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.
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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):
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to reduce signs and symptoms
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to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
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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
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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).
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NEWS HIGHLIGHTSMedia Articles Related to Arava (Leflunomide)
Women Who Smoke May Have Higher Risk for Rheumatoid Arthritis
Source: MedicineNet Rheumatoid Arthritis Specialty [2013.04.29]
Title: Women Who Smoke May Have Higher Risk for Rheumatoid Arthritis
Category: Health News
Created: 4/26/2013 12:35:00 PM
Last Editorial Review: 4/29/2013 12:00:00 AM
Risk For Rheumatoid Arthritis Increased By Smoking
Source: Arthritis / Rheumatology News From Medical News Today [2013.04.23]
Number of cigarettes smoked a day and the number of years a person has smoked both increase the risk of rheumatoid arthritis (RA), finds research in BioMed Central's open access journal Arthritis Research & Therapy. The risk decreases after giving up smoking but, compared to people who have never smoked, this risk is still elevated 15 years after giving up...
Smoking More Than Doubles The Risk Of Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2013.04.22]
Smoking just a few cigarettes each day can more than double a woman's risk of rheumatoid arthritis (RA), according to a new study. The research was conducted by scientists from the Karolinska Institutet and Karolinska University Hospital and was published in the journal Arthritis Research & Therapy...
Medications Used To Treat Rheumatoid Arthritis May Affect Abortion Rate In Women
Source: Abortion News From Medical News Today [2013.04.16]
A new study published in the American College of Rheumatology (ACR) journal, Arthritis Care & Research, reveals that women with rheumatoid arthritis (RA) who were on methotrexate (MTX), a drug commonly used to reduce inflammation caused by RA, had lower rates of induced abortions compared to women with RA who were not exposed to the medication...
Rheumatoid Arthritis
Source: MedicineNet Amyloidosis Specialty [2013.04.16]
Title: Rheumatoid Arthritis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/16/2013 12:00:00 AM
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.
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.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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! |
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| | 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 |
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| | 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 |
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Page last updated: 2013-04-29
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