Skin Health Psoriasis Treatment Arava (Leflunomide) for Psoriasis and Psoriatic Arthritis Rheumatoid arthritis drug used off-label for psoriasis By Ruth Jessen Hickman, MD facebook linkedin Ruth Jessen Hickman, MD, is a freelance medical and health writer and published book author. Learn about our editorial process Ruth Jessen Hickman, MD Medically reviewed by Medically reviewed by Casey Gallagher, MD on September 23, 2020 Casey Gallagher, MD, is board-certified in dermatology and works as a practicing dermatologist and clinical professor. Learn about our Medical Review Board Casey Gallagher, MD on September 23, 2020 Print Table of Contents View All Table of Contents How It Works Who Can Use It Dosage Side Effects Interactions Contraindications Arava (leflunomide) is an oral drug that can be used to treat psoriatic arthritis and moderate to severe psoriasis. Approved for use by the U.S. Food and Drug Administration (FDA) in 1998, Arava is classified as a disease-modifying anti-rheumatic drug (DMARD), which works by tempering the immune response. In addition to the original brand name drug, Arava is widely available in generic form under its chemical name leflunomide. Jose Luis Pelaez Inc / Getty Images How It Works Arava is one of the older DMARDs used to treat psoriatic arthritis and moderate to severe psoriasis. This places it in a group of drugs, like methotrexate and Sandimmune (cyclosporine), that treat autoimmune diseases by suppressing the immune response as a whole. Newer biologic drugs like Humira (adalimumab) and Cimzia (certolizumab pegol) only suppress specific portions of the immune system and, as a result, tend to be more effective with fewer systemic side effects. For its part, Arava works by blocking the synthesis of pyrimidine, an organic compound that immune cells, namely T-cells, need to function. By removing the "fuel" that T-cells need to survive, the overall immune response is reduced, as is the chronic inflammation inherent to autoimmune diseases. Although the tempering of the immune response by Arava can help alleviate psoriasis and psoriatic arthritis symptoms, it also leaves you vulnerable to infection. Who Can Use It The FDA originally approved Arava for the treatment of rheumatoid arthritis (a type of autoimmune arthritis). Technically speaking, the drug has never been approved by the FDA to treat either psoriasis or psoriatic arthritis. However, because they share similar disease pathways to rheumatoid arthritis, Arava is sometimes prescribed "off-label" for these conditions when methotrexate and other drugs fail to provide relief. It is almost never used in first-line therapy or for people with mild to moderate psoriasis. Arava is approved for use in adults only. The safety and effectiveness of Arava have not been established in children, who will likely have better and safer treatment options than Arava. Dosage Arava is available as an oral pill in 10-milligram (mg), 20-mg, and 100-mg doses. It is taken by mouth with food and generally prescribed as follows: 100 mg for three days as a "loading dose" Thereafter, 20 mg daily as a "maintenance dose" If the 20-mg dose is not well tolerated, it can be reduced to 10 mg daily. Side Effects Side effects are common with Arava, some of which may be persistent or intolerable. Those affecting at least 1% of users include (in order of frequency): Diarrhea Respiratory tract infections Hair loss High blood pressure Rash Nausea Bronchitis Headache Abdominal pain Back pain Indigestion Urinary tract infection (UTI) Dizziness Other infections Joint pain and inflammation Itchiness Weight loss Loss of appetite Cough Gastroenteritis (stomach flu) Sore throat Mouth sore Vomiting Weakness Allergic reaction Chest pain Eczema Paresthesia (abnormal skin sensations) Pneumonitis (lung inflammation) Runny nose Gallstones Shortness of breath Anaphylaxis, a severe whole-body allergy, occurs rarely with Arava. Still, if you develop hives, shortness of breath, rapid heart rate, or swelling of the face, tongue, or throat after taking the drug, call 911 or seek emergency care. Interactions Other immunosuppressive drugs should not be used with Arava, as the cumulative effect may cause severe and even life-threatening infections or complications. The concurrent use of methotrexate, in particular, may lead to severe or even fatal liver damage. Similarly, live attenuated vaccines (those made with living but disabled viruses) should not be used while taking Arava, since they can cause the very illness they aim to prevent due to the lack of an immune response. If you need vaccination for any reason, either get vaccinated before Arava is started or ask your doctor if an inactivated (dead) vaccine is available. Arava can also interact with drugs that use an enzyme called cytochrome (CYP) for metabolization. Arava also relies on CYP and may end up competing for the enzyme if taken together with these drugs. In some cases, this may cause a drug concentration to rise (increasing the risk of toxicity and side effects) or drop (reducing the drug's efficacy). Treatments most prone to interaction with Arava include: Cephalosporin antibiotics like Ceclor (cefaclor) H2 blockers like Tagamet (cimetidine) Prandin (repaglinide), used to treat diabetes Rifampin, used to treat tuberculosis Statin drugs like Crestor (rosuvastatin) and Lipitor (atorvastatin) St. John's wort A dose separation of several hours may be all that is needed to overcome the interaction. At other times, a drug substitution may be needed. To avoid interactions, always advise your doctor about any and all drugs and supplements you are taking. Contraindications The FDA has issued two black box warnings about Arava. The warnings highlight potentially devastating risks in two specific populations for whom Arava is contraindicated: Pregnant women need to avoid Arava due to the high risk of birth defects, including severe organ malformations, hydrocephalus, and miscarriage. Arava is classified as a Pregnancy X drug, indicating that it should never be used during pregnancy. Breastfeeding should also be avoided. People with pre-existing liver disease (including those with cirrhosis or chronic hepatitis C, or whose ALT liver enzymes are below 2) need to avoid Arava as well. Severe liver injuries, including fatal liver failure, have occurred as a result of Arava use. To reduce the risk, women of reproductive age should undergo pregnancy testing prior to starting Arava and use contraception during treatment and up to two years thereafter until all traces of the drug's metabolite (teriflunomide) have been eliminated from the body. If pregnancy occurs during treatment, the drug should be stopped immediately. Accelerated drug elimination can be induced using an 11-day course of either cholestyramine or activated charcoal in suspension. To prevent liver injury, a screening for liver disease or dysfunction should be performed prior to the start of treatment. Even in people with no indication of liver problems, liver enzymes should be routinely monitored every month for the first six months of treatment and every six to eight weeks thereafter. Arava should also be avoided in anyone with a known hypersensitivity to leflunomide or any of the other ingredients in the drug. This also includes people allergic to the drug Aubagio (teriflunomide) used to treat multiple sclerosis. Was this page helpful? Thanks for your feedback! Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit Article Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61(3):451-85. doi:10.1016/j.jaad.2009.03.027 Additional Reading Food and Drug Administration. Arava label. Revised August 2015.