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Arava (Leflunomide) - Summary

 
 



CONTRAINDICATIONS AND WARNINGS

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.

 

ARAVA SUMMARY

ARAVA® (leflunomide) is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4'-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide.

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)

Deactivating a cell protein may halt progress of rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.11]
Activation of the cell receptor TLR5 is all it takes to trigger inflammation and bone erosion in rheumatoid arthritis, and targeting it with drugs could stop it, says new study.

RoActemra (tocilizumab) receives EU approval for use in patients with early rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.11]
Roche has announced that RoActemra® (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA who previously have not been...

Smokers with a high sodium diet are at 'double the risk' of rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.11]
A new study finds that although having a diet high in sodium itself may not increase risk for rheumatoid arthritis, in people who smoke, this combination causes the risk to double.

Many Rheumatoid Arthritis Patients May Skip Meds: Study
Source: MedicineNet Rheumatoid Arthritis Specialty [2014.09.04]
Title: Many Rheumatoid Arthritis Patients May Skip Meds: Study
Category: Health News
Created: 9/3/2014 5:35:00 PM
Last Editorial Review: 9/4/2014 12:00:00 AM

Rheumatoid Arthritis: Test Your Arthritis IQ
Source: MedicineNet Arthritis Specialty [2014.09.03]
Title: Rheumatoid Arthritis: Test Your Arthritis IQ
Category: MedicineNet Quiz
Created: 1/31/2011 5:38:00 PM
Last Editorial Review: 9/3/2014 12:49:27 PM

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)

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis [Active, not recruiting]
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 Fed Conditions [Completed]

Bioavailability Study of Leflunomide Tablets Under Fasting Conditions [Completed]

Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma [Recruiting]
This research study is a Phase I/II clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug combination to use for the Phase II portion of the study, which will enroll more participants and continue to study the effects of the drug and the safest dose. "Investigational" means that the combination of vemurafenib and leflunomide is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this drug combination for your type of cancer.

Genes are a specific part of your cell materials which send code messages to determine what the investigators bodies look like, such as eye color, and instruct cells to control growth and development of the body. Researchers have found that a large number of melanoma cells have mutations in the BRAF gene. Normally, the BRAF gene helps to control how cells grow. Mutations in the BRAF gene may disrupt this control and allow cells in the skin to change into cancer cells, in which case, the cells keep dividing and growing out of control. Specifically, it has been shown that vemurafenib blocks the effects of these mutations in the BRAF gene, and, as a result, may help to prevent cancer growth. The FDA has approved vemurafenib for use in patients with BRAF mutation positive melanoma that is unable to be removed by surgery (unresectable) or that has spread (metastatic).

Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs). It is FDA approved for the treatment of rheumatoid arthritis and it is believed to decrease inflammation in that setting. However it is not approved for treatment of melanoma. The researchers of this study believe this agent may help prevent cancer growth as well as enhance the properties of drugs that target the BRAF gene (such as vemurafenib) based on recently published laboratory research, and would like to learn more about any effects this combination may have on your disease.

The main purposes of this study are to determine the highest dose of vemurafenib and leflunomide that can be given in combination without causing severe side effects, to see whether the combination of vemurafenib and leflunomide is safe in participants with BRAF mutant metastatic melanoma and to learn if the combination of vemurafenib and leflunomide shows any signs of effectively treating your disease.

A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients [Recruiting]
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

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: 2014-09-11

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