Contraindications : התוויות נגד

Contraindications (4)                                        08/2011                     blood cell count (WBC) or a history of leukopenia/neutropenia
Warnings and Precautions, Hypersensitivity Reactions (5.7) 08/2011                       should have their complete blood count (CBC) monitored frequently during the first few months of therapy and SAPHRIS should be discontinued at the first sign of a decline in WBC in the
---------------------------INDICATIONS AND USAGE----------------------------- absence of other causative factors. (5.9)
SAPHRIS is an atypical antipsychotic indicated for:
•      QT Prolongation: Increases in QT interval; avoid use with drugs
•     Treatment of schizophrenia in adults. (1.1)                                        that also increase the QT interval and in patients with risk factors Efficacy was established in two 6-week clinical trials and one                     for prolonged QT interval. (5.10) maintenance trial in patients with schizophrenia in adults. (14.1)
•      Seizures: Use cautiously in patients with a history of seizures or
•     Acute treatment, as monotherapy or adjunctive therapy, of manic                    with conditions that lower the seizure threshold. (5.12) or mixed episodes associated with bipolar I disorder. (1.2)
•      Potential for Cognitive and Motor Impairment: Use caution when Efficacy was established in two 3-week monotherapy trials and in                   operating machinery. (5.13) one 3-week adjunctive trial in patients with manic or mixed
•      Suicide: The possibility of a suicide attempt is inherent in episodes associated with bipolar I disorder in adults. (14.2) schizophrenia and bipolar disorder. Closely supervise high-risk
-------------------------DOSAGE AND ADMINISTRATION----------------------                 patients. (5.15) -------------------------------ADVERSE REACTIONS------------------------------ Commonly observed adverse reactions (incidence ≥5% and at least
Starting       Recommended             Maximum          twice that for placebo) were (6.2): Dose              Dose                  Dose           •      Schizophrenia: akathisia, oral hypoesthesia, and somnolence.
Schizophrenia –             5 mg              5 mg                 10 mg          •      Bipolar Disorder (Monotherapy): somnolence, dizziness, acute treatment in      sublingually      sublingually          sublingually             extrapyramidal symptoms other than akathisia, and weight adults (2.2)             twice daily       twice daily           twice daily             increased.
•      Bipolar Disorder (Adjunctive): somnolence and oral hypoesthesia.
Schizophrenia –             5 mg               10 mg               10 mg maintenance             sublingually        sublingually        sublingually       -------------------------------DRUG INTERACTIONS------------------------------ treatment in adults      twice daily         twice daily         twice daily      •      Fluvoxamine (strong CYP1A2 inhibitor) and Paroxetine (CYP2D6 (2.2)                      for one                                                       substrate and inhibitor): cautiously approach coadministration with week                                                         SAPHRIS. (7.1, 7.2) 
--------------------------USE IN SPECIFIC POPULATIONS--------------------- Bipolar mania –            10 mg              5-10 mg              10 mg •      Pregnancy: Use SAPHRIS during pregnancy only if the potential adults:                 sublingually        sublingually        sublingually benefit justifies the potential risk. (8.1) monotherapy (2.3)        twice daily         twice daily         twice daily •      Nursing Mothers: Breast feeding is not recommended. (8.3)
•      Pediatric Use: Safety and effectiveness have not been
Bipolar mania –             5 mg              5-10 mg              10 mg                 established. (8.4) adults:                 sublingually        sublingually        sublingually      •      Renal Impairment: No dose adjustment needed. (8.6) as an adjunct to         twice daily         twice daily         twice daily      •      Hepatic Impairment: SAPHRIS is not recommended in patients lithium or                                                                               with severe hepatic impairment (Child-Pugh C). (2.4, 8.7, 12.3) valproate (2.3)
See 17 for PATIENT COUNSELING INFORMATION
Administration: Do not swallow tablet. SAPHRIS sublingual tablets                                                                           Revised: 08/2011 should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration. (2.1, 17.1)

-----------------------DOSAGE FORMS AND STRENGTHS-------------------- Sublingual tablets: 5 mg and 10 mg (3)

-----------------------------CONTRAINDICATIONS--------------------------------- Known hypersensitivity to SAPHRIS (asenapine), or to any components in the formulation. (4, 5.7, 17.3)
FULL PRESCRIBING INFORMATION: CONTENTS*                          8    USE IN SPECIFIC POPULATIONS 8.1 Pregnancy
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS                      8.2 Labor and Delivery WITH DEMENTIA-RELATED PSYCHOSIS                                       8.3 Nursing Mothers 1 INDICATIONS AND USAGE                                               8.4 Pediatric Use 1.1 Schizophrenia                                                  8.5 Geriatric Use 1.2 Bipolar Disorder                                               8.6 Renal Impairment 2 DOSAGE AND ADMINISTRATION                                           8.7 Hepatic Impairment
2.1 Administration Instructions                               9    DRUG ABUSE AND DEPENDENCE
2.2 Schizophrenia                                                  9.1 Controlled Substance
2.3 Bipolar Disorder                                               9.2 Abuse
2.4 Dosage in Special Populations                             10   OVERDOSAGE
2.5 Switching from Other Antipsychotics                       11   DESCRIPTION
3 DOSAGE FORMS AND STRENGTHS                                     12   CLINICAL PHARMACOLOGY
4 CONTRAINDICATIONS                                                   12.1 Mechanism of Action