RISPERDAL CONSTA®
(risperidone long acting injection)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
RISPERDAL CONSTA® (risperidone long acting injection)
Medical Information
Adverse Event of RISPERDAL CONSTA - Hematologic Effects
Last Updated: 06/22/2023
Summary
- Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotics, including RISPERDAL CONSTA. Patients with history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood cell count (CBC) monitored frequently during the first few months of therapy and discontinuation of RISPERDAL CONSTA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.1
- During premarketing evaluations, the adverse reactions anemia and neutropenia were observed in patients receiving RISPERDAL CONSTA.1
- The following are additional adverse reactions reported with oral risperidone: granulocytopenia, increased eosinophil count, decreased white blood cell count, decreased hemoglobin, and decreased hematocrit.1
- During postmarketing experience, the adverse reactions agranulocytosis and thrombocytopenia were observed in patients receiving RISPERDAL CONSTA.1
- There are reports in the published literature of low WBC in patients treated with RISPERDAL CONSTA.2
- 4
PRODUCT LABELING
Open-Label Study
| Lead Author | Trial Design | Treatment | Hematologic Effects |
|---|---|---|---|
| Girardi 20102 | Prospective, open-label, 6-month matched mirror comparison with an additional 18-month extension in patients with schizophrenia or schizoaffective disorder (N=88) | Oral antipsychotic medication for 6 months RLAI 25-75 mg every 2 weeks for 6 months and an additional 18 months | Low WBC occurred in 87.1% of patients on previous oral treatment compared with 12.9% of patients on RLAI (relative risk 6.75; P<0.001). |
| Abbreviations: RLAI, risperidone long-acting injection; WBC, white blood cells. | |||
| Lead Author | Trial Design | Treatment | Hematologic Effects |
|---|---|---|---|
| Kim 20095 | Case series of 4 patients diagnosed with schizophrenia (2 males, 2 females) RLAI | Clozapine 200-300 mg/day in combination with RLAI 25 mg every 2 weeks | No abnormalities reported in WBC or ANC. |
Case Reports
| Lead Author | Trial Design | Treatment | Hematologic Effects |
|---|---|---|---|
| Bookstaver 20114 | 75-year-old African American female diagnosed with schizophrenia, presenting with hypothermia, bradycardia, altered mental status and a series of tonic-clonic seizures | RLAI 37.5 mg intramuscularly every 2 weeks. Patient was also taking phenytoin 250 mg daily, escitalopram 10 mg daily, clonazepam 1 mg three times daily, haloperidol 7.5 mg daily, phenobarbital 60 mg daily, donepezil 10 mg daily, and hydrochlorothiazide 25 mg daily. | Patient experienced leukopenia (WBC count of 1.9 x 109 Phenytoin, phenobarbital, and RLAI were discontinued. Within 4 days, patient's blood counts normalized and core temperature was 35.8ºC. Authors concluded that RLAI induced hypothermia, which may have led to altered phenytoin metabolism. Decreased phenytoin metabolism led to toxicity, resulting in neutropenia, bradycardia and seizures. |
| Uzun 20083 | 29-year-old male patient, diagnosed with schizophrenia | RLAI 50 mg every 2 weeks | After 5 injections, the patient experienced leukopenia with a WBC count of 2.2 x 103 cells/µL (normal: 4.5 to 11 x 103 cells/µL). RLAI was stopped, and within the next 10 days, the WBC count improved. The WBC count eventually returned back to normal levels. |
| Uzun 20083s | 38-year-old female patient, diagnosed with schizoaffective disorder | RLAI 25 mg every 2 weeks | Experienced a decrease in white blood cell count after 7 bi-weekly injections (WBC count of 2.5 x 103 µL) RLAI was discontinued. Quetiapine was initiated at 50 mg/day and increased to 100 mg/day after three days of therapy. Two days after initiating quetiapine, WBC count had improved, and by a week later, the WBC count was within the normal reference range. |
| Abbreviations: ANC, absolute neutrophil count; RLAI, risperidone long-acting injection; WBC, white blood cells. | |||
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 1 | RISPERDAL CONSTA (risperidone long-acting injection) [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://imedicalknowledge.veevavault.com/ui/approved_viewer?token=7994-63671f9d-1035-4290-a18b-1c9102cceb15. |
| 2 | Girardi P, Serafini G, Pompili M. Prospective, open study of long-acting injected risperidone versus oral antipsychotics in 88 chronically psychotic patients. Pharmacopsychiatry. 2010;43:66-72. |
| 3 | Uzun S, Kozumplik O, Jakovljevic M, et al. Leukopenia during therapy with risperidone long-acting injectable - two case reports. J Clin Psychopharmacol. 2008;28(6):713-714. |
| 4 | Bookstaver PB, Hive AA, Miller AD. Possible long-acting risperidone-induced hypothermia precipitating phenytoin toxicity in an elderly patients. J Clin Pharm Ther. 2011;36:426-429. |
| 5 | Kim SH, Jung DC, Ahn YM, et al. The combined use of risperidone long-acting injection and clozapine in patients with schizophrenia non-adherent to clozapine: a case series. J Psychopharmacol. 2010;24(7):981-986. |