July 26, 2016
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Fanapt

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Fanapt




Indications
Dosage
How Supplied

INDICATIONS

FANAPT® is indicated for the treatment of schizophrenia in adults.

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 [see WARNINGS AND PRECAUTIONS]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointestype 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 treatment of schizophrenia [see DOSAGE AND ADMINISTRATION and Clinical Studies].

DOSAGE AND ADMINISTRATION

Usual Dose

FANAPT must be titrated slowly from a low starting dose to avoid orthostatic hypotension due to its alphaadrenergic blocking properties. The recommended starting dose for FANAPT tablets is 1 mg orally twice daily. Dose increases to reach the target range of 6-12 mg twice daily (12_24 mg/day) may be made with daily dosage adjustments not to exceed 2 mg twice daily (4 mg/day). 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. 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 [see ADVERSE REACTIONS].

FANAPT can be administered without regard to meals.

Dosage In Special Populations

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 [see DRUG INTERACTIONS].

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 clarithromycin. When the CYP3A4 inhibitor is withdrawn from the combination therapy, FANAPT dose should be increased to where it was before [see DRUG INTERACTIONS].

Dosage adjustment for patients taking FANAPT who are poor metabolizers of CYP2D6: FANAPT dose should be reduced by one-half for poor metabolizers of CYP2D6 [see CLINICAL PHARMACOLOGY].

Hepatic Impairment: No dose adjustment to FANAPT is needed in patients with mild hepatic impairment. Patients with moderate hepatic impairment may require dose reduction, if clinically indicated. FANAPT is not recommended for patients with severe hepatic impairment [see Use In Specific Populations].

Maintenance Treatment

In a longer-term study, FANAPT was effective in delaying time to relapse in patients with schizophrenia who were stabilized on FANAPT up to 24 mg/day [see Clinical Studies]. 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 reinitiation 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.

HOW SUPPLIED

Dosage Forms And Strenghts

FANAPT tablets are available in the following strengths: 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. The tablets are white, round, flat, beveled-edged and identified with a logo " "debossed on one side and tablet strength "1", "2", "4", "6", "8", "10", or "12" debossed on the other side.

Storage And Handling

FANAPT tablets are white, round and identified with a logo " " debossed on one side and tablet strength "1", "2", "4", "6", "8", "10", or "12" debossed on the other side. Tablets are supplied in the following strengths and package configurations:

Package Configuration Tablet Strength (mg) NDC Code
Bottles of 60 1 mg 43068-101-02
Bottles of 60 2 mg 43068-102-02
Bottles of 60 4 mg 43068-104-02
Bottles of 60 6 mg 43068-106-02
Bottles of 60 8 mg 43068-108-02
Bottles of 60 10 mg 43068-110-02
Bottles of 60 12 mg 43068-112-02
Titration Pack 2x1 mg, 2x2 mg, 2x4 mg, 2x6 mg (Total of 8 tablets) 43068-113-04

Storage

Store FANAPT tablets at controlled room temperature, 25°C (77°F); excursions permitted to 15°to 30 °C (59° to 86°F) [See USP Controlled Room Temperature]. Protect FANAPT tablets from exposure to light and moisture.

Distributed by: Vanda Pharmaceuticals Inc.Washington, D.C. 20037 USA. Revised May 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/28/2016

Indications
Dosage
How Supplied

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