Preparation, Mixing and Administration

of ELIGARD®

© 2018 TOLMAR Pharmaceuticals, Inc. All rights reserved. TOLMAR and ELIGARD are trademarks of the TOLMAR group. Printed in USA. TPIC/ELI/0118/0001 01/18

A Guide to Proper

Proper Preparation, Mixing and Administration of ELIGARD®1

ELIGARD PackagingELIGARD is packaged in thermoformed trays containing:

• Make sure patient is in the treatment room, as ELIGARD must be administered within 30 minutes following mixing.

• Always wash your hands and use gloves.

• Open both ELIGARD packages.

• Discard the desiccant packs from each package and ensure all contents are in place. You are now ready to assemble and mix ELIGARD.

Follow instructions carefully

Handling and Preparation

IMPORTANT: ELIGARD must be brought to room temperature before administration for proper mixing and consistency.

ROOM TEMP.

59–86°F

Assembly

Pull out the short blue plunger rod with attached gray stopper from Syringe B and discard.

Start with Syringe B: Pull out blue plunger

B

1

• Unscrew the clear cap from Syringe A and remove the gray rubber cap from Syringe B.

• Discard both caps.

Remove caps

B

A3

Join the syringes

• Join the two syringes together by pushing Syringe A into Syringe B and twisting until secure.

• Be careful not to over tighten.

B A

4

Insert the long white plunger rod from Syringe A

Gently insert the long white plunger rod from the Syringe A package into the gray primary stopper inside Syringe B by twisting it into place.

B

2

BA

• Thoroughly mix the product by pushing back and forth between the syringes for about 45 seconds to obtain a uniform suspension.

NOTE: Product must be mixed as described to ensure a uniform suspension is achieved. Shaking will not provide adequate mixing of the product.

• When thoroughly mixed, the suspension will appear colorless to pale yellow or light tan to tan in color (depending on the strength).

Mixing

Mix contents

Inject the liquid contents of Syringe A into Syringe B (which contains the leuprolide acetate powder).

545

SECONDS

• One sterile Syringe A , prefilled with the ATRIGEL® Delivery System• One sterile Syringe B , prefilled with leuprolide acetate powder• One long white plunger rod for use with Syringe B• One sterile needle or One sterile safety needle• Desiccant pack(s)

Choosing an injection site

Administer injection

Administration via Subcutaneous Injection

Discard all components in an appropriate biohazard container.

Reference1. ELIGARD® (leuprolide acetate for injectable suspension) 7.5 mg, 22.5 mg, 30 mg, 45 mg prescribing information.

Fort Collins, CO: TOLMAR Therapeutics, Inc.; 2016.

Remove Syringe A

Activate needle safety shield

• Hold syringes vertically with Syringe B on the bottom. Syringes should remain securely coupled. Draw the entire mixed product into Syringe B.

• Uncouple Syringe A while continuing to push down on the Syringe A plunger.

• Small air bubbles will remain in the formulation (this is acceptable).

Activate the needle’s safety shield by using a thumb, finger or flat surface to push the shield forward until it covers the needle. It should lock into place with a click you can hear and feel.

• Hold Syringe B upright.

• Open the sterile needle package.

• Holding the needle in its protective sheath, twist the syringe clockwise until the needle is fully seated. Be careful not to over tighten the needle or it will become stripped.

• Remove the protective needle sheath.

• You are now ready to inject!

See full Prescribing Information at www.EligardHCP.com

Attach the sterile needle provided

• Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair

• Choose an area that has not recently been used for injection. Cleanse the area with an alcohol swab.

• Using the thumb and forefinger of your non-dominant hand, grasp an area of skin around the injection site.

• Using your dominant hand, insert needle quickly at a 90° angle, then release the skin with your non-dominant hand; inject the drug using a slow, steady push. Withdraw the needle quickly at the same angle of insertion.

or

“click”

B

B

A

68

9

10

7 90°ANGLE

See inside for a complete guide on how to properly prepare, mix and administer ELIGARD or view our mixing video at www.ELIGARDhcp.com

ROOM TEMP.

59–86°F

Preparation & Assembly1

Allow the product to reach room temperature before mixing

STEP

1

Syringe B: Pull out blue plunger and insert the long white plunger rod

Remove caps and join the syringes B

B B

A

B A

45SECONDS

Mixing1

Thoroughly mix the productfor approximately 45 seconds

Mix contents Remove Syringe A and attach the sterile needle provided

A

B B

A B

STEP

2

90°ANGLE

Administration1

Inject ELIGARD® at a 90° angle

Choose an injection site

Administerinjection

STEP

3

Upper arm

Abdomen

ThighUpperbuttocks

For the proper preparation, mixing and administration of ELIGARD®

Follow These Simple Steps: