- Severe and fatal liver injury has reported in some patients treated with leflunomide. Avoid using therapy in patients with preexisting acute or chronic liver disease or if ALT >2xULN before initiating treatment [US Black Box Warning]
- Monitor liver tests weekly until normalized. Consider resumption of therapy if there is no leflunomide-induced liver injury [US Black Box Warning]
- Therapy is not recommended for patients with severe immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections. If serious infection or evidence of bone marrow suppression occurs, discontinue the therapy and administer cholestyramine or charcoal
- Infections, including opportunistic infections, especially pneumocystis jiroveci pneumonia, tuberculosis, sepsis and aspergillosis may occur in patients receiving leflunomide
- Rare cases of pancytopenia, agranulocytosis and thrombocytopenia have been reported with leflunomide alone and seen frequently in patients who received concomitant treatment with methotrexate, immunosuppressive agents, discontinued these therapies and prior history of a significant hematologic abnormality
- Monitor platelet, WBC count, hemoglobin or hematocrit monthly for six months following initiation of therapy and every 6 to 8 weeks thereafter. Chronic monitoring should be done monthly if co-administered with methotrexate and/or other potential immunosuppressive agents
- Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported very rarely in patients receiving leflunomide. If these conditions occur, therapy should be discontinued and drug elimination procedure is recommended
- Risk of malignancy, including lymphoproliferative disorders, is increased with immunosuppression medications
- Avoid using therapy in pregnant women, or women of childbearing potential who are not using reliable contraception. Counsel patient on the potential for serious risk to the fetus before initiating treatment
- Advise patient if there is any delay in onset of menses or any other reason to suspect pregnancy; they must inform there physician immediately for pregnancy testing and, if positive, the physician and patient must discuss the risk to the pregnancy
- Interstitial lung disease and some fatal adverse reactions has been reported in patients receiving leflunomide
- Prior to initiating leflunomide, patients should be screened for latent tuberculosis infection with a tuberculin skin test; if found positive in tuberculosis screening; patients should be treated by standard medical practice prior to therapy with leflunomide
- Use with live vaccines not recommended. Consider long half-life of leflunomide when contemplating administration of a live vaccine after stopping leflunomide
- Examine blood pressure before starting therapy and periodically thereafter
- Peripheral neuropathy has been reported. Some cases may be persistent after discontinuation.
Cautions: Use cautiously in
- Renal impairment
- Concurrent hepatotoxic agents
- Myelosuppression
- Blood dyscrasia
- Severe immunodeficiency
- Severe uncontrolled infection
- Latent tuberculosis
Pregnancy Category:C
Breastfeeding: Avoid use. It is unknown whether if leflunomide is excreted in human milk. Manufacturer advises decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Arava 10 MG TABS [Bottle] (SANOFI-AVENTIS U.S.)
30 mg = $694.42
60 mg = $1376.88 - Leflunomide 10 MG TABS [Bottle] (SANDOZ)
30 mg = $64.99
90 mg = $188.91 - Leflunomide 20 MG TABS [Bottle] (PRASCO LABORATORIES)
30 mg = $39.99
90 mg = $110.97 - Arava 20 MG TABS [Bottle] (SANOFI-AVENTIS U.S.)
30 mg = $739.02
60 mg = $1425.02
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
