سعر اوباجيو 14مجم 28 قرص 2026

Aubagio 14 mg tablets, pack of 28 (Sanofi, Egypt): teriflunomide 14 mg, an oral immunomodulatory pyrimidine-synthesis (dihydroorotate dehydrogenase) inhibitor used for relapsing multiple sclerosis.

• Relapsing-remitting multiple sclerosisPopulation: Adults and paediatric patients aged 10 years and olderEuropean Medicines Agency (EMA)
• Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, active secondary progressive disease)Population: AdultsDailyMed (US National Library of Medicine)

• Most frequent (7 mg / 14 mg): headache, diarrhoea, increased ALT, nausea and alopecia (alopecia 9.8% at 7 mg and 13.5% at 14 mg; generally mild). Common: influenza, upper respiratory and urinary tract infections, herpes infections, neutropenia, anaemia, paraesthesia, hypertension, abdominal pain, vomiting, rash, acne, musculoskeletal pain, menorrhagia. Uncommon/rare/post-marketing: severe infections including sepsis, hypersensitivity (including anaphylaxis), peripheral neuropathy, interstitial lung disease, pancreatitis, severe skin reactions, drug-induced liver injury, pulmonary hypertension.International label, same product · European Medicines Agency (EMA)
• Most common adverse reactions in placebo-controlled trials (>=10% and >=2% above placebo): headache, increased ALT, diarrhea, alopecia and nausea.International label, same product · DailyMed (US National Library of Medicine)

• Hypersensitivity to teriflunomide or excipients; severe hepatic impairment (Child-Pugh C); pregnancy, or women of childbearing potential not using reliable contraception; breast-feeding; severe immunodeficiency (e.g. AIDS); significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia; severe active infection until resolution; severe renal impairment on dialysis; severe hypoproteinaemia (e.g. nephrotic syndrome).International label, same product · European Medicines Agency (EMA)
• Severe hepatic impairment; pregnant women and females of reproductive potential not using effective contraception; history of hypersensitivity to teriflunomide, leflunomide or inactive ingredients (anaphylaxis, angioedema, serious skin reactions); coadministration with leflunomide.International label, same product · DailyMed (US National Library of Medicine)

• Boxed warning - hepatotoxicity: clinically significant, potentially life-threatening liver injury including acute liver failure requiring transplant has been reported; risk higher with other hepatotoxic drugs; if drug-induced liver injury is suspected, stop and start accelerated elimination. Embryofetal toxicity: contraindicated in pregnancy; exclude pregnancy and ensure effective contraception.International label, same product · DailyMed (US National Library of Medicine)
• Hepatic effects: liver enzyme elevations (mostly within the first 6 months) and cases of drug-induced liver injury, sometimes life-threatening; risk may be higher with pre-existing liver disease, other hepatotoxic drugs or substantial alcohol use. Discontinue if liver injury is suspected or ALT >3x ULN is confirmed and consider accelerated elimination.International label, same product · European Medicines Agency (EMA)
• Slow elimination: without an accelerated elimination procedure it takes on average 8 months (up to 2 years) to reach plasma concentrations below 0.02 mg/l; accelerated elimination uses cholestyramine 8 g (or 4 g) three times daily or activated charcoal 50 g every 12 hours for 11 days.International label, same product · European Medicines Agency (EMA)

• Rifampicin and other potent CYP/transporter inducers (carbamazepine, phenobarbital, phenytoin, St John's Wort)Rifampicin reduced teriflunomide exposure by about 40%; use potent inducers with caution.European Medicines Agency (EMA)
• Cholestyramine or activated charcoalCause a rapid, significant fall in teriflunomide plasma levels; avoid unless accelerated elimination is intended.European Medicines Agency (EMA)
• CYP2C8 substrates (repaglinide, paclitaxel, pioglitazone, rosiglitazone)Teriflunomide inhibits CYP2C8 (repaglinide Cmax/AUC increased 1.7- and 2.4-fold); use with caution.European Medicines Agency (EMA)

• Contraindicated in pregnancy and in women of childbearing potential not using reliable contraception during treatment and afterwards while plasma levels exceed 0.02 mg/l; pregnancy must be excluded before starting. Human data are limited; animal studies showed reproductive toxicity and teriflunomide may cause serious birth defects.International label, same product · European Medicines Agency (EMA)
• Contraindicated in pregnant women and females of reproductive potential not using effective contraception; in rats and rabbits teriflunomide caused teratogenicity and embryolethality at exposures lower than those at the MRHD. Limited human data do not clearly indicate increased birth defects or miscarriage after inadvertent early first-trimester exposure followed by accelerated elimination; a pregnancy surveillance programme exists.International label, same product · DailyMed (US National Library of Medicine)
• Contraindicated during breast-feeding (excretion in animal milk).International label, same product · European Medicines Agency (EMA)

• Teriflunomide: Selectively and reversibly inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, reducing proliferation of rapidly dividing cells that depend on de novo pyrimidine synthesis; the therapeutic effect in MS is thought to be mediated by a reduced number of (activated) lymphocytes (EU SmPC; US label).