Saphris is now approved for use as maintenance monotherapy treatment in adults with bipolar I disorder. The patient should continue on the Saphris dose that was administered during stabilization (5–10mg twice daily). Based on the clinical response and tolerability in the patient, a dose of 10mg twice daily can be decreased to 5mg twice daily. The safety of doses greater than 10mg twice daily has not been evaluated in clinical trials.
For the acute treatment of manic or mixed episodes in bipolar I disorder, the recommended starting and treatment dose for monotherapy in adults has been changed to 5–10mg twice daily. The safety of doses greater than 10mg twice daily has not been evaluated in clinical trials. Previously, monotherapy in adults was recommended at 10mg twice daily.
The Contraindications section has been updated to state that Saphris is contraindicated in patients with a history of hypersensitivity reactions to asenapine. Reactions have included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing and rash.
Saphris is already indicated for the treatment of schizophrenia in adults and as acute treatment of manic or mixed episodes associated with bipolar I disorder, as monotherapy in adults and pediatric patients aged 10–17 years or adjunctive therapy with lithium or valproate in adults.
Saphris, an atypical antipsychotic, is available as 2.5mg, 5mg, and 10mg black-cherry flavored sublingual tablets in 60-count boxes.