WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED

INDICATIONS AND USAGE
FANAPT™ tablets are indicated for the acute treatment of adults with schizophrenia.
When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that FANAPT is associated with prolongation of the QTc interval. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially  fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether FANAPT will cause torsade de pointes or increase the rate of sudden death is not yet known.
Patients must be titrated to an effective dose of FANAPT. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the acute treatment of schizophrenia.
The effectiveness of FANAPT in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use FANAPT for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
 
DOSAGE AND ADMINISTRATION
Usual Dose
FANAPT must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg twice daily.
Increases to reach the target dose range of 6-12 mg twice daily may be made with daily dosage adjustments to 2 mg twice daily, 4 mg twice daily, 6 mg twice daily, 8 mg twice daily, 10 mg twice daily, and 12 mg twice daily on days 2, 3, 4, 5, 6, and 7, respectively. Efficacy was demonstrated with FANAPT in a dose range of 6 to 12 mg twice daily. Prescribers should be mindful of the fact that patients need to be titrated to an effective dose of FANAPT. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some  other antipsychotic drugs that do not require similar titration.
Prescribers should also be aware that some adverse effects associated with FANAPT use are dose related.      
The maximum recommended dose is 12 mg twice daily (24  mg/day); FANAPT doses above 24 mg/day have not been systematically evaluated in the clinical trials.
FANAPT can be administered without regard to meals.

DOSAGE AND ADMINISTRATION
Usual Dose
FANAPT must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alpha-adrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg twice daily.
Increases  to  reach  the  target  dose  range  of  6-12  mg  twice  daily  may  be  made  with  daily  dosage adjustments to 2 mg twice daily, 4 mg twice daily, 6 mg twice daily, 8 mg twice daily, 10 mg twice daily, and 12 mg twice daily on days 2, 3, 4, 5, 6, and 7, respectively.  Efficacy was demonstrated with FANAPT in a dose range of 6 to 12 mg twice daily.   Prescribers should be mindful of the fact that patients need to be titrated to an effective dose of FANAPT. Thus, control of symptoms may be delayed during the first 1 to 2 weeks  of  treatment  compared  to  some  other  antipsychotic  drugs  that  do  not  require  similar  titration.
Prescribers should also be aware that some adverse effects associated with FANAPT use are dose related.      
The  maximum  recommended  dose  is  12  mg  twice  daily  (24  mg/day);  FANAPT doses  above  24  mg/day have not been systematically evaluated in the clinical trials.
FANAPT can be administered without regard to meals.

Dosage in Special Populations
Dosage adjustments are not routinely indicated on the bases of age, gender, race, or renal impairment status.
Dosage adjustment for patients taking FANAPT concomitantly with potential CYP2D6  inhibitors:
FANAPT dose should be reduced by one-half when administered concomitantly with strong  CYP2D6 inhibitors such as fluoxetine or paroxetine. When the CYP2D6 inhibitor is withdrawn from the combination therapy, FANAPT dose should then be increased to where it was before.
Dosage adjustment for patients taking FANAPT concomitantly with potential CYP3A4 inhibitors:
FANAPT dose should be reduced by one-half when administered concomitantly with strong CYP3A4 inhibitors such as  ketoconazole or clarithomycin. When the CYP3A4 inhibitor is withdrawn from the combination therapy, FANAPT dose  should be increased to where it was before.
Hepatic Impairment:  FANAPT is not recommended for patients with hepatic impairment.

Maintenance Treatment
Although there is no body of evidence available to answer the question of how long the patient treated with FANAPT should be maintained, it is generally recommended that responding patients be continued beyond the acute  response. Patients should be periodically reassessed to determine the need for maintenance treatment.

Reinitiation of Treatment in Patients Previously Discontinued
Although there are no data to specifically address re-initiation of treatment, it is recommended that the initiation titration schedule be followed whenever patients have had an interval off FANAPT of more than 3 days.

Switching From Other Antipsychotics
There are no specific data to address how patients with schizophrenia can be switched from other antipsychotics to FANAPT or how FANAPT can be used concomitantly with other antipsychotics. Although 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.

CONTRAINDICATIONS
FANAPT is contraindicated in individuals with a known hypersensitivity reaction to the product.  Reactions have included pruritus and urticaria.

Common Adverse Reactions
Dizziness, dry mouth, fatigue, nasal congestion, somnolence, tachycardia, orthostatic hypotension, and weight increased.

Fanapt是一种多巴胺D2/血清素(5-羟色胺2A)双受体拮抗剂，属于非典型性抗精神病药。所有此类药物的说明书上均有加框警告以提醒处方医师，超适应证使用该药治疗老年痴呆性精神病患者的行为问题将导致死亡风险增加。因此，Fanapt在老年痴呆性精神病患者的治疗应用未获批准。
 
2个短期的临床试验数据支持Fanapt具有治疗精神分裂症的作用。2个试验均对Fanapt与安慰剂和阳性对照药做了比较研究，入选患者均符合DSM-III/IV精神分裂症诊断标准。 研究结果证明，每天接受12 mg至24 mg Fanapt的患者，其精神分裂症症状控制方面优于安慰剂。
 
患者接受Fanapt治疗的临床试验中，最常见不良反应有头晕、口干、疲劳、鼻塞、体位性低血压、嗜睡、心动过速以及体重增加。接受Fanapt治疗后，患者的锥体外系症状发病率较低，静坐不能发病率与安慰剂组相似。这两种不良事件往往与其他一些非典型性抗精神病药物相关。与同类的其他药品类似， Fanapt可能会影响心率参数，特别是QTc间期，这可能导致医生开处方时考虑将Fanapt排在其他抗精神病药物之后。
 
Fanapt推荐的靶剂量为每天12毫克到24毫克。开始可在4天内逐渐给药，达到每天12毫克的靶剂量。目前，尚不知患者需维持Fanapt治疗至何时。如无药物急性反应，一般建议应对患者继续进行治疗。应定期评估以确定是否需要维持治疗。

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详细处方信息以本药内容附件PDF文件（201932419310831.pdf）的“原文Priscribing Information”为准
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