October 2018

Important New Products

• Erenumab (rch) (Aimovig) is a human monoclonal antibody antagonist against the calcitonin gene-related peptide (CGRP) type 1 receptor. Erenumab lacks agonist activity at the CGRP receptor, and has no significant pharmacological activity at adrenomedullin, calcitonin and amylin receptors. CGRP is a neuropeptide that modulates nociceptive signaling and a vasodilator that has been associated with migraine pathophysiology. CGRP receptor is located at sites that are relevant to migraine pathophysiology. Aimovig is indicated for prophylaxis of migraine in adults. Aimovig should be initiated under the guidance of a neurologist or specialist in the management of migraine. Aimovig prefilled pen contains erenumab 70 mg/mL (1 mL) and is available in a pack of 1. 
   
• Midostaurin (Rydapt) inhibits multiple receptor tyrosine kinases including FLT3, KIT, PDGFR and VEGFR2, and serine/threonine kinases such as PKC isoforms. Midostaurin inhibits FLT3 receptor signaling and induces cell cycle arrest and apoptosis in leukaemic cells expressing ITD and TKD mutant receptors or overexpressing wild type receptors. Midostaurin inhibits both wild type and D816V mutant KIT, leading to interference with aberrant KIT signaling and inhibits mast cell proliferation and survival, and histamine release. Rydapt is indicated in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients with complete response by single agent maintenance therapy for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation positive; for the treatment of adults with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasms (SM-AHN), or mast cell leukaemia (MCL). Rydapt capsules contain midostaurin 25 mg and is available in packs of 56 and 112.

New Indications

• Abiraterone acetate (Zytiga) is now indicated in combination with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in combination with androgen deprivation therapy.
   
• Evolocumab (rch) (Repatha) is now indicated in adults with non-familial hypercholesterolaemia to reduce low density lipoprotein cholesterol; in adults with established cardiovascular disease (in combination with an optimally dosed statin and/or other lipid lowering therapies) to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation).
   
• Lacosamide (Vimpat, Vimpat Injection) is now indicated as monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older, and as add-on therapy in patients with epilepsy aged 4 years and older.
   
• Lumacaftor/ivacaftor (Orkambi) is now indicated for the treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene.

New Contraindications

• Acitretin (Neotigason) is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met; Acitretin is strictly contraindicated in pregnant women.
   
• Adapalene (Differin Topical Cream, Differin Topical Gel) is now contraindicated in pregnancy and women planning a pregnancy.
   
• Celecoxib (Celebrex) is now contraindicated in patients with documented myocardial infarction or stroke within 3 months.
   
• Clozapine (Clozaril) is now contraindicated in patients unable to undergo regular blood tests.
   
• Darunavir (Prezista) and cobicistat (Prezista/cobicistat) should not be coadministered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life threatening events (narrow therapeutic index). In addition, carbamazepine, phenobarbital and phenytoin are also contraindicated for use with Prezista/cobicistat.
  
  
• Factor VIII inhibitor bypassing fraction (Feiba NF) must not be used in patients with hypersensitivity to the product if therapeutic alternatives to Feiba NF are available.
   
• Sodium aurothiomalate (Myocrisin) is now contraindicated with a history of systemic lupus erythematosus.

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.

Active Ingredient Naming Changes

In this release, MIMS Australia will be including the following INNs (International Non-proprietary Names) as well as Australian Approved Names (AANs) as part of our push to support the Therapeutic Goods Administration (TGA) active ingredient name changes project.  

MIMS will begin referring to these ingredients by their new names, however, users may continue to search by the old AANs if preferred. ...(more)