Rykindo^®

• Schizophrenia in adults¹¹
• Monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder I in adults¹¹

Initiation Regimen Required for Schizophrenia

Yes¹¹

Oral Supplementation Required During Initiation for Schizophrenia

Yes¹¹

Initiation Regimen for Schizophrenia

25 mg IM (gluteal) Q2WK + 7 days of PO risperidone.¹¹

Disease States

• Schizophrenia in adults¹¹
• Monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder I in adults¹¹

Reconstitution Required

Yes¹¹

How Supplied

White to almost white powder for reconstitution + 2 mL of a colorless, clear diluent¹¹

Preparation Instructions

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, and peel back to 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.

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.

Inject diluent: Inject entire amount of diluent from syringe into the vial. Vial contents will now be under pressure. Keep holding the plunger rod down with thumb.

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 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.

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.

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.¹¹

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, wuick motion until needle is fully engaged in safety device.

Properly dispose of syringes: Check to confirm needle safety device is fully engaged. Discard in an approved sharps container.

Requirements Once Prepared or Reconstituted

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.¹¹

Number of Dosing Options Available

4¹¹

Preparation Kits Available

Single-dose, prefilled syringe kit

• 12.5 mg
• 25 mg
• 37.5 mg
• 50 mg¹¹

Dose Strengths

• 12.5 mg
• 25 mg
• 37.5 mg
• 50 mg¹¹

Equivalencies

Steady-state plasma concentration levels are reached after 2 injections and can be maintained for 2 to 3 weeks after the last injection.¹¹

Maintenance Dose for Schizophrenia

25 mg or 37.5 mg or 50mg Q2WK¹¹

25 mg or 37.5 mg or 50 mg IM (gluteal) Q2WK¹¹

2 mL¹¹

Needle Lengths

2¹¹

Needle Gauges

20¹¹

Injection Site(s)

IM (gluteal only)¹¹

Deltoid Administration (Needle Gauge & Length)

n/a

Gluteal Administration (Needle Gauge & Length)

20 gauge, 2-inch needle¹¹

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

White to almost white powder for reconstitution + 2 mL of a colorless, clear diluent¹¹

Preparation Kits Available

Single-dose, prefilled syringe kit

• 12.5 mg
• 25 mg
• 37.5 mg
• 50 mg¹¹

Kit Contents

A single-dose kit, consisting of: a vial containing a white to almost white powder, a prefilled syringe containing 2 mL of a colorless, clear diluent, a vial adapter, and a needle (a 20 gauge 2-inch needle with needle protection device¹¹)

Kit Storage (Refrigeration Required)

Yes¹¹

Kit Storage (Specific Temperature Requirements)

Store kit in refrigerator at 2° to 8°C (36° to 46°F).¹¹

Kit Storage (Excursions Permitted)

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.¹¹

Kit Storage (Protect from Light)

Yes¹¹

Kit Storage (Other Requirements)

After removal from the refrigerator, use RYKINDO within 7 days or discard.¹¹

Temperature Requirements for Drug Preparation

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.¹¹

Preparation Instructions

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, and peel back to 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.

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.

Inject diluent: Inject entire amount of diluent from syringe into the vial. Vial contents will now be under pressure. Keep holding the plunger rod down with thumb.

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 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.

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.

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.¹¹

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, wuick motion until needle is fully engaged in safety device.

Properly dispose of syringes: Check to confirm needle safety device is fully engaged. Discard in an approved sharps container.

Requirements Once Prepared or Reconstituted

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.¹¹