What is the appropriate treatment approach for a patient with multiple sclerosis who is considering or already taking Aubagio (teriflunomide)?

Treatment Approach for Aubagio (Teriflunomide) in Multiple Sclerosis

Aubagio (teriflunomide) 14 mg once daily is the recommended dose for treating relapsing forms of multiple sclerosis, as it significantly reduces relapse rates by 31-36% and decreases disability progression risk by approximately 30% compared to placebo. 1, 2, 3

Dosing and Administration

• Initiate treatment at 14 mg orally once daily, as this dose demonstrates superior efficacy over the 7 mg dose for preventing disability progression 1, 2
• The 7 mg dose reduces relapse rates but does not significantly impact disability progression and should be reserved for patients who cannot tolerate the higher dose 2, 3
• Teriflunomide can be taken with or without food 1

Mandatory Pre-Treatment Screening

Before initiating teriflunomide, complete the following assessments:

• Obtain transaminase (ALT) and bilirubin levels within 6 months before starting therapy, as clinically significant liver injury including acute liver failure requiring transplant has been reported 1
• Perform complete blood count (CBC) within 6 months of initiation to establish baseline values 1
• Screen for latent tuberculosis using tuberculin skin test or blood test for mycobacterium tuberculosis 1
• Exclude pregnancy in all females of reproductive potential before treatment initiation, as teriflunomide causes teratogenicity and embryolethality at therapeutic exposures 1
• Check baseline blood pressure before starting treatment 1

Required Monitoring During Treatment

Hepatic Monitoring (Critical)

• Monitor ALT levels at least monthly for the first 6 months after starting teriflunomide 1
• Elevated ALT levels ≥1 times upper limit of normal occur in 54-57% of patients, though levels ≥3 times upper limit occur in only 6-7% 3
• If drug-induced liver injury is suspected, immediately discontinue teriflunomide and initiate accelerated elimination with cholestyramine or activated charcoal 1
• Patients with pre-existing liver disease or those taking other hepatotoxic drugs face increased risk and require heightened vigilance 1

Hematologic Monitoring

• Monitor for signs and symptoms of infection based on clinical presentation rather than routine CBC monitoring after baseline 1
• Neutropenia occurs in approximately 2% of patients 4

Blood Pressure Monitoring

• Check blood pressure periodically after treatment initiation, as hypertension occurs in a small percentage of patients 1, 4

MRI Surveillance

• Perform annual brain MRI as the minimum standard using contrast-enhanced T1-weighted and T2-weighted/FLAIR sequences to detect new or enlarging lesions 5
• Do not assess treatment response before 6 months, as teriflunomide requires this duration to become effective 5
• New lesions during the first 6 months do not necessarily indicate treatment failure 5

Contraindications and Special Populations

Teriflunomide is absolutely contraindicated in:

• Patients with severe hepatic impairment 1
• Pregnant women and females of reproductive potential not using effective contraception 1
• Patients with history of hypersensitivity to teriflunomide or leflunomide, including anaphylaxis, angioedema, or serious skin reactions 1
• Co-administration with leflunomide 1

Pregnancy Management

• Females of reproductive potential must use effective contraception during treatment and during accelerated elimination after discontinuation 1
• If pregnancy occurs, immediately stop teriflunomide and perform accelerated elimination procedure using cholestyramine 8 g three times daily for 11 days or activated charcoal 50 g twice daily for 11 days 1

Common Adverse Events

The most frequent adverse events include:

• Hair thinning (alopecia) occurs in 10-13% of patients 2, 3
• Diarrhea and nausea are common gastrointestinal effects 3, 4
• Headache affects 11-15% of patients 2
• Serious infections occur in approximately 2.2-2.5% of patients, similar to placebo rates 2, 3

Clinical Efficacy Outcomes

Teriflunomide 14 mg demonstrates:

• 31-36% reduction in annualized relapse rate compared to placebo (0.32-0.37 vs 0.50-0.54) 2, 3
• 30-32% reduction in risk of sustained disability progression at 12 weeks (hazard ratio 0.68-0.70) 2, 3
• Significant reduction in MRI measures including total lesion volume and gadolinium-enhancing T1 lesions 3, 4

Critical Pitfalls to Avoid

• Do not use teriflunomide in patients taking other hepatotoxic medications without careful risk-benefit assessment, as concomitant hepatotoxic drugs increase severe liver injury risk 1
• Do not delay accelerated elimination if pregnancy occurs or liver injury is suspected, as teriflunomide has a long half-life requiring active removal 1
• Do not discontinue monitoring after the initial 6-month period, as liver injury can occur at any time during treatment 1
• Do not interpret early MRI changes (within 6 months) as treatment failure, as the medication requires time to achieve full therapeutic effect 5