­izumab re­duces eosinophilic in­flam­ma­tion through im­mune ef­fec­tor cell me­di­ated apop­to­sis of eosinophils and ba­sophils. Fasenra is in­di­cated as add-on ther­apy in pa­tients aged ≥ 12 years with se­vere eosinophilic asthma (blood eosinophil count ≥ 300 cells/mi­crolitre or ≥ 150 cells/mi­crolitre if on oral cor­ti­cos­teroid treat­ment). Fasenra should be pre­scribed by a health­care pro­fes­sional in con­sul­ta­tion with a spe­cial­ist physi­cian ex­pe­ri­enced in the di­ag­no­sis and treat­ment of se­vere asthma. Treat­ment with high dose in­haled cor­ti­cos­teroids and long-act­ing β-ag­o­nists should be op­ti­mised prior to com­mence­ment of treat­ment with Fasenra. Fasenra solution for sub­cu­ta­neous in­jec­tion pre­filled sy­ringe con­tains ben­ral­izumab 30 mg/1 mL and is avail­able in a pack of 1.

Er­tugliflozin (py­rog­lu­tamic acid) (Steglatro) is a sodium-glu­cose co-trans­porter 2 (SGLT2) in­hibitor. Steglatro is in­di­cated as an ad­junct to diet and ex­er­cise to im­prove gly­caemic con­trol in adults with type 2 di­a­betes mel­li­tus: as monother­apy when met­formin is con­sid­ered in­ap­pro­pri­ate due to in­tol­er­ance; in com­bi­na­tion with other an­ti­hy­per­gly­caemic agents. Steglatro is con­traindi­cated in pa­tients with chronic kid­ney dis­ease (CKD) re­ceiv­ing dial­y­sis; eGFR < 30 mL/min/1.73 m2 or eGFR per­sis­tently < 45 mL/min/1.73 m2 (CKD stage 3B, 4 and 5). The ef­fi­cacy of Steglatro is de­pen­dent on re­nal func­tion. Steglatro tablets con­tain er­tugliflozin 5 mg or 15 mg in a pack size of 28.

Er­tugliflozin (py­rog­lu­tamic acid)/sitagliptin (phos­phate mono­hy­drate) (Steglu­jan) com­bines two an­ti­hy­per­gly­caemic agents with com­ple­men­tary mech­a­nisms of ac­tion to im­prove gly­caemic con­trol in pa­tients with type 2 di­a­betes: er­tugliflozin (a SGLT2 in­hibitor) and sitagliptin (a dipep­tidyl pep­ti­dase-4 [DPP-4] in­hibitor). Steglu­jan is in­di­cated as an ad­junct to diet and ex­er­cise to im­prove gly­caemic con­trol in adults with type 2 di­a­betes mel­li­tus when treat­ment with both er­tugliflozin and sitagliptin is ap­pro­pri­ate. Steglu­jan is con­traindi­cated in pa­tients with CKD re­ceiv­ing dial­y­sis; eGFR < 30 mL/min/1.73 m2 or eGFR per­sis­tently < 45 mL/min/1.73 m2 (CKD stage 3B, 4 and 5). The ef­fi­cacy of Steglu­jan is de­pen­dent on re­nal func­tion. Steglu­jan tablets con­tain er­tugliflozin 5 mg/sitagliptin 100 mg (Steglu­jan 5/100) or er­tugliflozin 15 mg/sitagliptin 100 mg (Steglu­jan 15/100) in a pack size of 28.

Mi­gala­s­tat (Galafold) is a phar­ma­co­log­i­cal chap­er­one that se­lec­tively and re­versibly binds with high affin­ity to the ac­tive sites of cer­tain mu­tant (ab­nor­mally folded and un­sta­ble) forms of lyso­so­mal enzyme α-galac­tosi­dase A (α-Gal A), sta­bil­is­ing the mu­tant en­zymes. Mu­ta­tions in the GLA gene re­sult in a de­fi­ciency of α-Gal A in the lyso­so­mal stor­age dis­or­der Fabry dis­ease. Galafold is in­di­cated for longterm treat­ment of adults and ado­les­cents ≥ 16 years with a con­firmed di­ag­no­sis of Fabry dis­ease ( α-Gal A de­fi­ciency) and who have an amenable mu­ta­tion. Galafold cap­sules con­tain mi­gala­s­tat 123 mg and are avail­able in a pack size of 14.

Teno­fovir alafe­namide (fu­marate) (Vem­lidy) is a phos­pho­nami­date pro­drug of teno­fovir. In­tra­cel­lu­lar teno­fovir is phos­pho­ry­lated to the phar­ma­co­log­i­cally ac­tive me­tab­o­lite teno­fovir diphos­phate. Teno­fovir diphos­phate in­hibits hepatitis B virus (HBV) repli­ca­tion through in­cor­po­ra­tion into vi­ral DNA by the HBV re­verse tran­scrip­tase, which re­sults in DNA chain ter­mi­na­tion. Teno­fovir has an­tivi­ral ac­tiv­ity spe­cific to HBV and hu­man im­mun­od­e­fi­ciency virus (HIV-1 and HIV-2). Vem­lidy is in­di­cated for the treat­ment of chronic hepatitis B in adults. Vem­lidy tablets con­tain teno­fovir alafe­namide 25 mg and are avail­able in a pack size of 30.

New In­di­ca­tions

Cabozan­tinib ((S)-malate) (Cabome­tyx) is now in­di­cated for the treat­ment of ad­vanced re­nal cell car­ci­noma in treat­ment naïve adults with in­ter­me­di­ate or poor risk. Len­va­tinib (me­sy­late) (Len­vima) is now in­di­cated for the first-line treat­ment of un­re­sectable hep­a­to­cel­lu­lar car­ci­noma.

Pem­brolizumab (Keytruda) is now in­di­cated for the treat­ment of adult and pae­di­atric pa­tients with re­frac­tory pri­mary me­di­asti­nal B-cell lym­phoma, or who have re­lapsed af­ter 2 or more prior lines of ther­apy. The ap­proval of this in­di­ca­tion is on the ba­sis of ob­jec­tive re­sponse rate and du­ra­tion of re­sponse from non-ran­domised stud­ies. Quadri­va­lent in­fluenza vac­cine (split virion, in­ac­ti­vated) (Flu­arix Tetra) is now in­di­cated for ac­tive im­mu­ni­sa­tion of chil­dren from 6 months of age for the pre­ven­tion of in­fluenza dis­ease caused by the in­fluenza virus types A and B con­tained in the vac­cine. Vene­to­clax (Ven­clexta) in com­bi­na­tion with rit­ux­imab is now in­di­cated for the treat­ment of adults with chronic lym­pho­cytic leukaemia who have re­ceived at least one prior ther­apy.

New Con­traindi­ca­tions

Prala­trex­ate (Folo­tyn) is now con­traindi­cated in preg­nancy. Pro­tamine sul­fate (Fisons Pro­tamine Sul­fate In­jec­tion BP) is now con­traindi­cated with hy­per­sen­si­tiv­ity to pro­tamine (in­clud­ing pro­tamine con­tained in in­sulin NPH [Neu­tral Pro­tamine Hage­dorn]). Tretinoin (Re­Trieve Cream, Stieva-A) is now con­traindi­cated in preg­nancy and women plan­ning a preg­nancy. 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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