Key Points

• Yes, Aubagio (teriflunomide) may lower your white blood cell (WBC) count and possibly suppress your immune system. White blood cells are found in your blood and are used to fight infection.
• 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.

In placebo-controlled studies of Aubagio, no overall increase in the risk of serious infections was observed with Aubagio 7 mg (2.2%) or 14 mg (2.7%) compared to placebo (2.2%). If you develop a serious infection while taking Aubagio you may need to stop treatment and have an accelerated elimination procedure of the drug by taking a special medicine.

Use of Aubagio is not recommended if you have severe immunodeficiency, bone marrow disease, or severe, uncontrolled infections.

Medications like Aubagio that have immunosuppression potential may cause you to be more susceptible to infections, including opportunistic infections. In clinical studies with Aubagio, Cytomegalovirus hepatitis reactivation has been observed. One fatal case of Klebsiella pneumonia sepsis was also reported.

Taking Aubagio with other immunosuppressant drugs, like cancer treatments, may increase your risk for infections. Tell your doctor if you take medicines that could raise your chance of getting infections, including medicines used to treat cancer or to control your immune system.

White blood cells

Aubagio can lower white blood cell (WBC) counts on average by 15%. Your doctor will check your levels of white blood cells and other cells with a complete blood count (CBC) before you start treatment with Aubagio.

A reduction in WBCs was usually seen in the first 6 weeks of treatment in studies and remained low. The reduction in WBCs is mainly due to neutrophils and lymphocytes.

Platelets

A 10% reduction in platelets, a blood cell used for clotting, was also seen in studies. Cases of thrombocytopenia (low platelets) have been reported with Aubagio.

Pancytopenia

Pancytopenia can occur due to a problem in the bone marrow which makes blood cells. Levels of all three types of blood cells are low in pancytopenia: red blood cells, white blood cells, and platelets. Serious infections can occur.

Symptoms of pancytopenia include increased risk of bleeding, shortness of breath, and high fevers. No cases of serious pancytopenia were reported in clinical trials of Aubagio. However, rare cases of pancytopenia were reported with leflunomide (Arava). Leflunomide is converted to teriflunomide in the body.

Tuberculosis (TB)

Your doctor will screen you for a latent tuberculosis (TB) infection (one that is in your body but not active) before you start treatment. Do not start treatment if you have an active TB infection. It is not known if it is safe to use Aubagio in patients with a latent tuberculosis infection.

In clinical studies with Aubagio, cases of tuberculosis have been observed. For patients testing positive in tuberculosis screening, treat the TB prior to therapy with Aubagio.

Live vaccines

Vaccination with live vaccines is not recommended while you are taking Aubagio. Examples of common live vaccines include: the nasal flu vaccine (Flumist Quadrivalent), measles, mumps, and rubella vaccine (MMR), and the varicella (chickenpox) vaccine.

No studies have been done to determine if Aubagio is safe with live vaccinations. Aubagio remains in your blood for a long time. This should be considered when deciding upon vaccine use.

Talk to your doctor about this before you have any vaccines if you are taking, or have taken Aubagio. The manufacturer recommends that certain vaccines not be administered for at least 6 months after discontinuation of treatment.

Risk of malignancy

No increase in the numbers of cancers were reported in the Aubagio clinical trials, but larger and longer-term studies are needed to determine whether there is an increased risk.

Bottom Line

• Aubagio (teriflunomide) may lower your white blood cell (WBC) count and increase your risk for infections. However, the risk for serious infections while taking Aubagio was the same as placebo (inactive treatment) in studies.
• In studies, a reduction in WBCs was usually seen in the first 6 weeks after starting treatment and remained low.
• 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.

This is not all the information you need to know about Aubagio (teriflunomide) for safe and effective use. Review the full Aubagio information here, and discuss this information with your doctor or other health care provider.