Aubagio Labeling Updated with New Contraindication, Warnings
The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Aubagio (teriflunomide; Genzyme) that includes revisions to the Contraindications, Warnings and Precautions, Adverse Reactions, Patient Counseling Information, and the Medication Guide.
The Contraindications section has been updated to state Aubagio is contraindicated in patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in Aubagio. Reactions have included anaphylaxis, angioedema, and serious skin reactions.
A new update to the Bone Marrow Effects/Immunosuppression Potential/Infections section under Warnings and Precautions indicates that cases of thrombocytopenia have been reported with Aubagio in the post-marketing setting. Rare cases have reported platelet counts less than 50,000/mm3.
The sNDA also includes the addition of a new Warnings and Precautions subsection, "Section 5.5 Hypersensitivity and Serious Skin Reactions," describing the risk of hypersensitivity and serious skin reactions with Aubagio. Patients should be instructed to discontinue Aubagio and seek immediate medical care if signs and symptoms of anaphylaxis, angioedema, or a serious skin reaction occur. An accelerated elimination procedure should be started immediately, in which patients should not be re-exposed to Aubagio.
The Post-marketing Experience section was updated to include hypersensitivity reactions, severe skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome), thrombocytopenia, interstitial lung disease, and pancreatitis.
Changes to the Patient Counseling Information and the Medication Guide were made to reflect the respective updates made to the Contraindications and Warnings and Precautions sections.
Aubagio is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis. It is available as 7mg and 14mg strength tablets in 5- and 28-count cartons.
For more information call (800) 745-4447 or visit Aubagio.com.