Names and pronunciation
(ter′i-floo′noe-mide) Aubagio
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Drug reference
(ter′i-floo′noe-mide) Aubagio
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Func. class.: Multiple sclerosis agent
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Chem. class.: Pyrimidine synthesis inhibitor
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ACTION: Antiproliferative effects including peripheral T- and B-lymphocytes, might reduce inflammatory demyelination
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USES: Reduction of the frequency of relapses or remitting MS
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CONTRAINDICATIONS: Hyper- sensitivity to this product or leflunomide
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Black Box Warning: Pregnancy Precautions: Breastfeeding, alcohol- ism, diabetes mellitus, eosinophilic pneumonia, hepatitis, jaundice, male- mediated teratogenicity, pneumonitis, pulmonary disease/fibrosis, sarcoidosis, TB, vaccination, children, geriatrics Black Box Warning: Hepatic disease, contraception requirements, male-medi- ated teratogenicity Black Box Warning: Increase: hepato- toxicity—methotrexate, HMG-CoA reduc- tase inhibitors Increase: hematologic toxicity— zidovudine Increase: effect of—oral contraceptives, repaglinide, pioglitazone, rosiglitazone, PACLitaxel, naproxen, topotecan, bosen- tan, furosemide Decrease: effect of—warfarin, alosetron, DULoxetine, theophylline, tiZANidine, qui- NINE, tamoxifen, bendamustine, rasagi- line, rOPINIRole, selegiline, propafenone, mexiletine, lidocaine, anagrelide, cloZA Pine, cinacalcet, caffeine; monitor closely Decrease: effect of teriflunomide— cholestyramine Black Box Warning: Pregnancy: obtain pregnancy test in those of reproductive potential; this product should not be used during pregnancy or for 2 yr after last dose; those wishing to become pregnant must discontinue the product and undergo an accelerated elimination procedure with verification of teriflunomide plasma level <0.02 mg/L; do not use in breastfeeding Black Box Warning: To notify prescriber if pregnancy is planned or suspected; do not use in pregnancy or breastfeeding
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SIDE EFFECTS CNS: Anxiety, headache CV: Palpitations, hypertension, MI EENT: Blurred vision, conjunctivitis, sinusitis GI: Nausea, vomiting, diarrhea, cystitis, hepatotoxicity HEMA: Leukopenia, lymphopenia, neutropenia INTEG: Acne vulgaris, alopecia, pruritus META: Weight loss MISC: Infection, cystitis, Stevens-John son syndrome
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INTERACTIONS • Do not use with leflunomide, live virus vaccines Increase: teriflunomide effect—cyclo- SPORINE, eltrombopag, gefitinib
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DOSAGE AND ROUTES Adult: PO 7 or 14 mg/day, max 14 mg/day
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Available forms: Tabs 7, 14 mg
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Administer: PO route • May be taken without regard to food • Use precautions in handling, use gloves
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Assess: • Labs: ALT/AST, bilirubin, CBC within 6 mo of starting; measure ALT q6mo, CBC if infection is suspected, obtain TB test before beginning therapy • CNS symptoms: anxiety, confusion, vertigo • GI status: diarrhea, vomiting, abdomi- nal pain • Cardiac status: tachycardia, palpitations, vasodilation, chest pain; monitor B/P • Stevens-Johnson syndrome, toxic epidermal necrolysis: Assess for fever, blisters, aches, fatigue, if these occur, stop product immediately • Hepatotoxicity: Monitor LFTs after 6 mo or less of treatment, and monthly after start of treatment, do not use if ALT >2X ULN, dis continue if >3X ULN, monitor bilirubin • Blood dyscrasias: Monitor CBC, plate lets 6 mo before use and periodically, monitor for infection, monitor INR
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Evaluate: • Therapeutic response: decreased symptoms of MS
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That blurred vision can occur • That hair may be lost, that a wig or hairpiece may be used • Not to change dosing or stop taking without advice of prescriber • To report skin changes, rashes imme- diately • To avoid live virus vaccines; that up- T dated vaccines should be done before use • To report signs, symptoms of infection • Teach patient to take as directed, pro- vide “Medication Guide” • Teach patient to notify provider of nausea, vomiting, loss of appetite, dark urine, yellow eyes or skin
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PHARMACOKINETICS Protein binding >99%, median half-life 18-19 days, peak 1-4 hr
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