The duration may be modified depending on clinical or laboratory variables. In such cases re- exposure to leflunomide is contra-indicated (see section 4.3). In cases of significant adverse reactions, ‘washout’ procedure to speed elimination may be necessary. 0000003094 00000 n
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Alternatively, 50 g of activated powdered charcoal is administered 4 times daily. Please contact Sanofi Ireland Medical Information on 01 4035600 or IEmedinfo@sanofi.com. 0000127496 00000 n
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Leflunomide is a disease modifying anti-rheumatic drug indicated for
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Leflunomide can cause serious and potentially life-threatening adverse
severe reactions, Leflunomide ratiopharm and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately. methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i.e. Leflunomide has an elimination half life of several weeks. Washout Procedure The active metabolite persists for a long period; to aid drug elimination in case of serious adverse effect, or before starting another disease-modifying antirheumatic drug, or before conception, stop treatment and give either colestyramine or charcoal, activated . Prescribers are encouraged to familiarise themselves with the prescribing
Leflunomide contains lactose, lecithin (derived from soybeans) and sodium kinetic interaction, organ toxicity). Symptoms may further improve after several months. 0000128330 00000 n
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immediately.2 In addition, rheumatology advice should be sought for all
0000005349 00000 n
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the treatment of rheumatoid arthritis and active psoriatic arthritis. 0000005006 00000 n
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A wash-out procedure should be used for all serious adverse reactions. 0000128117 00000 n
Paediatrics Leflunomide is prescribed according to weight: o <10kg – 5mg once a day
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Colestyramine 8 g is administered 3 times daily. %PDF-1.4
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An ad hoc advisory service is available for providing information on leflunomide plasma level testing for patients treated with Arava®. 0000006321 00000 n
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Time to response is 8 to 12 weeks. 0000071206 00000 n
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If leflunomide-associated persistent diarrhea or weight loss is serious, leflunomide should be withdrawn and colonic endoscopy is recommended. A complete washout is essential in such cases. when given in combination with other immunosuppressant medicines.Prescribers are reminded that if serious adverse reactions occur, leflunomide
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reactions involving the liver, blood, lungs and skin. effects leflunomide can also cause life-threatening infections, particularly
As leflunomide has a long persistence in the body, a switching to another DMARD (e.g. 0000128580 00000 n
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methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i.e. 0000127930 00000 n
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This information is included in a new subsection of the data sheet “Washout procedure for severe adverse reactions”. 0000006715 00000 n
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stream Given the long half-life of leflunomide a washout procedure with colestyramine should be considered whenever the problem is severe or persistent [76, 93].
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information for leflunomide, available on the Medsafe website at:
must be stopped and a cholestyramine or charcoal wash-out procedure initiated
Due to its immunosuppressant
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As leflunomide has a long persistence in the body, a switching to another DMARD (e.g. 0000128706 00000 n
patients experiencing serious adverse reactions to leflunomide. 0000128538 00000 n
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As with all medicines, healthcare professionals are encouraged to continue to report all suspected serious or unexpected adverse reactions to leflunomide to CARM.
Washout procedure.
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kinetic interaction, organ toxicity). x�c```b``��������A��b�,Pf������&�����!9G�
K�&�8�,�����ZQTabA���/as��3�ʒ�00���d��8��dA����#�X��,�� 0000001202 00000 n
Duration of a complete washout is usually 11 days.
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