Arolef is an immunomodulating agent and DMARD. It inhibits pyrimidine synthesis by inhibiting dihydroorotate dehydrogenase enzyme activity resulting in antiproliferative and anti-inflammatory effects.
Arolef is used for adults for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms and to retard structural damage as manifested by x-ray erosions and joint space narrowing .
Arolef is also used to associated treatment for these conditions: Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis
|Other Names||Leflunomida, Leflunomide, Léflunomide, Leflunomidum|
|Therapeutic Class||Drugs used for Rheumatoid Arthritis|
|Manufacturer||General Pharmaceuticals Ltd|
|Last Updated:||June 23, 2021 at 11:22 am|
Table Of contents
Arolef once-daily oral dosing for rheumatoid arthritis patients. After a loading dose of 100 mg once daily for 3 days, the maintenance dose is 20 mg once daily. Arolef does not require step wise dose increment over time. The dose may be decreased to 10 mg daily if tolerability issues arise.
Adverse reactions associated with the use of leflunomide include diarrhea, nausea, vomiting, abdominal pain, headache, respiratory infection, bronchitis, elevated liver enzymes, aggravation of pre-existing hypertension, alopecia, and rash.
Caution should be taken for those female with child bearing potential who are not using reliable contraception and for the subject of renal insufficiency. Arolef should be stopped before becoming pregnant. Liver function should be monitored before starting treatment.
Cholestyramine and activated charcoal may decrease plasma concentration of active metabolite. Concurrent use of methotrexate and other hepatotoxic drugs may increase the risk of hepatotoxicity. Rifampicin increases serum levels of the active metabolite.
- Take with or without food. The absorption is unaffected by food.
Volume of Distribution
- 0.13 L/kg
Pregnancy & Breastfeeding use
Pregnancy: Arolef is not recommended for pregnant women. Pregnancy must be avoided during leflunomide treatment or prior to the completion of the drug elimination procedure after leflunomide treatment.
Nursing Mother: Arolef should not be used by nursing mothers. It is not known whether leflunomide is excreted in human milk. Many drugs are excreted in human milk and there is a potential for serious adverse reactions in nursing infants from leflunomide. Therefore, a decision should be made whether to proceed with nursing or initiate treatment with leflunomide, taking into account the importance of the drug to the mother.
Arolef is contraindicated in patients with known hypersensitivity to leflunomide or any of the other components of leflunomide, hepatic impairment, severe uncontrolled infections and bone marrow dysplasia.
There is no human experience regarding leflunomide over dosage. In the event of a significant overdose or toxicity, cholestyramine or charcoal administration is recommended to accelerate elimination.
Store at 25°C.