Leflunomid Winthrop Side effects

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What are the possible side effects of Leflunomid Winthrop?

Get emergency medical help if you have signs of an allergic reaction to Leflunomid Winthrop: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Common Leflunomid Winthrop side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Leflunomid Winthrop in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

The following serious adverse reactions are described elsewhere in the labeling:

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 Leflunomid Winthrop 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 Leflunomid Winthrop 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*
Leflunomid Winthrop 20 mg/day

(n= 182)



MTX 7.5 - 15 mg/wk


Leflunomid Winthrop 20mg/day




SSZ 2.0 g/day


Leflunomid Winthrop 20 mg/day


MTX 7.5 - 15 mg/wk


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, Leflunomid Winthrop 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 Leflunomid Winthrop-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 Leflunomid Winthrop treatment group).

Table 2: Percentage Of Patients With Adverse Events ≥ 5% In Any Leflunomid Winthrop 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 Leflunomid Winthrop treatment groups in phase III trials

Adverse events during a second year of treatment with Leflunomid Winthrop 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 Leflunomid Winthrop 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 Leflunomid Winthrop. 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.

What is the most important information I should know about Leflunomid Winthrop?

Leflunomid Winthrop contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Patients with hypersensitivity to Leflunomid Winthrop or to any of the excipients of Leflunomid Winthrop.

Severe deficiency of the immune system (eg, AIDS); significant impairment of the bone marrow function or a marked decrease in the number of red or white blood cells (anemia or leukopenia/neutropenia) or of platelets (thrombocytopenia), due to causes other than rheumatoid or psoriatic arthritis; serious infections; liver function impairment; severe excessive reduction in blood protein concentration (hypoproteinemia due eg, to a renal disease (nephrotic syndrome); moderate to severe renal insufficiency, since available clinical experience is insufficient.

Use in pregnancy & lactation: Pregnancy must be excluded before the start of treatment with Leflunomid Winthrop in pregnant women or in women of childbearing potential who do not use reliable contraception. This applies during treatment and after treatment discontinuation, as long as the plasma levels of the active metabolite are >0.02 mg/L. Pregnancy must be excluded before the start of treatment with Leflunomid Winthrop.

Sufficient elimination of the metabolite from the body prior to pregnancy is essential to avoid the risk of malformation in the infant. Therefore, women wishing to become pregnant who are taking Leflunomid Winthrop (or have taken it within the previous 2 years) must first speak with their physician, who may advise, as a follow-up measure to the discontinuation of Leflunomid Winthrop, either implementing the elimination procedure (for 11 days) or waiting until 2 full years have elapsed.

If there is any delay in onset of the period or any other reason to suspect pregnancy, the physician must be notified immediately and pregnancy testing carried out. If positive, the risk to the pregnancy must be discussed. Carrying out the elimination procedure at the 1st delay of the period may decrease the risk to the fetus from Leflunomid Winthrop.

Based on available information, the risk of malformations in newborn infants of men taking Leflunomid Winthrop cannot be excluded. Men should be aware of such a risk and should not take Leflunomid Winthrop without using reliable contraceptive measures. To minimize any possible risk, men wishing to father a child should contact their physician, who may advise that intake of Leflunomid Winthrop be discontinued and the previously mentioned elimination procedure be carried out for 11 days.

In both sexes, sufficient elimination of active metabolite should subsequently be confirmed by 2 separate blood laboratory tests, the first to be carried out after conclusion of the elimination procedure (or alternatively in the case of women, 2 years after discontinuation), and the second at least 14 days later. If both test values of active metabolite are <0.02 mg/L in blood plasma, the risk of malformation is very low.

Leflunomid Winthrop or its metabolites may pass into breast milk. Breastfeeding women must, therefore, not receive Leflunomid Winthrop.



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  2. DTP/NCI. "leflunomide: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "5-Methyl-N-[4-(trifluoromethyl)phenyl]-4-isoxazolecarboxamide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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