Summary

• RISPERDAL CONSTA (12.5, 25, 37.5, or 50 mg) is provided as a dose pack, consisting of a vial containing the risperidone microspheres, a pre-filled syringe containing 2 mL of diluent for RISPERDAL CONSTA, a vial adapter, and two Terumo SurGuard^® 3 safety needles for intramuscular injection (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).¹
• For inventory control purposes, the lot number on the dose pack is different from the lot numbers of the individual components. Each of these components (the needles, syringe, vial, adapter) has its own unique lot number and expiration date as provided by the manufacturer. To avoid the use of expired components or product, the dose pack is assigned the same expiration date as the next individual component to expire.²
• The extended-release microspheres formulation is a white to off-white, free-flowing powder. Risperidone is micro-encapsulated in 7525 polylactide-co-glycolide (PLG) at a concentration of 381 mg risperidone per gram of microspheres.¹
• The diluent for parenteral use is a clear, colorless solution. Composition of the diluent includes polysorbate 20, sodium carboxymethyl cellulose, disodium hydrogen phosphate dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide, and water for injection.¹
• RISPERDAL CONSTA must be reconstituted only in the diluent supplied in the dose pack, and must be administered with only the appropriate needle supplied in the dose pack for gluteal (2-inch needle) or deltoid (1-inch needle) administration. All components are required for administration. Do not substitute any components of the dose pack.¹
  • During development of RISPERDAL CONSTA a thin-walled needle was selected to ensure easy passage of the microsphere suspension leading to a smooth injection. Siliconization on the outside of the needle helps to reduce friction of the needle cannula when going through the skin upon injection.³

PRODUCT LABELING

Please refer to the following sections of the enclosed Full Prescribing Information that are relevant to your inquiry: DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, DESCRIPTION, and HOW SUPPLIED/STORAGE AND HANDLING.

LITERATURE SEARCH

A literature search of MEDLINE® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 24 August 2023. One publication is referenced below.⁴