Psychotropic Medication Audit Criteria and Guidelines

Fluphenazine decanoate (Prolixin®, decanoate) and Haloperidol decanoate (Haldol®, decanoate) PEFC Approved: July 2021

Indications Label: ● Patients with schizophrenia who require prolonged parenteral antipsychotic therapy

Off label: • Schizoaffective disorder

Black Box Warning ● Increased mortality in elderly patients with dementia-related psychosis

Contraindications ● Severe central nervous system depression or comatose states from any cause ● Hypersensitivity to the drug or derivatives ● Haloperidol decanoate  Parkinson’s disease  Dementia with Lewy bodies ● Fluphenazine decanoate  Suspected or established subcortical brain damage  Receiving large doses of hypnotics  Blood dyscrasias  Hepatic disease

Warnings and Precautions ● Severe cardiovascular disorders ● Concomitant use with other CNS depressants ● Diagnosis of a seizure disorder or history of seizures ● Haloperidol only

1 Texas Health and Human Services ● hhs.texas.gov Antipsychotics-decanoates

 Must not be administered intravenously.  QTc prolonging conditions (electrolyte imbalances, drugs known to prolong QTc, underlying cardiac abnormalities, hypothyroidism, familial long QT-syndrome)  Leukopenia/neutropenia  Thyrotoxicosis  Myasthenia gravis  Bipolar disorder ● Fluphenazine only  History of cholestatic jaundice, dermatoses, or other allergic reactions to phenothiazine derivatives  Reduced amounts of anesthetics or CNS depressants may be necessary  Effects of atropine may be potentiated  Use caution in patients exposed to extreme heat or phosphorus insecticides  Pheochromocytoma

Adverse Reactions Side Effects Which Require Medical Attention ● Extrapyramidal side effects ● Tardive dyskinesia ● Rashes ● Early symptoms of agranulocytosis (fever, sore throat, weakness) ● Galactorrhea/gynecomastia ● Amenorrhea ● Fluctuating vital signs ● Orthostatic hypotension ● Altered consciousness/lethargy ● Decreased sensation of thirst ● Signs and symptoms of neuroleptic malignant syndrome (NMS)

Drug Interactions of Major Significance

See: Indiana Univ Drug Interaction Table See: Lexicomp, Micromedex for more information

Special Populations ● Pediatrics/Adolescents  Safety and efficacy have not been established in children younger than 18 years.

2 Texas Health and Human Services ● hhs.texas.gov Antipsychotics-decanoates

● Geriatric  Lower doses recommended in geriatric patients ● Renal  No dosage adjustments provided in manufacturer labeling ● Hepatic  Haloperidol concentrations may increase in hepatically impaired patients  Fluphenazine is contraindicated in patients with hepatic impairment ● Pregnancy and Breastfeeding  Review product-specific labeling. Consider risks/benefits in reviewing medication-specific labeling

Patient Monitoring Parameters Baseline Tests: ● Pregnancy test (females) ● Waist circumference and BMI (weight in lbs x 703)/height2 in inches ● FPG or HbgA1c ● Fasting lipid profile within 30 days of initiation if not done within last year ● EPS evaluation (exam for rigidity, tremor, akathisia) ● TD assessment ● CMP ● CBC

Ongoing Tests: ● Pregnancy test (females) as clinically indicated ● BMI and waist circumference monthly for 6 months then quarterly when dose is stable ● FPG or HbgA1c repeat 3-4 months after starting then at least annually ● Fasting lipid panel 3-4 months after initiating a new antipsychotic and at least annually if lipid levels are in normal range; repeat every 6 months if LDL is > 130 mg/dL ● EPS evaluation weekly after initiation & dose increases, continue 2 weeks after last increase ● TD assessment every 3 months and as clinically indicated ● CMP, CBC as clinically indicated ● Inquiry for symptomatic prolactin elevation yearly (quarterly during 1st year for antipsychotics associated with increased prolactin) ● Prolactin level yearly if symptoms of prolactin elevation (e.g. gynecomastia, amenorrhea) ● Vision questionnaire and ocular evaluation yearly, ocular eval. every 2 years if ≤ 40 years old

3 Texas Health and Human Services ● hhs.texas.gov Antipsychotics-decanoates

● Determine if metabolic syndrome criteria (3 of the 5 criteria) are met 3-4 months after initiating a new antipsychotic medication and at least annually thereafter

Dosing ● See HHSC Psychiatric Drug Formulary for dosage guidelines. ● Exceptions to maximum dosage must be justified as per medication rule.

4 Texas Health and Human Services ● hhs.texas.gov