Common questions about Aubagio (FAQ)
Q: Is Aubagio safe for people with pre-existing kidney issues?
A: Official product information states that no dose adjustment is typically needed for people with non-dialysis-dependent kidney impairment. However, monitoring for signs of hyperkalemia (high potassium levels) or acute kidney failure is typically advised, as this medication can affect the renal system.
Q: What happens if you miss a dose of Aubagio?
A: Official labeling states that if a dose is missed, it should be skipped, and the patient should resume the normal dosing schedule the following day. It is important that the dose is never doubled to compensate for the one that was missed.
Q: Is there a generic version of Aubagio available?
A: Yes, the active ingredient, teriflunomide, is available in generic versions approved by regulatory bodies. These are available in the same 7 mg and 14 mg strengths as the brand-name medication.
Q: Are there any known interactions between Aubagio and supplements like Vitamin D?
A: While official labeling does not specifically name Vitamin D, it describes drug interactions with substances that affect specific metabolic enzymes (like CYP) and transporters. Patients should discuss all supplements with a healthcare provider, as potential interactions with metabolic pathways are described in the drug label.
Q: Does Aubagio have a known connection to weight changes?
A: Weight loss has been reported as a side effect in some of the clinical trial data. However, it is not classified as one of the most common adverse reactions listed in the primary regulatory labeling.
Q: What are the signs of a serious allergic reaction to Aubagio?
A: Serious allergic reactions, including anaphylaxis and angioedema (severe swelling), have been reported with this medication. Signs can include swelling of the face, lips, tongue, or throat, hives, blistering skin, or difficulty breathing. Seek immediate medical attention if these symptoms develop.
Q: Can taking Aubagio cause an increase in infections?
A: Yes. Because Aubagio acts as an immunomodulatory agent, it can sometimes cause a reduction in white blood cell count (neutropenia), which is listed as a common effect. This reduction is associated with an increased risk of infections. Treatment should not begin if an active infection is present.
Q: Is Aubagio safe for older adults with MS?
A: Official information states that use in patients over 65 years of age should be approached with caution. This is because there is limited clinical data available for this specific age group, and the full safety and efficacy profile has not been established for this group.
Q: How often do people experience elevated liver enzymes while on Aubagio?
A: Clinical trials reported that serum ALT, a measure of liver enzymes, was elevated in approximately 13% to 15% of patients taking Aubagio, compared to 9% of those on placebo. A smaller fraction, about 6% of patients, experienced elevations greater than three times the upper limit of normal.
Q: Are headaches a common side effect of Aubagio?
A: Yes, official clinical trial summaries list headache as a Common side effect. This means it was frequently reported in clinical trials.
Q: What kind of impact does Aubagio have on the immune system?
A: Aubagio is an immunomodulatory agent that functions as a selective immunosuppressant. Its action is to reduce the proliferation and numbers of activated T- and B-lymphocytes by inhibiting a key enzyme, dihydroorotate dehydrogenase (DHODH). This selective targeting helps modulate the overall immune response.
Q: Is it typical for blood pressure to increase after starting Aubagio?
A: High blood pressure (Hypertension) is listed as a Common side effect. Official guidance recommends that blood pressure be measured and monitored at the start of treatment and throughout the course of therapy.
Q: Does Aubagio have a risk evaluation and mitigation strategy (REMS)?
A: Yes. Due to the potential for serious safety risks, such as liver damage and fetal harm, Aubagio has restricted distribution under a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S. This limits its dispensing to registered prescribers and pharmacies.
Q: Is Aubagio used for primary progressive MS?
A: No. Aubagio is officially approved for treating relapsing forms of multiple sclerosis in adults and certain pediatric patients. This includes clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS, but not primary progressive MS.