Concise Prescribing Info
Active RA; active psoriatic arthritis.
Dosage/Direction for Use
RA Loading dose: 100 mg once daily for 3 days. Maintenance dose: 10-20 mg once daily depending on the severity. Psoriatic arthritis Loading dose: 100 mg once daily for 3 days. Maintenance dose: 20 mg once daily.
May be taken with or without food: Swallow whole w/ sufficient amount of liqd.
Hypersensitivity to leflunomide or teriflunomide. Severe immunodeficiency states eg, AIDS; impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than RA or psoriatic arthritis; serious infection; moderate to severe renal insufficiency; severe hypoproteinaemia eg, nephrotic syndrome. Women of childbearing potential. Hepatic impairment. Pregnancy & lactation.
Special Precautions
Serious ARs may occur in concomitant administration of hepatotoxic or haematotoxic disease-modifying antirheumatic drugs (DMARDs) (eg, methotrexate). Not advisable to be combined w/ antimalarials used in rheumatic diseases (eg, chloroquine & hydroxychloroquine), IM or PO gold, D-penicillamine, azathioprine & other immunosuppressive agents including tumor necrosis factor α-inhibitors. Co-administration of teriflunomide is not recommended. Increased possibility of additive risks when switching to another DMARD w/o washout procedure; increased side effects w/ recent treatment w/ hepatotoxic or hematotoxic agents; closely monitor liver enzymes & haematological parameters in the initial phase after switching. Discontinue use & initiate washout procedure in case of ulcerative stomatitis. Discontinue use & immediately initiate washout procedure as soon as skin &/or mucosal reactions are observed due to very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis; re-exposure is contraindicated in these cases. Potentially may increase susceptibility to infections including opportunistic infections. Rarely, cases of progressive multifocal leukoencephalopathy. Evaluate patients for active & inactive TB prior to treatment. Carefully monitor patient w/ history of TB for reactivation of infection. Potentially fatal, occurrence of interstitial lung disease; increased risk in patients w/ history of interstitial lung disease. Discontinue use & investigate further if patient develops pulmonary symptoms, eg, cough & dyspnoea. Increased risk of peripheral neuropathy in patients >60 yr, concomitant neurotoxic medications & diabetes. Consider discontinuation & perform drug elimination procedure if patient develops peripheral neuropathy. Check BP at the start of treatment & monitor periodically after. May affect ability to drive & use machines. Not recommended in childn <18 yr.
Adverse Reactions
Leucopenia; mild allergic reactions; increased creatinine phosphokinase; paraesthesia, headache, dizziness, peripheral neuropathy; mild BP increase; diarrhoea, nausea, vomiting, oral mucosal disorders, abdominal pain; elevated liver parameters [transaminases (especially ALT), less often γ-GT, alkaline phosphatase, bilirubin]; increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin; tenosynovitis; anorexia, wt loss, asthenia. Potentially, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Drug Interactions
Increased occurrence of side effects w/ recent or concomitant use of hepatotoxic or haematotoxic drugs. Vaccination w/ live attenuated vaccines is not recommended. Increased prothrombin time w/ warfarin; close INR follow-up & monitoring is recommended in co-administration w/ warfarin or another coumarin anticoagulant.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AA13 - leflunomide ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Lefno FC tab 20 mg
3 × 10's
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