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Fanapt

Fanapt

INDICATIONS

FANAPT® tablets are indicated for the treatment of adults with schizophrenia. Efficacy was established in two short-term (4-and 6-week) placebo-and active-controlled studies of adult patients with schizophrenia [see Clinical Studies].

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 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 treatment of schizophrenia [see DOSAGE AND ADMINISTRATION and Clinical Studies].

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 [see DOSAGE AND ADMINISTRATION].

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. 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.

FANAPT can be administered without regard to meals.

Dosage In Special Populations

Dosage adjustments are not routinely indicated on the basis of age, gender, race, or renal impairment status [see Use in Specific 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. Exercise caution when administering it to patients with moderate hepatic impairment. FANAPT is not recommended for patients with severe hepatic impairment [see Use In Specific Populations].

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 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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

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 0078-0595-20
Bottles of 60 2 mg 0078-0596-20
Bottles of 60 4 mg 0078-0597-20
Bottles of 60 6 mg 0078-0598-20
Bottles of 60 8 mg 0078-0599-20
Bottles of 60 10 mg 0078-0600-20
Bottles of 60 12 mg 0078-0601-20
Titration Pack 2x1 mg, 2x2 mg, 2x4 mg, 2x6 mg (Total of 8 tablets) 0078-0602-08

Storage

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

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936. April 2014

Last reviewed on RxList: 5/1/2014
This monograph has been modified to include the generic and brand name in many instances.

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