Leflunomide

DEA Class; Rx

Common Brand Names; Arava

Pregnancy

Hypersensitivity

Severe hapatic impairment

Current treatment with teriflunomide

Diarrhea (17%)

Respiratory infections (15%)

Alopecia (10%)

Hypertension (10%)

Rash (10%)

Nausea (9%)

Bronchitis (7%)

Headache (7%)

Abdominal pain (5%)

Abnormal LFT’s (5%)

Accidental injury (5%)

Back pain (5%)

Dyspepsia (5%)

UTI (5%)

Dizziness (4%)

Infection (4%)

Joint disorder (4%)

Pruritus (4%)

Weight loss (4%)

Anorexia (3%)

Cough (3%)

Gastroenteritis (3%)

Pharyngitis (3%)

Stomatitis (3%)

Tenosynovitis (3%)

Vomiting (3%)

Weakness (3%)

Allergic reaction (2%)

Chest pain (2%)

Dry skin (2%)

Eczema (2%)

Pain (2%)

Hepatotoxicity reported

Vaccination with live vaccines not recommended

Potential increase risk for malignancy

Increase in blood pressure reported with therapy; check blood pressure before initiating therapy and periodically thereafter

Rare cases of drug reaction with eosinophilia and systemic symptoms (DRESS) reported; discontinue therapy; a drug elimination procedure recommended

Co-administration of teriflunomide with leflunomide not recommended, as leflunomide is parent compound of teriflunomide

Peripheral neuropathy reported; most recover after discontinuing drug; risk factors include age >60 years, concomitant neurotoxic drugs, and diabetes; if patient develops peripheral neuropathy, consider discontinuing and performing accelerated elimination procedure

Interstitial lung disease (ILD) reported and has been associated with fatal outcomes; risk increased with prior history of ILD; if pulmonary symptoms worsen in patients with pre-exixting ILD, consider discontinuing therapy and performing accelerated drug elimination procedure

A pregnancy exposure registry monitors pregnancy outcomes in women exposed to therapy during pregnancy

Clinical lactation studies not conducted to assess presence of drug in human milk, effects on breastfed child, or on milk production

leflunomide

tablet

• 10mg
• 20mg
• 100mg