Psychosis:

Indications for: INVEGA HAFYERA

Schizophrenia after adequately treated with Invega Sustenna (1-month paliperidone palmitate ext-rel inj susp) for at least 4 months, or with Invega Trinza (3-month paliperidone palmitate ext-rel inj susp) for at least one 3-month cycle.

Adult Dosage:

Establish tolerability with Invega Sustenna or Invega Trinza prior to initiating. Give by gluteal IM inj only into the upper-outer quadrant (alternate future inj between the 2 gluteal muscles). Initiate Invega Hafyera dose based on the previous paliperidone palmitate ext-rel inj product. Administer as a single inj once every 6 months; may adjust dose every 6 months between 1092mg to 1560mg based on response and tolerability. Switching from Invega Sustenna: Initially 1092mg if the last dose was Invega Sustenna 156mg; initially 1560mg if the last dose was Invega Sustenna 234mg. May administer Invega Hafyera up to 1 week before or after the next scheduled Invega Sustenna dose; the two inj cycles immediately before the switch should be the same dosage strength before initiating Invega Hafyera. Switching from Invega Trinza: Initially 1092mg if the last dose was Invega Trinza 546mg; initially 1560mg if the last dose was Invega Trinza 819mg. May administer Invega Hafyera up to 2 weeks before or after the next scheduled Invega Trinza dose. Missed doses: see full labeling.

Children Dosage:

<18yrs: not established.

INVEGA HAFYERA Contraindications:

Risperidone hypersensitivity.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis.

INVEGA HAFYERA Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use): increased risk of death. Discontinue immediately if neuroleptic malignant syndrome (NMS) is suspected. Avoid in congenital long QT syndrome, history of cardiac arrhythmias. Consider discontinuation if tardive dyskinesia occurs. Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Conditions that predispose to hypotension (eg, dehydration, hypovolemia). Diabetes risk factors (obtain baseline fasting blood sugar and periodically thereafter). Perform fall risk assessments when initiating and recurrently on long-term therapy (esp. in elderly). History of significant low WBC/ANC or drug-induced leukopenia/neutropenia; obtain CBCs frequently during 1st few months of treatment; consider discontinuation if significant decline in WBC. Monitor for signs/symptoms of infection in those with neutropenia; discontinue if severe (ANC <1000mm3) and follow WBC until recovery. History of seizures. Conditions that lower the seizure threshold. Patients at risk for aspiration pneumonia. Exposure to extreme temperatures. Write ℞ for smallest practical amount. Reevaluate periodically. Parkinson's disease. Dementia with Lewy bodies. Renal impairment. Severe hepatic impairment. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.

INVEGA HAFYERA Classification:

Atypical antipsychotic.

INVEGA HAFYERA Interactions:

Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Avoid concomitant strong CYP3A4 and/or P-gp inducers (eg, carbamazepine, rifampin, St. John's Wort); if coadmin necessary, consider oral paliperidone ext-rel tabs. Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension (monitor). Caution with anticholinergic drugs that may elevate body temperature. May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone or oral paliperidone for long-term use; caution.

Adverse Reactions:

Inj site reactions, somnolence/sedation, dizziness, akathisia, extrapyramidal disorder, upper respiratory tract infection, weight increased, headache, parkinsonism; may cause NMS, tardive dyskinesia, QT prolongation, metabolic changes, hyperprolactinemia, orthostatic hypotension, syncope, agranulocytosis, priapism.

Generic Drug Availability:

NO

How Supplied:

Kit—1 (prefilled syringe + needles)

Pricing for INVEGA HAFYERA

5ml of 1560mg syringe (Qty: 1)
Appx. price $18002
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