iloperidone (Rx)

Brand and Other Names:Fanapt
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 2mg
  • 4mg
  • 6mg
  • 8mg
  • 10mg
  • 12mg

Schizophrenia

Day 1: 1 mg PO q12hr; increase qDay to effective dose of 6-12 mg PO q12hr

Day 2: 2 mg PO q12hr, THEN increase qDay by 2 mg/day to effective dose of 6-12 mg PO q12hr; not to exceed 24 mg/day

Must gradually increase dose to avoid orthostatic hypotension

Dosage Modifications

Coadministration with strong CYP2D6 or CYP3A4 inhibitors: Decrease iloperidone dose by 50%

Poor CYP2D6 metabolizers: Decrease iloperidone dose by 50%

Renal impairment: Unlikely to have a significant impact since <1% of drug is excreted unchanged in urine

Hepatic impairment

  • Mild: No dosage adjustment required
  • Moderate: Caution advised
  • Severe: Use not recommended

Safety and efficacy not established

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Interactions

Interaction Checker

and iloperidone

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness (20%)

            Dry mouth (15%)

            Nausea (10%)

            Somnolence (10%)

            Tachycardia (12%)

            1-10% (selected)

            Diarrhea

            Ejaculation failure

            Myalgia

            Nasal congestion

            Orthostatic hypotension

            Palpitations

            Urinary incontinence

            Weight gain

            <1% (selected)

            Amenorrhea

            Edema

            Hypothyroidism

            Frequency Not Defined (selected)

            Priapism

            Postmarketing Reports

            Retrograde ejaculation

            Hypersensitivity reactions (including anaphylaxis; angioedema; throat tightness; oropharyngeal swelling; swelling of the face, lips, mouth, and tongue; urticaria; rash; and pruritus)

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            Warnings

            Black Box Warnings

            Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials

            The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

            This drug is not approved for the treatment of patients with dementia-related psychosis

            Contraindications

            Hypersensitivity; anaphylaxis, angioedema, and other hypersensitivity reactions reported

            Cautions

            Prolongs QT interval; caution with other drugs/conditions that increase QTc

            Not recommended in hepatic impairment

            Risk of neuroleptic malignant syndrome and extrapyramidal symptoms

            May cause anticholinergic side effects (eg., confusion, agitation)

            Blood dyscrasias (leukopenia, neutropenia, agranulocytosis) may occur

            Orthostatic hypotension may occur

            Cases of priapism reported

            Should be avoided in patients with a known genetic susceptibility to congenital long QT syndrome and with a history of cardiac arrhythmias

            May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; for patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

            Use caution in patients with history of seizures or with conditions that lower seizure threshold

            Monitor closely patients at high risk of committing suicide

            Hyperprolactinemia may occur; gynecomastia and galactorrhea reported

            Antipsychotic agents may disrupt body temperature regulation and may cause esophageal dysmotility and aspiration; use caution

            Metabolic changes

            • Atypical antipsychotics have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk including hyperglycemia, dyslipidemia, and body weight gain
            • Increased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death
            • Monitor blood glucose of high risk patients
            • Possibility of weight gain
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            Pregnancy & Lactation

            Pregnancy Category: C

            Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

            These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization

            Lactation: not known if excreted in breast milk, do not nurse

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            May act by antagonizing a combination of dopamine type 2 (D2) and serotonin type 2 (5-HT2) receptors.

            Alpha blocker

            Absorption

            Bioavailability 96%

            Peak Plasma Time: 2-4 hr

            Distribution

            Protein Bound: 95%

            Vd: 1340-2800 L

            Metabolism

            Metabolized by CYP2D6 and CYP3A4

            Elimination

            Excretion: Urine (45-58%), feces (20-22%)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.