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Leflunomide (Arava)

Trade Name : Arava

sanofi-aventis U.S. LLC

TABLET, FILM COATED

Strength 10 mg/1

LEFLUNOMIDE Antirheumatic Agent [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Leflunomide (Arava) which is also known as Arava and Manufactured by sanofi-aventis U.S. LLC. It is available in strength of 10 mg/1 per ml. Read more

Leflunomide (Arava) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: EMBRYO-FETAL TOXICITY and HEPATOTOXICITY
  • See full prescribing information for complete boxed warning.
  • Embryo-Fetal Toxicity
  • Hepatotoxicity
  • ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA).
  • ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ()
  • No data
  • Loading dosage for patients at low risk for ARAVA-associated hepatotoxicity and ARAVA-associated myelosuppression: 100 mg daily for 3 days. ()
  • Maintenance dosage: 20 mg daily. ()n
  • Screen patients for active and latent tuberculosis, pregnancy test (females), blood pressure, and laboratory tests before starting ARAVA. ()
  • ARAVA Tablets are available in three strengths:
  • Tablets: 10 mg, 20 mg, 100 mg. ()
  • ARAVA is contraindicated in:
  • Pregnancy. (, , )
  • Severe hepatic impairment. (, )
  • Hypersensitivity to ARAVA or any of its inactive components. ()
  • Current teriflunomide treatment. ()
  • No data
  • After stopping ARAVA, it is recommended that an accelerated drug elimination procedure be used to reduce the plasma concentrations of the active metabolite, teriflunomide. ()
  • Severe infections (including sepsis), pancytopenia, agranulocytosis and thrombocytopenia: Stop ARAVA and use accelerated elimination procedure. Do not start ARAVA in patients with active infection. Monitor CBCs during treatment with ARAVA. ()
  • Stevens-Johnson syndrome and toxic epidermal necrolysis: Stop ARAVA and use accelerated elimination procedure. ()
  • Peripheral neuropathy: If patient develops symptoms consistent with peripheral neuropathy, evaluate patient and consider discontinuing ARAVA. ()
  • Interstitial lung disease: May be fatal. New onset or worsening symptoms may necessitate discontinuation of Arava and initiation of accelerated elimination procedure. ()
  • Increased blood pressure: Monitor and treat. ()
  • The following serious adverse reactions are described elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • The most commonly reported adverse reactions (u226510%) regardless of relation to ARAVA treatment were diarrhea, respiratory infection, nausea, headache, rash, abnormal liver enzymes, dyspepsia. ()
  • Following oral administration, leflunomide is metabolized to an active metabolite, teriflunomide, which is responsible for essentially all of leflunomide's activity. Drug interaction studies have been conducted with both ARAVA (leflunomide) and with its active metabolite, teriflunomide, where the metabolite was directly administered to the test subjects.
  • Drugs metabolized by CYP2C8 and OAT3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ()
  • Teriflunomide may increase exposure of ethinylestradiol and levonorgestrel. Choose an appropriate oral contraceptive. ()
  • Drugs metabolized by CYP1A2: Monitor patients because teriflunomide may decrease exposure of these drugs. ()
  • Warfarin: Monitor INR as teriflunomide may decrease INR. ()
  • Drugs metabolized by BCRP and OATP1B1/B3 transporters: Monitor patients because teriflunomide may increase exposure of these drugs. ()
  • Rosuvastatin: The dose of rosuvastatin should not exceed 10 mg once daily in patients taking ARAVA. ()
  • No data
  • Lactation: Discontinue breastfeeding. ()
  • Safety and effectiveness in pediatric patients <12 years of age has not been established. ()
  • There have been reports of chronic overdose in patients taking ARAVA at daily dose up to five times the recommended daily dose and reports of acute overdose in adults and children. Adverse events were consistent with the safety profile for ARAVA [See ]. The most frequent adverse events observed were diarrhea, abdominal pain, leukopenia, anemia and elevated liver function tests.
  • In the event of a significant overdose or toxicity, perform an accelerated drug elimination procedure to accelerate elimination [see .
  • Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that teriflunomide, the primary metabolite of leflunomide, is not dialyzable [See ].
  • ARAVA (leflunomide) is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4u00b4-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula CHFNO, a molecular weight of 270.2 and the following structural formula:
  • ARAVA is available for oral administration as tablets containing 10, 20, or 100 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, talc, titanium dioxide, and yellow ferric oxide (20 mg tablet only).
  • No data
  • No evidence of carcinogenicity was observed in a 2-year bioassay in rats at oral doses of leflunomide up to the maximally tolerated dose of 6 mg/kg (approximately 1/40 the maximum human teriflunomide systemic exposure based on AUC). However, male mice in a 2-year bioassay exhibited an increased incidence in lymphoma at an oral dose of 15 mg/kg, the highest dose studied (1.7 times the human teriflunomide exposure based on AUC). Female mice, in the same study, exhibited a dose-related increased incidence of bronchoalveolar adenomas and carcinomas combined beginning at 1.5 mg/kg (approximately 1/10 the human teriflunomide exposure based on AUC). The significance of the findings in mice relative to the clinical use of ARAVA is not known.
  • Leflunomide was not mutagenic in the Ames assay, the unscheduled DNA synthesis assay, or in the HGPRT gene mutation assay. In addition, leflunomide was not clastogenic in the mouse micronucleus assay or in the Chinese hamster bone marrow cell cytogenic test. However, 4-trifluoromethylaniline (TFMA), a minor metabolite of leflunomide, was mutagenic in the Ames assay and in the HGPRT gene mutation assay, and was clastogenic in the Chinese hamster cell chromosomal aberration assay. TFMA was not clastogenic in the mouse micronucleus assay or in the Chinese hamster bone marrow cell cytogenic test.
  • Leflunomide had no effect on fertility or reproductive performance in either male or female rats at oral doses up to 4.0 mg/kg (approximately 1/30 the human teriflunomide exposure based on AUC) .
  • The efficacy of ARAVA in the treatment of rheumatoid arthritis (RA) was demonstrated in three controlled trials showing reduction in signs and symptoms, and inhibition of structural damage. In two placebo controlled trials, efficacy was demonstrated for improvement in physical function. In these trials, efficacy was evaluated by:
  • In all ARAVA trials, participants of at least 18 years of age and in ARA functional class of I, II or III received an initial loading dosage of 100 mg Leflunomide per day for three days, followed by 20 mg per day thereafter.
  • Exclusion criteria included patients with a history of hypersensitivity to the study medication; women who were pregnant or breastfeeding and men or women of child bearing age and potential who had not received contraceptives for at least 4 weeks before entering the study and to be maintained throughout the study and for at least 6 months after discontinuing treatment; Patients with a history of inflammatory disease, impaired renal function or liver impairment, cardiac failure, congenital or acquired immunodeficiency, impaired coagulation, or a history of recent major traumatic injury; patients taking intra-articular or systemic concomitant medications which could affect the safety and/or efficacy of the study medication.
  • How Supplied
  • ARAVA (leflunomide) Tablets
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15 to 30u00b0C (59 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from light.
  • No data
  • Release date: February 2016
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807u00a92016 sanofi-aventis U.S. LLC
  • NDC 0088-2160-30
  • Aravan Tablets
  • leflunomide
  • 10
  • OVERSIZED CONTAINERFOR EASE OF PATIENT USE
  • 30
  • sanofi aventis
  • NDC 0088-2161-30
  • Aravan Tablets
  • leflunomide
  • 20
  • OVERSIZED CONTAINERFOR EASE OF PATIENT USE
  • 30
  • sanofi aventis
  • 0088-2162-33Rx Only
  • Aravan Tablets
  • leflunomide
  • 100
  • Initiation-Dose KittPHYSICIAN SAMPLE - NOT TO BE SOLD
  • Remember:
  • Please see enclosed additional important information.
  • Contains three 100-mg tablets
  • sanofi aventis

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