Generic Name and Formulations:
Clozapine 50mg/mL; oral susp.
Jazz Pharmaceuticals plc
Indications for VERSACLOZ:
Treatment-resistant schizophrenia. To reduce risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorders.
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.
Severe neutropenia. Orthostatic hypotension, bradycardia, and syncope. Seizure. Myocarditis and cardiomyopathy. Increased mortality in elderly patients with dementia-related psychosis.
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. 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. GI or GU obstruction. 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 (Cat.B). Nursing mothers: not recommended.
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). 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. May potentiate alcohol, anticholinergics, CNS drugs. Neuroleptic malignant syndrome possible with concomitant lithium.
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.
To register patients call Versacloz Patient Registry at (877) 329-2256.
Susp—100mL (w. 2 oral syringes, 1 bottle adapter).
Sign Up for Free e-newsletters
- Choice of Breast Reconstruction After Mastectomy Affects Satisfaction, Quality of Life
- Bariatric Surgery Reduced Risk of Some Cancers in Obese Patients
- Carfilzomib Benefits May Outweigh Cardiovascular Risk in Multiple Myeloma
- The Caregivers' Cancer Journey
- Genetic Link Between Depression and Breast Cancer Remains Unclear
- Implementing an Ambulatory Adherence Program May Improve Oral Anticancer Medications Compliance
- Exercise Habits Influence Mortality in Adult Survivors of Childhood Cancer
- Managing Dyspnea With Fentanyl in Patients With Cancer at End of Life
- CALM: A Depression Intervention for Cancer Patients at the End of Life
- High BMI Among Premenopausal Women May Improve Risk for Breast Cancer
- Fertility Preservation in Hodgkin's Lymphoma Patients That Undergo Targeted Molecular Therapies: An Important Step Forward From the Chemotherapy Era
- Survey of ACEP Councilors Reveals NP, PA Staffing Models, Practice Patterns Vary
- Breath Analysis May Be an Effective Diagnostic for Pancreatic Cancer
- Genetic Susceptibility to Pancreatic Cancer Linked to 6 Specific Gene Mutations
- Dinner Hour and Sleep Habits Affect Risk of Breast, Prostate Cancers
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|