Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland
Palmeux is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.
In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Palmeux may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Recommended initiation of Palmeux is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2). The third dose should be administered one month after the second initiation dose. The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy. Patients who are overweight or obese may require doses in the upper range (see section 5.2). Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged release characteristics of Palmeux should be considered (see section 5.2), as the full effect of maintenance doses may not be evident for several months.
Palmeux should be initiated as described at the beginning of section 4.2 above. During monthly maintenance treatment with Palmeux, patients previously stabilised on different doses of paliperidone prolonged release tablets can attain similar paliperdone steady-state exposure by injection. The Palmeux maintenance doses needed to attain similar steady-state exposure are shown as follows:
| Doses of paliperidone prolonged release tablets and Palmeux needed to attain similar steady-state paliperidone exposure during maintenance treatment | |
|---|---|
| Previous paliperidone prolonged release tablet dose | Palmeux injection |
| 3 mg daily | 25-50 mg monthly |
| 6 mg daily | 75 mg monthly |
| 9 mg daily | 100 mg monthly |
| 12 mg daily | 150 mg monthly |
Previous oral paliperidone or oral risperidone can be discontinued at the time of initiation of treatment with Palmeux. Some patients may benefit from gradual withdrawal. Some patients switching from higher paliperidone oral doses (e.g., 9-12 mg daily) to gluteal injections with Palmeux may have lower plasma exposure during the first 6 months after the switch. Therefore, alternatively, it could be considered to give deltoid injections for the first 6 months.
When switching patients from risperidone long acting injection, initiate Palmeux therapy in place of the next scheduled injection. Palmeux should then be continued at monthly intervals. The one-week initiation dosing regimen including the intramuscular injections (day 1 and 8, respectively) as described in section 4.2 above is not required. Patients previously stabilised on different doses of risperidone long acting injection can attain similar paliperidone steady-state exposure during maintenance treatment with Palmeux monthly doses according to the following:
| Doses of risperidone long acting injection and Palmeux needed to attain similar paliperidone exposure at steady-state | |
|---|---|
| Previous risperidone long acting injection dose | Palmeux injection |
| 25 mg every | 2 weeks 50 mg monthly |
| 37.5 mg every | 2 weeks 75 mg monthly |
| 50 mg every | 2 weeks 100 mg monthly |
Discontinuation of antipsychotic medicinal products should be made in accordance with appropriate prescribing information. If Palmeux is discontinued, its prolonged release characteristics must be considered. The need for continuing existing extrapyramidal symptoms (EPS) medicine should be re-evaluated periodically.
If the target date for the second Palmeux injection (day 8 ± 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the patient’s first injection.
If less than 4 weeks have elapsed since the first injection, then the patient should be administered the second injection of 100 mg in the deltoid muscle as soon as possible. A third Palmeux injection of 75 mg in either the deltoid or gluteal muscles should be administered 5 weeks after the first injection (regardless of the timing of the second injection). The normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy should be followed thereafter.
Missed second initiation dose (4-7 weeks from first injection)
If 4 to 7 weeks have elapsed since the first injection of Palmeux, resume dosing with two injections of 100 mg in the following manner:
If more than 7 weeks have elapsed since the first injection of Palmeux, initiate dosing as described for the initial recommended initiation of Palmeux above.
After initiation, the recommended injection cycle of Palmeux is monthly. If less than 6 weeks have elapsed since the last injection, then the previously stabilised dose should be administered as soon as possible, followed by injections at monthly intervals.
If more than 6 weeks have elapsed since the last injection of Palmeux, the recommendation is as follows:
For patients stabilised with doses of 25 to 100 mg
For patients stabilised with 150 mg
If more than 6 months have elapsed since the last injection of Palmeux, initiate dosing as described for the initial recommended initiation of Palmeux above.
Efficacy and safety in elderly >65 years have not been established.
In general, recommended dosing of Palmeux for elderly patients with normal renal function is the same as for younger adult patients with normal renal function. However, because elderly patients may have diminished renal function, dose adjustment may be necessary (see Renal impairment below for dosing recommendations in patients with renal impairment).
Palmeux has not been systematically studied in patients with renal impairment (see section 5.2). For patients with mild renal impairment (creatinine clearance ≥50 to <80 mL/min), recommended initiation of Palmeux is with a dose of 100 mg on treatment day 1 and 75 mg one week later, both administered in the deltoid muscle. The recommended monthly maintenance dose is 50 mg with a range of 25 to 100 mg based on patient tolerability and/or efficacy.
Palmeux is not recommended in patients with moderate or severe renal impairment (creatinine clearance <50 mL/min) (see section 4.4).
Based on experience with oral paliperidone, no dose adjustment is required in patients with mild or moderate hepatic impairment. As paliperidone has not been studied in patients with severe hepatic impairment, caution is recommended in such patients (see section 5.2).
The safety and efficacy of Palmeux in children and adolescents <18 years of age have not been established. No data are available.
Palmeux is intended for intramuscular use only. It must not be administered by any other route. It should be injected slowly, deep into the deltoid or gluteal muscle. Each injection should be administered by a health care professional. Administration should be in a single injection. The dose should not be given in divided injections.
The day 1 and day 8 initiation doses must each be administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2). Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle. A switch from gluteal to deltoid (and vice versa) should be considered in the event of injection site pain if the injection site discomfort is not well tolerated (see section 4.8). It is also recommended to alternate between left and right sides (see below).
For instructions for use and handling of Palmeux, see package leaflet (information intended for medical or healthcare professionals).
The recommended needle size for initial and maintenance administration of Palmeux into the deltoid muscle is determined by the patient’s weight. For those ≥90 kg, the 1½ inch, 22 gauge needle (38.1 mm x 0.72 mm) is recommended. For those <90 kg, the 1-inch, 23 gauge needle (25.4 mm x 0.64 mm) is recommended. Deltoid injections should be alternated between the two deltoid muscles.
The recommended needle size for maintenance administration of Palmeux into the gluteal muscle is the 1½-inch, 22-gauge needle (38.1 mm x 0.72 mm). Administration should be made into the upper-outer quadrant of the gluteal area. Gluteal injections should be alternated between the two gluteal muscles.
In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms. Torsade de pointes and ventricular fibrillation have been reported in a patient in the setting of overdose with oral paliperidone. In the case of acute overdose, the possibility of multiple drug involvement should be considered.
Consideration should be given to the prolonged release nature of the medicinal product and the long elimination half-life of paliperidone when assessing treatment needs and recovery. There is no specific antidote to paliperidone. General supportive measures should be employed. Establish and maintain a clear airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring for possible arrhythmias. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents. In case of severe extrapyramidal symptoms, anticholinergic agents should be administered. Close supervision and monitoring should continue until the patient recovers.
30 months.
Do not store above 30°C.
Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (chlorobutyl rubber) with a 22G 1½-inch safety needle and a 23G 1-inch safety needle.
Pack sizes: Pack contains 1 pre-filled syringe and 2 needles.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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