Saphris (Asenapine Maleate) - Indications and Dosage

INDICATIONS AND USAGE

Schizophrenia

SAPHRIS is indicated for the acute treatment of schizophrenia in adults [see Clinical Studies]. The physician who elects to use SAPHRIS for extended periods in schizophrenia should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient [see Dosage and Administration].

Bipolar Disorder

SAPHRIS is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults [see Clinical Studies]. If SAPHRIS is used for extended periods in bipolar disorder, the physician should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient [see Dosage and Administration].

DOSAGE AND ADMINISTRATION

Schizophrenia

Usual Dose for Acute Treatment in Adults: The recommended starting and target dose of SAPHRIS is 5 mg given twice daily. In controlled trials, there was no suggestion of added benefit with the higher dose, but there was a clear increase in certain adverse reactions. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies.

Maintenance Treatment: While there is no body of evidence available to answer the question of how long the schizophrenic patient should remain on SAPHRIS, it is generally recommended that responding patients be continued beyond the acute response.

Bipolar Disorder

Usual Dose for Acute Treatment in Adults: The recommended starting dose of SAPHRIS, and the dose maintained by 90% of the patients studied, is 10 mg twice daily. The dose can be decreased to 5 mg twice daily if there are adverse effects.

In controlled trials, the starting dose for SAPHRIS was 10 mg twice daily. On the second and subsequent days of the trials, the dose could be lowered to 5 mg twice daily, based on tolerability, but less than 10% of patients had their dose reduced. The safety of doses above 10 mg twice daily has not been evaluated in clinical trials.

Maintenance Treatment: While there is no body of evidence available to answer the question of how long the bipolar patient should remain on SAPHRIS, it is generally recommended that responding patients be continued beyond the acute response.

Administration Instructions

SAPHRIS is a sublingual tablet. To ensure optimal absorption, patients should be instructed to place the tablet under the tongue and allow it to dissolve completely. The tablet will dissolve in saliva within seconds. SAPHRIS sublingual tablets should not be crushed, chewed, or swallowed [see Clinical Pharmacology]. Patients should be instructed to not eat or drink for 10 minutes after administration [see Clinical Pharmacology and Patient Counseling Information].

Dosage in Special Populations

In a study of subjects with hepatic impairment who were treated with a single dose of SAPHRIS 5 mg, there were increases in asenapine exposures (compared to subjects with normal hepatic function), that correlated with the degree of hepatic impairment. While the results indicated that no dosage adjustments are required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, there was a 7-fold increase (on average) in asenapine concentrations in subjects with severe hepatic impairment (Child-Pugh C) compared to the concentrations of those in subjects with normal hepatic function. Therefore, SAPHRIS is not recommended in patients with severe hepatic impairment [ see Use in Special Populations ]. Dosage adjustments are not routinely required on the basis of age, gender, race, or renal impairment status [see Use in Specific Populations (8.4, 8.5, 8.6) and Clinical Pharmacology].

Switching from Other Antipsychotics

There are no systematically collected data to specifically address switching patients with schizophrenia or bipolar mania from other antipsychotics to SAPHRIS or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.

DOSAGE FORMS AND STRENGTHS

• SAPHRIS 5-mg tablets are round, white- to off-white sublingual tablets, with "5" on one side.
• SAPHRIS 10-mg tablets are round, white- to off-white sublingual tablets, with "10" on one side.
• SAPHRIS 5-mg tablets, black cherry flavor, are round, white- to off-white sublingual tablets, with "5" on one side within a circle.
• SAPHRIS 10-mg tablets, black cherry flavor, are round, white- to off-white sublingual tablets, with "10" on one side within a circle.

HOW SUPPLIED/STORAGE AND HANDLING

SAPHRIS (asenapine) sublingual tablets are supplied as:

5-mg Tablets

Round, white- to off-white sublingual tablets, with "5" on one side.

Child-resistant packaging
Box of 60	6 blisters with 10 tablets	NDC 0052-0118-06
Hospital Unit Dose
Box of 100	10 blisters with 10 tablets	NDC 0052-0118-90

10-mg Tablets

Round, white- to off-white sublingual tablets, with "10" on one side.

Child-resistant packaging
Box of 60	6 blisters with 10 tablets	NDC 0052-0119-06
Hospital Unit Dose
Box of 100	10 blisters with 10 tablets	NDC 0052-0119-90

5-mg Tablets, black cherry flavor

Round, white- to off-white sublingual tablets, with "5" on one side within a circle.

Child-resistant packaging
Box of 60	6 blisters with 10 tablets	NDC 0052-2139-03
Hospital Unit Dose
Box of 100	10 blisters with 10 tablets	NDC 0052-2139-04

10-mg Tablets, black cherry flavor

Round, white- to off-white sublingual tablets, with "10" on one side within a circle.

Child-resistant packaging
Box of 60	6 blisters with 10 tablets	NDC 0052-2142-03
Hospital Unit Dose
Box of 100	10 blisters with 10 tablets	NDC 0052-2142-04

Storage

Store at 15°-30°C (59°-86°F) [ see USP Controlled Room Temperature].