The rheumatoid arthritis (RA) treatment leflunomide (Arava) is now indicated to improve physical function in patients with RA. The disease modifying antirheumatic drug (DMARD) is a first-line oral treatment to reduce the signs and symptoms of rheumatoid arthritis and inhibit structural damage, as evidenced by x-ray erosions and joint space narrowing in adults. The FDA also approved revisions and alterations to the drug's safety information, which include revised liver function and hematology monitoring recommendations.
The PDA's expanded approval of leflunomide is based on data from three long-term clinical trials. Improvement in physical function was measured through a series of validated and widely accepted tools measuring patients' ability to conduct daily activities, their function in daily life, and their sense of well-being. In the trials, a marked, clinically meaningful improvement in physical function was shown in the same three studies that previously demonstrated improvement in signs and symptoms of RA and retardation of structural damage. The drug's efficacy was sustained for 2 years.
In clinical trials, adverse reactions associated with the use of leflunomide included diarrhea, elevated liver enzymes, alopecia, and rash. It is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception.
Rare cases of liver injury have been reported during treatment with leflunomide. The drug is not recommended in patients with significant hepatic impairment or evidence of infection with hepatitis B or C viruses.
Consult product labeling for full prescribing instructions.
Copyright Springhouse Corporation Feb 2004
Provided by ProQuest Information and Learning Company. All rights Reserved
Contact
Home
A
8-Hour Bayer