Some information presented within this Center of Excellence was created in collaboration with the California Department of State Hospitals (DSH). This includes that the content has been specifically aligned to the DSH’s medication guidelines (DSH Psychotropic Medication Operational Procedures, appended to DSH Policy Directive 3400). These medication guidelines are applicable only to the DSH settings and inclusion within this resource does not indicate that they must be followed in any non-DSH settings. The medication guidelines included in this resource are those of DSH and do not necessarily represent the views, policy(ies), and/or position(s) of the American Psychiatric Association (APA).
Erzofri | |
Indication(s) | Schizophrenia in adults Schizoaffective disorder in adults |
Dosing available as prefilled syringes | 39 mg (injection volume of 0.25 mL) corresponds to a daily oral dose of paliperidone 3 mg 78 mg (injection volume of 0.5 mL) corresponds to a daily oral dose of paliperidone 3 mg 117 mg (injection volume of 0.75 mL) corresponds to a daily oral dose of paliperidone 6 mg 156 mg (injection volume of 1mL) corresponds to a daily oral dose of paliperidone 9 mg 234 mg (injection volume of 1.5 mL) corresponds to a daily oral dose of paliperidone 12 mg 351 mg (injection volume of 2.25 mL) is utilized as a loading dose and not for maintenance injections |
Recommended starting and maintenance dose | The recommended maintenance dose for treatment of schizophrenia is 117 mg. |
Drug Metabolizing Enzymes | CYP3A4 |
Dosing exclusions | CrCL dosing: For patients with mild renal impairment (CrCl >/= 50 mL/min to < 80 mL/min: Initiate Sustenna with a dose of 234 mg on treatment day 1 in the deltoid muscle, 78 mg one week later either in the deltoid or gluteal muscle. Adjust monthly maintenance dose based on tolerability and/or efficacy. The maximum dose is 156 mg for patients with mild renal impairment. Not recommended in patients with moderate or severe renal impairment (CrCl < 50 mL/min) |
Loading dose | 351 mg on treatment Day 1 administered in the deltoid muscle |
Oral overlap | Not required |
Establishing tolerability | Prior to initiating Erzofri, establish tolerability with oral paliperidone or risperidone |
Storage | Dose pack to be refrigerated (36 °F to 46 °F), can be kept at room temperature (not exceeding 77 °F) for up to 7 days, ~45 minutes to reach room temperature |
Reconstitution or mixing | N/A |
Injection site | Choose between the deltoid or gluteal muscle (for maintenance doses) based on the patient preference and body habitus. Loading dose should be administered in the deltoid muscle. Rotate injection sites to avoid muscle hypertrophy, abscesses, and tissue damage by repeated, frequent injections at the same site. For deltoid injections: For patients weighing less than 90 kg, the 1-inch, 23 gauge needle is recommended. For patients weighing 90 kg or more, the 1 ½-inch, 22 gauge needle is recommended. For gluteal injections: The recommended needle size for administration of Erzofri into the gluteal muscle is the 1½-inch, 22 gauge needle regardless of patient weight. Deltoid is specifically recommended for faster distribution during the initiation phase. |
Injection interval | Every 4 weeks |
Preparation | Shake the syringe vigorously for a minimum of 10 seconds to ensure a homogeneous suspension. Priming the syringe is recommended. |
Administration considerations | Inject the entire contents intramuscularly slowly, deep into the selected deltoid or gluteal muscle of the patient. |
When a dose is missed | See this tip on how to manage missed doses of Erzofri. Monthly doses can be flexibly administered one week before or after the scheduled dose to avoid missed doses. |
REMS | No |
Additional Information | 351 mg dose is utilized for the first injection and not for maintenance monthly doses. The maximum monthly dose is 234 mg. |
Dose Conversion of Oral Paliperidone to Paliperidone Palmitate LAI | |
PO Dose | LAI/IM Dose |
Initiate LAI Dose | 351 mg on treatment day 1, followed by maintenance dose at monthly intervals |
3 mg paliperidone | 39-78 mg Erzofri every 4 weeks |
6 mg paliperidone | 117 mg Erzofri every 4 weeks |
9 mg paliperidone | 156 mg Erzofri every 4 weeks |
12 mg paliperidone | 234 mg Erzofri every 4 weeks |
Recommended available dose formulations include 39 mg, 78 mg, 117 mg, 156 mg, 234 mg, and 351 mg pre-filled syringes. | |
Dose reduction may be necessary for CYP450 interactions of side effect intolerance.
References:
1. FDA Medication Label: Information on this topic is found in the FDA medication label. Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions. Here is the most recent label, at time of writing. Medication labels can be found by searching Drugs@FDA at the FDA website. Labes are also available using Drugs@FDA app for Apple or Android devices. Labels change over time, and the current label should always be consulted. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216352s000lbl.pdf
2. DSH Psychotropic Medication Operational Procedures Chapter 20: Paliperidone Protocol
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