Clozapine still requires absolute neutrophil count (ANC) monitoring. What changed is the REMS. FDA removed the Clozapine REMS effective June 13, 2025. You no longer enroll prescribers, pharmacies, or patients in that program, and pharmacies are not required to verify ANC in a REMS portal before they dispense. The label still recommends baseline ANC and scheduled counts. The chart is now the only place that proves you looked at the number and decided the dose.
This is a monitoring visit, not a full clozapine start workup. Keep the rest of the regimen readable the way you would in a complex med-management visit.
Stop writing REMS attestation as if it were 2024
Do not chart “Clozapine REMS current, PDC obtained” unless you are describing a historical start. In 2026 that sentence is a fossil and it hides the real work.
If a pharmacy still asks for a lab printout as store policy, you can send it. That is operations. The medical record still needs the ANC, the date, and your interpretation.
Counsel that severe neutropenia remains a boxed risk, especially early. Tell patients to seek care for fever, sore throat, or other infection signs. Write that you said it.
Chart baseline and interval ANC against the label
Label-style cadence for patients without benign ethnic neutropenia (BEN / Duffy-null associated neutrophil count), when ANC is in the normal range: weekly for the first 6 months, every 2 weeks for months 7 to 12, then monthly. Confirm the current prescribing information if your shop uses a different protocol.
Every monitoring note:
- Date drawn (not “recent”)
- ANC in /µL (or 10^9/L, with units)
- WBC if you have it
- Whether this is weekly, biweekly, or monthly
- Prior ANC for trend
- Dose and whether any tablets were missed
Initiation is not recommended when baseline ANC is under 1500/µL (different threshold in documented BEN). If you are treating someone with BEN, write the diagnosis, the two baseline ANCs, and the BEN table you are following. Do not apply the 1500 cutover to a BEN patient by habit.
If a lab is late, write that you did not increase the dose, whether you bridged a short fill, and when the blood will be drawn. The REMS used to force this conversation at the pharmacy window. Now you have to force it in the note.
Write the dose decision when ANC is low
Use the label tables; do not improvise poetry.
Confirm a low ANC with a repeat within 24 hours when the label says to. Chart interruption vs continuation, the new monitoring frequency, infection symptoms (or their absence), and whether you involved hematology.
ANC 1100/µL today, repeat 4 hours later 1080. No fever. Clozapine 350 mg HS interrupted per neutropenia table. Recheck ANC daily until [threshold]. Crisis plan for psychosis: [who to call], do not restart without a documented ANC. Patient counseled that pharmacies may still dispense without a REMS check, so we are the ones stopping.
Myocarditis, constipation/ileus, seizures, orthostasis, and metabolic labs are still clozapine medicine. They are not a substitute for the ANC line. Constipation belongs in every maintenance note. Ileus is how people die on a “stable” dose.
Counsel and document infection precautions and constipation
Fever instructions, who to call after hours, and that they should mention clozapine in any ED. Smoking-status change (starting or stopping) because it moves clozapine levels. Caffeine. New fluvoxamine or carbamazepine.
Constipation: last BM, laxative plan, when to present for abdominal pain. This is not optional color.
Sample monitoring block
Clozapine 300 mg HS, month 8 (biweekly ANC).
ANC 2.4 x10^3/µL on 8/1/2026 (was 2.1, 2.6, 2.3). No fever, no sore throat.
No missed doses. Smoking unchanged (5 cig/day). Last BM this morning.
Constipation plan: PEG 17 g daily. Troponin not indicated today (no
chest pain, HR 82, no unexplained fatigue).
Decision: continue 300 mg. Next ANC week of 8/15. Pharmacy: ordinary
dispense, no REMS portal. Patient reminded to call for fever.Questions people ask
Can I skip ANC if the patient has been stable for years? The label still recommends monthly monitoring after month 12 when counts have been acceptable. If you and the patient choose a different cadence, write the shared decision and the infection precautions. Do not skip in silence because the REMS is gone.
Does the EHR need a REMS module? No. It needs a place for ANC, dates, and a dose decision. A spreadsheet in a desk drawer is how monitoring dies when you are on vacation.