Patient information: uses, side effects, how to take - Rykindo extended-release microspheres
INSTRUCTIONS FOR USE
RYKINDO® [ray-KIN-do]
(risperidone)
injection, for gluteal intramuscular use
This Instruction for Use contains information on how to inject RYKINDO®
Important Information You Need to Know Before Injecting RYKINDO®
- For gluteal intramuscular injection use only
For gluteal intramuscular injection only. Do not inject by any other route. Alternate injections between the two buttocks.
- Wait 30 minutes
Remove dose pack from the refrigerator and allow to sit at room temperature for at least 30 minutes prior to preparation. Do not warm any other way. Prepare medication when you are ready to administer the dose.
- Use components provided
The components in this dose pack are specifically designed for use with RYKINDO. RYKINDO must be reconstituted only in the diluent supplied in the dose pack. Do not substitute ANY components of the dose pack.
- Do not store suspension after reconstitution.
Administer dose as soon as possible after reconstitution to avoid settling.
- Proper dosing
The entire contents of the vial must be administered to ensure the intended dose of RYKINDO is delivered.
- Do not reuse.
RYKINDO® is for one-time use only. Do not reuse RYKINDO.
The components of the single-dose kit are shown in Figure 1.
Figure1: Single-dose Kit Components
Preparing to Inject RYKINDO®
Step 1. Take out kit and connect vial adapter to vial
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Wait 30 minutes Remove dose pack from the refrigerator and allow to sit at room temperature for at least 30 minutes before reconstituting. Do not warm any other way. | Remove cap from vial Flip off colored cap from vial. Wipe top of the gray stopper with an alcohol swab. Allow to air dry. Do not remove gray rubber stopper. | Prepare vial adapter Hold sterile blister as shown. Peel back and remove paper backing. Do not remove vial adapter from blister. Do not touch spike tip at any time. This will result in contamination. | Connect vial adapter to vial Place vial on a hard surface and hold by the base. Center vial adapter over the gray rubber stopper. Push vial adapter straight down onto vial top until it snaps securely into place. Do not place vial adapter on at an angle or diluent may leak upon transfer to the vial.  |
Step 2. Connect prefilled syringe to vial adapter
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Remove sterile blister  Keep vial vertical to prevent leakage. Hold base of vial and pull up on the sterile blister to remove. Do not shake. Do not touch exposed luer opening on vial adapter. This will result in contamination. | Use proper grip Hold by the LUER-LOK ADAPTER at the tip of the syringe. Do not hold syringe by the glass barrel during assembly.  | Remove cap Holding the transparent LUER-LOK ADAPTER, unscrew the translucent gray cap. Do not snap or cut off the translucent gray cap. Do not touch syringe tip. This will result in contamination.  The unscrewed cap can be discarded. | Connect syringe to vial adapter Hold vial adapter by skirt to keep stationary. Hold syringe by the LUER-LOK ADAPTER then turn it to connect with the luer opening of the vial adapter. Do not hold the glass syringe barrel. This may cause the LUER-LOK ADAPTER to loosen or detach. Attach the syringe to the vial adapter with a firm clockwise twisting motion until it feels snug. Do not over-tighten. Over-tightening may cause the syringe tip to break. |
Step 3. Reconstitute powder
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Inject diluent Inject entire amount of diluent from syringe into the vial.  | Suspend powder in diluent Continuing to hold down the plunger rod, shake vigorously for at least 30 seconds, as shown. Check the suspension. When properly mixed, the suspension appears uniform, thick and milky in color. Immediately proceed to the next step so suspension does not settle. | Transfer suspension to syringe Invert vial completely. Slowly pull plunger rod down to withdraw entire contents from the vial into the syringe. | Remove vial adapter Hold the LUER-LOK ADAPTER on the syringe and unscrew from vial adapter. Tear section of the vial label at the perforation. Apply detached label to the syringe for identification purposes. Discard both vial and vial adapter appropriately. |
Step 4. Attach needle
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Take out needle Take out needle for gluteal injection. | Attach needle Peel blister pouch open part way and use to grasp the base of the needle, as shown. Holding the LUER-LOK ADAPTER on the syringe, attach syringe to needle luer connection with a firm clockwise twisting motion until snug. Do not touch needle luer opening. This will result in contamination. | Resuspend powder Fully remove the blister pouch. Just before injection, shake syringe vigorously for 20 to 30 seconds until there is no deposition of powder, as some settling will have occurred. |
Step 5. Inject RYKINDO®
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Remove transparent needle protector Move the needle safety device back towards the syringe, as shown. Then hold the LUER-LOK ADAPTER on syringe and carefully pull the transparent needle protector straight off. Do not twist transparent needle protector, as the luer connection may loosen. | Remove air bubbles Hold syringe upright and tap gently to make any air bubbles rise to the top. Slowly and carefully press plunger rod upward to remove air. | Inject Immediately inject entire contents of syringe intramuscularly into the upper outer quadrant of the gluteal muscle of the patient. Do not administer by any other route. | Secure needle in safety device Using one hand, place needle safety device at a 45-degree angle on a hard, flat surface. Press down with a firm, quick motion until needle is fully engaged in safety device. Avoid needle stick injury: Do not use two hands. Do not intentionally disengage or mishandle the needle safety device. Do not attempt to straighten the needle or engage the safety device if the needle is bent or damaged. | Properly dispose of syringes Check to confirm needle safety device is fully engaged. Discard in an approved sharps container. |
Storing RYKINDO®
Store kit in refrigerator at 2° to 8°C (36° to 46°F). Protect from light.
If refrigeration is unavailable, RYKINDO can be stored in its unopened original packaging at temperatures not exceeding 77°F (25°C) for no more than 7 days prior to administration. After removal from the refrigerator, use RYKINDO within 7 days or discard.
For product or service related questions, call 1-800-548-9765 or visit www.rykindo.com.
Shandong Luye Pharmaceutical Co., Ltd.
No.15 Chuangye Road, High-tech Zone,
Yantai, Shandong, 264003
China
This Instruction for Use has been approved by the U.S. Food and Drug Administration.
Issued: 05/2023