What is Leflunomida Mylan?
Leflunomida Mylan affects the immune system and reduces swelling and inflammation in the body.
Leflunomida Mylan is used to treat the symptoms of rheumatoid arthritis. Leflunomida Mylan also helps reduce joint damage and improves physical functioning.
Leflunomida Mylan may also be used for other purposes not listed in this medication guide.
Leflunomida Mylan indications
Treatment of active rheumatoid arthritis (RA) in adults to reduce signs and symptoms, inhibit structural damage as evidence by X-ray erosions and joint space narrowing, and improve physical function.
Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with Leflunomida Mylan. The combined use of Leflunomida Mylan with antimalarials, IM or oral gold, D-penicillamine, azathioprine or methotrexate has not been adequately studied.
How should I use Leflunomida Mylan?
Use Leflunomida Mylan as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Leflunomida Mylan by mouth with or without food.
- It may take 4 weeks or more to notice any improvement while taking Leflunomida Mylan.
- If you miss a dose of Leflunomida Mylan, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Leflunomida Mylan.
Uses of Leflunomida Mylan in details
Use: Labeled Indications
Rheumatoid arthritis: Treatment of adults with active rheumatoid arthritis (RA).
Off Label Uses
BK virus (viremia or nephropathy; in kidney transplant recipients)
Data from a small retrospective study suggest Leflunomida Mylan may be of benefit as a replacement for mycophenolate in kidney transplant recipients with BK virus (viremia or nephropathy).
Leflunomida Mylan description
Leflunomida Mylan is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomida Mylan was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.
Leflunomida Mylan dosage
Leflunomida Mylan Dosage
Generic name: Leflunomida Mylan 10mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosage
The recommended dosage of Leflunomida Mylan is 20 mg once daily. Treatment may be initiated with or without a loading dose, depending upon the patient's risk of Leflunomida Mylan-associated hepatotoxicity and Leflunomida Mylan-associated myelosuppression. The loading dosage provides steady-state concentrations more rapidly.
- For patients who are at low risk for Leflunomida Mylan-associated hepatotoxicity and Leflunomida Mylan-associated myelosuppression the recommended Leflunomida Mylan loading dosage is 100 mg once daily for 3 days. Subsequently administer 20 mg once daily.
- For patients at high risk for Leflunomida Mylan-associated hepatotoxicity (e.g., those taking concomitant methotrexate) or Leflunomida Mylan-associated myelosuppression (e.g., patients taking concomitant immunosuppressants), the recommended Leflunomida Mylan dosage is 20 mg once daily without a loading dose.
The maximum recommended daily dosage is 20 mg once per day. Consider dosage reduction to 10 mg once daily for patients who are not able to tolerate 20 mg daily (i.e., for patients who experience any adverse events listed in Table 1).
Monitor patients carefully after dosage reduction and after stopping therapy with Leflunomida Mylan, since the active metabolite of Leflunomida Mylan, teriflunomide, is slowly eliminated from the plasma. After stopping Leflunomida Mylan treatment, an accelerated drug elimination procedure is recommended to reduce the plasma concentrations of the active metabolite, teriflunomide. Without use of an accelerated drug elimination procedure, it may take up to 2 years to reach undetectable plasma teriflunomide concentrations after stopping Leflunomida Mylan.
Evaluation and Testing Prior to Starting Leflunomida Mylan
Prior to starting Leflunomida Mylan treatment the following evaluations and tests are recommended:
- Evaluate patients for active tuberculosis and screen patients for latent tuberculosis infection
- Laboratory tests including serum alanine aminotransferase (ALT); and white blood cell, hemoglobin or hematocrit, and platelet counts
- For females of reproductive potential, pregnancy testing
- Check blood pressure
More about Leflunomida Mylan (Leflunomida Mylan)
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- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Support Group
- Pricing & Coupons
- En Espanol
- 19 Reviews - Add your own review/rating
- Generic Availability
Consumer resources
- Leflunomida Mylan
- Leflunomida Mylan (Advanced Reading)
Professional resources
- Leflunomida Mylan (AHFS Monograph)
- Leflunomida Mylan (FDA)
Related treatment guides
- Rheumatoid Arthritis
Leflunomida Mylan interactions
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What other drugs will affect Leflunomida Mylan?
Following oral administration, Leflunomida Mylan is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of Leflunomida Mylan's in vivo activity. Drug interaction studies have been conducted with both Leflunomida Mylan (Leflunomida Mylan) and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects.
Effect of Potent CYP and Transporter Inducers
Leflunomida Mylan is metabolized by CYP450 metabolizing enzymes. Concomitant use of Leflunomida Mylan and rifampin, a potent inducer of CYP and transporters, increased the plasma concentration of teriflunomide by 40%. However, when co-administered with the metabolite, teriflunomide, rifampin did not affect its pharmacokinetics. No dosage adjustment is recommended for Leflunomida Mylan when coadministered with rifampin. Because of the potential for Leflunomida Mylan concentrations to continue to increase with multiple dosing, caution should be used if patients are to be receiving both Leflunomida Mylan and rifampin.
Effect on CYP2C8 Substrates
Teriflunomide is an inhibitor of CYP2C8 in vivo. In patients taking Leflunomida Mylan, exposure of drugs metabolized by CYP2C8 (e.g., paclitaxel, pioglitazone, repaglinide, rosiglitazone) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP2C8 as required.
Effect on Warfarin
Coadministration of Leflunomida Mylan with warfarin requires close monitoring of the international normalized ratio (INR) because teriflunomide, the active metabolite of Leflunomida Mylan, may decrease peak INR by approximately 25%.
Effect on oral Contraceptives
Teriflunomide may increase the systemic exposures of ethinylestradiol and levonorgestrel. Consideration should be given to the type or dose of contraceptives used in combination with Leflunomida Mylan.
Effect on CYP1A2 Substrates
Teriflunomide, the active metabolite of Leflunomida Mylan, may be a weak inducer of CYP1A2 in vivo. In patients taking Leflunomida Mylan, exposure of drugs metabolized by CYP1A2 (e.g., alosetron, duloxetine, theophylline, tizanidine) may be reduced. Monitor these patients and adjust the dose of the concomitant drug(s) metabolized by CYP1A2 as required.
Effect on Organic Anion Transporter 3 (OAT3) Substrates
Teriflunomide inhibits the activity of OAT3 in vivo. In patients taking Leflunomida Mylan, exposure of drugs which are OAT3 substrates (e.g., cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, zidovudine) may be increased. Monitor these patients and adjust the dose of the concomitant drug(s) which are OAT3 substrates as required.
Effect on BCRP and Organic Anion Transporting Polypeptide B1 and B3 (OATP1B1/1B3) Substrates
Teriflunomide inhibits the activity of BCRP and OATP1B1/1B3 in vivo. For a patient taking Leflunomida Mylan, the dose of rosuvastatin should not exceed 10 mg once daily. For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking Leflunomida Mylan.
Leflunomida Mylan side effects
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What are the possible side effects of Leflunomida Mylan?
The following serious adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity
- Immunosuppression
- Bone marrow suppression
- Stevens-Johnson syndrome and toxic epidermal necrolysis
- Peripheral neuropathy
- Interstitial lung disease
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical studies (Trials 1, 2, and 3), 1,865 patients were treated with Leflunomida Mylan administered as either monotherapy or in combination with methotrexate or sulfasalazine. Patients ranged in age from 19 to 85 years, with an overall median age of 58 years. The mean duration of RA was 6 years ranging from 0 to 45 years.
Elevation of Liver Enzymes
Treatment with Leflunomida Mylan was associated with elevations of liver enzymes, primarily ALT and AST, in a significant number of patients; these effects were generally reversible. Most transaminase elevations were mild ( ≤ 2-fold ULN) and usually resolved while continuing treatment. Marked elevations ( > 3-fold ULN) occurred infrequently and reversed with dose reduction or discontinuation of treatment. Table 1 shows liver enzyme elevations seen with monthly monitoring in clinical trials Trial 1 and Trial 2. It was notable that the absence of folate use in Trial 3 was associated with a considerably greater incidence of liver enzyme elevation on methotrexate.
Table 1: Liver Enzyme Elevations > 3-fold Upper Limits of Normal (ULN) in Patients with RA in Trials 1, 2, and 3**
| Trial 1 | Trial 2 | Trial 3* | ||||||
| Leflunomida Mylan 20 mg/day (n= 182) | PL (n=118) | MTX 7.5 - 15 mg/wk (n=182) | Leflunomida Mylan 20mg/day (n=133) | PL (n=92) | SSZ 2.0 g/day (n=133) | Leflunomida Mylan 20 mg/day (n=501) | MTX 7.5 - 15 mg/wk (n=498) | |
| ALT (SGPT) > 3-fold ULN (n %) | 8 (4.4) | 3 (2.5) | 5 (2.7) | 2 (1.5) | 1 (1.1) | 2 (1.5) | 13 (2.6) | 83 (16.7) |
| Reversed to ≤ 2-fold ULN: | 8 | 3 | 5 | 2 | 1 | 2 | 12 | 82 |
| Timing of Elevation | ||||||||
| 0-3 Months | 6 | 1 | 1 | 2 | 1 | 2 | 7 | 27 |
| 4-6 Months | 1 | 1 | 3 | - | - | - | 1 | 34 |
| 7-9 Months | 1 | 1 | 1 | - | - | - | - | 16 |
| 10-12 Months | - | - | - | - | - | - | 5 | 6 |
| MTX = methotrexate, PL = placebo, SSZ = sulfasalazine, ULN = Upper limit of normal *Only 10% of patients in Trial 3 received folate. All patients in Trial 1 received folate. |
In a 6 month study of 263 patients with persistent active rheumatoid arthritis despite methotrexate therapy, and with normal LFTs, Leflunomida Mylan was administered to a group of 130 patients starting at 10 mg per day and increased to 20 mg as needed. An increase in ALT greater than or equal to three times the ULN was observed in 3.8% of patients compared to 0.8% in 133 patients continued on methotrexate with placebo.
Most Common Adverse Reactions
The most common adverse reactions in Leflunomida Mylan-treated patients with RA include diarrhea, elevated liver enzymes (ALT and AST), alopecia and rash. Table 2 displays the most common adverse reactions in the controlled studies in patients with RA at one year ( ≥ 5% in any Leflunomida Mylan treatment group).
Table 2: Percentage Of Patients With Adverse Events ≥ 5% In Any Leflunomida Mylan Treated Group in all RA Studies in Patients with RA
| Placebo-Controlled Trials | Active-Controlled Trials | All RA Studies | |
| Trial 1 and 2 | Trial 3 Hypertension as a preexisting condition was overrepresented in all Leflunomida Mylan treatment groups in phase III trials |
Adverse events during a second year of treatment with Leflunomida Mylan in clinical trials were consistent with those observed during the first year of treatment and occurred at a similar or lower incidence.
Less Common Adverse Reactions
In addition, in controlled clinical trials, the following adverse events in the Leflunomida Mylan treatment group occurred at a higher incidence than in the placebo group. These adverse events were deemed possibly related to the study drug.
Blood and Lymphatic System: leukocytosis, thrombocytopenia;
Cardiovascular: chest pain, palpitation, thrombophlebitis of the leg, varicose vein;
Eye: blurred vision, eye disorder, papilledema, retinal disorder, retinal hemorrhage;
Gastrointestinal: alkaline phosphatase increased, anorexia, bilirubinemia, flatulence, gamma-GT increased, salivary gland enlarged, sore throat, vomiting, dry mouth;
General Disorders: malaise;
Immune System: anaphylactic reaction;
Infection: abscess, flu syndrome, vaginal moniliasis;
Nervous System: dizziness, headache, somnolence;
Respiratory System: dyspnea;
Post Marketing Experience
The following additional adverse reactions have been identified during postapproval use of Leflunomida Mylan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System: agranulocytosis, leukopenia, neutropenia, pancytopenia;
Infection: opportunistic infections, severe infections including sepsis;
Gastrointestinal: acute hepatic necrosis, hepatitis, jaundice/cholestasis, pancreatitis; severe liver injury such as hepatic failure
Immune System: angioedema;
Nervous system: peripheral neuropathy;
Respiratory: interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, which may be fatal;
Skin and Appendages: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis including cutaneous necrotizing vasculitis, cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis.
Leflunomida Mylan contraindications
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What is the most important information I should know about Leflunomida Mylan?
Leflunomida Mylan can harm an unborn baby or cause birth defects. Do not use Leflunomida Mylan if you are pregnant. Your doctor may want you to have a pregnancy test to make sure you are not pregnant before you start taking Leflunomida Mylan.
Stop taking Leflunomida Mylan and tell your doctor right away if you become pregnant during treatment. You will need to receive medications to help your body eliminate the drug quickly and reduce the risk of harm to your unborn baby.
Use effective birth control while you are taking Leflunomida Mylan, whether you are a man or a woman. After your treatment ends, continue using birth control until you have received the drug elimination medications.
Before taking Leflunomida Mylan, tell your doctor if you have a history of liver disease or hepatitis, kidney disease, any type of infection, a history of tuberculosis, a blood cell disorder such as anemia or low platelets, a bone marrow disorder, or if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).
Leflunomida Mylan can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with Leflunomida Mylan, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
After you stop taking Leflunomida Mylan, you may need to be treated with other medications to help your body eliminate Leflunomida Mylan quickly. Without receiving this drug elimination procedure, Leflunomida Mylan could stay in your body for up to 2 years. Follow your doctor's instructions.
Active ingredient matches for Leflunomida Mylan:
Leflunomide in Spain.
List of Leflunomida Mylan substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Leflunomida Winthrop (Portugal) | |
| Leflunomide (Argentina, Australia, Austria, Bahrain, Belgium, Bosnia & Herzegowina, Brazil, Chile, Colombia, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom) | |
| Tablet; Oral; Leflunomide 10 mg | |
| Tablet; Oral; Leflunomide 20 mg | |
| Arava 10 mg tablet | $ 24.76 |
| Arava 20 mg tablet | $ 24.76 |
| Leflunomide 10 mg tablet | $ 16.75 |
| Leflunomide 20 mg tablet | $ 16.75 |
| Tablets; Oral; Leflunomide 10 mg | |
| Tablets; Oral; Leflunomide 20 mg | |
| Leflunomide tablet, film coated 20 mg/1 (Prasco LLC (US)) | |
| Leflunomide tablet 20 mg (Sanis Health Inc (Canada)) | |
| Leflunomide tablet, film coated 10 mg/1 (Prasco LLC (US)) | |
| Leflunomide tablet 10 mg (Sanis Health Inc (Canada)) | |
| Leflunomide tablet 10 mg/1 (Trigen Laboratories, LLC (US)) | |
| Leflunomide tablet 20 mg/1 (Avera Mc Kennan Hospital (US)) | |
| Léflunomide | |
| Tablet; Oral; Leflunomide 10 mg | |
| Tablet; Oral; Leflunomide 20 mg | |
| Arava 10 mg tablet | $ 24.76 |
| Arava 20 mg tablet | $ 24.76 |
| Leflunomide 10 mg tablet | $ 16.75 |
| Leflunomide 20 mg tablet | $ 16.75 |
| Tablets; Oral; Leflunomide 10 mg | |
| Tablets; Oral; Leflunomide 20 mg | |
| Leflunomide tablet, film coated 20 mg/1 (Prasco LLC (US)) | |
| Leflunomide tablet 20 mg (Sanis Health Inc (Canada)) | |
| Leflunomide tablet, film coated 10 mg/1 (Prasco LLC (US)) | |
| Leflunomide tablet 10 mg (Sanis Health Inc (Canada)) | |
| Leflunomide tablet 10 mg/1 (Trigen Laboratories, LLC (US)) | |
| Leflunomide tablet 20 mg/1 (Avera Mc Kennan Hospital (US)) | |
| Tablet; Oral; Leflunomide 10 mg | |
| Tablet; Oral; Leflunomide 20 mg | |
| Arava 10 mg tablet | $ 24.76 |
| Arava 20 mg tablet | $ 24.76 |
| Leflunomide 10 mg tablet | $ 16.75 |
| Leflunomide 20 mg tablet | $ 16.75 |
| Tablets; Oral; Leflunomide 10 mg | |
| Tablets; Oral; Leflunomide 20 mg | |
| Leflunomide tablet, film coated 20 mg/1 (Prasco LLC (US)) | |
| Leflunomide tablet 20 mg (Sanis Health Inc (Canada)) | |
| Leflunomide tablet, film coated 10 mg/1 (Prasco LLC (US)) | |
| Leflunomide tablet 10 mg (Sanis Health Inc (Canada)) | |
| Leflunomide tablet 10 mg/1 (Trigen Laboratories, LLC (US)) | |
| Leflunomide tablet 20 mg/1 (Avera Mc Kennan Hospital (US)) | |
| Leflunomide Alembic (United States) | |
| Leflunomide AN (Australia) | |
| Leflunomide Apotex (United States) | |
| Leflunomide Arena (Romania) | |
| Leflunomide Aspire (United Kingdom) | |
| Leflunomide Barr (United States) | |
| Leflunomide CF (Netherlands) | |
See 395 substitutes for Leflunomida Mylan | |
References
- DailyMed. "LEFLUNOMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "leflunomide". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "leflunomide". http://www.drugbank.ca/drugs/DB01097 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Leflunomida Mylan are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Leflunomida Mylan. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
