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Teriflunomide Accord is a brand name for Teriflunomide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Verbatim from this product's EMA label. Tap a section to expand.
The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis. Posology Adults In adults, the recommended dose of teriflunomide is 14 mg once daily. 3 Paediatric population (10 years and older) In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight: - Paediatric patients with body weight >40 kg: 14 mg once daily.
- Paediatric patients with body weight ≤40 kg: 7 mg once daily. Paediatric patients who reach a stable body weight above 40 kg should be switched to 14 mg once daily. Special populations Elderly population Teriflunomide Accord should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy.
Renal impairment No dose adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis. Patients with severe renal impairment undergoing dialysis were not evaluated. 3). Hepatic impairment No dose adjustment is necessary for patients with mild and moderate hepatic impairment.
3). Paediatric population (less than 10 years of age) The safety and efficacy of teriflunomide in children aged below 10 years have not been established. No data are available. Method of administration The film-coated tablets are for oral use.
The tablets should be swallowed whole with some water. Film-coated tablets can be taken with or without food.
5%). In general, headache, diarrhoea, nausea and alopecia, were mild to moderate, transient and infrequently led to treatment discontinuation. Teriflunomide is the main metabolite of leflunomide. The safety profile of leflunomide in patients suffering from rheumatoid arthritis or psoriatic arthritis may be pertinent when prescribing teriflunomide in MS patients.
Tabulated list of adverse reactions Teriflunomide was evaluated in a total of 2,267 patients exposed to teriflunomide (1,155 on teriflunomide 7 mg and 1,112 on teriflunomide 14 mg) once daily for a median duration of about 672 days in four placebo-controlled studies (1,045 and 1,002 patients for teriflunomide 7 mg and 14 mg, respectively) and one active comparator study (110 patients in each of the teriflunomide treatment groups) in adult patients with relapsing forms of MS (Relapsing Multiple Sclerosis, RMS).
Listed below are the adverse reactions reported with teriflunomide in placebo-controlled studies in adult patients, reported for teriflunomide 7 mg or 14 mg from clinical studies in adult patients. Frequencies were defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness. 1% in patients treated with placebo. 1%) patients treated with teriflunomide 14 mg. 1% in the placebo group. 3%) Mild increases in transaminase, ALT below or equal to 3-fold ULN were more frequently seen in teriflunomide-treated groups as compared to placebo.
The frequency of elevations above 3-fold ULN and higher was balanced across treatment groups. These elevations in transaminase occurred mostly within the first 6 months of treatment and were reversible after treatment cessation. The recovery time varied between months and years.
Monitoring Before treatment Before starting treatment with teriflunomide the following should be assessed: • Blood pressure • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) • Complete blood cell count including differential white blood cell and platelet count.
During treatment During treatment with teriflunomide the following should be monitored: • Blood pressure o Check periodically • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) o Liver enzymes should be assessed at least every four weeks during the first 6 months of treatment and regularly thereafter.
o Consider additional monitoring when teriflunomide is given in patients with pre-existing liver disorders, given with other potentially hepatotoxic drugs or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and at least every 8 weeks thereafter for at least 2 years from initiation of treatment o For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
g. infections) during treatment. Accelerated elimination procedure Teriflunomide is eliminated slowly from the plasma. 02 mg/l, although due to individual variation in substance clearance it may take up to 2 years. 2 for procedural details).
8). These elevations occurred mostly within the first 6 months of treatment. Cases of drug-induced liver injury (DILI) have been observed during treatment with teriflunomide, sometimes life-threatening. Most cases of DILI occurred with time to onset of several weeks or several months after treatment initiation of teriflunomide, but DILI can also occur with prolonged use.
The risk for liver enzyme increases and DILI with teriflunomide might be higher in patients with pre-existing liver disorder, concomitant treatment with other hepatotoxic drugs, and/or consumption of substantial quantities of alcohol.
1. Patients with severe hepatic impairment (Child-Pugh class C). 6). 6). 6). g. acquired immunodeficiency syndrome (AIDS). Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia.
4). Patients with severe renal impairment undergoing dialysis, because insufficient clinical experience is available in this patient group. g. in nephrotic syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6% receiving placebo. 7%) as compared to […]
Patients should therefore be closely monitored for signs and symptoms of liver injury. Teriflunomide therapy should be discontinued and accelerated elimination procedure considered if liver injury is suspected. If elevated liver enzymes (greater than 3-fold ULN) are confirmed, teriflunomide therapy should be discontinued.
5 In case of treatment discontinuation, liver tests should be pursued until normalisation of transaminase levels. g. in nephrotic syndrome. Teriflunomide should not be used in patients with conditions of severe hypoproteinaemia. 8). Blood pressure must be checked before the start of teriflunomide treatment and periodically thereafter.
Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide. Infections Initiation of treatment with teriflunomide should be delayed in patients with severe active infection until resolution.
8). 8), with some of them being serious, including herpetic meningoencephalitis and herpes dissemination. They may occur at any time during treatment. Based on the immunomodulatory effect of teriflunomide, if a patient develops any serious infection, suspending treatment with teriflunomide should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Due to the prolonged half-life, accelerated elimination with cholestyramine or charcoal may be considered. Patients receiving teriflunomide should be instructed to report symptoms of infections to a physician. Patients with active acute or chronic infections should not start treatment with teriflunomide until the infection(s) is resolved.
The safety of teriflunomide in individuals with latent tuberculosis infection is unknown, as tuberculosis screening was not systematically performed in clinical studies. Patients tested positive in tuberculosis screening should be treated by standard medical practice prior to therapy.
Respiratory reactions Interstitial lung disease (ILD) as well as cases of pulmonary hypertension have been reported with teriflunomide in the postmarketing setting. The risk might be increased in patients with a history of ILD. ILD may occur acutely at any time during therapy with a variable clinical presentation.
ILD may be fatal. New onset or worsening pulmonary symptoms, such as persistent cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate. If discontinuation of the medicinal product is necessary, initiation of an accelerated elimination procedure should be considered.
8). As a precaution, a recent complete blood cell count, including differential white blood cell count and platelets, should be available before the initiation of treatment and the complete blood cell count […]