(paliperidone palmitate 6-month)
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INVEGA HAFYERA® (paliperidone palmitate 6-month)
Medical Information
Adverse Events of INVEGA HAFYERA - General
Last Updated: 06/12/2024
- The most common adverse reactions (incidence at least 5% in the double-blind phase) of the INVEGA HAFYERA clinical trial were: upper respiratory tract infection, injection site reaction, weight increased, headache and parkinsonism.1
- The percentage of patients who discontinued due to adverse events in the double-blind phase of the INVEGA HAFYERA clinical trial were 1.3% of patients in the INVEGA HAFYERA group and 0.4% of patients in the INVEGA TRINZA group.1
- For questions regarding specific adverse events, please contact Medical Information at 1-800-726-5536 (1-800-526-7736)
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Please refer to the following sections of the Full Prescribing Information which are relevant to your inquiry: BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. INVEGA HAFYERA is not approved for use in patients with dementia-related psychosis.
INVEGA HAFYERA is contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the INVEGA HAFYERA formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone and paliperidone. Paliperidone palmitate is converted to paliperidone, which is a metabolite of risperidone.1
Please refer to the Full Prescribing Information for detailed information regarding the Boxed Warning and Warnings and Precautions for INVEGA HAFYERA.1
- Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
- Neuroleptic Malignant Syndrome
- QT Prolongation
- Tardive Dyskinesia
- Metabolic Changes
- Hyperglycemia and Diabetes Mellitus
- Dyslipidemia
- Change in Body Weight
- Orthostatic Hypotension and Syncope
- Falls
- Leukopenia, Neutropenia, and Agranulocytosis
- Hyperprolactinemia
- Potential for Cognitive and Motor Impairment
- Seizures
- Dysphagia
- Priapism
- Disruption of Body Temperature Regulation
Adverse Reactions in the Double-Blind, Active-Controlled Clinical Trial
| Double-Blind | ||
|---|---|---|
| INVEGA TRINZA | INVEGA HAFYERA | |
| (N=224) | (N=478) | |
| System Organ Class | % | % |
| Adverse Reaction | ||
| Gastrointestinal disorders | ||
| Diarrheaa | 1 | 2 |
| General disorders and administration site conditions | ||
| Injection site reactionb | 5 | 11 |
| Infections and infestations | ||
| Upper respiratory tract infectiond | 13 | 12 |
| Urinary tract infection | 1 | 3 |
| Metabolism and nutrition disorders | ||
| Weight increasedc | 8 | 9 |
| Musculoskeletal and connective tissue disorders | ||
| Back paine | 1 | 3 |
| Musculoskeletal painf | 1 | 3 |
| Nervous system disorders | ||
| Akathisiag | 4 | 4 |
| Headache | 5 | 7 |
| Extrapyramidal symptomsh | 5 | 7 |
| Psychiatric disorders | ||
| Psychosisi | 3 | 3 |
| Anxiety | 0 | 3 |
| Insomniaj | 2 | 3 |
| aDiarrhea includes: Diarrhea, Diarrhea infectious. bInjection site reaction includes: Injection site reaction, Injection site discomfort, Injection site erythema, Injection site hemorrhage, Injection site induration, Injection site nodule, Injection site oedema, Injection site pain, Injection site swelling. cWeight increased includes: Weight increased, Body mass index increased, Obesity, Waist circumference increased. dUpper respiratory tract infection includes: Upper respiratory tract infection, Nasopharyngitis, Pharyngitis, Rhinitis, Viral pharyngitis, Viral upper respiratory tract infection. eBack pain includes: Back pain, Neck pain, Spinal pain. fMusculoskeletal pain includes: Musculoskeletal pain, Musculoskeletal chest pain, Myalgia, Pain in extremity. gAkathisia includes: Akathisia, Restless legs syndrome, Restlessness. hExtrapyramidal symptoms includes: Blepharospasms, Bradykinesia, Drooling, Dyskinesia, Dystonia, Hypokinesia, Musculoskeletal stiffness, Muscle rigidity, Muscle spasms, Oculogyric crisis, Parkinsonism, Parkinsonism rest tremor, Reduced facial expression, Tardive Dyskinesia. iPsychosis includes: Acute psychosis, Delusion, Delusion of reference, Hallucination (auditory), Psychotic disorder, Psychotic symptom, Schizophrenia. jInsomnia includes: Insomnia, Initial insomnia, Middle insomnia. | ||
Data from the randomized double-blind active controlled study provided information regarding EPS. Several methods were used to measure EPS: (1) the Simpson-Angus Rating Scale Global Score which broadly evaluates parkinsonism, (2) the Barnes Akathisia Rating Scale Global Clinical Rating Score which evaluates akathisia, (3) the Abnormal Involuntary Movement Scale scores which evaluates dyskinesia, and (4) use of anticholinergic medications to treat EPS (Table: Extrapyramidal Symptoms (EPS) Assessed by Rating Scales Incidence and Use of Anticholinergic Medication During the Double-blind Phase) and (5) incidence of spontaneous reports of EPS (Table: Extrapyramidal Symptoms (EPS)-Related Events by MedDRA Preferred Term).1
| INVEGA TRINZA (N=224) % | INVEGA HAFYERA (N=478) % | |
|---|---|---|
| Use of Anticholinergic Medicationsa | 13 | 15 |
| Parkinsonismb | 6 | 7 |
| Akathisiac | 3 | 3 |
| Dyskinesiad | 1 | 1 |
| aUse of Anti-EPS Medication During the Double-blind Phase; bPercent of subjects with Simpson-Angus Scale Global Score >0.3 (Global Score defined as total sum of items score divided by the number of items); cPercent of subjects with Barnes Akathisia Rating Scale Global Clinical Rating Score ≥2; dPercent of subjects with a score ≥3 on any of the first seven items or a score ≥2 on two or more of any of the first seven items of the Abnormal Involuntary Movement Scale.Note: Percentages are calculated based on number of subjects in the DB Safety analysis set per treatment group. | ||
| Double-blind Phase | ||
|---|---|---|
| INVEGA TRINZA (N=224) % | INVEGA HAFYERA (N=478) % | |
| Overall percentage of subjects with EPS-related adverse events | 9 | 10 |
| Parkinsonisma | 4 | 5 |
| Hyperkinesiab | 4 | 4 |
| Tremor | 0 | <1 |
| Dyskinesiac | 1 | 2 |
| Dystoniad | 1 | 1 |
| aParkinsonism group includes: Bradykinesia, drooling, hypokinesia, muscle rigidity, musculoskeletal stiffness, parkinsonism, parkinsonian rest tremor, reduced facial expressionbHyperkinesia group includes: Akathisia, restlessness, restless legs syndromecDyskinesia group includes: Dyskinesia, muscle twitching, tardive dyskinesiadDystonia group includes: Blepharospasm, dystonia, muscle spasms, oculogyric crisis | ||
Investigator ratings of injection site. Induration, redness and swelling were observed in 13% in the INVEGA HAFYERA group and 9% in the INVEGA TRINZA group during the double-blind phase. Investigator evaluation of tenderness was higher for patients in the INVEGA HAFYERA group versus the INVEGA TRINZA group (31% vs. 19%) during the double-blind phase. Active INVEGA HAFYERA medication was given at double-blind baseline and Month 6, while placebo medication was given at the other injection times.1
Patient ratings of injection-site pain: The average score for the patient’s evaluation of injection pain on a scale of 0 to 100 was approximately 16 at the open-label phase end point and approximately 5 in both groups at the double-blind phase end point.1
References
| 1 | INVEGA HAFYERA (paliperidone palmitate) extended-release injectable suspension [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVEGA+HAFYERA-pi.pdf. |