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Aubagio

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Aubagio

Aubagio Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Aubagio (teriflunomide) is used to treat relapsing forms of multiple sclerosis (MS). Aubagio is a pyrimidine synthesis inhibitor. Side effects of Aubagio use are liver problems. Other side effects may include influenza, hair loss, nausea, and diarrhea.

The recommended dose for Aubagio is 7 mg or 14 mg taken orally, once daily, with or without food. Aubagio may increase exposure of ethinyl estradiol and levonorgestrel. Patients taking Coumadin (warfarin) should be closely monitored as interactions may occur. Aubagio may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting treatment with Aubagio. Pregnancy must be avoided while taking Aubagio treat relapsing forms of multiple sclerosis (MS). If Aubagio is used during pregnancy, or if the patient becomes pregnant while taking Aubagio, the drug should be discontinued immediately and an accelerated elimination procedure should be initiated. Consult your doctor before breastfeeding.

Our Aubagio (teriflunomide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Aubagio in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using teriflunomide and call your doctor at once if you have:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fast or racing heartbeats;
  • numbness or tingling in your hands or feet that feels different from your regular MS symptoms;
  • pain in your side or lower back, confusion, little or no urinating;
  • chest pain, dry cough, wheezing, feeling short of breath;
  • skin redness or peeling;
  • swelling, rapid weight gain; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • diarrhea;
  • thinning hair; or
  • burning or prickly feeing in your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Aubagio (Teriflunomide Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Aubagio FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the prescribing information:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 2047 patients receiving AUBAGIO (7 mg or 14 mg once daily) constituted the safety population in the pooled analysis of placebo controlled studies in patients with relapsing forms of multiple sclerosis; of these, 71% were female. The average age was 37 years.

Table 1 lists adverse reactions in placebo-controlled trials with rates that were at least 2% for AUBAGIO patients and also at least 2% above the rate in placebo patients. The most common were headache, an increase in ALT, diarrhea, alopecia, and nausea. The adverse reaction most commonly associated with discontinuation was an increase in ALT (3.3%, 2.6%, and 2.3% of all patients in the AUBAGIO 7 mg, AUBAGIO 14 mg, and placebo treatment arms, respectively).

Table 1: Adverse Reactions in Pooled Placebo-Controlled Studies in Patients with Relapsing Forms of Multiple Sclerosis

Adverse Reaction AUBAGIO 7 mg
(N=1045)
AUBAGIO 14 mg
(N=1002)
Placebo
(N=997)
Headache 18% 16% 15%
Increase in Alanine aminotransferase 13% 15% 9%
Diarrhea 13% 14% 8%
Alopecia 10% 13% 5%
Nausea 8% 11% 7%
Paresthesia 8% 9% 7%
Arthralgia 8% 6% 5%
Neutropenia 4% 6% 2%
Hypertension 3% 4% 2%

Cardiovascular Deaths

Four cardiovascular deaths, including three sudden deaths, and one myocardial infarction in a patient with a history of hyperlipidemia and hypertension were reported among approximately 2600 patients exposed to AUBAGIO in the premarketing database. These cardiovascular deaths occurred during uncontrolled extension studies, one to nine years after initiation of treatment. A relationship between AUBAGIO and cardiovascular death has not been established.

Acute Renal Failure

In placebo-controlled studies, creatinine values increased more than 100% over baseline in 8/1045 (0.8%) patients in the 7 mg AUBAGIO group and 6/1002 (0.6%) patients in the 14 mg AUBAGIO group versus 4/997 (0.4%) patients in the placebo group. These elevations were transient. Some elevations were accompanied by hyperkalemia. AUBAGIO may cause acute uric acid nephropathy with transient acute renal failure because AUBAGIO increases renal uric acid clearance.

Hypophosphatemia

In clinical trials, 18% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels of at least 0.6 mmol/L, compared to 7% of placebo-treated patients; 4% of AUBAGIO-treated patients had hypophosphatemia with serum phosphorus levels at least 0.3 mmol/L but less than 0.6 mmol/L, compared to 0.8% of placebo-treated patients. No patient in any treatment group had a serum phosphorus below 0.3 mmol/L.

Read the entire FDA prescribing information for Aubagio (Teriflunomide Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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