Let's talk about AUBAGIO side effects
When taking any medication, it's important to understand how it might affect your body, and AUBAGIO is no different. This section details the side effects reported in clinical trials. Scroll down to see all sections, or click a link below to go directly to that section:
Possible serious side effects of AUBAGIO
It's important to know the serious risks of any medication you take. And when it comes to AUBAGIO, it's no different. If you experience any of the following side effects while taking AUBAGIO, call your healthcare provider right away.
In addition to the risk of liver problems and the risk of harm to an unborn baby, other serious side effects include:
- Reduced white blood cell count—this may cause you to have more infections
- Numbness or tingling in your hands and feet that is different from your MS symptoms
- Allergic reactions, including serious skin problems
- Breathing problems (new or worsening)
- High blood pressure
- Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after
Tell your doctor if you have any side effect that bothers you or does not go away.
The most common side effects of AUBAGIO
AUBAGIO was associated with some side effects, and below is a graph of the most common side effects seen in clinical trials. Of course, not every individual reacts the same to medicine. So your healthcare provider is a great person to discuss your concerns about side effects with you. You can also call the MS One to One® Nurses at 1‑855‑MSOne2One (1‑855‑676‑6326).
THE MOST COMMON SIDE EFFECTS OF AUBAGIO
- Most cases of hair thinning or hair loss were mild to moderate, had a median time to onset of 99 days, and improved without corrective therapy while patients remained in the clinical trials
- Most cases of nausea and diarrhea were mild to moderate and not persistent
AUBAGIO quiets relapsing MS quietly*
*AUBAGIO (teriflunomide) is effective across key measures of disease activity: sustained disability progression† (14 mg only), annualized relapse rate, and MRI activity. Common side effects with AUBAGIO led to treatment discontinuation rates ≤3.3% in clinical trials.
The overall discontinuation rates due to adverse events were 12.5% with AUBAGIO 14 mg, 11.2% with AUBAGIO 7 mg, and 7.5% with placebo.
†Doctors measure disability progression using a test called the Expanded Disability Status Scale, or EDSS. Your first score — or your "baseline" — will determine how your disability is gauged moving forward. If your baseline score is ≤ 5.5, you're considered to have sustained disability progression if that score goes up by one point (lasting at least 12 weeks). If your baseline score is > 5.5 you're considered to have sustained disability progression if that score goes up by at least 0.5 points (lasting at least 12 weeks).
DISCONTINUATION RATES FROM COMMON SIDE EFFECTS
The facts about possible hair thinning or hair loss and AUBAGIO
Hair thinning or hair loss was a side effect of AUBAGIO reported in clinical trials. 87% of patients on AUBAGIO 14 mg and 90% of patients on AUBAGIO 7 mg did not report hair thinning or hair loss. In most cases, hair thinning or hair loss was mild to moderate, had a median time to onset of 99 days, and improved without corrective therapy while patients remained in the clinical trials.
“I did experience a little hair loss and noticed extra hair in the shower and in my brush, but it stopped for me after 6 months.”
Individual experiences may vary.
Information for women of childbearing potential
Women who are pregnant or not using effective birth control should not take AUBAGIO because it’s possible that AUBAGIO may harm your unborn baby. If you’re not pregnant and are using effective birth control, you can take AUBAGIO. Always talk to your healthcare provider about all your medications if you are planning to become pregnant.
If you become pregnant while taking AUBAGIO, tell your healthcare provider right away. A process called accelerated elimination helps remove AUBAGIO from your blood if needed. It is recommended that you continue using birth control until the level of AUBAGIO is lower than 0.02 mg/L in your blood.
It is not known if AUBAGIO passes into breast milk. Your healthcare provider can help you decide if you should take AUBAGIO or breastfeed—you should not do both at the same time.
If you become pregnant while taking AUBAGIO or within 2 years after stopping, tell your healthcare provider right away and enroll in the AUBAGIO Pregnancy Registry at 1‑800‑745‑4447, option 2. The purpose of this registry is to collect information about your health and your baby's health.
Men considering or taking AUBAGIO should also talk to their healthcare provider about family planning.