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Clozapine REMS Certification – Questions & Solutions
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Clozapine REMS Certification – Questions & Solutions
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Clozapine REMS Certification – Questions & SolutionsWhat are box warnings for clozapine? ✔ - Neutropenia
Orthostatic Hypotension
Bradycardia
Syncope
Seizure
Myocarditis Cardiomyopathy
What group is clozapine not FDA approved for? ✔ - Increased mortality in elderly patients with dementia related psychosis
What should the ANC be before starting clozapine medication? ✔ - 1500 for general population
1000 for BEN (benign ethnic neutropenia)
What is considered neutropenia? ✔ - Neutropenia = ANC < 500
(Absolute neutrophil count)
What are symptoms of severe neutropenia/infection? ✔ - Fever
Lethargy
Weakness
Sore throat
T/F: Risk of neutropenia is greatest from years 1-2 of treatment. ✔ - False;
risk is greatest during first 18 months
T/F: Risk of neutropenia is not dose dependent. ✔ - True
For which conditions is clozapine contraindicated? ✔ - Photosensitivity
Vasculitis Erythema multiforme
Stevens Johnsons syndrome
Hx of hypersensitivity to clozapine
What is the starting dose for clozapine? ✔ - 12.5mg either qd or BID Your patient taking clozapine starts showing lowered heart rate, dizziness, and chest pain. What do you do? ✔ - If patients are showing symptoms of cardiac complications, discontinue and obtain labs
What is the method of increasing the clozapine dose? ✔ - Increase in increments of 25-50mg/day.
What is the clozapine target dose by the end of 2 weeks? ✔ - 300mg to 450mg/day (in divided doses)
What is the max daily dose of clozapine? ✔ - 900mg/day
Weekly ANC monitoring for the first ___ months, then every ___ weeks. ✔ - First 6 months
Then every 2 weeks
T/F: If ANC is greater than or equal to 1500 for the first year, monitoring can be reduced o every 4 weeks. ✔ - True
How is ANC calculated? ✔ - Total WBC count x Total percentage of neutrophils obtained from differential
A patient taking clozapine presents with an ANC of 1300, what do you do? ✔ - - Continue treatment
- Monitor ANC 3x/week
^ Protocol for mild neutropenia (100-1499)
A patient taking clozapine presents with an ANC of 850, what do you do? ✔ - - Hematology consult
- Interrupt tx, resume once ANC > 1000
- Monitor ANC daily. Once ANC remains at 1000 for 4 weeks, return to normal ANC monitoring interval
^ Protocol for moderate neutropenia (500-999)
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