Iloperidone

What is Iloperidone?

• Iloperidone (Fanapt) is an atypical antipsychotic agent used for treatment of schizophrenia.

Iloperidone

Iloperidone ball-and-stick xtal 2014

What are the uses of this medicine?

• 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.

How does this medicine work?

• Iloperidone (eye" loe per' i done) is a second generation antipsychotic agent which appears to act as a dopamine type 2 (D2) and serotonin (5-HT)-2A receptor antagonist whose structure and mechanism of action are similar to risperidone.
• Several randomized controlled trials have shown that iloperidone improves symptoms of schizophrenia with effects comparable to risperidone and ziprasidone.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with a known hypersensitivity reaction to the product.

What drug interactions can this medicine cause?

• Caution should be used when it is taken in combination with other centrally acting drugs and alcohol.
• Fanapt has the potential to enhance the effect of certain antihypertensive agents.
• The dose of Fanapt should be reduced in patients co-administered a strong CYP2D6 (e.g., fluoxetine, paroxetine) or CYP3A4 inhibitor(e.g., ketoconazole).
• Fanapt should not be used with any other drugs that prolong the QT interval.

Is this medicine FDA approved?

• Iloperidone was approved for use in schizophrenia in the United States in 2009.

How should this medicine be used?

Recommended dosage:

• The recommended target dosage of Fanapt tablets is 12 to 24 mg/day administered twice daily.
• This target dosage range is achieved by daily dosage adjustments, alerting patients to symptoms of orthostatic hypotension, starting at a dose of 1 mg twice daily, then moving to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg twice daily on Days 2, 3, 4, 5, 6, and 7 respectively, to reach the 12 mg/day to 24 mg/day dose range.

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.

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.

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

Administration:

• Fanapt can be administered without regard to meals.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets.

This medicine is available in fallowing brand namesː

• Fanapt

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• dry mouth
• fatigue
• nasal congestion
• orthostatic hypotension
• somnolence
• tachycardia
• weight increased

What special precautions should I follow?

• Elderly patients with dementia-related psychosis who are treated with atypical antipsychotic drugs are at an increased risk of death and cerebrovascular-related adverse events, including stroke.
• Fanapt Prolongs QT interval and may be associated with arrhythmia and sudden death-consider using other antipsychotics first. Avoid use of Fanapt in combination with other drugs that are known to prolong QTc; use caution and consider dose modification when prescribing Fanapt with other drugs that inhibit Fanapt metabolism. Monitor serum potassium and magnesium in patients at risk for electrolyte disturbances.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Fanapt.
• Manage with immediate discontinuation of drug and close monitoring.
• Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, which may develop in patients treated with antipsychotic drugs.
• Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain.
• Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
• Fanapt can induce orthostatic hypotension associated with dizziness, tachycardia, and syncope. Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension.
• Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Fanapt at the first sign of a decline in WBC in the absence of other causative factors.
• The possibility of a suicide attempt is inherent in psychotic illness, and close supervision of high-risk patients should accompany drug therapy. Close supervision of high risk patients.
• Three cases of priapism were reported in the premarketing Fanapt program.
• Fanapt, like other antipsychotics, has the potential to impair judgment, thinking or motor skills. Use caution when operating machinery.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drowsiness
• sedation
• tachycardia
• hypotension
• extrapyramidal symptoms

Management of overdosage:

• There is no specific antidote for Fanapt.
• Therefore appropriate supportive measures should be instituted.
• Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered.
• Cardiovascular monitoring should commence immediately and should include continuous ECG monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide and quinidine should not be used, as they have the potential for QT-prolonging effects that might be additive to those of Fanapt.
• Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids or sympathomimetic agents.
• In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Fanapt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric and adolescent patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• ILOPERIDONE

Inactive ingredients:

• LACTOSE MONOHYDRATE
• CELLULOSE, MICROCRYSTALLINE
• HYPROMELLOSES
• CROSPOVIDONE
• MAGNESIUM STEARATE
• SILICON DIOXIDE
• WATER

Who manufactures and distributes this medicine?

• Fanapt® is a registered trademark of Vanda Pharmaceuticals Inc. and is used by Novartis Pharmaceuticals Corporation under license.

• Distributed by:

Novartis Pharmaceuticals Corporation East Hanover, NJ

What should I know about storage and disposal of this medication?

• Storage Store Fanapt tablets at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F).
• Protect Fanapt tablets from exposure to light and moisture.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Iloperidone
• FDA Iloperidone

Iloperidone Resources
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