Risperdal Consta was the first of the second-generation antipsychotics that became available as a long-acting injectable antipsychotic. The efficacy and side effect profile corresponds to oral risperidone. It is FDA-approved for the treatment of schizophrenia and for the maintenance treatment of bipolar 1 disorder.
Risperdal Consta | |
Indication(s) | Schizophrenia |
Dosing available as prefilled syringes | 12.5 mg (2 mL) |
Recommended starting and maintenance dose | The recommended dose is 25 mg IM every 2 weeks. |
Drug Metabolizing Enzyme | CYP2D6, CYP3A4 |
Dosing exclusions | Patients with renal or hepatic impairment should be treated with titrated doses of oral Risperdal prior to initiating treatment with Risperdal Consta. |
Loading dose | No established loading-dose strategy. |
Oral overlap | Initiating Consta requires overlap with oral risperidone (at a therapeutic dose) for 3 weeks. |
Establishing tolerability | Prior to initiating Risperdal Consta, establish tolerability with oral risperidone in risperidone-naïve patients. |
Storage | Requires refrigeration |
Reconstitution or mixing | Use only components of the pre-packed dose packages containing the drug and syringe prefilled with diluent. Follow instructions from package insert regarding reconstitution. |
Injection site | Deltoid or gluteal injections are bioequivalent; the site can be chosen based on patient preference. Alternate sites and use 1-inch needle for deltoid, 2-inch needle for gluteal injection. |
Injection interval | Every 2 weeks |
Preparation | Allow product to come to room temperature for at least 30 minutes before reconstituting. Flip the cap from the vial. Attach the vial adapter to the vial. Swab the syringe connection point with an alcohol pad. Snap the white cap off the prefilled syringe. Attach the syringe to the vial adapter. Inject the entire contents of the syringe containing the diluent into the vial. Shake the vial vigorously while holding the plunger rod down with the thumb for a minimum of 10 seconds to ensure a homogeneous suspension. If 2 minutes pass before injection, re-suspend by shaking vigorously. Invert the vial completely and slowly withdraw the suspension from the vial into the syringe. Unscrew the syringe from the vial adapter and inject per package insert instructions. Priming of the syringe is recommended. |
Administration considerations |
|
Timing variations | N/A |
When a dose is missed | |
REMS | No |
Additional information | Adjustment in dose should not be made more frequently than every 4 weeks. |
Dose Conversion of Oral Risperidone to Risperidone Microspheres LAI | |
PO Dose | LAI/IM Dose |
1 mg daily | 12.5 mg (injection volume of 2 ml) every 2 weeks |
2 mg daily | 25 mg (injection volume 2 ml) every 2 weeks |
3-5 mg daily | 37.5 mg (injection volume 2 ml) every 2 weeks |
4-5 mg daily | 50 mg (injection volume 2 ml) every 2 weeks |
Recommended available dose formulations include 12.5 mg, 25 mg, 37.5 mg, and 50 mg pre-filled vial kits. 5. Taylor, D.M., Barnes, T.R.E, & Young, A.H. (2021). The Maudsley prescribing guidelines in psychiatry (14th ed.). Wiley Blackwell. | |
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.
Prescribing should always be informed by the FDA medication label. Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices.
Labels change over time, and the current label should always be consulted. Here is the most recent label, at time of writing.