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Indication and Important Safety Information Prescribing Information Medication Guide

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Do not take AUBAGIO if you have severe liver problems, are pregnant or of childbearing potential and not using effective birth control, have had an allergic reaction to AUBAGIO or leflunomide, or are taking a medicine called leflunomide for rheumatoid arthritis. View IMPORTANT SAFETY INFORMATION.

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Aubagio & You > Specialty pharmacy, explained

Specialty pharmacy, explained

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Learn about support your specialty pharmacy can offer to help you get started on AUBAGIO and stay with it as prescribed.

A specialty pharmacy is different than a traditional retail pharmacy you might find in your neighborhood. A specialty pharmacy focuses on medication therapy for more complex disease states such as cancer, rheumatoid arthritis and multiple sclerosis.1

Specialty pharmacies can provide medications that are not generally kept in stock by a local drug store. They can handle medications that require special shipping and storage conditions (such as refrigeration). They also offer specialized, knowledgeable support and counseling for their patients.

You can expect that your specialty pharmacy can offer helpful support when it comes to taking AUBAGIO for treating relapsing MS.

Four tips to getting started with your specialty pharmacy

  1. It all starts when you connect with your dedicated nurse at MS One to One. Your Nurse will help determine your insurance benefits and connect you to the specialty pharmacy required by your insurance.
  2. You should expect a phone call from the Specialty Pharmacy a couple of days after the information has been sent to them from MS One to One. Your specialty pharmacy will contact you to review some information and set up your first shipment of AUBAGIO. Be on the lookout for this call from your Specialty Pharmacy as it’s important to get you started on AUBAGIO in a timely fashion!
  3. If you have questions about your Specialty Pharmacy shipments, you can call your Specialty Pharmacy directly, or call MS One to One at 1-855-676-6326 and your dedicated nurse can assist you.
  4. When you connect with your specialty pharmacy, be sure to ask for your medication to be filled via auto-refill. This means your medication will be shipped to you regularly as your doctor has prescribed.

How can my specialty pharmacy provide support?

You should consider your specialty pharmacy another member of your supportive healthcare team. They can offer helpful guidance for certain questions you might have. Here’s a handy guide of what you can expect from your pharmacy, and questions you might want to ask.

Your specialty pharmacy will ship your AUBAGIO prescription directly to your home, in a timely fashion, so you can take AUBAGIO as your doctor prescribed.

What you can ask to learn more?

  • Do they offer 24-hour access to pharmacists?
  • Do they provide voice, text, or email confirmations when they ship medication?

Your specialty pharmacy will be in communication with your doctor and can help handle prior authorization requests.

What you can ask to learn more?

  • Can they offer help if you need to learn more about patient assistance programs or financial assistance?
  • Remember that your MS One to One Nurse can be a helpful resource if you cannot afford your medication.

Your specialty pharmacy can review certain questions about taking AUBAGIO, such as when and how it should be taken and how it should be stored.

What you can ask to learn more?

  • Will they be proactive when it’s time for prescription refill and renewal so that you have no gaps in your medication shipment?
  • Do they offer a mobile app or other tools that can help you with remembering to take your medication or other helpful tips and information?

Your specialty pharmacy has pharmacists available to answer questions and may be able to offer tips to help with certain side effects, such as an upset stomach, hair thinning or loss, or headache.

What you can ask to learn more?

  • Can they offer tips to help you stay on therapy as prescribed?

IMPORTANT SAFETY INFORMATION

Do not take AUBAGIO if you have severe liver problems. AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. View More

INDICATION

AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

DO NOT TAKE AUBAGIO IF YOU:
  • Have severe liver problems. AUBAGIO may cause serious liver problems, including liver failure that can be life-threatening and may require a liver transplant. Your risk may be higher if you already have liver problems or take other medicines that affect your liver. Your healthcare provider should do blood tests to check your liver within 6 months before you start AUBAGIO and monthly for 6 months after starting AUBAGIO. Tell your healthcare provider right away if you develop any of these symptoms of liver problems: nausea, vomiting, stomach pain, loss of appetite, tiredness, yellowing of your skin or whites of your eyes, or dark urine.
  • Are pregnant. AUBAGIO may harm an unborn baby. You should have a pregnancy test before starting AUBAGIO. After stopping AUBAGIO, continue to use effective birth control until you have made sure your blood levels of AUBAGIO are lowered. 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.

  • Are of childbearing potential and not using effective birth control.

    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 are a man whose partner plans to become pregnant, you should stop taking AUBAGIO and talk with your healthcare provider about reducing the levels of AUBAGIO in your blood. If your partner does not plan to become pregnant, use effective birth control while taking AUBAGIO.

  • Have had an allergic reaction to AUBAGIO or a medicine called leflunomide.
  • Take a medicine called leflunomide for rheumatoid arthritis.

AUBAGIO may stay in your blood for up to 2 years after you stop taking it. Your healthcare provider can prescribe a medicine that can remove AUBAGIO from your blood quickly.

Before taking AUBAGIO, talk with your healthcare provider if you have: liver or kidney problems; a fever or infection, or if you are unable to fight infections; numbness or tingling in your hands or feet that is different from your MS symptoms; diabetes; serious skin problems when taking other medicines; breathing problems; or high blood pressure. Your healthcare provider will check your blood cell count and TB test before you start AUBAGIO. Talk with your healthcare provider if you take or are planning to take other medicines (especially medicines for treating cancer or controlling your immune system), over-the-counter medicines, vitamins or herbal supplements.

AUBAGIO may cause serious side effects. Tell your doctor if you have any of the following:

  • decreases in white blood cell count — this may cause you to have more infections. Symptoms include fever, tiredness, body aches, chills, nausea, or vomiting. Patients with low white blood cell count should not receive certain vaccinations during AUBAGIO treatment and 6 months after.
  • allergic reactions such as difficulty breathing, itching, or swelling on any part of your body including lips, eyes, throat, or tongue. Stop taking AUBAGIO and call your doctor right away.
  • serious skin reactions that may lead to death. Stop taking AUBAGIO if you have rash or redness and peeling, mouth sores or blisters.
  • other allergic reactions that may affect different parts of the body. If you have a fever or rash in combination with severe muscle pain, swollen lymph glands, swelling of your face, unusual bruising or bleeding, weakness or tiredness, or yellowing of your skin or the whites of your eyes, stop taking AUBAGIO and call your doctor right away.
  • numbness or tingling in your hands or feet that is different from your MS symptoms
  • high blood pressure
  • breathing problems (new or worsening) — these may be serious and lead to death

The most common side effects when taking AUBAGIO include: headache; diarrhea; nausea; hair thinning or loss; and abnormal liver test results. These are not all the side effects of AUBAGIO. Tell your healthcare provider about any side effect that bothers you.

Consult your healthcare provider if you have questions about your health or any medications you may be taking, including AUBAGIO.

Please click here for full Prescribing Information, including boxed WARNING and Medication Guide.

Reference

1. Specialty pharmacy: A unique and growing industry. American Pharmacists Association. July 1, 2013.
https://www.pharmacist.com/specialty-pharmacy-unique-and-growing-industry accessed on 3/22/19.