Aubagio.co.uk

Abbreviated Prescribing Information. AUBAGIO 14 mg film-coated
risk of developing elevated liver enzymes when taking teriflunomide not recommended. For co-administration of warfarin with tablets. Please refer to the Summary of Product Characteristics and should be closely monitored for signals of liver disease. AUBAGIO teriflunomide, close INR follow-up and monitoring is recommended. (SmPC) before prescribing. PRODUCT COMPOSITION: Each film-coated
should be used with caution in patients who consume substantial PREGNANCY AND LACTATION: Pregnancy: Women of childbearing
tablet contains 14 mg of teriflunomide. INDICATIONS: AUBAGIO is
quantities of alcohol. Blood pressure: Must be checked before the start potential have to use effective contraception during treatment and after indicated for the treatment of adult patients with relapsing remitting of teriflunomide treatment and periodically thereafter. Infections: treatment as long as teriflunomide plasma concentration is above multiple sclerosis (MS). DOSAGE AND ADMINISTRATION: The
Patients receiving AUBAGIO should be instructed to report symptoms 0.02 mg/l. In case of suspicion of pregnancy, patient must notify the treatment should be initiated and supervised by a physician of infections to a physician. Patients with active acute or chronic physician. In case of pregnancy, the physician and patient must discuss experienced in the management of multiple sclerosis. The infections should not start treatment with AUBAGIO until the the risk to the pregnancy and the accelerated elimination procedure. In recommended dose of teriflunomide is 14 mg once daily. The film- infection(s) is resolved. For patients testing positive in tuberculosis women wishing to become pregnant, teriflunomide should be stopped coated tablets are for oral use. The tablets should be swallowed whole screening, treat by standard medical practice prior to therapy with and an accelerated elimination procedure is recommended (Please with some water. AUBAGIO can be taken with or without food. Elderly teriflunomide. Haematological effects: A mean decrease of less than refer to the SmPC for further information). Both cholestyramine and population: AUBAGIO should be used with caution in patients aged 65 15% from baseline affecting white blood cell counts have been activated powdered charcoal may influence the absorption of years and over due to insufficient data on safety and efficacy. Renal observed. Obtain complete blood count with differential prior to oestrogens and progestogens during the accelerated elimination impairment: No dosage adjustment is necessary for patients with mild, initiation of treatment, thereafter CBC should be assessed as indicated procedure. Use of alternative contraceptive methods is recommended. moderate or severe renal impairment not undergoing dialysis. Hepatic by clinical signs and symptoms. In patients with pre-existing cytopenias Lactation: Breast-feeding women must not receive teriflunomide. impairment: No dosage adjustment is necessary for patients with mild there might be a higher risk of haematological disorders with UNDESIRABLE EFFECTS: Based on placebo-controlled studies the
and moderate hepatic impairment. Paediatric population: The safety teriflunomide. In cases of severe haematological reactions, including most commonly reported adverse reactions in the teriflunomide and efficacy of AUBAGIO in children aged from 10 to less than 18 years pancytopenia, AUBAGIO and all concomitant myelosuppressive treated patients were: influenza, upper respiratory tract infection, has not yet been established. CONTRAINDICATIONS: Hypersensitivity
treatment must be discontinued and the accelerated elimination urinary tract infection, paraesthesia, diarrhoea, increased ALT, nausea, to the active ingredient or excipients. Severe hepatic impairment procedure be considered. Respiratory reactions: Due to the potential and alopecia. Very common (≥ 1/10) Influenza, upper respiratory tract (Child-Pugh class C). Pregnant women, or women of childbearing risk of interstitial lung disease, pulmonary symptoms, such as infection, urinary tract infection, paresthesia, diarrhoea, nausea, potential not using reliable contraception during treatment with persistent cough and dyspnoea, may be a reason for discontinuation of alopecia, ALT increase. Common (≥ 1/100 to < 1/10); Bronchitis, teriflunomide and thereafter as long as its plasma levels are above the therapy and for further investigation, as appropriate. Skin reactions: sinusitis, pharyngitis, cystitis, gastroenteritis viral, oral herpes, tooth 0.02 mg/l. Breast-feeding women. Severe immunodeficiency states, In case of ulcerative stomatitis, or if skin and /or mucosal reactions are infection, laryngitis, tinea pedis, neutropenia, mild allergic reactions, e.g. AIDS. Significantly impaired bone marrow function or significant observed which raise the suspicion of severe generalised major skin anxiety, sciatica, carpal tunnel syndrome, hyperaesthesia, neuralgia, anaemia, leucopenia, neutropenia or thrombocytopenia. Severe active reactions, teriflunomide must be discontinued and an accelerated peripheral neuropathy, hypertension, vomiting, toothache, rash, acne, infection until resolution. Severe renal impairment undergoing dialysis, p ro c e d u re i n i t i a t e d i m m e d i a t e ly. I m m u n o s u p p re s s i v e / musculoskeletal pain, myalgia, pollakiuria, menorrhagia, pain, GGT because insufficient clinical experience is available in this patient Immunomodulating therapies: Co-administration with leflunomide is increase, AST increase, weight decrease, neutrophil count decrease, group. Severe hypoproteinaemia, e.g. in nephrotic syndrome. not recommended. Co-administration with antineoplastic or WBC decrease, post-traumatic pain. For listings and further EDUCATIONAL GUIDANCE: Prior to prescribing AUBAGIO, physicians
immunosuppressive therapies has not been evaluated. Peripheral information on adverse reactions, please refer to the SmPC. Legal
must familiarise themselves with educational materials which consist neuropathy: Confirmed peripheral neuropathy, consider discontinuing Classification: POM (Prescription Only Medicine). List Price: £1037.84
of a Healthcare Professional Education/Discussion guide and they AUBAGIO therapy and performing the accelerated elimination per 28 day pack. MARKETING AUTHORISATION NUMBER :
should provide their patients with a Patient Card and Patient Leaflet. procedure. Vaccination: Live attenuated vaccines should be avoided. EU/1/13/838/001-005. MARKETING AUTHORISATION HOLDER: Sanofi-
WARNINGS AND PRECAUTIONS: Monitoring: Before starting treatment
SWITCHING to or from AUBAGIO: No waiting period is required when
Aventis Groupe. 54, Rue La Boétie. F-75008 Paris. France. FULL
the following should be assessed: blood pressure, alanine initiating teriflunomide after interferon beta or glatiramer acetate. Due PRESCRIBING INFORMATION AVAILABLE FROM Genzyme
aminotransferase (ALT/SGPT), complete blood cell count (CBC) to the risk of concomitant immune effects for up to 2-3 months, caution Therapeutics Ltd, 4620 Kingsgate, Cascade Way, Oxford Business Park including differential white blood cell (WBC) and platelet count. Exclude is required when switching patients immediately from natalizumab to South, Oxford OX4 2SU. DATE OF PREPARATION: October 2013.
pregnancy. During treatment the following should be monitored: blood teriflunomide. To avoid concomitant immune effects when switching pressure, ALT/SGPT. A CBC should be performed based on signs and from fingolimod, 10-14 weeks is needed for lymphocytes to return to symptoms. Accelerated elimination procedure: Without an accelerated the normal range. If a decision is made to stop treatment with elimination procedure, it takes an average of 8 months to reach plasma AUBAGIO, during the interval of 5 half-lives (approximately 3.5 months, AUBAGIO is subject to additional monitoring.
concentrations less than 0.02 mg/l, although due to individual variation although may be longer in some patients), starting other therapies will This will allow quick identification of new safety
in substance clearance it may take up to 2 years. An accelerated result in concomitant exposure to AUBAGIO. This may lead to an information. Adverse Events should be reported.
elimination procedure can be used at any time after discontinuation of additive effect on the immune system and caution is, therefore, teriflunomide. (For further information, please refer to the SmPC). indicated. CONCOMITANT USE AND DRUG INTERACTION: Co-
Reporting forms and information can be found at:
Hepatic effects: Assess liver enzymes before initiation of teriflunomide administration of teriflunomide with leflunomide is not recommended. www.mhra.gov.uk/yellowcard
therapy - every two weeks during the first 6 months of treatment, and Co-administration with antineoplastic or immunosuppressive therapies every 8 weeks thereafter or as indicated by clinical signs and has not been evaluated. Rifampicin and other known potent CYP and Adverse events should also be reported to
symptoms. For ALT (SGPT) elevations between 2- and 3-fold the upper transporter inducers, medicinal products metabolised by CYP2C8, oral limit of normal, monitoring must be performed weekly. Teriflunomide contraceptives, medicinal products metabolised by CYP1A2, OAT3 therapy should be discontinued if liver injury is suspected and substrates, BCRP substrates and OATP substrates should be used with Tel: 01865 405 200
discontinuation should be considered if liver enzymes are confirmed as caution during treatment with teriflunomide. For patients receiving >3x ULN. Patients with pre-existing liver disease may be at increased teriflunomide treatment with cholestyramine or activated charcoal is

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