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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
CLOZARIL (NDA-019758)
(CLOZAPINE)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
06/13/2025 (SUPPL-107)
Boxed Warning
Additions and/or revisions underlined:
Severe Neutropenia
CLOZARIL has caused severe neutropenia which is associated with an increased risk of serious and potentially fatal infections. Prior to initiating CLOZARIL treatment, obtain baseline ANC(s). CLOZARIL initiation is not recommended in patients with a baseline ANC less than 1500/mcgL (less than 1000/mcgL for those with Benign Ethnic Neutropenia (also known as Duffy-null associated neutrophil count)). See recommendations for dosage modifications based on ANC levels during CLOZARIL treatment [see Dosage and Administration (2.3, 2.4)].
Consider a hematology consultation before initiating CLOZARIL or during CLOZARIL treatment [see Warnings and Precautions (5.1)].
5 Warnings and Precautions
5.1 Severe Neutropenia
Extensive changes; please refer to label for complete information
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Discuss the following issues with patients and caregivers:
. . .
About the importance of having frequent ANC testing.
. . .
Missed Doses and Re-initiating Treatment: Inform patients and caregivers that if the patient misses taking CLOZARIL 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 (2.6), Warnings and Precautions (5.1, 5.2)].
MEDICATION GUIDE
Newly added section; please refer to label for complete information01/22/2025 (SUPPL-106)
Boxed Warning
Additions and/or revisions underlined:
WARNING: SEVERE NEUTROPENIA; ORTHOSTATIC HYPOTENSION, BRADYCARDIA, AND SYNCOPE; SEIZURE; MYOCARDITIS, PERICARDITIS, AND CARDIOMYOPATHY; INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
…
Myocarditis, Pericarditis, Cardiomyopathy and Mitral Valve Incompetence
Fatal myocarditis and cardiomyopathy have occurred with CLOZARIL treatment. Discontinue CLOZARIL and obtain a cardiac evaluation upon suspicion of these reactions. Generally, patients with CLOZARIL-related myocarditis or cardiomyopathy should not be rechallenged with CLOZARIL. Consider the possibility of myocarditis, pericarditis, or cardiomyopathy if chest pain, tachycardia, palpitations, dyspnea, fever, flu-like symptoms, hypotension, or ECG changes occur [see Warnings and Precautions (5.6)].
…
5 Warnings and Precautions
5.6 Myocarditis, Pericarditis, Cardiomyopathy and Mitral Valve Incompetence
Section title revised
Additions and/or revisions underlined:
Myocarditis, pericarditis, and cardiomyopathy have occurred with the use of CLOZARIL. These reactions can be fatal. Discontinue CLOZARIL and obtain a cardiac evaluation upon suspicion of myocarditis or cardiomyopathy. Generally, patients with a history of clozapine-associated myocarditis or cardiomyopathy should not be rechallenged with CLOZARIL. However, if the benefit of CLOZARIL treatment is judged to outweigh the potential risks of recurrence, the clinician may consider rechallenge with CLOZARIL in consultation with a cardiologist.
Myocarditis and pericarditis most frequently present within the first 2 months of clozapine treatment. Symptoms of cardiomyopathy generally occur later than clozapine-associated myocarditis or pericarditis and usually after 8 weeks of treatment. However, myocarditis, pericarditis, and cardiomyopathy can occur at any period during treatment with CLOZARIL. In patients who are diagnosed with cardiomyopathy while taking CLOZARIL mitral valve incompetence has been reported.
6 Adverse Reactions
Addition of the following to the bulleted line listing:
…
- Myocarditis, Pericarditis, Cardiomyopathy, and Mitral Valve Incompetence [see Warnings and Precautions (5.6)]
…
6.2 Postmarketing Experience
Additions and/or revisions underlined:
…
Cardiovascular System
Atrial or ventricular fibrillation, ventricular tachycardia, palpitations, QT interval prolongation, Torsades de Pointes, mitral valve incompetence associated with clozapine-related cardiomyopathy, myocardial infarction, cardiac arrest, myocarditis, pericarditis, and periorbital edema.
Endocrine System Pseudopheochromocytoma Gastrointestinal System
Acute pancreatitis, dysphagia, salivary gland swelling, colitis, megacolon, fecal incontinence, and intestinal ischemia, infarction, perforation, ulceration or necrosis.
…
09/12/2024 (SUPPL-104)
8 Use in Specific Populations
8.1 Pregnancy
PLLR conversion:
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including CLOZARIL, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Atypical Antipsychotics at1-866-961-2388 or visiting http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Risk Summary
Neonates exposed to antipsychotic drugs, including CLOZARIL, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Available data from published epidemiologic studies over decades of use with clozapine during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
There are risks to the mother associated with untreated schizophrenia and with exposure to antipsychotics, including CLOZARIL, during pregnancy (see Clinical Considerations).
In animal reproduction studies, no adverse developmental effects were observed when clozapine was administered orally to pregnant rats or rabbits during the period of organogenesis, or to pregnant rats during pregnancy and lactation, at doses up to approximately 0.4 and 0.9 times the maximum recommended human dose (MRHD) of 900 mg/day, for rats and rabbits respectively, based on mg/m2 body surface area (see Data).
The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
There is a risk to the mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide. Schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors.
Fetal/Neonatal adverse reactions
Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who have been exposed to antipsychotic drugs, including CLOZARIL, during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.
Data
Animal Data
In embryofetal developmental studies, clozapine had no effects on maternal parameters, litter sizes, or fetal parameters when administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 0.4 and 0.9 times, respectively, the MRHD of 900 mg/day on a mg/m2 body surface area basis.
In peri/postnatal developmental studies, pregnant female rats were administered clozapine over the last third of pregnancy and until day 21 postpartum. Observations were made on fetuses at birth and during the postnatal period; the offspring were allowed to reach sexual maturity and mated. Clozapine caused a decrease in maternal body weight but had no effects on litter size or body weights of either F1 or F2 generations at doses up to 0.4 times the MRHD of 900 mg/day on a mg/m2 body surface area basis.
8.2 Lactation
PLLR conversion:
Risk Summary
Clozapine is present in human milk. There is one case report of sedation and a report of agranulocytosis in an infant exposed to clozapine through human milk (see Clinical Considerations). There is no information on the effects of clozapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CLOZARIL and any potential adverse effects on the breastfed child from CLOZARIL or from the underlying maternal condition.
Clinical Considerations
Infants exposed to CLOZARIL should be monitored for excess sedation and neutropenia.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONAdditions and/or revisions underlined:
…
Pregnancy: Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with CLOZARIL. Advise patients that CLOZARIL may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distresss, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CLOZARIL during pregnancy [see Use in Specific Populations 8.1)].
Lactation: Advise breastfeeding women using CLOZARIL to monitor infants for excess sedation and seek medical care if they notice this sign. Inform breastfeeding women using CLOZARIL that their healthcare provider will monitor infants for neutropenia [see Use in Specific Populations (8.2)].
…
05/19/2023 (SUPPL-103)
Boxed Warning
Orthostatic Hypotension, Bradycardia, Syncope
(Additions and/or revisions underlined)
Orthostatic hypotension, bradycardia, syncope, and cardiac arrest have occurred with CLOZARIL treatment. The risk is highest during the initial titration period, particularly with rapid dose escalation. These reactions can occur with the first dose, with doses as low as 12.5 mg per day, or when restarting patients who have had even a brief interruption in treatment with CLOZARIL. Initiate treatment at 12.5 mg once or twice daily; titrate slowly; and use divided dosages to minimize risk. Use CLOZARIL cautiously in patients with cardiovascular or cerebrovascular disease or conditions predisposing to hypotension (e.g., dehydration, use of antihypertensive medications) [see Dosage and Administration (2.2, 2.5), Warnings and Precautions (5.3)].
5 Warnings and Precautions
5.2 Orthostatic Hypotension, Bradycardia, and Syncope
(Additions and/or revisions underlined)
Hypotension, bradycardia, syncope, and cardiac arrest have occurred with clozapine treatment. The risk is highest during the initial titration period, particularly with rapid dose-escalation. These reactions can occur with the first dose, at doses as low as 12.5 mg. These reactions can be fatal. The syndrome is consistent with neurally mediated reflex bradycardia (NMRB).
Treatment must begin at a maximum dose of 12.5 mg once daily or twice daily. The total daily dose can be increased in increments of 25 mg to 50 mg per day, if well-tolerated, to a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of 2 weeks. Subsequently, the dose can be increased weekly or twice weekly, in increments of up to 100 mg. The maximum dose is 900 mg per day. Use cautious titration and a divided dosage schedule to minimize the risk of serious cardiovascular reactions [see Dosage and Administration (2.2)]. Consider reducing the dose if hypotension occurs. When restarting CLOZARIL in patients who have had even a brief interruption in treatment with CLOZARIL, the dosage must be reduced. This is necessary to minimize the risk of hypotension, bradycardia, and syncope [see Dosage and Administration (2.5)].
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions underlined)
· 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 Administraton (2.2, 2.5)]. 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 (5.3)].
12/19/2022 (SUPPL-101)
5 Warnings and Precautions
5.8 Gastrointestinal Hypomotility with Severe ComplicationsAdditions and/or revisions underlined:
… In post marketing experience, reported effects range from constipation to paralytic ileus. Increased frequency of constipation and delayed diagnosis and treatment increased the risk of severe complications of gastrointestinal hypomotility, which can result in fecal impaction, megacolon, and intestinal obstruction, ischemia, infarction, perforation, ulceration or necrosis [see Adverse Reaction (6.2)]. These reactions have resulted in hospitalization, surgery, and death …
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions and/or revisions underlined:
Gastrointestinal System
Acute pancreatitis, dysphagia, salivary gland swelling, colitis, megacolon, and intestinal ischemia, infarction, perforation, ulceration or necrosis.
02/11/2021 (SUPPL-88)
6 Adverse Reactions
6.2 Postmarketing Experience
(Additions and/or revisions underlined)
The following adverse reactions have been identified during post-approval use of clozapine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Central Nervous System
Delirium, EEG abnormal, myoclonus, paresthesia, possible cataplexy, status epilepticus, obsessive compulsive symptoms, restless leg syndrome, and post-discontinuation cholinergic rebound adverse reactions.
Cardiovascular System
Atrial or ventricular fibrillation, ventricular tachycardia, palpitations, QT interval prolongation, Torsades de Pointes, mitral valve incompetence associated with clozapine-related cardiomyopathy, myocardial infarction, cardiac arrest, myocarditis, and periorbital edema.
Vision Disorders Narrow-angle glaucoma.
Narrow-angle glaucoma.
Miscellaneous
Creatine phosphokinase elevation, hyperuricemia, hyponatremia, polyserositis, and weight loss.
04/14/2020 (SUPPL-95)
5 Warnings and Precautions
5.16 Anticholinergic Toxicity(Additions and/or revisions underlined)
CLOZARIL has potent anticholinergic effects. Treatment with CLOZARIL can result in CNS and peripheral anticholinergic toxicity, especially at higher dosages, or in overdose situations. Use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions. When possible, avoid concomitant use, with other anticholinergic medications because the risk for anticholinergic toxicity or severe gastrointestinal adverse reactions is increased.
(Newly added subsection)
Severe gastrointestinal adverse reactions have occurred with the use of CLOZARIL, primarily due to its potent anticholinergic effects and resulting gastrointestinal hypomotility. In post marketing experience, reported effects range from constipation to paralytic ileus. Increased frequency of constipation and delayed diagnosis and treatment increased the risk of severe complications of gastrointestinal hypomotility, resulting in intestinal obstruction, fecal impaction, megacolon and intestinal ischemia or infarction. These reactions have resulted in hospitalization, surgery, and death. The risk of severe adverse reactions is further increased with anticholinergic medications (and other medications that decrease gastrointestinal peristalsis); therefore, concomitant use should be avoided when possible.
Prior to initiating CLOZARIL, screen for constipation and treat as necessary. Subjective symptoms of constipation may not accurately reflect the degree of gastrointestinal hypomotility in CLOZARIL treated patients. Therefore, reassess bowel function frequently with careful attention to any changes in the frequency or character of bowel movements, as well as signs and symptoms of complications of hypomotility (e.g., nausea, vomiting, abdominal distension, abdominal pain).
If constipation or gastrointestinal hypomotility are identified, monitor closely and treat promptly with appropriate laxatives, as necessary, to prevent severe complications. Consider prophylactic laxatives in high risk patients.
6 Adverse Reactions
(Additions and/or revisions underlined)
The following adverse reactions are discussed in more detail in other sections of the labeling:
Severe Neutropenia
Orthostatic Hypotension, Bradycardia, and Syncope
Falls
Seizures
Myocarditis, Cardiomyopathy, and Mitral Valve Incompetence
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Gastrointestinal Hypomotility with Severe Complications
Eosinophilia
QT Interval Prolongation
Metabolic Changes
Neuroleptic Malignant Syndrome
Hepatotoxicity
Fever
Pulmonary Embolism
Anticholinergic Toxicity
Interference with Cognitive and Motor Performance
Tardive Dyskinesia
Cerebrovascular Adverse Reactions
- Recurrence of Psychosis and Cholinergic Rebound after Abrupt Discontinuation
(Additions and/or revisions underlined)
The following adverse reactions have been identified during post-approval use of clozapine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Central Nervous System
Delirium, EEG abnormal, myoclonus, paresthesia, possible cataplexy, status epilepticus, obsessive compulsive symptoms, pleurothotonus, restless legs syndrome and post-discontinuation cholinergic rebound adverse reactions.
Cardiovascular System
Atrial or ventricular fibrillation, ventricular tachycardia, palpitations, QT interval prolongation, Torsades de Pointes, mitral valve incompetence associated with clozapine-related cardiomyopathy, myocardial infarction sometimes fatal, cardiac arrest, myocarditis sometimes fatal and periorbital edema.
Endocrine System
Pseudopheochromocytoma
Gastrointestinal System
Acute pancreatitis, dysphagia, salivary gland swelling, colitis, megacolon, intestinal ischemia or infarction.
Hepatobiliary System
Cholestasis, hepatitis, jaundice, hepatotoxicity, hepatic steatosis, hepatic necrosis, hepatic fibrosis, hepatic cirrhosis, liver injury (hepatic, cholestatic, and mixed), and liver failure.
Immune System Disorders
Angioedema, leukocytoclastic vasculitis.
Urogenital System
Acute interstitial nephritis, nocturnal enuresis, priapism, renal failure, and retrograde ejaculation.
Skin and Subcutaneous Tissue Disorders
Hypersensitivity reactions: photosensitivity, vasculitis, erythema multiforme, skin pigmentation disorder, and Stevens- Johnson Syndrome.
Musculoskeletal System and Connective Tissue Disorders
Myasthenic syndrome, rhabdomyolysis, and systemic lupus erythematosus.
Respiratory System
Aspiration, pleural effusion, pneumonia, lower respiratory tract infection, sleep apnea.
Hemic and Lymphatic System
Mild, moderate, or severe leukopenia, agranulocytosis, granulocytopenia, WBC decreased, deep-vein thrombosis, elevated hemoglobin/hematocrit, erythrocyte sedimentation rate (ESR) increased, sepsis, thrombocytosis, and thrombocytopenia.
Vision Disorders
Narrow-angle glaucoma.
Metabolic Changes
Obesity
Miscellaneous
Creatine phosphokinase elevation, hyperuricemia, hyponatremia, polyserositis and weight loss.
7 Drug Interactions
7.1 Potential for Other Drugs to Affect CLOZARIL(Additions and/or revisions underlined)
…
Anticholinergic Drugs
Concomitant treatment with clozapine and other drugs with anticholinergic activity (e.g., benztropine, cyclobenzaprine, diphenhydramine) can increase the risk for anticholinergic toxicity and severe gastrointestinal adverse reactions related to hypomotility. Avoid concomitant use of CLOZARIL with anticholinergic drugs when possible.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION(Additions and/or revisions underlined)
…
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 care 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).
…
02/23/2017 (SUPPL-84)
5 Warnings and Precautions
5.12 Hepatotoxicity(Newly added subsection)
Severe, life threatening, and in some cases fatal hepatotoxicity including hepatic failure, hepatic necrosis, and hepatitis have been reported in post marketing studies in patients treated with clozapine. Monitor for the appearance of signs and symptoms of hepatotoxicity such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinemia, coagulopathy, and hepatic encephalopathy. Perform serum tests for liver injury and consider permanently discontinuing treatment if hepatitis or transaminase elevations combined with other systemic symptoms are due to clozapine.
(Newly added subsection)
Clozaril may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long- term antipsychotic therapy.
6 Adverse Reactions
(Additions and/or revisions are underlined)
The following adverse reactions are discussed in more detail in other sections of the labeling:
• Falls.
• Hepatotoxicity.
01/26/2017 (SUPPL-81)
6 Adverse Reactions
6.2 Postmarketing Experience(Additions and/or revisions are underlined)
Respiratory System
Aspiration, pleural effusion, pneumonia, lower respiratory tract infection, sleep apnea.
12/20/2016 (SUPPL-80)
Boxed Warning
(Additions and/or revisions are underlined in WARNING section title)
Myocarditis, Cardiomyopathy, and Mitral Valve Incompetence
Fatal myocarditis and cardiomyopathy have occurred with CLOZARIL treatment…
5 Warnings and Precautions
5.5 Myocarditis, Cardiomyopathy, and Mitral Valve Incompetence(Additions and/or revisions are underlined)
In patients who are diagnosed with cardiomyopathy while taking CLOZARIL mitral valve incompetence has been reported . These cases reported either mild or moderate mitral regurgitation on two-dimensional echocardiography In patients with suspected cardiomyopathy, consider a 2D-echo Doppler examination to identify mitral valve incompetence.
6 Adverse Reactions
(Additions and/or revisions are underlined)
The following adverse reactions are discussed in more detail in other sections of the labeling:
Myocarditis, Cardiomyopathy, and Mitral Valve Incompetence
(Additions and/or revisions are underlined)
Cardiovascular System
Atrial or ventricular fibrillation, ventricular tachycardia, palpitations, QT interval prolongation, Torsades de Pointes, mitral valve incompetence associated with clozapine-related cardiomyopthay, …
Gastrointestinal System
Acute pancreatitis, dysphagia, salivary gland swelling, colitis.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION(Additions and/or revisions are underlined)
- Severe Neutropenia:
…Provide patients (and caregivers) with website information and the telephone number on how to obtain the product (www.clozapinerems.com or 1-844-267-8678)
- Nursing: Advise patients and caregivers that the patient should not breastfeed…