SAPHRIS Tablet (2017)

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Allergan, Inc.

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BOXED WARNING SECTION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...

1. Indications and Usage

SAPHRIS is indicated for: Schizophrenia in adults [see Clinical Studies (14.1)] Bipolar I disorder [see Clinical Studies (14.2)] Acute monotherapy of manic or mixed episodes, in adults ...

2. Dosage and Administration

2.1 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 ...

3. Dosage Forms and Strengths

SAPHRIS 2.5 mg tablets, black cherry flavor, are round, white to off-white sublingual tablets, with a hexagon on one side. SAPHRIS 5 mg tablets, black cherry flavor, are round, white to off-white sublingual ...

4. Contraindications

SAPHRIS is contraindicated in patients with: Severe hepatic impairment (Child-Pugh C) [see Specific Populations (8.7), Clinical Pharmacology (12.3)].

5. Warnings and Precautions

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses ...

6. Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ...

6.1. Clinical Trials Experience

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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of SAPHRIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Drug Interactions with SAPHRIS Table 12. Clinically Important Drug Interactions with SAPHRIS: Concomitant Drug Name or Drug Class Clinical Rationale Clinical ...

8. Use in Specific Populations

8.8 Other Specific Populations No dosage adjustment for SAPHRIS is required on the basis of a patients sex, race (Caucasian and Japanese), or smoking status [see Clinical Pharmacology (12.3)] ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SAPHRIS during pregnancy. For more information contact the National Pregnancy Registry ...

8.2. Lactation

Risk Summary Lactation studies have not been conducted to assess the presence of asenapine in human milk, the effects of asenapine on the breastfed infant, or the effects of asenapine on milk production. ...

8.4. Pediatric Use

Safety and efficacy of SAPHRIS in pediatric patients below the age of 10 years of age have not been evaluated. Bipolar I Disorder The safety and efficacy of SAPHRIS as monotherapy in the treatment of bipolar ...

8.5. Geriatric Use

Clinical studies of SAPHRIS in the treatment of schizophrenia and bipolar mania did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than ...

8.6. Renal Impairment

No dosage adjustment for SAPHRIS is required on the basis of a patients renal function (mild to severe renal impairment, glomerular filtration rate between 15 and 90 mL/minute). The exposure of asenapine ...

8.7. Hepatic Impairment

SAPHRIS is contraindicated in patients with severe hepatic impairment (Child-Pugh C) because asenapine exposure is 7-fold higher in subjects with severe hepatic impairment than the exposure observed in ...

9.1. Controlled Substance

SAPHRIS is not a controlled substance.

9.2. Abuse

SAPHRIS has not been systematically studied in animals or humans for its abuse potential or its ability to induce tolerance or physical dependence. Thus, it is not possible to predict the extent to which ...

10. Overdosage

Human Experience: In adult pre-marketing clinical studies involving more than 3350 patients and/or healthy subjects, accidental or intentional acute overdosage of SAPHRIS was identified in 3 patients. ...

11. Description

SAPHRIS contains asenapine maleate which is an atypical antipsychotic that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation ...

12.1. Mechanism of Action

The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. It has been suggested that the efficacy of asenapine in schizophrenia could be mediated through a combination ...

12.2. Pharmacodynamics

Asenapine exhibits high affinity for serotonin 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2B, 5-HT2C, 5-HT5A, 5-HT6 and 5-HT7 receptors ...

12.3. Pharmacokinetics

Following a single 5 mg dose of SAPHRIS, the mean Cmax was approximately 4 ng/mL and was observed at a mean tmax of 1 hour. Elimination of asenapine is primarily through direct glucuronidation ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a lifetime carcinogenicity study in CD-1 mice asenapine was administered subcutaneously at doses up to those resulting in plasma levels (AUC) estimated to be 5 times those in humans receiving ...

14. Clinical Studies

Efficacy of SAPHRIS was established in the following trials: Two fixed-dose, short-term trials and one flexible-dose, maintenance trial in adult patients with schizophrenia as monotherapy [see Clinical ...

16.1. How Supplied

SAPHRIS (asenapine) sublingual tablets are supplied as: 2.5 mg Tablets, black cherry flavor: Round, white to off-white sublingual tablets, with a hexagon on one side. Child-resistant packaging: ...

16.2. Storage and Handling

Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Dosage and Administration Counsel patients on proper sublingual administration of SAPHRIS and advise them to ...