Aubagio (teriflunomide) Side effects, Cost, Prescribing Information

Category: Multiple Sclerosis by Lisa Binsin, PharmD - August 26, 2013 | Views: 3832 | Likes: 0 | Comment: 0

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Aubagio | teriflunomide

Medication Class: Dihydroorotate dehydrogenase inhibitor (enzyme involved in de novo pyrimidine synthesis)
Manufacturer: Genzyme A Sanofi Company
Approval Date: September 13, 2012

Aubagio (teriflunomide) Side effects, Cost, Prescribing Information

What is Aubagio and how does it work (mechanism of action)

Aubagio’s exact mechanism of action for treating multiple sclerosis (MS) is unknown. It blocks the production of white blood cells (T and B lymphocytes) which limits over activation of the body’s immune response. In doing so, it reduces flare up of MS.

What does Aubagio treat  

Aubagio is an oral medication used for treatment of patients with relapsing forms of multiple sclerosis. Relapsing forms of multiple sclerosis are defined as having periods of worsening of function followed by periods of temporary improvement. Relapsing patients may develop new or previous symptoms such as loss of sensitivity, muscle weakness, numbness or tingling sensations.

How effective is Aubagio

A 2-year clinical trial showed that patients on 14 mg Aubagio had a 31% reduction in MS relapse versus placebo (sugar pill). Patients on Aubagio 7 mg also showed similar reductions in MS relapse. The clinical trial included 1,000 patients and measured relapses, disability progression and MRI brain lesions. There was 80% reduction in brain lesions in patients on Aubagio 14 mg and 57% reduction in patients on 7 mg. Lastly, participants in the trial were 30% and 24%  less likely to have disability progression if they were taking Aubagio 14 mg and 7 mg respectively.

What are the side effects of Aubagio

Common: The most common side effects include diarrhea, abnormal liver tests, nausea, hair thinning or loss, flu-like symptoms, and paresthesia (tingling, tickling, prickling, or burning sensation in arms and legs)

Serious:

  • Reduced white blood cell count. This may increase risk of infections. 
  • Kidney problems
  • High potassium levels in your blood
  • Serious skin problems
  • Breathing problems (new or worsening)
  • High blood pressure

What is the dosage of Aubagio

Forms and strength:  Aubagio comes in 7 mg and 14 mg film-coated tablets

Dosing: 7 mg or 14 mg orally once daily with or without food

Aubagio drug interactions

Aubagio interacts with drugs broken down by certain liver enzymes (CYP2C8 enzymes), increasing their levels. It can also increase blood levels of many oral contraceptives (for example, ethinylestradiol and levonorgestrel). Aubagio can increase the chances of clotting in patients taking Warfarin, thus caution is advised.

What is the price of Aubagio

The cost of either strength of Aubagio is approximately $148.35 per pill or $4,153.85 per month.

How to obtain prescription assistance for Aubagio

For people who have primary commercial insurance, there is the Aubagio One to One Co-Pay Program which helps with out-of-pocket expenses, including co-pays and co-insurance.

People without insurance can be enrolled in the Aubagio One to One Co-pay Program that will assist them with their first 3 fills of Aubagio at no cost. Subsequent prescriptions for a 28 day supply will be no more than $35 each.

Interesting facts about Aubagio

  • Aubagio is one of only 3 oral medications that is currently FDA approved for treating relapsing MS.
  • Aubagio can remain in your body for up to 2 years after you have stopped taking it.
  • A man who is taking Aubagio and whose partner plans to become pregnant needs to stop the medication and talk to their doctor. There is a pregnancy registry for women taking Aubagio to help monitor outcomes in women who accidentally become pregnant by calling 1-800-745-4447, option 2.

For more information about Aubagio visit the following websites

www.aubagio.com

www.nationalmssociety.org

References

Genzyme; genzyme's once-daily, oral AUBAGIO(R) teriflunomide approved in argentina for the treatment of relapsing multiple sclerosis. (2013). Pharma Business Week

Aubagio Package Insert. Sanofi, Sept. 2012. Web. 23 Aug. 2013. 

Aubagio. Genzyme A Sanofi Company, Sept. 2013. Retrieved August 23, 2013 from 

MS National Multiple Sclerosis Society. Aubagio. Retrieved August 25, 2013 

 

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