175 mg, 263 mg, 350 mg & 525 mg prolonged release suspension for injectionPRESCRIBING INFORMATION
175 mg, 263 mg, 350 mg & 525 mg paliperidone
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
The TREVICTA® SmPCs are available at:
Please click the following product name to access the full SmPC
TREVICTA® 175mg, 263mg, 350mg, 525mg prolonged release suspension for injection
TREVICTA®, a 3-monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate injectable product.
DOSAGE & ADMINISTRATION:
Intramuscular injection. Patients who are treated with 1-monthly paliperidone palmitate injectable (4 months or more) and do not require dose adjustment may be switched to TREVICTA®.
Adults: Administer dose in either deltoid or gluteal muscle. Deltoid administration, use 1½ inch, 22 gauge needle (0.72 mm x 38.1 mm) patients ≥ 90 kg, or 1-inch, 22 gauge needle (0.72 mm x 25.4 mm) patients < 90 kg. For gluteal administration use the 1½ inch, 22 gauge needle (0.72 mm x 38.1 mm). Initiate TREVICTA® in place of the next scheduled dose of 1-month paliperidone palmitate injectable (± 7 days). Base TREVICTA® dose on the previous 1-month paliperidone palmitate injectable dose using a 3.5-fold higher dose. Thereafter TREVICTA® should be administered by intramuscular injection once every 3 months (± 2 weeks). Dose adjustment of TREVICTA® can be made every 3 months in increments within the range of 175 mg to 525 mg. Alternate injections between left and right sides.
Children: No safety or efficacy data available.
Elderly: No safety or efficacy data available for patients > 65 years.
Mild (creatinine clearance ≥ 50 to < 80 ml/min): dose should be adjusted. Stabilise patient using 1-month paliperidone palmitate injectable, and then transition to TREVICTA®.
Moderate or severe (creatinine clearance < 50 ml/min): Not recommended.
Hepatic impairment: Caution in severe hepatic impairment.
Hypersensitivity to paliperidone, risperidone or any of the excipients.
SPECIAL WARNINGS & PRECAUTIONS:
Do not use in acutely agitated or severely psychotic patients. Not recommended in elderly dementia patients. Caution in cardiovascular disease (including family history of QT prolongation), cerebrovascular disease, hypotension, prolactin-dependent tumours, seizures, Parkinson’s disease and in conjunction with medicines that prolong QT interval. May induce orthostatic hypotension. If tardive dyskinesia occurs consider discontinuing all antipsychotics. Caution is warranted in patients receiving both, psychostimulants (e.g., methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications. Gradual withdrawal of stimulant treatment is recommended. Events of leucopenia, neutropenia, and agranulocytosis reported with antipsychotics, including TREVICTA®, additional monitoring or cessation of treatment may be required. If Neuroleptic Malignant Syndrome (NMS) occurs discontinue all antipsychotics. Rarely, anaphylactic reactions reported in patients previously tolerating oral risperidone/paliperidone. If occur, discontinue TREVICTA®, initiate general supportive measures, monitor until resolved. Appropriate clinical monitoring in diabetics and those with risk factors for diabetes advisable. Advise of potential for weight gain, monitor weight regularly. Priapism reported with oral paliperidone. Caution in patients experiencing conditions which may contribute to core body temperature elevation. Identify all possible risk factors for venous thromboembolism (VTE) before and during treatment and take preventive measures. Antiemetic effect (observed in paliperidone preclinical studies) may mask overdosage with certain medicines, intestinal obstruction, Reye’s syndrome, brain tumour etc. Avoid inadvertent injection into a blood vessel. Intraoperative floppy iris syndrome (IFIS) observed during cataract surgery in patients treated with medicines with alpha-1a adrenergic antagonist effect, such as TREVICTA®.
Very common: insomnia.
Common: upper respiratory tract infection, urinary tract infection, influenza, hyperprolactinaemia, hyperglycaemia, weight increased, weight decreased, decreased appetite, agitation, depression, anxiety, parkinsonism, akathisia, sedation/ somnolence, dystonia, dizziness, dyskinesia, tremor, headache, tachycardia, hypertension, cough, nasal congestion, abdominal pain, vomiting, nausea, constipation, diarrhoea, dyspepsia, toothache, transaminases increased, musculoskeletal pain, back pain, arthralgia, amenorrhoea, galactorrhoea, pyrexia, asthenia, fatigue, injection site reaction.
Other side effects reported with paliperidone include: pneumonia, respiratory tract infection, cellulitis, thrombocytopenia, diabetes mellitus, electrocardiogram QT prolonged, bradycardia, subcutaneous abscess, neutropenia, inappropriate antidiuretic hormone secretion, diabetic ketoacidosis, NMS, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, glaucoma, atrial fibrillation, pulmonary congestion, pancreatitis, faecaloma, urinary retention, hypothermia, agranulocytosis, anaphylactic reaction, water intoxication, diabetic coma, pulmonary embolism, pneumonia aspiration, intestinal obstruction, ileus, angioedema, rhabdomyolysis, injection site necrosis.
Other side effects reported with risperidone (paliperidone is the active metabolite of risperidone):
Weight gain: 10% of TREVICTA®-treated subjects experienced weight gain of ≥ 7%.
Laboratory tests: Serum prolactin: increases in serum prolactin observed.
Class effects: QT prolongation, ventricular arrhythmias, sudden unexplained death, cardiac arrest, and Torsade de pointes may occur with antipsychotics. Cases of venous thromboembolism, including pulmonary embolism and deep vein thrombosis, also reported.
Refer to SmPC for other side effects
Should not be used during pregnancy unless clearly necessary.
Should not be used while breastfeeding.
Caution with medicines that prolong QT interval e.g., class IA and class III antiarrhythmics, some antihistaminics, some antibiotics, some other antipsychotics, some antimalarials.
Potential for TREVICTA® to affect other medicines: Caution in conjunction with: other centrally acting medicines e.g., anxiolytics, antipsychotics, hypnotics, opiates, alcohol; medicines known to lower seizure threshold i.e., phenothiazines, butyrophenones, tricyclics, SSRI’s, tramadol, mefloquine; medicines capable of inducing orthostatic hypotension (an additive effect may be observed when TREVICTA® is co-administered); levodopa and other dopamine agonists (paliperidone may antagonize their effect- use lowest effective dose of each treatment if this combination necessary e.g., end-stage Parkinson’s disease). Interaction of TREVICTA® with lithium unlikely.
Potential for other medicines to affect TREVICTA®: Administration of oral paliperidone and paroxetine (a potent CYP2D6 inhibitor) showed no clinically significant effect on paliperidone pharmacokinetics. Co-administration of oral paliperidone once daily with carbamazepine 200 mg twice daily decreases plasma concentration of paliperidone by 37%. Re-evaluate/increase TREVICTA® dose at carbamazepine initiation. No clinically significant interaction expected between valproate and TREVICTA®. Caution when TREVICTA® is co administered with risperidone or with oral paliperidone for extended periods of time. Limited safety data for concomitant use of TREVICTA® with other antipsychotics. The combined use of psychostimulants (e.g. methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either/both treatments.
Refer to SmPC for full details of interactions.
LEGAL CATEGORY: Prescription Only Medicine.
PRESENTATIONS, PACK SIZES, MARKETING AUTHORISATION NUMBER(S) & BASIC NHS COSTS
|PRESENTATIONS||PACK SIZES||MARKETING AUTHORISATION NUMBERS||BASIC NHS COSTS|
|175 mg pre-filled syringe||1 dose||EU/1/14/971/007||£551.76|
|263 mg pre-filled syringe||EU/1/14/971/008||£734.70|
|350 mg pre-filled syringe||EU/1/14/971/009||£942.21|
|525 mg pre-filled syringe||EU/1/14/971/010||£1177.77|
MARKETING AUTHORISATION HOLDER: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
FURTHER INFORMATION IS AVAILABLE FROM: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Prescribing information last revised: September 2018