Aubagio is an oral treatment approved to treat clinically isolated syndrome (CIS), relapsing-remitting MS, and active secondary progressive MS. Aubagio is a type of immunomodulatory drug, called a pyrimidine synthesis inhibitor.1
What are the ingregients in Aubagio?
The active ingredient in Aubagio is teriflunomide.1
How does Aubagio work?
The exact mechanism by which Aubagio works in people with MS is unknown. However, Aubagio does have recognized anti-inflammatory properties, which may inhibit the immune response thought to be involved in MS.1
As an autoimmune disease, MS is believed to develop when the immune system becomes overactive and begins attacking the nerves in the central nervous system, causing demyelination.2
Aubagio inhibits a key enzyme called dihydroorotate dehydrogenase that is required by lymphocytes (a type of white blood cell involved in immune system) for normal functioning. Aubagio decreases the production of two specific types of lymphocytes, T-cells and B-cells, which play a key role in promoting CNS inflammation that causes demyelination.1
What are the possible side effects?
Like all medicines, Aubagio can cause side effects. The most common side effects experienced by people taking it in clinical trials were:1
- Headache
- Diarrhea
- Nausea
- Alopecia (thinning of hair or hair loss)
- Increase in alanine transaminase (ALT), an enzyme that in high levels can indicate liver damage
Aubagio has a boxed warning, the strictest warning from the U.S. Food and Drug Administration (FDA). It has this warming because of its potential to cause liver damage (hepatotoxicity) and birth defects to fetuses during pregnancy.1
Liver damage
Severe liver damage, which may lead to fatal liver failure, has been seen in people treated with Arava® (leflunomide), a treatment for rheumatoid arthritis. A similar risk of liver damage is expected with Aubagio because both Arava and Aubagio increase the levels of teriflunomide in the blood. Because of this risk, blood tests to check for liver function are recommended before starting treatment with Aubagio (within 6 months prior to starting treatment), and at least monthly for the first six months of treatment.1
Birth defects
Although Aubagio has not specifically been studied in people who are pregnant, results from studies conducted in animals indicate that Aubagio may cause birth defects to a fetus. Aubagio should not be taken if you are pregnant or planning to become pregnant. If you become pregnant while taking Aubagio, you should stop taking the drug immediately and contact your doctor. If you are of childbearing age, you should use reliable contraception while taking Aubagio and after treatment until the prescriber says it is safe to stop.1
These are not all the possible side effects of Aubagio. Talk to your doctor about what to expect when taking Aubagio. You also should call your doctor if you have any changes that concern you when taking Aubagio.
Other things to know about Aubagio
Before using Aubagio, talk to your doctor about all your medical conditions, particularly if you have:1
- Severe liver disease
- Liver or kidney problems
- Pregnancy, or plan to become pregnant
- An allergic reaction to Aubagio or leflunomide (Arava)
- A fever or infection, or if you are unable to fight infections
- Numbness or tingling in the hands or feet (different than your symptoms of MS)
- Diabetes
- Serious skin problems when taking other medications
- Breathing problems
- High blood pressure
Drug interactions
Aubagio should not be used if you are taking leflunomide (Arava). Other drugs with known interactions with Aubagio include, but not limited to:1
- Drugs that are metabolized by the enzyme CYP2C8, such as paclitaxel, pioglitazone, repaglinide, and rosiglitazone
- Warfarin (a common blood thinner)
- Certain oral contraceptives
- Drugs metabolized by the enzyme CYP1A2, such as alosetron, duloxetine, theophylline, and tizanidine
- Drugs that are OAT3 substrates, such as cefaclor, cimetidine, ciprofloxacin, penicillin G, ketoprofen, furosemide, methotrexate, and zidovudine
- Drugs used for high cholesterol, such as atorvastatin, pravastatin, simvastatin, and rosuvastatin
- Drugs such as mitoxantrone, rifampin, and nateglinide
Before beginning treatment for MS, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
Monitoring blood cell count
Because Aubagio may cause a decrease in white blood cells and platelets and can increase the risk of infection, a complete blood cell count should be taken before starting Aubagio (within 6 months prior to starting treatment), and further monitoring should be done during treatment if there are signs that suggest bone marrow suppression. White blood cells are produced in the bone marrow.1
Risk of infection
There is an increased risk of infection with Aubagio. If you have an infection (acute or chronic), you should not start Aubagio until the infection is resolved. If you develop a serious infection while taking Aubagio, you and your doctor should consider discontinuing the drug and use an accelerated elimination procedure (as described by the manufacturer) to remove the drug from your system more quickly.1
Since Aubagio takes a long time to clear from the body, you may still experience the effects of the drug for a long time after discontinuing it. Aubagio is not recommended for use in people with severe immunodeficiency, bone marrow disease, or uncontrolled infections.1
For more information, read the full prescribing information of Aubagio.