• Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Contraindicated in:

• Hypersensitivity to teriflunomide or leflunomide
• Severe hepatic impairment
• Concurrent use of leflunomide
• Live virus vaccinations
• Active acute or chronic infection
• Women of reproductive potential not using effective contraception
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Mild or moderate hepatic impairment
• Severe immunodeficiency, bone marrow disease or severe uncontrolled infection
• Concurrent use of neurotoxic medications or diabetes mellitus (↑ risk of peripheral neuropathy)
• Hypertension (control before therapy is initiated)
• Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: ↑risk of peripheral neuropathy in older adults.

CV: hypertension.

Derm: alopecia, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

F and E: hyperkalemia, hypophosphatemia.

GI: ↑liver enzymes, diarrhea, nausea, HEPATOTOXICITY.

GU: acute renal failure (urate nephropathy).

Hemat: leukopenia, neutropenia, thrombocytopenia.

Neuro: paresthesia, peripheral neuropathy.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS, ANGIOEDEMA, AND URTICARIA), (INCLUDING LATENT TUBERCULOSIS [TB] AND VIRAL INFECTIONS)INFECTION .

Drug-Drug:

• May ↑ levels and the risk of toxicity of CYP2C8 substrates, including paclitaxel, pioglitazone, and repaglinide.
• May ↓ levels and effectiveness of CYP1A2 substrates, including alosetron, duloxetine, theophylline, and tizanidine.
• May ↓ response to and ↑ risk of adverse reactions from live vaccines; avoid live vaccinations and consider long half-life of teriflunomide before administering.
• May ↑ levels and the risk of toxicity of ethinyl estradiol and levonorgestrel.
• May ↑ risk the of bleeding with warfarin.
• ↑risk of additive immunosuppression with other immunosuppressants or antineoplastics; consider long half-life of teriflunomide.
• Breast cancer resistant protein inhibitors, including cyclosporine, eltrombopag, and gefitinib, may ↑ levels and the risk of toxicity.

(Generic available)

• Film-coated tablets: 7 mg; 14 mg;

• PO (Adults): 7 mg once daily or 14 mg once daily.

Aubagio

• Inhibits an enzyme required for pyrimidine synthesis; has antiproliferative and anti-inflammatory effects.

• ↓incidence and severity of relapses in MS, with a decrease in disability progression.

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: immune response modifiers, pyrimidine synthesis inhibitors

Absorption: Well absorbed following oral administration.

Distribution: Well distributed to tissues.

Protein Binding: >99%.

Metabolism/Excretion: Metabolized via hydrolysis to inactive metabolites. 38% excreted in feces, and 23% excreted in urine.

Half-life: 18–19 days.

(decrease in disability progression)

• Instruct patient to take teriflunomide as directed. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• Advise patient to notify health care professional promptly if symptoms of liver problems (nausea, vomiting, stomach pain, loss of appetite, tiredness, skin or whites of eyes yellowing, dark urine), serious skin problems (redness or peeling), infection (fever, tiredness, body aches, chills, nausea, vomiting), or interstitial lung disease (cough, dyspnea, with or without fever) occur.
• Instruct patient to notify health care professional if symptoms of peripheral neuropathy (numbness and tingling in hands and feet different from symptoms of MS), kidney problems (flank pain), high potassium level (nausea or racing heartbeat), or high BP occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Instruct patient to avoid vaccinations with live vaccines during and following therapy without consulting health care professional.
• Discuss the possibility of hair loss with patient. Explore methods of coping.
• May cause fetal harm. Effective birth control should be used during therapy and until blood levels of teriflunomide are low enough. If pregnancy is planned or suspected, or if breastfeeding, notify health care professional immediately; an accelerated elimination procedure may be used to decrease blood levels more rapidly. Male patients with female partners of reproductive potential who plan to become pregnant may also use this method. If female partner does not plan to become pregnant, use effective birth control until blood levels are low enough; may require 2 yr. Females of reproductive potential are recommended to undergo accelerated elimination procedure upon discontinuation of teriflunomide. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to teriflunomide during pregnancy. Patients who become pregnant should be encouraged to enroll in the Aubagio Pregnancy Registry at 1-800-745-4447 to collect information about mother and baby's health. Advise patient to avoid breastfeeding during therapy.

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