Australian Doctor Australian Doctor 7th September 2018 | Page 27

restart the conversation.
it’s time
to prevent
migraine.
1
Aimovig ® is the 1 st TGA approved therapy
specifi cally designed to help prevent
migraine in adults by targeting and
blocking the CGRP* receptor. 1
Aimovig ® will initially be available through a Product Familiarisation Program and a
3-month Free Trial for Private Pay patients to be conducted by Australian neurologists
or pain specialists. Your migraine patients may be eligible for this new treatment.
Give them a referral now to restart their migraine treatment conversation.
PBS Information: This product is not listed on the PBS
See TGA approved Product Information before prescribing.
TGA approved Product Information available on request. For the most up to date
Product Information go to http://www.novartis.com.au/products_healthcare.html
Minimum Product Information – 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 insuffi cient 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 benefi t justifi es 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 benefi t-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-infl ammatory 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 70 mg injected subcutaneously once every 4 weeks. Some patients may benefi t 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 prefi lled 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 effi cacy or safety of erenumab. (aim280618m). Reference: 1. AIMOVIG ® Approved Product Information. *Calcitonin gene-related peptide (CGRP).
© 2018 NOVARTIS AG Novartis Pharmaceuticals Pty Ltd ABN 18 004 244 160 54 Waterloo Rd, Macquarie Park NSW 2113. AU-6582. Date of preparation July 2018.