Australian prescription medicine decision summaries

MS-2 Step is approved for the following extension of indications:
-an extension of the current indication for the medical termination of an intrauterine pregnancy from up to 63 days' gestation to up to 70 days' gestation; and
-a new indication for the medical management of missed miscarriage up to 70 days' gestation, determined by ultrasound equivalence rather than menstrual period.
MS-2 Step contains the active ingredients mifepristone and misoprostol.

Aflivu and Ahzantive (aflibercept) are approved for wet age-related macular degeneration, macular oedema secondary to central retinal vein occlusion and branch retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation.

Aujemflu (influenza virus haemagglutinin) has been approved for active immunisation against influenza in persons 50 years of age and older.

Zoladex is approved for the management of oestrogen-receptor (ER)-positive early and advanced breast cancer in pre- and peri- menopausal women. Zoladex contains the active ingredient goserelin.

Coveram Plus SR (slow release) has been approved as a substitution therapy for the treatment of hypertension, in patients already controlled with perindopril, amlodipine and indapamide, taken at the same dose level. Coveram Plus SR contains the active ingredients perindopril arginine, amlodipine (as besilate) and indapamide.

Reaptan Plus SR (slow release) has been approved as a substitution therapy for the treatment of hypertension, in patients already controlled with perindopril, amlodipine and indapamide, taken at the same dose level. Reaptan Plus SR contains the active ingredients perindopril arginine, amlodipine (as besilate) and indapamide.

Triplixam SR (slow release) has been approved as a substitution therapy for the treatment of hypertension, in patients already controlled with perindopril, amlodipine and indapamide, taken at the same dose level. Triplixam SR contains the active ingredients perindopril arginine, amlodipine (as besilate) and indapamide.

Fetroja has been approved for the treatment of infections due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options. It has specifically been approved for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Fetroja contains the active ingredient cefiderocol (as sulfate tosilate).

Exdensur (depemokimab) has been approved as an add-on maintenance treatment for severe asthma in adults and adolescents with eosinophilic airways inflammation, and for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults.

ALTUVIIIO (efanesoctocog alfa) is approved for adults, adolescents and children with haemophilia A.

Sodium Oxybate-Reach has been approved for the treatment of narcolepsy in adults, adolescents and children from the age of 7 years.

Wainua (eplontersen) is approved for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adults with stage 1 or 2 polyneuropathy.

Cifoban (sodium citrate dihydrate) is approved for use in adults and children for regional citrate anticoagulation (RCA) in continuous venovenous haemodialysis (CVVHD), continuous venovenous haemodiafiltration (CVVHDF), sustained low efficiency (daily) dialysis (SLEDD) and therapeutic plasma exchange (TPE) via membrane plasma separation.

Tabrecta has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation. Tabrecta contains the active ingredient capmatinib.

Zirdawny has been approved for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

Slenyto has been approved for the treatment of insomnia in children and adolescents with neurogenetic disorders and/or attention-deficit hyperactivity disorder (ADHD).

Hibruka (orelabrutinib) has provisional approval in Australia for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Cenrifki (tolebrutinib) has been approved for the treatment of Secondary Progressive Multiple Sclerosis (SPMS) in adults.

Tzield (teplizumab) is approved to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus.

Rhapsido has been approved for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Rhapsido contains the active ingredient remibrutinib.

Qalsody has been provisionally approved for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene. ALS is a type of motor neurone disease (MND).

Filsuvez (Birch bark dry extract - 84-95% triterpenes) has been approved for the treatment of partial-thickness wounds of the skin associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

Niktimvo is approved for the treatment of chronic graft-versus host disease (cGVHD). Niktimvo contains the active ingredient axatilimab.

Orserdu is approved for the treatment of advanced breast cancer in postmenopausal women, and men. Orserdu contains the active ingredient elacestrant.

Redemplo has been approved as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome (FCS).