Aubagio

Aubagio

Manufacturer:

Genzyme

Distributor:

DKSH
Concise Prescribing Info
Contents
Teriflunomide
Indications/Uses
Adult patients w/ relapsing remitting multiple sclerosis.
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow whole w/ water.
Contraindications
Hypersensitivity. Severe immunodeficiency states eg, AIDS; significant bone marrow function impairment or anaemia, leucopenia, neutropenia or thrombocytopenia; severe active infection & hypoproteinaemia eg, nephrotic syndrome. Severe renal & hepatic (Child-Pugh class C) impairment. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Discontinue use if liver injury is suspected; new onset or worsening pulmonary symptoms eg, persistent cough & dyspnoea, severe haematological reactions eg, pancytopenia; ulcerative stomatitis, skin &/or mucosal reactions occurs; peripheral neuropathy develops. Not to be used in severe hypoproteinaemia. Active acute or chronic infections, latent TB; history of interstitial lung disease; new onset or worsening of psoriasis. Delay initiation in patients w/ severe active infection until resolution. Substantial alcohol consumption. Monitor & assess BP, ALT/SGPT & complete blood count ie, differential WBC & platelet count prior to & during treatment. Assess hepatic enzymes prior to & every 2 wk during 1st 6 mth & every 8 wk thereafter. Determine total albumin adjusted serum Ca conc. Avoid use w/ live attenuated vaccines. Not recommended w/ leflunomide. Concomitant use w/ interferon β or glatiramer acetate. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Preexisting hepatic disease. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Childn 10 to <18 yr. Elderly ≥65 yr.
Adverse Reactions
Headache; diarrhoea, nausea; increased ALT; alopecia. Flu, upper resp tract infection, UTI, bronchitis, sinusitis, pharyngitis, cystitis, viral gastroenteritis, oral herpes, tooth infection, laryngitis, tinea pedis; neutropenia, anaemia; mild allergic reactions; anxiety; paraesthesia, sciatica, carpal tunnel syndrome; palpitations; HTN; upper abdominal pain, vomiting, toothache; increased γ-glutamyltransferase; rash, acne; musculoskeletal pain, myalgia, arthralgia; pollakiuria; menorrhagia; pain, asthenia; decreased wt, neutrophil & WBC counts, increased blood creatine phosphokinase.
Drug Interactions
Decreased exposure w/ rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort, P-gp & breast cancer resistant protein inducers. Rapid & significant decreased plasma conc w/ cholestyramine or activated charcoal. Increased mean Cmax & AUC of repaglinide, paclitaxel, pioglitazone, rosiglitazone, ethinylestradiol, levonorgestrel, cefaclor, benzylpenicillin, ciprofloxacin, indometacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, rosuvastatin, topotecan, sulfasalazine, daunorubicin, doxorubicin, simvastatin, atorvastatin, pravastatin, nateglinide. Decreased mean Cmax & AUC of caffeine. Reduced efficacy of duloxetin, alosetron, theophylline, tizanidine. Decreased peak INR w/ warfarin.
MIMS Class
Immunosuppressants
ATC Classification
L04AA31 - teriflunomide ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Aubagio FC tab 14 mg
Packing/Price
28's
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