Names and pronunciation
(pal-ee-per′i-done) Invega, Invega Hafyera, Invega Sustenna, Invega Trinza
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Drug reference
(pal-ee-per′i-done) Invega, Invega Hafyera, Invega Sustenna, Invega Trinza
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Func. class.: Antipsychotic, atypical, 2nd generation
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Chem. class.: Benzisoxazole derivative
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Do not confuse: Invega/Iveegam paliperidone/risperiDONE
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ACTION: Mediated through both DOPamine type 2 (D2) and serotonin type 2 (5-HT2) antagonism
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USES: Schizophrenia, schizoaffective disorder
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CONTRAINDICATIONS: Breast feeding, geriatric patients, seizure dis orders, AV block, QT prolongation, torsades de pointes; hypersensitivity to this product, risperidone Precautions: Pregnancy, children, renal/hepatic disease, obesity, Parkin- son’s disease, suicidal ideation, diabetes mellitus, hematological disease
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Black Box Warning: Dementia-related psychosis (mortality) Black Box Warning: Mental status: mood, behavior, confusion, orientation, suicidal thoughts/behaviors; dementia, especially in geriatric patients before ini- tial administration and periodically • QT prolongation: ECG for QT prolonga- tion, ejection fraction; chest pain, palpita- tions, dyspnea • AIMS assessment, blood glucose, CBC, glycosylated hemoglobin A1c (HbA1c), LFTs, neurologic function, pregnancy test- ing, serum creatinine/electrolytes/lipid pro- file/prolactin, thyroid function tests, weight • Swallowing of PO medication; check for hoarding, giving of medication to others • Affect, orientation, LOC, reflexes, gait, coordination, sleep pattern disturbances • VS: B/P (standing, lying), pulse, respira- tions; often during initial treatment; estab- lish baseline before starting treatment; re- port drops of 30 mm Hg; watch for ECG changes • Hyperprolactinemia: sexual dysfunc- tion, decreased menstruation, breast pain • Dizziness, faintness, palpitations, tachycardia on rising • EPS: akathisia, tardive dyskinesia (bi- zarre movements of jaw, mouth, tongue, extremities), pseudoparkinsonism (ri- gidity, tremors, pill rolling, shuffling gait) • Serotonin syndrome, neuroleptic ma- lignant syndrome: monitor for hyperther- mia, increased CPK, altered mental status, muscle rigidity, fever, seizures; discontinue • Constipation, urinary retention daily; if these occur, increase bulk and water in diet; monitor for weight gain, especially among adolescents P • Safety: Supervised ambulation until patient is stabilized on medication; do not involve patient in strenuous exercise program because fainting is possible; patient should not stand still for a long time • Increased fluids to prevent constipation • Sips of water, candy, gum for dry mouth • Beers: avoid in older adults except for schizophrenia, bipolar disorder, or short-term use as an antiemetic in che- motherapy; increase in stroke risk • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; EPS may re- sult; pregnant patients should enroll in the National Pregnancy Registry for Atypical Antipsychotics, 1-866-961-2388; do not breastfeed Black Box Warning: Suicidal thoughts/ behaviors: to notify prescriber of suicidal thoughts/behaviors, other changes in behavior; identify dementia in the elderly
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SIDE EFFECTS CNS: EPS, pseudoparkinsonism, akathi sia, dystonia, tardive dyskinesia; drows iness, insomnia, agitation, anxiety, headache, seizures, neuroleptic malignant syndrome, dizziness, suicidal thoughts/ behaviors CV: Orthostatic hypotension, tachycardia; heart failure, QT prolongation, dysrhythmias, heart block EENT: Blurred vision, cough ENDO: Hyperinsulinemia, weight gain, hyperglycemia, dyslipidemia GI: Nausea, vomiting, anorexia, consti pation, weight gain in adolescents, xerostomia GU: Priapism, menstrual irregularities, impotence, priapism MS: Back pain MISC: Angioedema, anaphylaxis HEMA: Agranulocytosis, leukopenia, neutropenia
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INTERACTIONS Increase: sedation—other CNS depres- sants, alcohol, sedative/hypnotics, opiates Increase: QT prolongation—class IA, III antidysrhythmics, azole antifungals, tricy- clics (high doses), some phenothiazines, β- blockers, chloroquine, pimozide, droperidol, some antipsychotics, abarelix, alfuzosin, amoxapine, apomorphine, dasatinib, dolas- etron, flecainide, halogenated anesthetics Increase: neurotoxicity—lithium Increase: serotonin syndrome, neurolep- tic malignant syndrome—SSRIs, SNRIs Increase: EPS—other antipsychotics Decrease: levels of carBAMazepine, increased dose of paliperidone may be needed Decrease: effect of paliperidone—car- BAMazepine, other CYP3A4 inducers Decrease: levodopa effect—levodopa Drug/Lab Test Increase: prolactin levels
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TREATMENT OF OVERDOSE: Lavage if orally ingested; provide airway; do not induce vomiting
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DOSAGE AND ROUTES • Adult: PO 6 mg/day, max 12 mg/day; IM (Invega Sustenna) 234 mg on day 1, then 156 mg 1 wk later; after 2nd dose, give 117 mg each mo; range 39- 234 mg; (Invega Trinza) dose based on previous 1-mo injection dose of Invega Sustenna; if last dose of Invega Sustenna was 78 mg, give 273 mg of Invega Trinza; if last dose of Invega Sustenna was 117 mg, give 410 mg of Invega Trinza; if last dose of Invega Sustenna was 156 mg, give 546 mg of Invega Trinza; if last dose of Invega Sustenna was 234 mg, give 819 mg of Invega Trinza; give dose q3mo, adjust as needed • Child/adolescent ≥12 yr and ≥51 kg: PO 3 mg daily, may increase if needed by 3 mg/day in intervals of >5 days, up to max 12 mg/day; <51 kg max 6 mg/day Invega Hafyera (6-month extended- release injection) Adult: Initial, only after adequate treatment with once-a month extended-release injec- tion for at least 4 months or an every- 3-month extended-release injection (PP3M) for at least one 3-month cycle, 1092 mg or 1560 mg (based upon the previous dose of PP1M or PP3M) IM into the gluteal muscle q6mo maintenance, adjust every 6 months between 1092 and 1560 mg Renal dose • Adult: PO CCr 50-79 mL/min, 3 mg/day, max 6 mg/day; EXT REL/IM 156 mg on day 1, 117 mg 1 wk later, then 78 mg each mo; CCr 10-49 mL/min, 1.5 mg/day, max 3 mg/day; IM not recommended
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Available forms: Ext rel tabs 1.5, 3, 6, 9 mg; ext rel susp for inj 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, 234 mg/1.5 mL; Invega Trinza extended- release suspension 273, 410, 546, 819 mg; Invega Hafyera: 1092 mg/3.4 mL, 1560 mg/5 mL extended release suspension
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Administer: • Avoid use with CNS depressants PO route • Do not break, crush, or chew ext rel tabs; use plenty of water • Without regard for food • Reduced dose for geriatric patients IM route • Use for IM only; do not use IV or subcut; inj kits contain prefilled syringe and 2 safety needles; for single use only; shake for 10 sec; deltoid inj: ≥90 kg, use 1.5-inch, 22-G needle; <90 kg, use 1-inch, 23-G needle; alternate injections between deltoid muscles; gluteal inj: use 1.5-inch, 22-G needle; attach needle to Luer connection in clockwise motion; pull needle sheath away using straight pull; bring syringe with at- tached needle upright to de-aerate, de-aer- ate, inject; after inj, use finger, thumb, or flat surface to activate needle protection system until click heard; use deltoid × 2 doses
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Assess:
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Evaluate: • Therapeutic response: decrease in emotional excitement, hallucinations, de- lusions, paranoia; reorganization of pat- terns of thought, speech
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That orthostatic hypotension may occur; to rise gradually from sitting or lying position • To avoid abrupt withdrawal of this product, EPS may result; that product should be withdrawn slowly • To avoid OTC preparations (cough, hay fever, cold) unless approved by pre- scriber because serious product interac- tions may occur; to avoid alcohol be- cause increased drowsiness may occur • To avoid hazardous activities if drowsy or dizzy • About compliance with product regi- men; that nonabsorbable tab shell is ex- pelled in stool • To report impaired vision, tremors, muscle twitching • To avoid hot tubs, hot showers, tub baths because hypotension may occur • That heat stroke may occur in hot weather; to take extra precautions to stay cool • To use contraception; to inform pre- scriber if pregnancy is planned or sus- pected; not to breastfeed
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PHARMACOKINETICS Peak 24 hr; elimination half-life 23 hr; excreted 80% urine, 11% feces, protein binding >74%
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• Adult: PO 6 mg/day, max 12 mg/day; IM (Invega Sustenna) 234 mg on day 1, then 156 mg 1 wk later; after 2nd dose, give 117 mg each mo; range 39- 234 mg; (Invega Trinza) dose based on previous 1-mo injection dose of Invega Sustenna; if last dose of Invega Sustenna was 78 mg, give 273 mg of Invega Trinza; if last dose of Invega Sustenna was 117 mg, give 410 mg of Invega Trinza; if last dose of Invega Sustenna was 156 mg, give 546 mg of Invega Trinza; if last dose of Invega Sustenna was 234 mg, give 819 mg of Invega Trinza; give dose q3mo, adjust as needed
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• Adult: PO CCr 50-79 mL/min, 3 mg/day, max 6 mg/day; EXT REL/IM 156 mg on day 1, 117 mg 1 wk later, then 78 mg each mo; CCr 10-49 mL/min, 1.5 mg/day, max 3 mg/day; IM not recommended
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