Aubagio

Approved Uses

Aubagio is indicated for the treatment of various relapsing forms of multiple sclerosis (MS) in adults. This includes the following conditions:

• Clinically isolated syndrome (CIS): A first episode of neurologic symptoms that may lead to MS.
• Relapsing-remitting disease (RRMS): A form of MS where patients experience clear attacks of symptoms followed by periods of recovery.
• Active secondary progressive disease (SPMS): A stage of MS that follows a relapsing-remitting course and continues to show signs of active relapses or new imaging changes.

Treatment Goals

The primary goals of treatment with Aubagio are to:

• Reduce the frequency of clinical flare-ups (relapses).
• Slow the progression of physical disability associated with the disease.

Aubagio is intended to help manage the course of MS over time; however, it is not a cure for the condition.

Aubagio belongs to a class of drugs known as immunomodulatory agents. While the exact way it works to treat multiple sclerosis (MS) is not fully understood, it is believed to work by limiting the overactivity of the immune system.

In people with MS, certain white blood cells called lymphocytes attack the protective covering of nerves in the brain and spinal cord. Aubagio works by blocking a specific enzyme that these cells need to multiply quickly. By reducing the number of these activated immune cells, the medication helps:

• Decrease inflammation: By lowering the number of activated immune cells, there is less inflammation in the central nervous system.
• Lower relapse rates: Reducing the immune attack helps decrease the frequency of MS flare-ups.
• Slow disability progression: By protecting nerves from damage, the medication can help slow the worsening of physical symptoms.

Because it targets the production of these cells, Aubagio helps prevent them from reaching the brain and spinal cord where they would otherwise cause damage to the nerves.

Common Side Effects

Many people taking Aubagio experience mild to moderate side effects. These may include:

• Hair thinning or hair loss
• Diarrhea
• Nausea
• Headache
• Abnormal liver function test results
• Numbness or tingling in the hands or feet
• Joint pain
• Cold or flu-like symptoms

Serious Side Effects

While less common, some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Signs of liver problems, such as yellowing of the skin or eyes, dark urine, or pain in the upper right stomach area
• Severe skin reactions, including rash, peeling skin, or mouth sores
• New or worsening lung symptoms, such as shortness of breath or a persistent cough
• Significant increases in blood pressure
• Signs of infection, such as fever, chills, or persistent sore throat
• Severe pain, burning, or weakness in the hands or feet

Boxed Warnings

Liver Injury

Aubagio can cause severe liver injury, including cases of fatal liver failure. Healthcare providers typically check liver enzyme levels (ALT) within six months before starting treatment and then monthly for the first six months of therapy. Treatment is stopped if significant liver injury is suspected.

Fetal Harm

This medication may cause serious birth defects or fetal death if taken during pregnancy. It is contraindicated for pregnant women or those of childbearing potential who are not using effective contraception. Because the drug can remain in the body for up to two years after stopping, an accelerated elimination procedure using specific medications may be necessary for those wishing to become pregnant or for men fathering a child.

Other Serious Precautions

Infections

Aubagio may decrease the body's ability to fight infections by lowering white blood cell counts. Screening for latent tuberculosis (TB) is required before starting treatment. Patients are monitored for signs of active infection, and treatment may be delayed if a serious infection is present.

Blood Pressure

Increases in blood pressure can occur during treatment. Blood pressure is usually checked before starting the medication and periodically thereafter. Management of hypertension may be necessary while taking this drug.

Respiratory Effects

Interstitial lung disease and other lung problems have been reported. New or worsening pulmonary symptoms, such as a persistent cough or shortness of breath, require medical evaluation, as these conditions can be fatal.

Skin Reactions

Serious and sometimes fatal skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have occurred. Treatment is discontinued if a severe skin reaction or suspicious rash develops.

Peripheral Neuropathy

Some individuals may experience nerve damage, known as peripheral neuropathy. Symptoms include numbness, tingling, or burning sensations in the hands or feet. This risk may be higher in patients over age 60 or those taking other medications associated with nerve damage.

Pregnancy Risks

Aubagio carries a high risk of causing severe birth defects or fetal death. It is contraindicated for use in pregnant women and those of childbearing potential who are not using reliable contraception. A pregnancy test is typically required before starting the medication to confirm the patient is not pregnant.

Long-term Presence in the Body

After stopping Aubagio, the drug can remain in the blood for up to two years. If a patient wishes to become pregnant or if an unplanned pregnancy occurs, healthcare providers may perform an accelerated elimination procedure. This involves taking specific medications, such as cholestyramine or activated charcoal, to help the body clear the drug more quickly.

Men taking Aubagio should also be aware that the drug can be passed through semen. Men who plan to father a child should talk to their doctor about the potential risks and the elimination procedure.

Breastfeeding

It is currently unknown if Aubagio is excreted in human breast milk. Because of the risk of serious adverse reactions in nursing infants, breastfeeding is not recommended while taking this medication. Patients should consult with their healthcare provider to weigh the benefits of treatment against the risks of breastfeeding.

Dosage Forms

Aubagio is available in the following form:

• Film-coated tablet: This medication is an oral tablet intended to be swallowed whole.

FDA Approval and Indications

Aubagio (teriflunomide) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing forms of multiple sclerosis (MS) in adults. The approved indications include:

• Clinically isolated syndrome
• Relapsing-remitting disease
• Active secondary progressive disease

Boxed Warnings

The FDA requires a boxed warning for Aubagio due to two significant safety concerns:

• Severe Liver Injury: There is a risk of severe liver damage, which can be fatal. Healthcare providers are required to conduct blood tests to evaluate liver function before starting the medication and continue monitoring periodically during treatment.
• Teratogenicity (Birth Defects): Aubagio may cause serious birth defects or fetal death if taken during pregnancy. It is strictly contraindicated for use in pregnant women or women of childbearing potential who are not using effective contraception.

Safety Monitoring and Communications

The FDA monitors the safety profile of Aubagio through the FDA Adverse Event Reporting System (FAERS). Regulatory authorities have identified potential signals of serious risks, such as drug-induced liver injury, which are evaluated to ensure the medication's labeling remains accurate. Additionally, a pregnancy exposure registry exists to monitor the outcomes of individuals who may have been exposed to the drug during pregnancy.

Generic Availability

Generic versions of Aubagio, known as teriflunomide, are available. Generic medications typically cost significantly less than brand-name drugs while providing the same active ingredient and therapeutic effect.

Insurance and Prior Authorization

Most health insurance plans provide coverage for Aubagio or its generic equivalent, but the specific out-of-pocket cost depends on the plan's formulary. Many insurance companies require prior authorization, which means a healthcare provider must submit documentation to the insurer to justify the medical necessity of the drug before coverage is approved.

Specialty Pharmacy Requirements

Aubagio is often classified as a specialty medication. Because of this, it is frequently dispensed through specialty pharmacies rather than standard retail pharmacies. Specialty pharmacies may offer additional support services but can have different billing and delivery procedures.

Financial Assistance Programs

The manufacturer of Aubagio may offer patient assistance programs or copay cards to help reduce costs for eligible individuals. Additionally, some non-profit organizations provide financial support or grants for patients with multiple sclerosis who are unable to afford their medication.