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Arava (Leflunomide) - Summary

 
 



CONTRAINDICATIONS AND WARNINGS

Pregnancy

Pregnancy must be excluded before the start of treatment with ARAVA. ARAVA is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. (See CONTRAINDICATIONS and WARNINGS.) Pregnancy must be avoided during ARAVA treatment or prior to the completion of the drug elimination procedure after ARAVA treatment.

Hepatotoxicity

Severe liver injury, including fatal liver failure, has been reported in some patients treated with ARAVA. Patients with pre-existing acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) >2×ULN before initiating treatment, should not be treated with ARAVA. Use caution when ARAVA is given with other potentially hepatotoxic drugs.

Monitoring of ALT levels is recommended at least monthly for six months after starting ARAVA, and thereafter every 6-8 weeks. If ALT elevation > 3 fold ULN occurs, interrupt ARAVA therapy while investigating the probable cause of the ALT elevation by close observation and additional tests. If likely leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If leflunomide-induced liver injury is unlikely because some other probable cause has been found, resumption of ARAVA therapy may be considered. (SEE WARNINGS – HEPATOTOXICITY.)

 

ARAVA SUMMARY

ARAVA® (leflunomide) is a pyrimidine synthesis inhibitor.

ARAVA is indicated in adults for the treatment of active rheumatoid arthritis (RA):

  1. to reduce signs and symptoms
  2. to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
  3. to improve physical function.

(see CLINICAL STUDIES)

Aspirin, nonsteroidal anti-inflammatory agents and/or low dose corticosteroids may be continued during treatment with ARAVA (see PRECAUTIONS – Drug Interactions – NSAIDs). The combined use of ARAVA with antimalarials, intramuscular or oral gold, D penicillamine, azathioprine, or methotrexate has not been adequately studied. (See WARNINGS - Immunosuppression Potential/Bone Marrow Suppression.)


See all Arava indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Arava (Leflunomide)

Could Oral Contraceptives Help Ease Rheumatoid Arthritis?
Source: MedicineNet Rheumatoid Arthritis Specialty [2015.08.28]
Title: Could Oral Contraceptives Help Ease Rheumatoid Arthritis?
Category: Health News
Created: 8/28/2015 12:00:00 AM
Last Editorial Review: 8/28/2015 12:00:00 AM

UNMC study: knee replacement viable option for rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2015.08.06]
Kaleb Michaud, Ph.D., has for a long time listened to patients with rheumatoid arthritis (RA) talking about improved quality of life after their total joint replacements.

Rheumatoid Arthritis: Test Your Arthritis IQ
Source: MedicineNet Arthritis Specialty [2015.08.06]
Title: Rheumatoid Arthritis: Test Your Arthritis IQ
Category: MedicineNet Quiz
Created: 1/31/2011 12:00:00 AM
Last Editorial Review: 8/6/2015 6:32:37 PM

Juvenile Idiopathic Arthritis (Juvenile Rheumatoid Arthritis)
Source: MedicineNet Anemia Specialty [2015.08.04]
Title: Juvenile Idiopathic Arthritis (Juvenile Rheumatoid Arthritis)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/4/2015 12:00:00 AM

Knee Replacement May Ease Pain for Rheumatoid Arthritis Patients
Source: MedicineNet Osteoarthritis Specialty [2015.07.31]
Title: Knee Replacement May Ease Pain for Rheumatoid Arthritis Patients
Category: Health News
Created: 7/30/2015 12:00:00 AM
Last Editorial Review: 7/31/2015 12:00:00 AM

more news >>

Published Studies Related to Arava (Leflunomide)

Leflunomide or methotrexate? Comparison of clinical efficacy and safety in low socio-economic rheumatoid arthritis patients. [2011]
In order to compare the efficacy and toxicity of methotrexate and leflunomide for the treatment of rheumatoid arthritis, a double-blind randomized clinical trial was carried out at the Department of Medicine, Jinnah Medical College Hospital, Korangi, Karachi... It was concluded that methotrexate, which is a much cheaper drug than leflunomide, is the drug of choice, especially for patients who belong to low socioeconomic groups.

The effect of leflunomide on cycling and activation of T-cells in HIV-1-infected participants. [2010.08.03]
CONCLUSIONS: Leflunomide was effective in reducing immune activation in the setting of chronic HIV-1 infection suggesting that targeting immune activation with immunomodulatory agents may be a feasible strategy. TRIAL REGISTRATION: ClinicalTrials.gov NCT00101374.

Comparison of the therapeutic effects of leflunomide and mycophenolate mofetil in the treatment of immunoglobulin A nephropathy manifesting with nephrotic syndrome. [2010.08]
OBJECTIVE: To evaluate the therapeutic effects and safety of a combination therapy of leflunomide (LEF) and prednisone for the treatment of immunoglobulin A (IgA) nephropathy manifesting with nephrotic syndrome... CONCLUSION: LEF is a safe and effective drug for the treatment of IgA nephropathy manifesting with nephrotic syndrome.

Comparison of combination therapies in the treatment of rheumatoid arthritis: leflunomide-anti-TNF-alpha versus methotrexate-anti-TNF-alpha. [2010.05]
To compare the efficacy and safety of leflunomide (LEF)-anti-TNF-alpha combination therapy to methotrexate (MTX)-anti-TNF-alpha combination therapy in a group of patients with active rheumatoid arthritis (RA). We have recruited 120 patients with RA with a high disease activity despite being treated with MTX (15 mg/week) or LEF (20 mg/die) for 3 months, without side effects...

Pharmacokinetics and the antiplatelet effect of a new clopidogrel formulation, clopidogrel besylate, in healthy subjects. [2010.04]
CONCLUSION: Both clopidogrel formulations were well-tolerated. The study population showed no serious AEs. The test formulation proved pharmacokinetically non-inferior to the reference formulation. The test formulation showed an antiplatelet effect on ADP-induced platelet aggregation similar to the reference formulation. The two formulations were considered pharmacodynamically equivalent in terms of platelet aggregation inhibition.

more studies >>

Clinical Trials Related to Arava (Leflunomide)

Bioavailability Study of Leflunomide Tablets Under Fed Conditions [Completed]

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis [Completed]
The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.

Bioavailability Study of Leflunomide Tablets Under Fasting Conditions [Completed]

Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis [Recruiting]
A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of refractory juvenile idiopathic arthritis. Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos will be added to conventional treatment for three months. therapeutic responses will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.

Leflunomide 20 mg Tablets, Non-Fasting [Completed]
The objective of this study is to compare the relative bioavailability of leflunomide 20 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of ARAVA 20 mg tablets (Aventis) in healthy, adult, non-smoking subjects [females (who are unable to become pregnant) and vasectomized males] under non-fasting conditions.

more trials >>

Reports of Suspected Arava (Leflunomide) Side Effects

Maternal Exposure During Pregnancy (89)Diarrhoea (28)Asthenia (27)Weight Decreased (25)Nausea (24)Pyrexia (20)Anaemia (19)Abdominal Pain (17)Vomiting (16)Pancytopenia (15)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Arava has an overall score of 6. The effectiveness score is 7.33 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst.
 

Arava review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   rheumatoid arthritis
Dosage & duration:   20mg taken once daily for the period of over 2 years
Other conditions:   sjogren's syndrome, hashimoto's thyroiditis
Other drugs taken:   armour thyroid, orencia
  
Reported Results
Benefits:   I added this medication 8 months after I began monthly infusions of Orencia. Orencia alone gave mild improvement in symptoms of severe rheumatoid arthritis. (I had extensive and severe joint pain and inflammation, severe edema in legs due to knee inflammation, and had very limited mobility.) Within 6-8 weeks of beginning Leflunomide (and still continuing Orencia), symptoms began to decrease significantly, and my lab values improved dramatically. As I write this I have very little pain and inflammation, and much more mobility than before - even considering the joint damage I've sustained. Recently, I tried reducing my dose of Leflunomide to 10 mg/day. After 4-6 weeks or so, I began to have more symptoms. When I resumed the 20mg/day dose, symptoms decreased dramatically again - in about 6-8 weeks.
Side effects:   I have some GI distress, but am not sure if it's directly due to Leflunomide or to a long history of taking RA medications which also negative have GI effects. I had a very serious eye infection last year which resulted in corneal scarring and loss of much vision in one eye. It's very possible that my immune-suppressed condition (Leflunomide and Orencia)resulted in a more serious infection and slower healing time than if I were not on immunosuppressants.
Comments:   One pill a day with dinner!

 

Arava review by 66 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   RA and Ankylizing Spondolitis
Dosage & duration:   20 mg taken once daily for the period of 6 weeks
Other conditions:   crohn's
Other drugs taken:   diclofinac
  
Reported Results
Benefits:   diclofinac has helped with the pain and swelling of joints.Lefluonomide, for me, had no noticible benefits.
Side effects:   Nausea, weakness leg and feet cranps shortness of breath rapid heart rate. After a short time I discontinued the medicine, symptoms held on for three more days, Still not feeling well but there has been mild improvement
Comments:   see side effects

 

Arava review by 66 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   RA and Ankylizing Spondolitis
Dosage & duration:   20 mg taken once daily for the period of 6 weeks
Other conditions:   crohn's
Other drugs taken:   diclofinac
  
Reported Results
Benefits:   diclofinac has helped with the pain and swelling of joints.Lefluonomide, for me, had no noticible benefits.
Side effects:   Nausea, weakness leg and feet cranps shortness of breath rapid heart rate. After a short time I discontinued the medicine, symptoms held on for three more days, Still not feeling well but there has been mild improvement
Comments:   see side effects

See all Arava reviews / ratings >>

Page last updated: 2015-08-28

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