LEFLUNOMIDE

Background and Date of Approval

Leflunomide is an antirheumatic drug approved by the U.S. Food and Drug Administration on 9 October 1998 for the treatment of rheumatoid arthritis and psoriatic arthritis.

Uses

Leflunomide helps to treat rheumatoid arthritis, a chronic inflammatory condition that affects the joints. It is also used in the treatment of psoriatic arthritis, which is a type of inflammatory arthritis that occurs in some individuals with psoriasis. Psoriatic arthritis affects the joints and can cause pain, swelling, stiffness, and reduced range of motion.

How is it administered?

Take the Leflunomide as advised by your physician. Do not crush, chew, or open the medicine. Your physician will decide the correct dosage and duration based on age, body weight, and disease condition. Only stop taking the tablet if your doctor advises you to stop.

Side Effects

The side effects known to occur commonly during the treatment with Leflunomide are loss of appetite, weight loss, low white blood cells, mild increase in blood pressure, diarrhea, nausea, vomiting, hair loss, dry skin, and itching. Some serious side effects include serious allergic reactions (difficulty breathing, feeling dizzy or light-headed, weakness), skin rash or ulcers in the mouth, bruising, pale skin, yellow discoloration of eyes and skin, abdominal pain, infections (fever, sore throat, cough), and tingling or pain in hands or feet.

Warnings

This drug is contraindicated in individuals with known hypersensitivity or allergy to it or its component. Before taking Leflunomide, it is necessary to consult with your physician if you have a history of interstitial lung disease, tuberculosis, skin ulcers, unexplained chronic diarrhea, liver, and kidney problems. Your doctor may perform certain tests for further diagnosis and prescribe you a low dose if necessary. Certain vaccinations may not be recommended while on treatment with this drug because this drug can affect the immune system, and this can impact the effectiveness or safety of vaccines. This drug remains in the body for a considerable period even after discontinuation. Therefore, it's important to discuss vaccination plans with your doctor before initiating the treatment.

Precautions

If you are currently experiencing a severe infection, it may be necessary to delay or avoid starting Leflunomide treatment until the infection is resolved. This drug is contraindicated during pregnancy because it can have harmful effects on a developing fetus and may also be present in breast milk. Drinking alcohol while taking this drug can further stress the liver and lead to liver toxicity or other complications. Hence it is strongly advised to avoid consuming alcohol during the treatment.

Word of Advice

Leflunomide is indicated to reduce joint pain, swelling, and stiffness. The full therapeutic benefits may take several weeks or months to manifest; patients should continue treatment as prescribed during this period.

References

Aspire Pharma Ltd, Electronic medicines compendium (EMC), [Revised on June 2022] [ Accessed on 17th August 2023], https://www.medicines.org.uk/emc/files/pil.5399.pdf Sanofi-aventis US LLC, US Food and Drug Administration, [Revised on July 2011] [ Accessed on 17th August 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020905s022lbl.pdf Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Immunosuppressants, tolerogens, and immunostimulants, 12th edition, 2011, 1014. KD Tripathi, Essentials of Medical Pharmacology, Antirheumatoid and antigout drugs, 7th edition, 2013, 212.

Frequently Asked Questions

Can Leflunomide cure rheumatoid arthritis?

Leflunomide is not a cure for rheumatoid arthritis or other autoimmune conditions. It is a long-term treatment that helps manage symptoms, reduce inflammation, and slow down the progression of the disease.

What are the common side effects of Leflunomide?

Common side effects of Leflunomide may include loss of appetite, weight loss, low white blood cells, mild increase in blood pressure, diarrhea, nausea, vomiting, hair loss, dry skin, and itching. It is important to report any severe side effects to your physician.

Can Leflunomide be used in children?

Leflunomide is generally not recommended for use in children and adolescents under the age of 18.

How does Leflunomide work?

Leflunomide works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which is involved in the synthesis of DNA and RNA. By blocking this enzyme, this drug helps to reduce inflammation and suppress the overactive immune response associated with rheumatoid arthritis.

Can Leflunomide interact with other medications?

Yes, Leflunomide can interact with certain medications, including some immunosuppressants, such as methotrexate, and certain antimalarial drugs. It is important to inform your physician about all the medications, supplements, or herbal products you are taking to avoid serious interactions.

Available Brands 18

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS