PracticeUpdate Neurology June 2019

*Pharmacists may choose to discount the PBS patient co-payment by up to $1.00. 2 Private prescription prices may vary. Same cost to patients as generic teriflunomide on the PBS *1

Sanofi Genzyme offers: • Ongoing clinical trials including safety registries • patient support program • Risk management tools and resources • Plasma testing after washout for some circumstances (e.g. pregnancy or serious adverse event) • Compassionate supply

PBS information: Authority Required. For use in patients with relapsing-remitting multiple sclerosis who meet certain criteria. Refer to the PBS Schedule for full authority information.

MINIMUM PRODUCT INFORMATION AUBAGIO ® (teriflunomide). INDICATIONS: AUBAGIO is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability. DOSAGE AND ADMINISTRATION: AUBAGIO 14mg tablet orally once daily with or without food. CONTRAINDICATIONS: Hypersensitivity to leflunomide, teriflunomide or to any of the excipients; severe immunodeficiency states e.g. AIDS; significantly impaired bone marrow function or significant anaemia, leukopenia or thrombocytopenia; severe uncontrolled infections; severe impairment of liver function; pregnant women; women of childbearing potential who are not using reliable contraception (refer to full PI); when breastfeeding; severe hypoproteinaemia and patients who have or have had Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme. PRECAUTIONS: Elevations of liver enzymes; Blood pressure elevation; Infection; Haematological effects; Decrease in WBC count; Skin disorders; Respiratory (interstitial lung disease); Use in caution in patients showing signs of immunosuppression or renal impairment; Live viral vaccines; Peripheral neuropathy; switching to or from AUBAGIO. Rapid Elimination Procedure: Teriflunomide is eliminated slowly from the plasma. When desired, a rapid elimination procedure can be used. Monitoring: LFT (ALT/AST); FBC; Serious infections. Pregnancy Cat X (exclude pregnancy before starting treatment; effective contraception required during and post-treatment). INTERACTIONS: Potent CYP and transporter inducers such as rifampicin, carbamazepine, and St John’s Wort may decrease teriflunomide exposure; Caution with drugs metabolised by CYP2C8 such as repaglinide; CYP3A substrates such as midazolam; CYP1A2 such as duloxetine; Concomitant teriflunomide and warfarin resulted in a 25% decrease in peak INR; Teriflunomide may increase oral contraceptive levels; Use with caution when administered with OAT3 substrates such as penicillin G; BCRP/B1 and B3 substrates such as rosuvastatin. ADVERSE EFFECTS: Very common: Diarrhoea; nausea; alopecia; ALT increase. Common: Influenza; infections; neutropenia; paraesthesia; hypertension; abdominal pain upper; toothache; rash; musculoskeletal pain; myalgia; menorrhagia; GGT increase; AST increase; weight decrease; neutrophil count decrease; WBC count decrease; polyneuropathy; Refer to full PI. NAME OF SPONSOR: sanofi-aventis australia pty ltd ABN 31 008 558 807, 12–24 Talavera Road, Macquarie Park, NSW 2113. Based on Full PI with TGA date of approval of 14 November 2012 with most recent amendment on 23 December 2016. MS: multiple sclerosis; PBS: Pharmaceutical Benefits Scheme. References: 1. Pharmaceutical Benefits Scheme. Available at www.pbs.gov.au/medicine/item/2898M (accessed May 2018). 2. The Pharmaceutical Benefits Scheme. About the PBS. Available at: www.pbs.gov.au/info/about-the-pbs (accessed May 2019). 3. AUBAGIO (teriflunomide) Approved Product Information. December 2016. ©2019 Genzyme Corporation, a Sanofi company. All rights reserved. sanofi-aventis australia pty ltd ABN 31 008 558 807, 12–24 Talavera Road, Macquarie Park, NSW 2113. GZANZ.AUBA.19.04.0085b. May 2019. GEAB16412W. Ward6. Please review full Product Information before prescribing. Full Product Information is available at http://www.guildlink.com.au/gc/ws/sw/pi.cfm?product=swpaubag or 1800 818 806. Further information is available on request from Sanofi.