Generic Name: Order arava
What is Order Arava?
Monitor CBCs during treatment with ARAVA. New onset or worsening symptoms may necessitate discontinuation of Arava and initiation of accelerated elimination procedure.
They must also use reliable forms of birth control before starting leflunomide, while taking it, and after stopping it until they have finished taking another drug that helps leflunomide leave the body and confirmed through 2 blood tests that the leflunomide levels are very low see How to Use section. If you become pregnant or think you may be pregnant, inform your doctor right away see Precautions section. This drug may rarely cause serious possibly fatal liver disease. Most cases occur within 6 months of taking this drug.
If you already have liver disease such as hepatitis B or Cleflunomide should not be used. Liver function blood tests must be performed periodically while taking leflunomide. Take this medication by mouth with or without food, usually once daily or as directed by your doctor.
Monitoring of ALT levels is recommended at least monthly for six months after starting ARAVA, and thereafter every 6-8 weeks. 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. The 11 days do not need to be consecutive unless there is a need to lower the plasma level rapidly.
Verify plasma levels less than 0. If plasma levels are higher than 0. Additional safety information ARAVA is contraindicated in patients with known hypersensitivity to leflunomide, teriflunomide, or any of the other components of ARAVA. Severe infections including sepsis, which may be fatal, have been reported.
This site is intended for use by U. ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www. Teratogenicity and embryo-lethality occurred in animals administered leflunomide at doses lower than the human exposure level. Exclude pregnancy before the start of treatment with ARAVA in females of reproductive potential.
Advise females of reproductive potential to use effective contraception during ARAVA treatment and during an accelerated drug elimination procedure after ARAVA treatment. Stop ARAVA and use an accelerated drug elimination procedure if the patient becomes pregnant.
How should I take Order Arava?
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic medicinal products or when leflunomide treatment is followed by such medicinal products without a washout period see also guidance concerning combination with other treatments, section 4. Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.
All elevations resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide. A more than 3-fold increase was seen in another 5 patients.
What should I avoid while taking Order Arava?
No apparent increase in the incidence of malignancies and lymphoproliferative disorders was reported in the clinical trials of ARAVA, but larger dosages and longer-term studies would be needed to determine whether there is an increased risk of malignancy or lymphoproliferative disorders with ARAVA.
Cases of peripheral neuropathy have been reported in patients receiving ARAVA and in clinical studies with teriflunomide, the active metabolite of leflunomide. Most patients recovered after discontinuation of treatment, but some patients had persistent symptoms. Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy. The risk of ARAVA-associated interstitial lung disease is increased in patients with a history of interstitial lung disease.
Interstitial lung disease is a potentially fatal disorder that may occur acutely at any time during therapy and has a variable clinical presentation. The long half-life of the active metabolite of ARAVA should be considered when contemplating administration of a live vaccine after stopping ARAVA. In placebo-controlled studies with the active metabolite of ARAVA, teriflunomide, elevations in blood pressure were observed in some subjects.
Order Arava side effects
Do not be alarmed by this list of possible side effects. You may not experience any of them. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Arava. It helps most people with arthritis, but it may have unwanted side effects in a few people.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:These may be serious side effects of Arava. Serious side effects are uncommon. If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:These are very serious side effects. Do not leave it in the car on hot days or on window sills.
Common Order Arava ide effects may include:
The procedure may be repeated as needed, based on teriflunomide concentrations and clinical status.
The safety of ARAVA was studied in 74 patients with polyarticular course JIA ranging in age from 3-17 years 47 patients from the active-controlled study and 27 from an open-label safety and pharmacokinetic study.
Hoechst Marion RousselEndocrinologyRheumatologyFamily MedicineRheumatoid ArthritisArava is indicated in adults for the treatment of active rheumatoid arthritis RA to reduce signs and symptoms and to retard structural damage as evidenced by X-ray erosions and joint space narrowing.
Other information about AravaThe European Commission granted a marketing authorisation valid throughout the European Union for Arava to Sanofi-Aventis Deutschland GmbH on 2 September 1999.
Instruct patients to immediately contact their health care professional if signs and symptoms of liver disease develop e. When methotrexate is given concomitantly, follow the American College of Rheumatology ACR guidelines for monitoring methotrexate liver toxicity i. Counsel patients about the reproductive risk and contraception requirements during leflunomide treatment.
Where can I get more information?
Leflunomide was also similar to sulfasalazine in RA disease control.
In wild-type mice that received leflunomide, the anti-inflammatory reaction was accompanied by a more powerful suppression of osteoclast formation.