Haloperidol Decanoate
Generic: HALOPERIDOL DECANOATE
Basic Information
Manufacturer
Gland Pharma Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
1a0e38cb-fd9f-4962-9f81-5c0023ca6b4c
Indications & Usage
1 INDICATIONS AND USAGE Haloperidol decanoate injection is indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product.
Haloperidol decanoate injection is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product
Haloperidol decanoate injection is a typical antipsychotic indicated for the treatment of schizophrenia in adults who were previously taking a stable dosage of an immediate-release oral haloperidol product
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Sudden Death, Torsades de Pointes, and QTc Interval Prolongation [see Warnings and Precautions ( 5.2 )] • Tachycardia and Hypotension [see Warnings and Precautions ( 5.3 )] • Tardive Dyskinesia [see Warnings and Precautions ( 5.5 )] • Neuroleptic Malignant Syndrome [see Warnings and Precautions ( 5.6 )] • Seizures [see Warnings and Precautions ( 5.8 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.9 )] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.13 )] • Hyperprolactinemia [see Warnings and Precautions ( 5.14 )] • Risk of Severe Neurotoxicity in Patients with Thyrotoxicosis [see Warnings and Precautions ( 5.15 )] The most common adverse reactions (incidence ≥5%) were oculogyric crisis and parkinsonism ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions Identified in Clinical Trials with Haloperidol Decanoate The data described below reflect exposure to 15 mg to 500 mg (1.7 times the maximum recommended dosage) of haloperidol decanoate monthly in 13 clinical trials of 410 adult patients with schizophrenia or an unapproved condition.
These clinical trials comprised of: • 1 double-blind, active comparator-controlled trial with fluphenazine decanoate (Trial 1).
• 2 trials comparing haloperidol decanoate injection to oral haloperidol (Trials 2 and 3).
• 9 open-label trials.
• 1 dose-response trial.
The most common adverse reactions that occurred in ≥5% of haloperidol decanoate-treated patients in Trial 1 were Parkinsonism and oculogyric crisis.
Adverse reactions that occurred in ≥1% of haloperidol decanoate-treated patients in Trial 1 are shown in Table 2.
Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate and fluphenazine decanoate treatment groups.
Table 2: Adverse Reactions that Occurred in ≥1% of Haloperidol Decanoate-treated Patients and Fluphenazine Decanoate-treated Patients in Trial 1 a Haloperidol Decanoate (n=36) Fluphenazine decanoate (n=36) Extrapyramidal disorder: Parkinsonism 31% 44% Oculogyric crisis 6% 0% Akinesia 3% 22% Akathisia 3% 14% Tremor 3% 0% Abdominal pain 3% 0% Headache 3% 0% a The study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate and the fluphenazine decanoate treatment groups.
Less common adverse reactions (<1%) that occurred in Trial 1 and other adverse reactions that occurred in Trials 2 and 3, and open-label and dose-response clinical trials of haloperidol decanoate are listed below.
• Cardiac Disorders: Tachycardia • Endocrine Disorders: Hyperprolactinemia • Eye Disorders: Vision blurred • Gastrointestinal Disorders: Constipation, Dry mouth, Salivary hypersecretion • General Disorders and Administration Site Conditions : Weight increased, Injection site reaction • Musculoskeletal and Connective Tissue Disorders : Muscle rigidity • Nervous System Disorders: Dyskinesia, Dystonia, Cogwheel rigidity, Hypertonia, Masked facies, Sedation, Somnolence • Reproductive System Disorders : Erectile dysfunction Adverse Reactions Identified in Clinical Trials with Immediate-Release Haloperidol Products Based on clinical trials with immediate-release haloperidol products that included 1,579 patients, the following adverse reactions were reported: • Musculoskeletal and Connective Tissue Disorders: Torticollis, Trismus, Muscle twitching • Nervous System Disorders: Neuroleptic malignant syndrome, Tardive dyskinesia, Bradykinesia, Hyperkinesia, Hypokinesia, Dizziness, Nystagmus • Psychiatric Disorders : Loss of libido, Restlessness • Reproductive System and Breast Disorders: Amenorrhea, Galactorrhea, Dysmenorrhea, Menorrhagia, Breast discomfort • Skin and Subcutaneous Tissue Disorders: Acneiform skin reactions • Vascular Disorders: Hypotension, Orthostatic hypotension 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of haloperidol, including haloperidol decanoate injection.
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.
• Blood and Lymphatic System Disorders : Pancytopenia, Agranulocytosis, Thrombocytopenia, Leukopenia, Neutropenia • Cardiac Disorders : Ventricular fibrillation, Torsade de pointes, Ventricular tachycardia, Extrasystoles, QTc interval prolongation • Endocrine Disorders : Inappropriate antidiuretic hormone secretion • Gastrointestinal Disorders : Vomiting, Nausea • General Disorders and Administration Site Conditions : Sudden death, Face edema, Edema, Hyperthermia, Hypothermia, Injection site abscess, Weight decreased • Hepatobiliary Disorders : Acute hepatic failure, Hepatitis, Cholestasis, Jaundice, Liver function test abnormal • Immune System Disorders: Anaphylactic reaction, Hypersensitivity • Metabolic and Nutritional Disorders: Hypoglycemia • Musculoskeletal and Connective Tissue Disorders : Rhabdomyolysis • Nervous System Disorders: Convulsion, Opisthotonus, Tardive dystonia • Pregnancy, Puerperium and Perinatal Conditions: Neonatal drug withdrawal syndrome • Psychiatric Disorders: Agitation, Confusional state, Depression, Insomnia • Renal and Urinary Disorders : Urinary retention • Reproductive System and Breast Disorders: Priapism, Gynecomastia • Respiratory, Thoracic and Mediastinal Disorders : Laryngeal edema, Bronchospasm, Laryngospasm, Dyspnea • Skin and Subcutaneous Tissue Disorders: Angioedema, Dermatitis exfoliative, Hypersensitivity vasculitis, Photosensitivity reaction, Urticaria, Pruritus, Rash, Hyperhidrosis
To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at 866-770-7144 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions Identified in Clinical Trials with Haloperidol Decanoate The data described below reflect exposure to 15 mg to 500 mg (1.7 times the maximum recommended dosage) of haloperidol decanoate monthly in 13 clinical trials of 410 adult patients with schizophrenia or an unapproved condition.
These clinical trials comprised of: • 1 double-blind, active comparator-controlled trial with fluphenazine decanoate (Trial 1).
• 2 trials comparing haloperidol decanoate injection to oral haloperidol (Trials 2 and 3).
• 9 open-label trials.
• 1 dose-response trial.
The most common adverse reactions that occurred in ≥5% of haloperidol decanoate-treated patients in Trial 1 were Parkinsonism and oculogyric crisis.
Adverse reactions that occurred in ≥1% of haloperidol decanoate-treated patients in Trial 1 are shown in Table 2.
Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate and fluphenazine decanoate treatment groups.
Table 2: Adverse Reactions that Occurred in ≥1% of Haloperidol Decanoate-treated Patients and Fluphenazine Decanoate-treated Patients in Trial 1 a Haloperidol Decanoate (n=36) Fluphenazine decanoate (n=36) Extrapyramidal disorder: Parkinsonism 31% 44% Oculogyric crisis 6% 0% Akinesia 3% 22% Akathisia 3% 14% Tremor 3% 0% Abdominal pain 3% 0% Headache 3% 0% a The study was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the haloperidol decanoate and the fluphenazine decanoate treatment groups.
Less common adverse reactions (<1%) that occurred in Trial 1 and other adverse reactions that occurred in Trials 2 and 3, and open-label and dose-response clinical trials of haloperidol decanoate are listed below.
• Cardiac Disorders: Tachycardia • Endocrine Disorders: Hyperprolactinemia • Eye Disorders: Vision blurred • Gastrointestinal Disorders: Constipation, Dry mouth, Salivary hypersecretion • General Disorders and Administration Site Conditions : Weight increased, Injection site reaction • Musculoskeletal and Connective Tissue Disorders : Muscle rigidity • Nervous System Disorders: Dyskinesia, Dystonia, Cogwheel rigidity, Hypertonia, Masked facies, Sedation, Somnolence • Reproductive System Disorders : Erectile dysfunction Adverse Reactions Identified in Clinical Trials with Immediate-Release Haloperidol Products Based on clinical trials with immediate-release haloperidol products that included 1,579 patients, the following adverse reactions were reported: • Musculoskeletal and Connective Tissue Disorders: Torticollis, Trismus, Muscle twitching • Nervous System Disorders: Neuroleptic malignant syndrome, Tardive dyskinesia, Bradykinesia, Hyperkinesia, Hypokinesia, Dizziness, Nystagmus • Psychiatric Disorders : Loss of libido, Restlessness • Reproductive System and Breast Disorders: Amenorrhea, Galactorrhea, Dysmenorrhea, Menorrhagia, Breast discomfort • Skin and Subcutaneous Tissue Disorders: Acneiform skin reactions • Vascular Disorders: Hypotension, Orthostatic hypotension 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of haloperidol, including haloperidol decanoate injection.
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.
• Blood and Lymphatic System Disorders : Pancytopenia, Agranulocytosis, Thrombocytopenia, Leukopenia, Neutropenia • Cardiac Disorders : Ventricular fibrillation, Torsade de pointes, Ventricular tachycardia, Extrasystoles, QTc interval prolongation • Endocrine Disorders : Inappropriate antidiuretic hormone secretion • Gastrointestinal Disorders : Vomiting, Nausea • General Disorders and Administration Site Conditions : Sudden death, Face edema, Edema, Hyperthermia, Hypothermia, Injection site abscess, Weight decreased • Hepatobiliary Disorders : Acute hepatic failure, Hepatitis, Cholestasis, Jaundice, Liver function test abnormal • Immune System Disorders: Anaphylactic reaction, Hypersensitivity • Metabolic and Nutritional Disorders: Hypoglycemia • Musculoskeletal and Connective Tissue Disorders : Rhabdomyolysis • Nervous System Disorders: Convulsion, Opisthotonus, Tardive dystonia • Pregnancy, Puerperium and Perinatal Conditions: Neonatal drug withdrawal syndrome • Psychiatric Disorders: Agitation, Confusional state, Depression, Insomnia • Renal and Urinary Disorders : Urinary retention • Reproductive System and Breast Disorders: Priapism, Gynecomastia • Respiratory, Thoracic and Mediastinal Disorders : Laryngeal edema, Bronchospasm, Laryngospasm, Dyspnea • Skin and Subcutaneous Tissue Disorders: Angioedema, Dermatitis exfoliative, Hypersensitivity vasculitis, Photosensitivity reaction, Urticaria, Pruritus, Rash, Hyperhidrosis