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Versacloz Generic Name & Formulations
Legal Class
Rx
General Description
Clozapine 50mg/mL; oral susp.
Pharmacological Class
Atypical antipsychotic.
How Supplied
Susp—100mL (w. 2 oral syringes, 1 bottle adapter).
Manufacturer
Versacloz Indications
Indications
Treatment-resistant schizophrenia. To reduce risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorders.
Versacloz Dosage and Administration
Adult
Shake well. Initially 12.5mg 1–2 times daily; then usually given in divided doses; may increase by 25–50mg/day to 300–450mg/day by the end of 2 weeks. Then may increase once or twice weekly in increments of up to 100mg; max 900mg/day. Reevaluate periodically. Reduce gradually over 1–2 weeks if discontinuing; can discontinue abruptly if necessary (eg, severe neutropenia; may cause relapse or cholinergic rebound). Retitrate if stopped for ≥2 days. Caution with rechallenge (see full labeling). Dose adjustments with concomitant other medications: see full labeling. Renal or hepatic impairment, CYP2D6 poor metabolizers: may need to reduce dose.
Children
Not established.
Versacloz Contraindications
Not Applicable
Versacloz Boxed Warnings
Boxed Warning
Severe neutropenia. Orthostatic hypotension, bradycardia, and syncope. Seizure. Myocarditis and cardiomyopathy. Increased mortality in elderly patients with dementia-related psychosis.
Versacloz Warnings/Precautions
Warnings/Precautions
See full labeling. Risk of severe neutropenia; obtain CBC and confirm baseline ANC ≥1500/μL (≥1000/μL if benign ethnic neutropenia) prior to initiation. Monitor WBC and ANC weekly for 1st 6 months and for 4 weeks after discontinuing; if acceptable WBC and ANC maintained, may reduce monitoring to every 2 weeks after 6 months, then every 4 weeks after 12 months. Increased mortality in elderly with dementia-related psychosis (not approved use). Cardio- or cerebrovascular disease or predisposition to hypotension. Perform fall risk assessments when initiating and recurrently on long-term therapy. Reevaluate periodically. History of or risk factors for seizure. Monitor for myocarditis or cardiomyopathy; discontinue if suspected. Mitral valve incompetence. Increased risk of QT prolongation; discontinue if interval >500msec. Significant cardiac arrhythmia. Recent MI. Uncompensated heart failure. Consider obtaining baseline ECG and serum chemistry panel. Correct electrolyte abnormalities prior to starting; obtain baseline serum potassium and magnesium levels; monitor periodically thereafter. Monitor for hepatotoxicity; consider permanently discontinuing if clozapine-associated hepatitis or elevated transaminases occur. Monitor for hyperglycemia. Diabetes or risk factors thereof. Exclude severe neutropenia, infection, neuroleptic malignant syndrome if fever occurs. Narrow-angle glaucoma. Constipation (screen and treat prior to initiation). Urinary retention. Significant prostatic hypertrophy. Renal or hepatic impairment. CYP2D6 poor metabolizers. Use lowest effective dose for shortest duration. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: monitor infants.
REMS
Versacloz Pharmacokinetics
See Literature
Versacloz Interactions
Interactions
Caution with drugs that affect or are affected by CYPA1A2, 2D6, 3A4. Concomitant strong CYP1A2 inhibitors (eg, fluvoxamine, ciprofloxacin, or enoxacin): reduce clozapine dose by ⅓. Concomitant moderate or weak CYP1A2 inhibitors (eg, oral contraceptives, caffeine), CYP2D6 or 3A4 inhibitors (eg, cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, sertraline): monitor and reduce clozapine dose if needed. Concomitant strong CYP3A4 inducers (eg, phenytoin, carbamazepine, St. Johns wort, rifampin): not recommended; may need to increase clozapine dose. Concomitant weak or moderate CYP1A2 (eg, tobacco smoking) or 3A4 inducers: monitor and increase clozapine dose if needed. Caution with concomitant drugs known to prolong the QT interval: certain antipsychotics (eg, ziprasidone, iloperidone, chlorpromazine, thioridazine, mesoridazine, droperidol, pimozide), antibiotics (eg, erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class IA or Class III antiarrhythmics (eg, quinidine, procainamide, amiodarone, sotalol), and others (eg, pentamidine, levomethadyl acetate, methadone, halofantrine, mefloquine, dolasetron mesylate, probucol, tacrolimus). Caution with drugs that can cause electrolyte imbalance (eg, diuretics). Increased risk for anticholinergic toxicity, severe GI hypomotility effects when concomitant other anticholinergic drugs (eg, benztropine, cyclobenzaprine, diphenhydramine); avoid use when possible. May potentiate anticholinergics, CNS drugs. May potentiate other drugs that are metabolized by CYP2D6 (eg, certain antidepressants, phenothiazines, carbamazepine, propafenone, flecainide, encainide); may need to use lower doses of these. Neuroleptic malignant syndrome possible with concomitant lithium.
Versacloz Adverse Reactions
Adverse Reactions
Sedation, dizziness/vertigo, headache, tremor, tachycardia, hypotension, syncope, hypersalivation, sweating, dry mouth, visual disturbances, constipation, nausea, fever; severe neutropenia, seizures, bradycardia, weight gain, hyperglycemia, dyslipidemia, myocarditis, cardiomyopathy, eosinophilia, neuroleptic malignant syndrome, anticholinergic toxicity, thrombosis, pulmonary embolism, tardive dyskinesia, hepatotoxicity, GI hypomotility with severe complications.
Versacloz Clinical Trials
See Literature
Versacloz Note
Notes
To register patients call Versacloz Patient Registry at (877) 329-2256.
Versacloz Patient Counseling
See Literature
