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ACCEL-LEFLUNOMIDE is a brand name for Leflunomide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ACCEL-LEFLUNOMIDE (leflunomide) should be used only by physicians who have fully familiarized themselves with the efficacy and safety profile of ACCEL-LEFLUNOMIDE and who are experienced in the therapy of rheumatoid diseases. ACCEL-LEFLUNOMIDE is indicated in adults for the treatment of active rheumatoid arthritis.…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Loading Dose Due to the long half-life in patients with rheumatoid arthritis and recommended dosing interval (24 hr), a loading dose is needed to yield steady-state concentrations more rapidly.
It is recommended that ACCEL-LEFLUNOMIDE therapy be initiated with a loading dose of 100 mg per day for 3 days. Maintenance Therapy Daily dosing of 20 mg is recommended for treatment of patients with rheumatoid arthritis. A small cohort of patients (n=104) treated with 25 mg/day experienced a greater incidence of side effects: alopecia, weight loss, liver enzyme elevations.
Doses higher than 20 mg/day are not recommended. If dosing at 20 mg/day is not well tolerated clinically, the dose may be decreased to 10 mg daily. Due to the prolonged half-life of the active metabolite of ACCEL- LEFLUNOMIDE, patients should be carefully observed after dose reduction since it may take several weeks for metabolite levels to decline (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests section).
ACCEL-LEFLUNOMIDE (Leflunomide tablets) Page 6 of 76 A treatment effect may be evident after 4 weeks and may further improve up to 4 to 6 months after start of treatment. Geriatrics (≥ 65 years) No dosage adjustment is needed in patients over 65 years of age.
Pediatrics (< 18 years) The use in patients less than 18 years of age is contraindicated. Dose Modification for Patients with Renal Impairment Because the kidney plays a role in the elimination of ACCEL-LEFLUNOMIDE, and without sufficient studies of the use of ACCEL-LEFLUNOMIDE in patients with renal insufficiency, caution should be used when considering the administration of ACCEL-LEFLUNOMIDE to patients with mild renal insufficiency (see 2 CONTRAINDICATIONS section).
4 Administration ACCEL-LEFLUNOMIDE tablets should be swallowed whole, with sufficient liquid. ACCEL- LEFLUNOMIDE can be taken with or without food, without regard to meals, at the same time everyday. 5 Missed Dose If the patient forgot to take a tablet of ACCEL-LEFLUNOMIDE they should be advised to take it as soon as they remember, unless it is nearly time for their next dose.
The patient should be advised not to double-up on the next dose to make up for the missed dose.
section). The most frequent adverse events observed were diarrhea, abdominal pain, leucopenia, anemia and elevated liver function tests. In the event of relevant overdose or toxicity, cholestyramine or activated charcoal administration is recommended.
Cholestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40% in 24 hours and by 49- 65% in 48 hours (see 7 WARNINGS AND PRECAUTIONS, General, Washout Procedures section).
Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite, A771726, by 37% in 24 hours and by 48% in 48 hours.
ACCEL-LEFLUNOMIDE (Leflunomide tablets) Page 7 of 76 These washout procedures may be repeated if clinically necessary. Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialyzable.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients oral film-coated tablets 10, 20 mg Cellulose microcrystalline, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, povidone, pregelatinized starch, silica colloidal anhydrous, talc, titanium dioxide ACCEL-LEFLUNOMIDE is available for oral administration as film-coated tablets containing 10 mg or 20 mg of leflunomide.
1 mm. 1 mm. ACCEL-LEFLUNOMIDE tablets in 10 mg and 20 mg strengths are packaged in HDPE bottles in counts of 30 and 100 tablets. 7 WARNINGS AND PRECAUTIONS General The active metabolite of ACCEL-LEFLUNOMIDE, A771726, has a long half-life.
09/2023 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics ..................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................
4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
6 5 OVERDOSAGE............................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 7 7 WARNINGS AND PRECAUTIONS .................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
ACCEL-LEFLUNOMIDE is contraindicated in: 1. Patients with known hypersensitivity to ACCEL-LEFLUNOMIDE (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme), to teriflunomide or to any of ACCEL-LEFLUNOMIDE excipients.
2. , AIDS) (see 7 WARNINGS AND PRECAUTIONS, Immune section). ii) Patients with impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid arthritis. iii) Patients with serious infections.
3. Patients with moderate to severe renal insufficiency because the kidney plays a role in the elimination of ACCEL-LEFLUNOMIDE. 4. , Disease Modifying Antirheumatic Drugs [DMARDs] such as methotrexate) given the possible risk of increased hepatotoxicity and the role of the liver in activation, elimination and recycling of ACCEL-LEFLUNOMIDE (see 9 DRUG INTERACTIONS section).
While the mechanism of action of ACCEL-LEFLUNOMIDE and methotrexate are different, their pharmacodynamic action of interfering with cell division is similar. Concomitant treatment with methotrexate and/or other liver and bone marrow toxic medications is associated with an ACCEL-LEFLUNOMIDE (Leflunomide tablets) Page 5 of 76 increased risk of serious hepatic or marrow reactions and requires strict vigilance in monitoring (see 7 WARNINGS AND PRECAUTIONS General, Monitoring and Laboratory Tests section).
If a switch in treatment from ACCEL-LEFLUNOMIDE to another hepatotoxic DMARD is required the washout and monitoring must be adhered to as mentioned in the 7 WARNINGS AND PRECAUTIONS , Monitoring and Laboratory Tests and General, Washout Procedures section.
, in nephrotic syndrome). Since the active metabolite of ACCEL-LEFLUNOMIDE, A771726, is highly protein-bound and cleared via hepatic metabolism and biliary secretion. 02 mg/L). Pregnancy must be excluded before start of treatment with ACCEL-LEFLUNOMIDE (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women section).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. hepatotoxicity, hematotoxicity or allergic reactions, see below), even if the treatment with ACCEL-LEFLUNOMIDE has been stopped. For the management of the above - mentioned toxicities a washout procedure should be performed. If a severe adverse reaction to ACCEL-LEFLUNOMIDE occurs, or if for any other reason A771726 needs to be cleared rapidly from the body, cholestyramine or activated charcoal has to be initiated and continued/repeated as clinically necessary (see 5 OVERDOSAGE section).
For suspected severe immunologic/allergic reactions, more prolonged cholestyramine or ACCEL-LEFLUNOMIDE (Leflunomide tablets) Page 8 of 76 activated charcoal administration may be necessary to achieve rapid and sufficient clearance (see below the Washout Procedures).
g. methotrexate) after treatment with ACCEL- LEFLUNOMIDE a washout procedure should be performed since there exist a possibility of additive risks of adverse events for a long time after the switching (see below the Washout Procedures and see also the 2 CONTRAINDICATIONS and
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
17 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................
3 Less Common Clinical Trial Adverse Reactions ...................................................... 5 Post-Market Adverse Reactions............................................................................. 22 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interactions Overview ................................................................................... 4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions ..........................................................................................
6 Drug-Herb Interactions .......................................................................................... 7 Drug-Laboratory Test Interactions......................................................................... 32 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ....................................................................................... 3 Pharmacokinetics ............................................................................................. 33 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
35 PART II: SCIENTIFIC INFORMATION ..................................................................................... 36 13 PHARMACEUTICAL INFORMATION .......................................................................... 36 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .............................................................................. 2 Comparative Bioavailability Studies ................................................................ 46 15 MICROBIOLOGY ......................................................................................................
46 16 NON-CLINICAL TOXICOLOGY .................................................................................... 47 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 66 PATIENT MEDICATION INFORMATION ................................................................................
67 ACCEL-LEFLUNOMIDE (Leflunomide tablets) Page 4 of 76 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ACCEL-LEFLUNOMIDE (leflunomide) should be used only by physicians who have fully familiarized themselves with the efficacy and safety profile of ACCEL-LEFLUNOMIDE and who are experienced in the therapy of rheumatoid diseases.
ACCEL-LEFLUNOMIDE is indicated in adults for the treatment of active rheumatoid arthritis. 1 Pediatrics The use in patients less than 18 years of age is contraindicated. 2 Geriatrics No dosage adjustment is needed in patients over 65 years of age.
There are no overall differences in effectiveness and safety between elderly and younger patients. 2 CONTRAINDICATIONS ACCEL-LEFLUNOMIDE is contraindicated in: 1. Patients with known hypersensitivity to ACCEL-LEFLUNOMIDE (especially previous Stevens-Johnson syndrome, toxic […]
7) Women who are breast feeding (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Breast-feeding section). 8) Patients less than 18 years of age. Male patients should be aware of the possible male-mediated foetal toxicity. Reliable contraception during treatment with ACCEL-LEFLUNOMIDE should also be guaranteed (see 7 WARNINGS AND PRECAUTIONS, Sexual Function/Reproduction and Special Populations, Pregnant Women section).