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Leflunomide: Brands, Price & Uses in Bangladesh
Established Indications Rheumatoid Arthritis (RA): Leflunomide is approved for the treatment of active rheumatoid arthritis in adults and more.
About Leflunomide
Indications of Leflunomide
Established Indications
- Rheumatoid Arthritis (RA): Leflunomide is approved for the treatment of active rheumatoid arthritis in adults, to reduce signs and symptoms and to slow the progression of structural joint damage. It may be used as monotherapy or in combination with methotrexate in patients who have had an inadequate response to methotrexate alone.
Guideline-Supported / Off-Label Uses
- Psoriatic Arthritis: Leflunomide is used off-label, with support from rheumatology guidelines, for active psoriatic arthritis in patients who cannot tolerate or have not responded to other DMARDs.
- Other inflammatory arthropathies: Occasionally used off-label at a specialist's discretion when standard DMARDs are unsuitable.
Leflunomide is not established as effective in children (see Pediatric Use) and should be prescribed only by, or in consultation with, a physician experienced in disease-modifying antirheumatic drugs.
Dosage & Administration of Leflunomide
Adults - Rheumatoid Arthritis
| Phase | Dose |
|---|---|
| Loading dose (optional; low-risk patients only) | 100 mg orally once daily for 3 days |
| Maintenance dose | 20 mg orally once daily; may be reduced to 10 mg once daily if not well tolerated |
The maximum recommended maintenance dose is 20 mg once daily. Many prescribers omit the loading dose in patients at higher risk of hepatotoxicity or bone marrow suppression and start directly at 20 mg (or 10 mg) daily.
Renal Impairment
No dedicated dose adjustment is established; use Leflunomide with caution and close monitoring, as it has not been well studied in significant renal impairment.
Hepatic Impairment
Leflunomide is contraindicated in severe hepatic impairment (see Contraindications). Use with caution and enhanced liver monitoring in mild-to-moderate hepatic impairment.
Pediatric Dose
Safety and efficacy have not been established in pediatric patients (see Use in Special Populations).
Side Effects of Leflunomide
Common Side Effects
- Diarrhea, nausea, abdominal pain, dyspepsia
- Headache, dizziness
- Reversible alopecia (hair thinning)
- Rash, mild allergic reactions
- Elevated liver enzymes
- Mild hypertension
- Upper respiratory tract infections
Serious Side Effects (Seek Medical Attention)
| Reaction | Action |
|---|---|
| Severe hepatotoxicity/liver failure | Stop Leflunomide immediately, seek urgent medical care |
| Severe skin reactions (Stevens-Johnson syndrome, TEN, DRESS) | Discontinue immediately, seek emergency care |
| Interstitial lung disease (new/worsening cough, breathlessness) | Seek prompt medical evaluation |
| Severe infections | Seek prompt medical evaluation |
| Peripheral neuropathy (numbness/tingling) | Report to physician; may require discontinuation |
| Significant bone marrow suppression (unusual bleeding/bruising) | Seek urgent medical evaluation |
Contraindications of Leflunomide
- Known hypersensitivity to Leflunomide or any of its excipients, or to its active metabolite teriflunomide
- Pregnancy, or women of childbearing potential not using reliable contraception (see Pregnancy and Lactation)
- Severe hepatic impairment
- Severe immunodeficiency states (e.g., AIDS)
- Significant bone marrow dysfunction or significant pre-existing hematologic abnormalities from causes other than rheumatoid arthritis
- Serious, uncontrolled active infections
- Concurrent treatment with teriflunomide
Frequently Asked Questions about Leflunomide
What is Leflunomide used for?
Leflunomide is a disease-modifying antirheumatic drug (DMARD) used to treat active rheumatoid arthritis in adults, helping to reduce joint pain and swelling and slow long-term joint damage. See Indications for full details.
Can I take Leflunomide during pregnancy?
No. Leflunomide is contraindicated in pregnancy because it can cause serious harm to the developing baby. Pregnancy must be ruled out before starting treatment, and effective contraception is required during and after treatment as advised by your physician. If you become pregnant while taking Leflunomide, stop the medicine immediately and contact your doctor for urgent management, which may include a procedure to remove the drug from your body faster.
What tests will I need while taking Leflunomide?
Before starting Leflunomide, your doctor will check for tuberculosis, pregnancy status, blood pressure, and baseline liver and blood tests. While taking Leflunomide, you will need regular liver function tests (monthly for the first six months, then periodically) and periodic blood counts and blood pressure checks.
What should I do if I want to stop Leflunomide?
Do not stop Leflunomide or change your dose without consulting your physician. Leflunomide is used for long-term disease control, and because it stays in the body for a long time, stopping it (especially before a planned pregnancy) may require a special elimination procedure directed by your doctor.
What are the most serious side effects of Leflunomide?
The most serious risks with Leflunomide are severe liver damage (sometimes fatal), harm to an unborn baby if taken during pregnancy, serious infections due to a weakened immune system, and rare severe skin reactions. Contact your doctor immediately if you notice yellowing of the skin/eyes, unusual bruising or bleeding, signs of infection, or a severe skin rash.
Can Leflunomide be combined with other arthritis medicines?
Leflunomide is sometimes combined with methotrexate under close medical supervision, but this combination increases the risk of liver toxicity and requires more frequent monitoring. Do not combine Leflunomide with other DMARDs or with teriflunomide without your doctor's guidance.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.