"The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic, inflammatory, autoimmune disease of the central nervous system"...
- Clinician Information:
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Aubagio FDA Prescribing Information: Side Effects
The following serious adverse reactions are described elsewhere in the prescribing information:
- Hepatotoxicity [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
- Bone Marrow Effects/Immunosuppression Potential/Infections [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Acute Renal Failure [see WARNINGS AND PRECAUTIONS]
- Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Blood Pressure Effects [see WARNINGS AND PRECAUTIONS]
- Respiratory Effects [see WARNINGS AND PRECAUTIONS]
The most frequent adverse reactions for AUBAGIO (incidence ≥ 10% and ≥ 2% greater than placebo) in the placebo-controlled studies were ALT increased, alopecia, diarrhea, influenza, nausea, and paresthesia. Alopecia was the most common cause of discontinuation because of adverse events in controlled clinical studies as compared to placebo (0.5% and 1.4% of patients on AUBAGIO 7 mg and 14 mg, respectively, and 0% on placebo).
If desired, teriflunomide can be rapidly cleared from the body by the use of an accelerated elimination procedure [see WARNINGS AND PRECAUTIONS].
Clinical Trial Experience
A total of 844 patients on teriflunomide (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 MS (RMS). Approximately 72% of patients were female and the mean age was 38 years.
Study 1 was a 108-week placebo-controlled clinical study in 1086 RMS patients treated with teriflunomide 7 mg (n=368), teriflunomide 14 mg (n=358), or placebo (n=360).
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.
Table 1 : Adverse Reactions in Study 1 (occurring in
≥ 2% of patients, and reported for teriflunomide 7 mg or 14 mg at ≥
2% higher rate than for placebo)
|PRIMARY SYSTEM ORGAN CLASS Preferred Term (%)||Teriflunomide|
|INFECTIONS AND INFESTATIONS|
|Upper respiratory tract infection||9%||9%||7%|
|BLOOD AND LYMPHATIC SYSTEM DISORDERS|
|IMMUNE SYSTEM DISORDERS|
|NERVOUS SYSTEM DISORDERS|
|Carpal tunnel syndrome||3%||1%||0.3%|
|Abdominal pain upper||6%||5%||4%|
|SKIN AND SUBCUTANEOUS TISSUE DISORDERS|
|MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS|
|Alanine aminotransferase increased||14%||12%||7%|
|Aspartate aminotransferase increased||3%||2%||1%|
|Neutrophil count decreased||2%||3%||0.3%|
|White blood cell count decreased||1%||3%||0%|
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 teriflunomide and cardiovascular death has not been established.
In clinical trials, 18% of teriflunomide-treated subjects had mild hypophosphatemia ( ≥ 0.6 mmol/L and < lower limit of normal), compared to 9% of placebo-treated subjects; 5% of teriflunomide-treated subjects had moderate hypophosphatemia ( ≥ 0.3 mmol/L and < 0.6 mmol/L), compared to 1% of placebo-treated subjects. No subject in either treatment group had a serum phosphorus < 0.3 mmol/L.
Read the entire FDA prescribing information for Aubagio (Teriflunomide Tablets) »
Additional Aubagio Information
- Aubagio Drug Interactions Center: teriflunomide oral
- Aubagio Side Effects Center
- Aubagio FDA Approved Prescribing Information including Dosage
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