| Synonyms | Clozaril; Fazaclo |
| SPECIMEN REQUIREMENTS | |
| Container Type | Red top tube (plain) |
| Supply Item Number | 1372 |
| Specimen Type | Serum |
| Preferred Volume | 0.25 mL |
| Emergency Minimum Volume | 0.1 mL |
| Patient Prep | Timing of specimen collection: Pre-dose (trough) draw - At steady state concentration. |
| Specimen Processing | Separate serum from cells and transfer to a standard PAML aliquot tube. |
| Store and Transport | Refrigerated |
| Stability | Room Temp 2 weeks Refrigerated 2 weeks Frozen (-20 °C) 1 month |
| Unacceptable Condition | DO NOT use gel separator tubes (Corvac®, SST or equivalent) for the collection of blood samples for this test. |
| Alternate Specimens | EDTA, sodium heparinized or sodium fluoride/potassium oxalate plasma (lavender, green or grey top tube) |
| Reference Laboratory | PAML |
| CPT Codes | 80159, (HCPCS G0480) |
| Interface Order Code | 80299.Z69 |
| Billing Code | CLONOR |
| Test Schedule | Mon, Wed, Fri |
| Turnaround Time | 1-3 days |
| Method | Tandem Mass Spectrometry |
| Reference Ranges | | Title | Ranges | Units | | Clozapine | 350-650 | ng/mL | | Norclozapine | Not Established | ng/mL | | Total(Cloz+Norcloz) | | ng/mL | | Patients dosed with 400 mg clozapine daily for 4 weeks were most liekly to exhibit a therapeutic effect whe nteh sum of clozapine and norclozapine concentrations were at least 450 ng/ml. |
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| Compliance Remarks | This test was developed and its performance characteristics determined by PAML. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. PAML is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing. |
| Notes | Clozapine is associated with severe neutropenia (absolute neutrophil count (ANC) less than 500/uL). The requirements to prescribe, dispense, and receive clozapine are incorporated into a single, shared program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy to manage known or potential risks associated with a drug or group of drugs, and is required by the FDA for clozapine to ensure that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS Program replaces the individual clozapine patient registries and the National Non-Rechallenge Master File (NNRMF).
For additional information about the Clozapine REMS Program, please call 844-267-8678. |
