Aubagio: 7 things you should know

Medically reviewed by Carmen Fookes, BPharm. Last updated on Dec 28, 2022.

1. How it works

• Aubagio is a brand (trade) name for teriflunomide and is used to treat relapsing forms of multiple sclerosis (MS) in adults.
• Experts aren't sure exactly how Aubagio works in MS, but it is thought to decrease inflammation by lowering the number of white blood cells (activated lymphocytes) in the central nervous system, which protects the nerves.
• Aubagio belongs to the class of medicines known as selective immunosuppressants. It may also be called a pyrimidine synthesis inhibitor.

2. Upsides

• May be used to treat relapsing forms of MS in adults including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
• Trails have shown Aubagio significantly reduces MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions. Aubagio will not cure MS.
• Aubagio is taken orally, once a day.
• May be taken with or without food.
• Available as 7mg and 14mg tablets
• No dosage adjustment is needed for people with mild, moderate, and severe renal impairment.
• Research has shown that mild and moderate hepatic impairment has no impact on the pharmacokinetics of teriflunomide; however, it is unknown what effect severe hepatic impairment has.
• There is no evidence that Aubagio prolongs the QT interval.
• Aubagio is available as a generic under the name teriflunomide.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Aubagio carries a boxed warning (the most stringent FDA warning) about the risk of liver toxicity and harm to an unborn baby. Aubagio should not be taken by people with severe liver problems, or those who are pregnant or of childbearing potential and not using effective birth control. People who have had an allergic reaction to Aubagio or leflunomide, or who are already taking leflunomide (brand name Arava) for rheumatoid arthritis, should also not take Aubagio.
• Headache, an increase in liver enzymes (such as alanine aminotransferase), diarrhea, hair loss (alopecia), nausea, paresthesia (an abnormal sensation of the skin, such as tingling, pricking, chilling, burning, or numbness), joint pain, neutropenia (low neutrophils), low phosphate levels, and high blood pressure are the most commonly reported side effects of Aubagio.
• Anaphylaxis and severe allergic reactions have been reported with Aubagio. Symptoms have included dyspnea, urticaria, and angioedema including lips, eyes, throat, and tongue. Serious skin reactions, including Stevens-Johnson syndrome (SJS) and a fatal case of toxic epidermal necrolysis (TEN), have also been reported.
• Aubagio may lower a person's white blood cell (WBC) count and increase their risk of infections.
• Before starting Aubagio, screening for latent tuberculosis (TB) using a tuberculin skin test or blood test for mycobacterium tuberculosis infection will need to be undertaken. If the patient is positive for TB, then they will be treated for TB before starting Aubagio. Aubagio should not be started in people with an active TB infection.
• Other laboratory tests, such as a completed blood cell count (CBC) and transaminase and bilirubin levels within 6 months of initiation of Aubagio. ALT levels will need to be monitored monthly for 6 months after starting Aubagio.
• Check blood pressure before starting Aubagio and monitor regularly thereafter.
• May be associated with an increased risk of malignancy or lymphoproliferative disorders and also with interstitial lung disease.
• Peripheral neuropathy is also more common in those receiving Aubagio compared with a placebo. People older than 60 years, taking other neurotoxic medications, or with diabetes may be at increased risk.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

Aubagio is a selective immunosuppressant that may be used in the treatment of multiple sclerosis. It interacts with many other medications and carries a boxed warning about the risk of liver toxicity and harm to a developing baby. Aubagio can persist in the body for up to 2 years once discontinued and an accelerated removal process may be necessary for those who wish to conceive a baby or with intolerable and persisting side effects.

5. Tips

• Aubagio may be taken with or without food. The recommended dosage of Aubagio is one tablet (either the 7mg strength or 14mg strength) taken once daily with a glass of water.
• It does not matter if you take Aubagio in the morning or at night, but you should take it at around the same time each day. If you experience fatigue, tiredness, or weakness with Aubagio, you may find it better to take it at night.
• You may be more likely to get an infection while taking Aubagio. Symptoms of low white blood cells and an infection may include fever, fatigue, chills or body aches, or feeling sick to your stomach (nausea and vomiting).
• You should not start taking Aubagio during an active infection. Contact your doctor right away if you develop symptoms of an infection or a fever.
• Aubagio should not be taken by people with severe liver problems. Tell your doctor about any other medical conditions you have before you start treatment. Aubagio is not recommended for people with severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections.
• Most side effects of Aubagio are short-lived and resolve with continued treatment within a few weeks or months. However, if you have severe side effects you should call your doctor or 911 for emergency care right away.
• If you develop an infection or a fever while you are taking Aubagio, call your doctor right away. Do not start taking Aubagio during an active infection.
• Weight loss is reported as a common side effect of Aubagio, occurring in 1% to 10% of people in post-marketing studies, although it is not listed as a side effect in the product information.
• Aubagio can harm an unborn baby. If you are a woman of childbearing age, use adequate contraception to ensure you don't become pregnant. Men taking Aubagio should also use condoms during sexual intercourse as Aubagio is detectable in a man's semen. If you wish to become pregnant, talk to your doctor about discontinuing Aubagio and removing it from your body before you conceive. If you inadvertently become pregnant while taking Aubagio, tell your doctor straight away.
• Seek urgent medical help if you develop any side effects such as shortness of breath, a rash or hives, numbness or tingling of the hands or feet, a persistent cough or shortness of breath, or swelling of the lips, eyes, throat, and tongue.

6. Response and effectiveness

• Treatment with Aubagio significantly reduced the annualized relapse rate for MS compared to patients who received a placebo. There was a consistent reduction of the ARR noted in subgroups defined by sex, age group, prior multiple sclerosis therapy, and baseline disease activity.
• There was also a significant reduction in the risk of disability progression after approximately two years that was sustained for 12 weeks.
• Aubagio has a long half-life of roughly 18-19 days and is eliminated slowly from your body. The half-life is the amount of time it takes for half of a drug’s concentration to be eliminated from your body. Because of the long half-life, it can potentially take several months for many side effects to dissipate. It takes, on average, 8 months to eliminate the drug (to reach a plasma concentration less than 0.02 mg/L), but this is variable and may take up to 2 years based on differences between patients.
• Your doctor may need to do an accelerated removal process using a specific medicine if you have any serious side effects, are pregnant, or are considering having a baby (both men and women).
• Studies have shown that the clearance rate of Aubagio in females is 23% less than in males.

7. Interactions

Medicines that interact with Aubagio may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Aubagio. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Aubagio interacts with a lot of medications. Examples of medications that may interact with Aubagio include:

• BCRP substrates, such as mitoxantrone
• live vaccines, such as the BCG vaccine, yellow fever, measles, and mumps vaccines
• oral contraceptives containing ethinylestradiol and levonorgestrel (Aubagio may increase levels of these hormones)
• organic anion transporter 3 (OAT3) substrates, such as cefaclor, cimetidine, ciprofloxacin, furosemide, ketoprofen, methotrexate, penicillin G, or zidovudine (Aubagio inhibits the activity of OAT3, and levels of these drugs may be increased
• OATP1B1/1B3 substrates, such as methotrexate, rifampin, and HMG-Co reductase inhibitors such as atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin. A dose reduction of these drugs may need to be considered
• other biologics or targeted treatments, such as adalimumab, tofacitinib, or etanercept (may increase the risk of serious or life-threatening infections)
• other medications metabolized by CYP2C8 such as paclitaxel, pioglitazone, repaglinide, or rosiglitazone (Aubagio inhibits CYP2C8 and may increase levels of these medications)
• other medications metabolized by CYP1A2 such as alosetron, duloxetine, theophylline, or tizanidine (Aubagio may weakly induce CYP1A2, and levels of these drugs may be reduced)
• other medications used to treat multiple sclerosis, such as fingolimod, (may increase the risk of serious or life-threatening infections)
• warfarin (Aubagio may decrease peak INR by 25%).

Note that this list is not all-inclusive and includes only common medications that may interact with Aubagio. You should refer to the prescribing information for Aubagio for a complete list of interactions.

References

• Aubagio (teriflunomide). Updated 04/2022. Genzyme Corporation https://www.drugs.com/pro/aubagio.html

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Aubagio only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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