Aubagio (Teriflunomide) FAQs: What MS Patients Need to Know
Starting Aubagio (teriflunomide) or considering it as a treatment for multiple sclerosis? You probably have questions about how it works, what side effects to expect, and what monitoring you’ll need.
This guide walks through the most common questions MS patients ask about Aubagio — from how the medication functions in your body to what your neurologist will be watching as you take it. Information here is sourced from FDA prescribing information and clinical references used by pharmacists.
What Is Aubagio Used For?
Aubagio (Teriflunomide) treats relapsing forms of Multiple Sclerosis (MS) in adults. The National Multiple Sclerosis Society provides comprehensive information about MS treatment categories and how oral disease-modifying therapies like Aubagio fit into treatment plans. Specifically, doctors prescribe Aubagio for:
Relapsing-Remitting Multiple Sclerosis (RRMS): Aubagio reduces the frequency of relapses and delays the progression of physical disability in adults with relapsing forms of MS.
Clinically Isolated Syndrome (CIS): Doctors prescribe Aubagio to individuals with CIS, the first episode of neurological symptoms suggestive of MS. It helps reduce the risk of developing clinically definite MS.
Active Secondary Progressive Multiple Sclerosis (SPMS): Aubagio treats active SPMS in individuals who continue to experience relapses or evidence of inflammatory activity.
Aubagio is not approved for primary progressive MS or for individuals younger than 18 years old. Researchers don’t fully understand the exact mechanism of action, but it involves immunomodulatory effects that suppress the immune response contributing to inflammation and damage in MS.
Make the decision to use Aubagio or any other medication in consultation with a healthcare professional who can evaluate your specific condition, medical history, and individual needs.
How Does Aubagio Work?
Aubagio is classified as a pyrimidine synthesis inhibitor. Pyrimidines are essential building blocks for DNA and RNA. By limiting their production, Aubagio reduces the activity of rapidly dividing immune cells — including the T cells and B cells involved in the inflammatory damage seen in MS.
Here are the proposed ways Aubagio works:
Inhibition of pyrimidine synthesis: Aubagio inhibits pyrimidine synthesis. Pyrimidines are essential building blocks for DNA and RNA synthesis. Their inhibition affects the proliferation of rapidly dividing cells, including certain immune cells. By reducing pyrimidine production, Aubagio may suppress the proliferation and activation of immune cells involved in the inflammatory process of MS.
Effects on immune cell activation: Aubagio inhibits the activation of immune cells, including T cells and B cells, which play a role in the immune response in MS. By dampening the activation of these cells, Aubagio helps reduce immune-mediated inflammation and damage to the central nervous system.
Reduction of pro-inflammatory cytokines: Aubagio decreases the production of pro-inflammatory cytokines, such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha). These cytokines contribute to the inflammatory response in MS, and their reduction helps mitigate the inflammatory process.
By modulating the immune response and reducing inflammation, Aubagio aims to decrease the frequency of relapses, delay the progression of disability, and improve overall outcomes for individuals with relapsing forms of MS. The FDA provides detailed prescribing information for Aubagio.
What Is the Standard Aubagio Dose?
Aubagio is available in two oral tablet strengths: 7 mg and 14 mg, taken once daily. Your neurologist will determine the appropriate dose based on your individual response and tolerability. Aubagio can be taken with or without food.
It’s important to take Aubagio exactly as prescribed by your healthcare provider. Do not change your dose or stop taking it without first consulting with your healthcare provider.
How Long Until Aubagio Starts Working?
Aubagio reaches peak concentrations in the blood within 1–4 hours of taking it, but the full therapeutic effects on MS relapses develop gradually over weeks to months as the medication builds up in your system.
Aubagio has a notably long half-life — approximately 18–19 days. This means the drug stays in your body for an extended period, which is one reason monitoring and contraception planning are so important. The response to Aubagio may vary among individuals, and some patients may experience a more rapid or slower onset of action. If you have any concerns or questions about the timing of Aubagio’s onset of action, consult with your healthcare provider.
What Are the Most Common Aubagio Side Effects?
Based on FDA clinical trial data, the most common side effects of Aubagio (occurring in more than 10% of patients) include:
- Headache (16–18%)
- Hair thinning or loss (10–13%)
- Diarrhea (13–14%)
- Nausea (8–11%)
- Elevated liver enzymes (ALT) (13–15%)
- Low phosphate levels (18%)
- Decreased lymphocyte counts (10–12%)
Less common side effects (1–10%) include:
- High blood pressure (3–4%)
- Decreased neutrophil counts (4–6%)
- Paresthesia — tingling, numbness, or pins-and-needles sensation (8–9%)
- Joint pain (6–8%)
Most side effects are mild to moderate. However, Aubagio carries an FDA Boxed Warning for severe liver injury and birth defects (described below). Patients should report any signs of jaundice, dark urine, unusual fatigue, or stomach pain to their healthcare provider immediately.
Why Does My Doctor Order So Many Blood Tests on Aubagio?
Aubagio requires regular lab monitoring because of its FDA Boxed Warning for liver toxicity. Your healthcare provider will typically:
- Check liver enzymes (ALT) and bilirubin within 6 months before starting Aubagio
- Monitor ALT levels at least monthly for the first 6 months of treatment
- Check a complete blood count (CBC) within 6 months of starting and periodically after
- Screen for tuberculosis and other latent infections before initiating therapy
- Monitor blood pressure at the start of treatment and periodically afterward
If liver enzymes rise to more than 3 times the upper limit of normal, Aubagio will likely be discontinued. Don’t skip these labs — they’re how your care team catches problems early, before serious injury occurs.
Can I Take Aubagio During Pregnancy or While Breastfeeding?
No. Aubagio carries an FDA Boxed Warning for embryofetal toxicity. The medication has caused birth defects and embryolethality in animal studies and is contraindicated in pregnancy and in women of reproductive potential who are not using effective contraception.
Here’s important information regarding Aubagio and pregnancy:
Teratogenic effects: Aubagio has been associated with fetal harm in animal studies, including birth defects and embryofetal death. The active metabolite of Aubagio, which has a longer half-life than the parent compound, can persist in the body for up to 2 years after the last dose if no elimination procedure is performed.
Pregnancy planning: If you plan to become pregnant, discuss your treatment options with your healthcare provider. An accelerated drug elimination procedure using cholestyramine or activated charcoal can lower teriflunomide concentrations to undetectable levels.
Contraception: Effective contraception is required during treatment and during the elimination procedure if Aubagio is discontinued. Aubagio has a long half-life, so the medication takes a significant amount of time to be eliminated from the body.
For male patients: Teriflunomide is detectable in semen. Male patients and their female partners should use reliable contraception during therapy. Men who wish to father a child should discontinue Aubagio and complete the elimination procedure.
Breastfeeding: It is not known whether teriflunomide is present in breast milk. Due to the potential for serious adverse effects in nursing infants, breastfeeding is not recommended during Aubagio therapy.
Pregnancy registry: There is a pregnancy registry that tracks outcomes for patients exposed to Aubagio during pregnancy. Healthcare providers can enroll patients by calling 1-800-745-4447 (option 2).
Consult with your healthcare provider if you are considering pregnancy, are pregnant, or become pregnant while taking Aubagio.
What Drug Interactions Should I Know About?
Aubagio has clinically significant interactions with many medications. Always provide your pharmacist and neurologist with a complete list of everything you take, including over-the-counter products and supplements. A few important examples:
- Other immunosuppressants: Combining Aubagio with other strong immunosuppressants increases infection risk and may require alternatives.
- Live vaccines: Avoid live-attenuated vaccines while on Aubagio (and shortly after stopping). Common examples include the live shingles vaccine and yellow fever vaccine.
- Leflunomide: Aubagio should not be combined with leflunomide.
- Warfarin: Aubagio can affect warfarin’s anticoagulant effects; INR monitoring may be needed.
- Rosuvastatin: Aubagio increases rosuvastatin concentrations. The maximum rosuvastatin dose should be limited to 10 mg daily.
- Bile acid sequestrants (cholestyramine) and activated charcoal: These dramatically lower Aubagio levels and are used intentionally for the elimination procedure.
Your pharmacy team should run a full interaction check whenever a new medication is added.
What Are the Alternatives to Aubagio for Multiple Sclerosis?
Several alternative medications are available for Multiple Sclerosis (MS) treatment if Aubagio (Teriflunomide) is not suitable or preferred. The choice of alternative depends on various factors such as the specific type and severity of MS, individual patient characteristics, and treatment goals. Here are some common alternative options:
Interferons: Interferon beta medications, such as Avonex, Betaseron, and Rebif, are commonly prescribed for MS. They modulate the immune response and reduce inflammation. These medications are available in different formulations (intramuscular, subcutaneous) and dosing schedules.
Glatiramer acetate: Glatiramer acetate (Copaxone, Glatopa) is another commonly prescribed medication for MS. It is a synthetic protein that resembles myelin, the protective covering of nerve fibers. It modifies the immune response and reduces inflammation.
Dimethyl fumarate: Dimethyl fumarate (Tecfidera) treats relapsing forms of MS. Researchers believe it has anti-inflammatory and immunomodulatory effects, although they don’t fully understand its exact mechanism of action.
Natalizumab: Natalizumab (Tysabri) treats moderate to severe relapsing forms of MS through intravenous infusion. It blocks specific immune cells from entering the central nervous system, thereby reducing inflammation.
Fingolimod: Fingolimod (Gilenya) modulates the immune system by trapping certain immune cells in the lymph nodes. This prevents them from reaching the central nervous system and causing inflammation.
Ocrelizumab: Ocrelizumab (Ocrevus) treats both relapsing forms of MS and primary progressive MS through intravenous infusion. It targets specific immune cells involved in the immune response against myelin, reducing inflammation and disease activity.
These are just a few examples of alternative medications for MS. Consult with a healthcare professional, such as a neurologist or MS specialist, who can evaluate your specific situation and recommend the most appropriate treatment option based on your individual needs and circumstances.
How Should Aubagio Be Stored?
Store Aubagio at room temperature (68°F to 77°F / 20°C to 25°C). Brief excursions are allowed between 59°F and 86°F. Keep the tablets in their original container, away from moisture and out of reach of children and pets.
Aubagio is classified as a hazardous drug under NIOSH guidelines, which means healthcare workers and pharmacy staff use special handling precautions. For patients taking the medication at home, normal storage and standard hand-washing after handling are sufficient.
What Should I Do If I Miss a Dose of Aubagio?
If you miss a dose of Aubagio, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.
Aubagio’s long half-life means a single missed dose has less immediate impact than with shorter-acting medications, but consistency still matters for long-term efficacy. If you have any concerns or questions about missed doses or your medication regimen, consult with your healthcare provider.
QuickRx Specialty Pharmacy supports MS patients prescribed Aubagio with prescription coordination, prior authorization handling, and questions about affording your medication. Visit our Aubagio copay assistance page to learn more, or call us at (917) 830-2525 to speak with a pharmacist.
