Aray

Aray

leflunomide

Manufacturer:

Hanlim

Distributor:

SB Pharma
Concise Prescribing Info
Contents
Leflunomide
Indications/Uses
Active RA or active psoriatic arthritis in adults.
Dosage/Direction for Use
Initial dose: One 100-mg tab once daily for the 1st 3 days. Subsequent dose: RA 10 or 20 mg once daily, depending on disease severity. Psoriatic arthritis 20 mg once daily.
Contraindications
Hypersensitivity to leflunomide or teriflunomide. Hypoproteinaemia. Any problem affecting the immune system (eg, AIDS). Any bone marrow problem; low RBCs or WBCs, or reduced blood platelets. Serious infection. Liver problems. Moderate to severe kidney problems. Pregnancy & lactation.
Special Precautions
Patients w/ history of ILD; history of TB or close contact w/ a TB patient; unexplained chronic diarrhoea; intolerance to some sugars. Detection of falsely low Ca levels. Can occasionally cause some problems w/ the blood, liver, lungs, or nerves in the arms or legs. May cause some serious allergic reactions (including DRESS), or increase the chance of a severe infection. Reports of rare cases of severe liver injury. Perform blood tests at regular intervals before & during treatment. Regularly check BP. Do not give certain vaccinations during treatment & for a certain amount of time after stopping treatment. Not recommended to drink alcohol during treatment. May impair ability to drive or operate machinery. Women of childbearing potential & men wishing to father a child should use reliable contraception during treatment. Blood test should confirm that Aray has been sufficiently removed from the body before becoming pregnant or attempting to father a child; women should wait for at least another mth before becoming pregnant, while men should wait for at least another 3 mth before attempting to father a child. Not recommended for use in childn & adolescents <18 yr.
Adverse Reactions
Leucopenia; mild allergic reactions; loss of appetite, wt loss (usually insignificant); tiredness/asthenia; headache, dizziness; paraesthesia; mild increase in BP; colitis; diarrhoea; nausea, vomiting; mouth inflammation or ulcers; abdominal pain; increase in some liver test results; increased hair loss; eczema, dry skin, rash, itching; tendonitis; increased creatine phosphokinase; peripheral neuropathy.
Drug Interactions
Potential interaction w/ other medicines for RA eg, antimalarials (eg, chloroquine & hydroxychloroquine), IM or oral gold, D-penicillamine, azathioprine & other immunosuppressive medicines (eg, methotrexate); warfarin & other oral blood thinners; teriflunomide; repaglinide, pioglitazone, nateglinide, or rosiglitazone; daunorubicin, doxorubicin, paclitaxel, or topotecan; duloxetine; alosetron; theophylline; tizanidine; OCs (containing ethinylestradiol & levonorgestrel); cefaclor, benzylpenicillin (penicillin G), ciprofloxacin; indomethacin, ketoprofen; furosemide; zidovudine; rosuvastatin, simvastatin, atorvastatin, pravastatin; sulfasalazine; colestyramine or activated charcoal. Increased chance of liver damage w/ alcohol during treatment.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AK01 - leflunomide ; Belongs to the class of dihydroorotate dehydrogenase (DHODH) inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Aray FC tab 10 mg
Packing/Price
30's
Form
Aray FC tab 20 mg
Packing/Price
30's
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