PracticeUpdate Neurology Best of 2018

restart the conversation. it’s time to prevent migraine. 1 Aimovig® is the 1 st TGA approved therapy specifically designed for the prophylaxis of migraine in adults by targeting and blocking the CGRP* receptor. 1

Your migraine patients may be eligible for this new treatment through the AIMOVIG® PRODUCT FAMILIARISATION PROGRAM (PFP)

Find out more about Aimovig® and the PFP • To register for the Aimovig ® PFP, visit myaimprogram.com.au or contact 1800 979 607 • Alternatively please contact your Novartis Representative for more information

PBS information: This product is not listed on the PBS. See TGA approved Product Information before prescribing. TGA approved Product Information available on request. Aimovig (erenumab) Indication: Aimovig is indicated for prophylaxis of migraine in adults. Contraindications: Hypersensitivity to erenumab or to any of the excipients. Precautions: Traceability: In order to improve the traceability of biological medicinal products, the name and batch number of the administered medicinal product should be clearly recorded. Use in hepatic impairment: No clinical studies have been conducted to evaluate the effect of hepatic impairment. Use in renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. Use in the elderly: Dose adjustments are not recommended due to insufficient data to determine whether geriatric patients respond differently from younger subjects. Paediatric use: The safety and effectiveness of Aimovig has not been studied in paediatric patients. Pregnancy: Safety has not been established. Aimovig should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether erenumab is present in human milk. A decision should be made whether to discontinue nursing or discontinue Aimovig, taking into account the benefit-risk assessment for the mother and the infant. Females and males of reproductive potential: No human data are available. There were no adverse effects on surrogate markers of fertility in monkeys. Interactions: Erenumab is not metabolised by cytochrome P450 enzymes and is unlikely to cause marked changes in pro-inflammatory cytokines that may impact cytochrome P450 enzyme expression or activity. Interactions with concomitant medications that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely. Aimovig did not affect the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate and had no effect on the pharmacokinetics of sumatriptan. Concomitant administration of Aimovig with sumatriptan had no effect on resting blood pressure compared with sumatriptan alone. Dosage: The recommended dose of Aimovig is 70mg injected subcutaneously once every 4 weeks. Some patients may benefit from a dosage of 140 mg injected subcutaneously once every 4 weeks. Aimovig should be initiated under the guidance of a neurologist or specialist in the management of migraine. Treatment response should be evaluated by the prescriber after 8-12 weeks as recommended by the current Australian treatment guideline. Aimovig is intended for patient self-administration in the abdomen, thigh, or, if someone else is giving the injection, also into the outer area of the upper arm. Administration should be performed by an individual who has been trained to administer the product. The need for treatment continuation should be re-evaluated within regular intervals of 3-6 months as recommended by the current treatment guideline. The needle cover of Aimovig prefilled syringe and autoinjector/pen contain dry natural rubber, which may cause allergic reactions in individuals sensitive to latex. Adverse effects: Common: Injection site reactions, constipation, muscle spasm, pruritus. Description of selected adverse reactions: Injections site reactions include injection site pain, injection site erythema and injection site pruritus. A majority of injection site reactions were mild and transient. Immunogenicity: In pivotal studies the incidence of anti-erenumab antibody was 6.3% for the 70 mg dose (in-vitro neutralizing activity in 3 patients) and 2.6% for the 140 mg dose (no patients with in-vitro neutralizing activity). There was no impact of anti-erenumab antibody development on efficacy or safety of erenumab. (aim280618m) . For the most up to date Product Information go to http://www.novartis.com.au/products_healthcare.html *Calcitonin gene-related peptide. Reference: 1 . Aimovig® Product Information, 2 July 2018. Novartis Pharmaceuticals Australia Pty Limited. ABN 18 004 244 160. 54 Waterloo Road, Macquarie Park, NSW 2113. © 2018 Novartis Pharmaceuticals Australia Pty Limited. AU7109