PENBRAYA™ Dosage and Administration

(meningococcal groups A, B, C, W, and Y vaccine)

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dose and Schedule

Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart.

2.2 Preparation

PENBRAYA is supplied in a kit that includes a vial of Lyophilized MenACWY Component (a sterile white powder), a prefilled syringe containing the MenB Component and a vial adapter.

Vial of Lyophilized MenACWY Component

Syringe of MenB Component

Vial Adapter

VialSyringeVial adapter

To form PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component as described in the panels below.

Step 1

Step 1. Preparation of vial and vial adapter

•
Remove plastic flip-off cap from vial containing the Lyophilized MenACWY Component.
•
Cleanse the rubber stopper.
•
Without removing the vial adapter from its packaging, peel off the top cover.
Step 2

Step 2. Attachment of vial adapter

•
Hold the base of the vial on a flat surface.
•
Keep the vial adapter in the packaging and orient it vertically over the center of the vial so that the adapter spike aligns with the center of the vial’s rubber stopper.
•
Connect the vial adapter to the vial with a straight downward push. The vial adapter will lock into place.
•
Do not push vial adapter in at an angle as this may result in leaking during use.
•
Remove the vial adapter packaging.
Step 3

Step 3. Resuspension of the MenB Component

•
Shake the syringe vigorously to obtain a white homogenous suspension. Do not use if the contents cannot be resuspended.
Step 4

Step 4. Removal of syringe cap

•
For all syringe assembly steps, hold the syringe only by the Luer lock adapter located at the tip of the syringe. This will prevent the Luer lock adapter from detaching during use.
•
Remove the syringe cap by slowly turning the cap counter-clockwise while holding the Luer lock adapter.
Step 5

Step 5. Connection of syringe to vial adapter

•
Hold the syringe’s Luer lock adapter and connect it to the vial adapter by turning clockwise.
•
Stop turning when you feel resistance, overtightening the syringe may result in leaking during use.
•
Once the syringe is securely attached to the vial adapter, there will be a small space between the top of the vial adapter and the Luer lock adapter of the syringe.
Step 6

Step 6. Reconstitution of Lyophilized MenACWY Component with MenB Component to form PENBRAYA

•
Inject the entire contents of the syringe containing the MenB Component into the vial.
•
Do not remove the empty syringe.
•
While holding the plunger rod down, gently swirl the vial in a circular motion until the powder is completely dissolved (less than 1 minute).
Step 7

Step 7. Withdrawal of PENBRAYA

•
Invert the vial completely with the vial adapter and syringe still attached.
•
Slowly withdraw the entire contents into the syringe to ensure an approximately 0.5 mL dose of PENBRAYA for administration.
•
Do not pull the plunger rod out.
Step 8

Step 8. Disconnection of syringe

•
Hold the Luer lock adapter of the syringe and disconnect the syringe from the vial adapter by turning counter-clockwise.
Step 9

Step 9. Attachment of needle

•
Attach a sterile needle suitable for intramuscular injection to the syringe containing PENBRAYA.
Step 10

Step 10. Visual inspection

•
PENBRAYA is a homogeneous white suspension. If the vaccine is not a homogenous suspension, shake to resuspend prior to administration.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

2.3 Administration

For intramuscular use only.

After reconstitution, administer PENBRAYA immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

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Prescribing Information
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Health Professional Information

Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dose and Schedule

Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart.

2.2 Preparation

PENBRAYA is supplied in a kit that includes a vial of Lyophilized MenACWY Component (a sterile white powder), a prefilled syringe containing the MenB Component and a vial adapter.

Vial of Lyophilized MenACWY Component

Syringe of MenB Component

Vial Adapter

VialSyringeVial adapter

To form PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component as described in the panels below.

Step 1

Step 1. Preparation of vial and vial adapter

•
Remove plastic flip-off cap from vial containing the Lyophilized MenACWY Component.
•
Cleanse the rubber stopper.
•
Without removing the vial adapter from its packaging, peel off the top cover.
Step 2

Step 2. Attachment of vial adapter

•
Hold the base of the vial on a flat surface.
•
Keep the vial adapter in the packaging and orient it vertically over the center of the vial so that the adapter spike aligns with the center of the vial’s rubber stopper.
•
Connect the vial adapter to the vial with a straight downward push. The vial adapter will lock into place.
•
Do not push vial adapter in at an angle as this may result in leaking during use.
•
Remove the vial adapter packaging.
Step 3

Step 3. Resuspension of the MenB Component

•
Shake the syringe vigorously to obtain a white homogenous suspension. Do not use if the contents cannot be resuspended.
Step 4

Step 4. Removal of syringe cap

•
For all syringe assembly steps, hold the syringe only by the Luer lock adapter located at the tip of the syringe. This will prevent the Luer lock adapter from detaching during use.
•
Remove the syringe cap by slowly turning the cap counter-clockwise while holding the Luer lock adapter.
Step 5

Step 5. Connection of syringe to vial adapter

•
Hold the syringe’s Luer lock adapter and connect it to the vial adapter by turning clockwise.
•
Stop turning when you feel resistance, overtightening the syringe may result in leaking during use.
•
Once the syringe is securely attached to the vial adapter, there will be a small space between the top of the vial adapter and the Luer lock adapter of the syringe.
Step 6

Step 6. Reconstitution of Lyophilized MenACWY Component with MenB Component to form PENBRAYA

•
Inject the entire contents of the syringe containing the MenB Component into the vial.
•
Do not remove the empty syringe.
•
While holding the plunger rod down, gently swirl the vial in a circular motion until the powder is completely dissolved (less than 1 minute).
Step 7

Step 7. Withdrawal of PENBRAYA

•
Invert the vial completely with the vial adapter and syringe still attached.
•
Slowly withdraw the entire contents into the syringe to ensure an approximately 0.5 mL dose of PENBRAYA for administration.
•
Do not pull the plunger rod out.
Step 8

Step 8. Disconnection of syringe

•
Hold the Luer lock adapter of the syringe and disconnect the syringe from the vial adapter by turning counter-clockwise.
Step 9

Step 9. Attachment of needle

•
Attach a sterile needle suitable for intramuscular injection to the syringe containing PENBRAYA.
Step 10

Step 10. Visual inspection

•
PENBRAYA is a homogeneous white suspension. If the vaccine is not a homogenous suspension, shake to resuspend prior to administration.
•
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

2.3 Administration

For intramuscular use only.

After reconstitution, administer PENBRAYA immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.
Medication Guide

Health Professional Information

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