Label Changes for:
Saphris (asenapine) Sublingual Tablets
March 2013
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2013
ADVERSE REACTIONS
Postmarketing Experience
- The following adverse reactions have been identified during post-approval use of SAPHRIS. Application site reactions, primarily in the sublingual area, have been reported. These application site reactions included oral ulcers, blisters, peeling/sloughing, and inflammation. In many cases, the occurrence of these application site reactions led to discontinuation of therapy.
PATIENT COUNSELING INFORMATION
- Inform patients that application site reactions including oral ulcers, blisters, peeling/sloughing and inflammation have been reported. Instruct patients to monitor for these reactions.
October 2011
ADVERSE REACTIONS
Clinical Studies Experience
- Other Findings: Oral hypoesthesia and/or oral paraesthesia may occur directly after administration of asenapine and usually resolves within 1 hour.
USE IN SPECIAL POPULATIONS
Geriatric Use
- In elderly patients with psychosis, asenapine exposure (AUC) was on average 40% higher compared to younger adult patients [see Clinical Pharmacology (12.3)].
August 2011
CONTRAINDICATIONS
- Hypersensitivity reactions, including anaphylaxis and angioedema, have been observed in patients treated with asenapine. Therefore, SAPHRIS is contraindicated in patients with a known hypersensitivity to the product
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
- Hypersensitivity reactions, including anaphylaxis and angioedema, have been observed in patients treated with asenapine. In several cases, these reactions occurred after the first dose. These hypersensitivity reactions included: anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash.
ADVERSE REACTIONS
- Hypersensitivity reactions
PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions
- Patients should be informed of the signs and symptoms of a serious allergic reaction (e.g., difficulty breathing, itching, swelling of the face, tongue or throat, feeling lightheaded etc.). Patients should be instructed to seek immediate emergency assistance if they develop any of these signs and symptoms.
