Teriflunomide被制剂化为薄膜衣片为口服给药。AUBAGIO片含7 mg或14 mg的teriflunomide和以下无活性成分：一水乳糖，玉米淀粉，羟丙基纤维素，微晶纤维素，羟基乙酸淀粉钠，和硬脂酸镁。为14 mg片包膜是羟丙纤维素，二氧化钛，滑石粉，聚乙二醇和靛蓝胭脂红铝色淀。7 mg片包膜处理这些包括氧化铁黄。
7 mg或14 mg口服每天1次，有或无食物。(2)
7 mg和14 mg薄膜衣片(3)
AUBAGIO可得到7 mg和14 mg片。
The 7 mg片 is 非常亮-蓝灰色至浅绿蓝色，六角形薄膜衣片，一侧印有有剂量强度“7”和另一侧刻有公司的标志。每片含7 mg teriflunomide.
AUBAGIO 14 mg片被供应为：
NDC 58468-0210-2 为28片纸盒含1纸袋包括 2个折叠泡卡，每泡卡14片
NDC 58468-0210-1 为5片纸盒有5片泡卡
AUBAGIO 7 mg片供应如下：
NDC 58468-0211-1 为28片纸盒含1纸袋包括 2个折叠泡卡，每泡卡14片
NDC 58468-0211-2 为5片纸盒有一个5片泡卡。
贮存在68°F至77°F (20°C至25°C)外出时允许 59°F和86°F (15°C和30°C)间。
Aubagio Approved for Relapsing Multiple Sclerosis
AUBAGIO (teriflunomide) 14mg tablets by Genzyme Genzyme announced that the FDA has approved Aubagio (teriflunomide tablets), a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Aubagio has shown significant efficacy in reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.
The approval was based on efficacy data from the Phase 3 TEMSO (TEriflunomide Multiple Sclerosis Oral) trial evaluating more than 5,000 patients in 36 countries. Aubagio 14mg significantly reduced the annualized relapse rate (P=0.0005) and the time to disability progression (P=0.0279) at two years vs. placebo in patients with relapsing forms of MS. Additionally, Aubagio 7mg significantly reduced the annualized relapse rate (P=0.0002) in the trial.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system. Aubagio will be supplied as 7mg and 14mg tablets. Genzyme expects to make Aubagio available on October 1st, 2012
Generic Name: teriflunomide
Date of Approval: September 12, 2012
Company: Genzyme Corporation
Treatment for: Multiple Sclerosis
FDA Approves Aubagio
The U.S. Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Aubagio has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).
The Aubagio label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data).
Aubagio Medication Guide
Read this Medication Guide before you start using Aubagio and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about Aubagio?
Aubagio may cause serious side effects, including:
Liver problems: Aubagio may cause serious liver problems that may lead to death. Your risk of liver problems may be higher if you take other medicines that also affect your liver. Your doctor should do blood tests to check your liver:
within 6 months before you start taking Aubagio
once a month for 6 months after you start taking Aubagio
Call your doctor right away if you have any of the following symptoms of liver problems:
loss of appetite
your skin or the whites of your eyes turn yellow
Harm to your unborn baby: Aubagio may cause harm to your unborn baby. Do not take Aubagio if you are pregnant. Do not take Aubagio unless you are using effective birth control.
If you are a female, you should have a pregnancy test before you start taking Aubagio. Use effective birth control during your treatment with Aubagio.
After stopping Aubagio, continue using effective birth control until you have blood tests to make sure your blood levels of Aubagio are low enough. If you become pregnant while taking Aubagio or within 2 years after you stop taking it, tell your doctor right away.
For men taking Aubagio:
If your female partner plans to become pregnant, you should stop taking Aubagio and ask your doctor how to quickly lower the levels of Aubagio in your blood.
If your female partner does not plan to become pregnant, you and your female partner should use effective birth control during your treatment with Aubagio. Aubagio remains in your blood after you stop taking it, so continue using effective birth control until Aubagio blood levels have been checked and they are low enough.
Aubagio may stay in your blood for up to 2 years after you stop taking it. Your doctor can prescribe a medicine to help lower your blood levels of Aubagio more quickly. Talk to your doctor if you want more information about this.
What is Aubagio?
Aubagio is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS). Aubagio can decrease the number of MS flare-ups (relapses). Aubagio does not cure MS, but it can help slow down the physical problems that MS causes.
It is not known if Aubagio is safe and effective in children.
Who should not take Aubagio?
Do not take Aubagio if you:
have severe liver problems
are pregnant or are of childbearing age and not using effective birth control
take a medicine called leflunomide
What are the ingredients in Aubagio?
Active ingredient: teriflunomide
Inactive ingredients: lactose monohydrate, corn starch, hydroxypropylcellulose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol and indigo carmine aluminum lake.
Aubagio side effects
Aubagio may cause serious side effects, including:
See What is the most important information I should know about Aubagio?
decreases in your white blood cell count. Your white blood cell counts should be checked before you start taking Aubagio. When you have a low white blood cell count you:
may have more frequent infections. You should have a skin test for TB (Tuberculosis) before you start taking Aubagio.
Tell your doctor if you have any of these symptoms of an infection:
should not receive certain vaccinations during your treatment with Aubagio and for 6 months after your treatment with Aubagio ends.
numbness or tingling in your hands or feet that is different from your MS symptoms. You have a greater chance of getting peripheral neuropathy if you:
are over 60 years of age
take certain medicines that affect your nervous systemhave diabetes
Tell your doctor if you have numbness or tingling in your hands or feet that is different from your MS.
kidney problems. Tell your doctor if you have pain in your side (flank pain).
high potassium levels in your blood. Tell your doctor if you have nausea that does not go away or a racing heartbeat.
serious skin problems. Tell your doctor if you have any skin problems such as redness and peeling.
new or worsening breathing problems. Tell your doctor if you have shortness of breath or coughing with or without fever.
high blood pressure. Your doctor should check your blood pressure before you start taking Aubagio and while you are taking Aubagio.
The most common side effects of Aubagio include:
increases in the results of blood tests to check your liverhair thinning or loss (alopecia)
burning or prickling feeling in your skin (paraesthesia)