Dosing and administration of Versacloz

Before administering Versacloz, please review the full Prescribing Information, including the BOXED Warning.

Absolute Neutrophil Count Testing Prior to VERSACLOZ Initiation

Prior to initiating VERSACLOZ treatment, obtain a baseline absolute neutrophil count (ANC). VERSACLOZ initiation is not recommended in patients with an ANC less than 1500/µL [see Warnings and Precautions (5.1) of the full Prescribing Information].

For patients with documented Benign Ethnic Neutropenia (BEN) (also known as Duffy-null associated neutrophil count)), obtain at least two baseline ANC levels. VERSACLOZ initiation is not recommended in patients with BEN with an ANC less than 1000/µL [see Warnings and Precautions (5.1) of the full Prescribing Information].

For dosage modifications based on ANC results, see Dosage and Administration (2.4, 2.5) of the full Prescribing Information.

Dosage Modification Based on ANC Results

Table 1 provides recommended VERSACLOZ dosage modifications based on ANC results [see Warnings and Precautions (5.1) of the full Prescribing Information]. For dosage modifications based on ANC results for patients with Benign Ethnic Neutropenia (BEN) (also known as Duffy-null associated neutrophil count), see Table 2 [see Dosage and Administration (2.5) of the full Prescribing Information].

Table 1: VERSACLOZ Dosage Modifications Based on ANC Results and Frequency of ANC Testing

Recommended Dosage Modification	Recommended Frequency of ANC Testing During VERSACLOZ Treatment
ANC Within Normal Range (≥1500/µL)
No dosage modification: continue treatment	Day 1 to Month 6: Weekly Month 7 to Month 12: Every 2 weeks Month 13 and thereafter: Every month If VERSACLOZ treatment is reinitiated after a dosage interruption (e.g., patient had neutropenia which required dosage interruption and now has a normal ANC level) for: < 30 days, continue the previous ANC testing frequency ≥ 30 days, obtain ANC tests according to the frequency for patients who initiate treatment
Mild Neutropenia (ANC between 1000 to 1499/µL)¹
No dosage modification: continue treatment	Three times weekly Once ANC ≥ 1500/µL, recommend returning to the patient’s last Normal Range ANC testing frequency
Moderate Neutropenia (ANC between 500 to 999/µL)¹
Interrupt treatment and recommend hematology consultation Resume treatment once ANC ≥1000/µL	Daily Once ANC ≥ 1000/µL, three times weekly Once ANC ≥ 1500/µL, test weekly for 4 weeks. If ANC ≥ 1500/µL after monitoring weekly for 4 weeks, return to the patient’s last Normal Range ANC testing frequency
Severe Neutropenia (ANC less than 500/µL)¹
Discontinue treatment and recommend hematology consultation	Daily Once ANC ≥ 1000/µL, three times weekly Once ANC ≥ 1500/µL, if the benefits outweigh the risks of restarting treatment, resume treatment and obtain ANC tests according to the frequency for patients who initiate treatment

¹ Confirm all initial reports of ANC less than 1500/μL with a repeat ANC measurement within 24 hours

Dosage Modifications Based on ANC Results for Patients with Benign Ethnic Neutropenia

Table 2 provides recommended VERSACLOZ dosage modifications based on ANC results for patients with Benign Ethnic Neutropenia (BEN) (also known as Duffy-null associated neutrophil count). [see Warnings and Precautions (5.1) of the full Prescribing Information]. For dosage modifications based on ANC results for patients without BEN, see Table 1 [see Dosage and Administration (2.4) of the full Prescribing Information].

Table 2: Dosage Modifications Based on ANC Results and Frequency of ANC Testing in Patients with Benign Ethnic Neutropenia¹

Recommended Dosage Modification	Recommended Frequency of ANC Testing During VERSACLOZ Treatment in Patients with BEN¹
ANC Within the Normal Range for Patients with BEN (≥ 1000/µL)
No dosage modification: continue treatment	Day 1 to Month 6: Weekly Month 7 to Month 12: Every 2 weeks Month 13 and thereafter: Monthly If VERSACLOZ treatment is reinitiated after a dosage interruption (e.g., patient had neutropenia which required dosage interruption and now their ANC (≥ 1000/µL and ≥ the patient’s ANC baseline prior to treatment) for: < 30 days, continue the previous ANC testing frequency ≥ 30 days, obtain ANC tests according to the frequency for patients with BEN who initiate treatment
Neutropenia in Patients with BEN (ANC level between 500 to 999/μL)²
Recommend hematology consultation No dosage modification: continue treatment	Three times weekly Once ANC ≥ 1000/μL and ≥ the patient’s ANC baseline, obtain ANC tests weekly for 4 weeks If ANC ≥1000/μL and ≥ the patient’s baseline after monitoring for 4 weeks, return to the patient’s last Normal ANC Range testing frequency for patients with BEN.
Severe Neutropenia in Patients with BEN (ANC level less than 500/μL)²
Discontinue treatment and recommend hematology consultation	Daily Once ANC ≥ 500/µL, obtain ANC three times weekly Once ANC ≥ 1000/µL and ≥ the patient’s baseline, if the benefits outweigh the risks of restarting treatment, resume treatment and obtain ANC tests according to the frequency for patients with BEN who initiate treatment

¹Benign Ethnic Neutropenia (BEN) is also known as Duffy-null associated neutrophil count.

²Confirm all initial reports of ANC less than 1500/μL with a repeat ANC measurement within 24 hours.

Discontinuation of VERSACLOZ Treatment

If discontinuing VERSACLOZ in patients with:

Moderate or severe neutropenia, see Table 1 [see Dosage and Administration (2.4) of the full Prescribing Information].
Normal or mild neutropenia, reduce the dosage gradually over a period of 1 to 2 weeks, and continue monitoring ANC levels until their ANC is ≥1500/μL.

If discontinuing VERSACLOZ in patients with Benign Ethnic Neutropenia (BEN) (also known as Duffy-null associated neutrophil count) with:

Neutropenia, see Table 2 [see Dosage and Administration (2.5) of the full Prescribing Information].
ANC within their normal range of ANC reduce the dosage gradually over a period of 1 to 2 weeks.

When discontinuing VERSACLOZ, monitor patients for the symptoms related to psychotic recurrence and cholinergic rebound (e.g., profuse sweating, headache, nausea, vomiting, diarrhea).

Restarting VERSACLOZ Treatment After Interrupting VERSACLOZ

When restarting VERSACLOZ in patients who have interrupted VERSACLOZ treatment, use a lower dosage to minimize the risk of hypotension, bradycardia, and syncope [see Warnings and Precautions (5.2) of the full Prescribing Information].

If one day’s dosage is missed, resume VERSACLOZ treatment at 40% to 50% of the previous dosage.
If two days of dosing is missed, resume VERSACLOZ treatment at approximately 25% of the previous dosage.
For longer interruptions, restart VERSACLOZ treatment with a dosage of 12.5 mg once or twice daily. If this dosage is well-tolerated, may increase the dosage to the previous dosage more quickly than recommended than for initial VERSACLOZ treatment.

Important Safety Information

PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication guide and Instructions for Use).

Discuss the following issues with patients and caregivers:

Severe Neutropenia:

Instruct patients (and caregivers) [see Warnings and Precautions (5.1) of the Full Prescribing Information]:
- About the risk of developing severe neutropenia and infection with VERSACLOZ treatment.
- To immediately report to their healthcare provider any symptom or sign of infection during VERSACLOZ treatment.
- About the importance of having frequent ANC testing.
Orthostatic Hypotension, Bradycardia, and Syncope: Inform patients and caregivers about the risk of orthostatic hypotension and syncope, especially during the period of initial dose titration. Instruct them to strictly follow the clinician’s instructions for dosage and administration [see Dosage and Administration (2.2, 2.7) of the Full Prescribing Information]. Advise patients to consult their clinician immediately if they feel faint, lose consciousness or have signs or symptoms suggestive of bradycardia or arrhythmia [see Warnings and Precautions (5.2) of the Full Prescribing Information].
Falls: Inform patients of the risk of falls, which may lead to fractures or other injuries [see Warnings and Precautions (5.3) of the Full Prescribing information].
Seizures: Inform patients and caregivers about the significant risk of seizure during VERSACLOZ treatment. Caution them about driving and any other potentially hazardous activity while taking VERSACLOZ [see Warnings and Precautions (5.4) of the Full Prescribing Information].
Gastrointestinal Hypomotility with Severe Complications: Educate patients and caregivers on the risks, prevention, and treatment of clozapine-induced constipation, including medications to avoid when possible (e.g., drugs with anticholinergic activity). Encourage appropriate hydration, physical activity, and fiber intake and emphasize that prompt attention and treatment to the development of constipation or other gastrointestinal symptoms is critical in preventing severe complications. Advise patients and caregivers to contact their health carehealthcare provider if they experience symptoms of constipation (e.g., difficulty passing stools, incomplete passage of stool, decreased bowel movement frequency) or other symptoms associated with gastrointestinal hypomotility (e.g., nausea, abdominal distension or pain, vomiting) [see Warnings and Precautions (5.7), Drug Interactions (7.1) of the Full Prescribing Information].
QT Interval Prolongation: Advise patients to consult their clinician immediately if they feel faint, lose consciousness, or have signs or symptoms suggestive of arrhythmia. Instruct patients to not take VERSACLOZ with other drugs that cause QT interval prolongation. Instruct patients to inform their clinicians that they are taking VERSACLOZ before any new drug [see Warnings and Precautions (5.9) and Drug Interactions (7.1) of the Full Prescribing Information].
Metabolic Changes (hyperglycemia and diabetes mellitus, dyslipidemia, weight gain): Educate patients and caregivers about the risk of metabolic changes and the need for specific monitoring. The risks include hyperglycemia and diabetes mellitus, dyslipidemia, weight gain, and cardiovascular reactions. Educate patients and caregivers about the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus (e.g., polydipsia, polyuria, polyphagia, and weakness). Monitor all patients for these symptoms. Patients who are diagnosed with diabetes or have risk factors for diabetes (obesity, family history of diabetes) should have their fasting blood glucose monitored before beginning treatment and periodically during treatment. Patients who develop symptoms of hyperglycemia should have assessments of fasting glucose. Clinical monitoring of weight is recommended [see Warnings and Precautions (5.10) of the Full Prescribing Information].
Interference with Cognitive and Motor Performance: Because VERSACLOZ may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that VERSACLOZ therapy does not affect them adversely [see Warnings and Precautions (5.16) of the Full Prescribing Information].
Hepatotoxicity: Instruct patients to immediately report to their physician any symptoms or signs of potential liver injury (e.g. fatigue, malaise, anorexia, nausea, jaundice, bilirubinemia, coagulopathy, and hepatic encephalopathy). [see Warnings and Precautions (5.12) of the Full Prescribing Information].
Missed Doses and Re-Initiating Treatment: Inform patients and caregivers that if the patient misses taking VERSACLOZ for 1 day or more, they should not restart their medication at the same dosage but should contact their physician for dosing instructions [see Dosage and Administration (2.7) and Warnings and Precautions (5.1, 5.2) of the Full Prescribing Information].
Pregnancy: Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with VERSACLOZ. Advise patients that VERSACLOZ may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VERSACLOZ during pregnancy [see Use in Specific Populations (8.1) of the Full Prescribing Information].
Lactation: Advise breastfeeding women using VERSACLOZ to monitor infants for excess sedation and to seek medical care if they notice this sign. Inform breastfeeding women using VERSACLOZ that their healthcare provider will monitor infants for neutropenia [see Use in Specific Populations (8.2) of the Full Prescribing Information].
Concomitant Medication: Advise patients to inform their healthcare provider if they are taking, or plan to take, any prescription or over-the-counter drugs; there is a potential for significant drug-drug interactions [see Dosage and Administration (2.6), Drug Interactions (7.1) of the Full Prescribing Information].
Patient Instructions for Use: Educate the patient and caregiver about the Patient Instructions for Use if VERSACLOZ will be administered at home. Discuss the specific steps for administering the prescribed dose using the oral syringe [see Dosage and Administration (2.3) of the Prescribing Information].

Please see the full Prescribing Information for Important Safety Information, including
BOXED Warning.

Click here for additional safety information.

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United States.

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