Zilbrysq Dosage

Vaccination and Prophylaxis for Meningococcal Infection

Vaccinate patients for meningococcal infection (serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) according to current ACIP recommendations at least 2 weeks prior to administering the first dose of ZILBRYSQ [see Warnings and Precautions (5.1].

If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with vaccines for both MenACWY and MenB according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis [see Warnings and Precautions (5.1)].

Healthcare providers who prescribe ZILBRYSQ must enroll in the ZILBRYSQ REMS [see Warnings and Precautions (5.2)].

Recommended Testing Before Initiating ZILBRYSQ

Before initiating ZILBRYSQ, obtain baseline lipase and amylase levels [see Warnings and Precautions (5.4)].

Recommended Dosage

The recommended dosage of ZILBRYSQ is given once daily as a subcutaneous injection and is dependent on actual body weight (see Table 1).

Preparation Instructions

• ZILBRYSQ prefilled syringes can be stored in a refrigerator in the original carton. ZILBRYSQ can also be stored at room temperature in the original carton for up to 3 months or until the expiration date, whichever occurs first.
  If stored in the refrigerator:
  • Before injecting, take 1 ZILBRYSQ prefilled syringe out of the refrigerator and place it on a clean, flat surface. Allow ZILBRYSQ to reach room temperature out of direct sunlight (30 to 45 minutes). Do not heat or place in microwave.
  • Immediately return the carton with the other prefilled syringes to the refrigerator.
  If stored at room temperature:
  • Remove 1 ZILBRYSQ prefilled syringe from the carton.
  • Do not return ZILBRYSQ to the refrigerator after it has been stored at room temperature.
• Visually inspect ZILBRYSQ for particulate matter and discoloration prior to administration. ZILBRYSQ is a clear to slightly opalescent, colorless solution. Do not use if the solution contains visible particles, is cloudy, or if foreign particulate matter is present. ZILBRYSQ does not contain preservatives; unused portions of drug remaining in the syringe should be discarded.
• Each prefilled syringe is single-dose only.

Administration Instructions

• ZILBRYSQ is intended for use under the guidance and supervision of a healthcare professional. Patients may self-inject ZILBRYSQ after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of ZILBRYSQ according to the "Instructions for Use" [see Instructions for Use].
• Administer ZILBRYSQ subcutaneously into areas of the abdomen, thighs, or back of the upper arms that are not tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. Rotate injection sites for each administration. Administration of ZILBRYSQ in the upper, outer arm should be performed by a caregiver.
• When using ZILBRYSQ prefilled syringes, inject the full contents of the single-dose prefilled syringe.
• Discard ZILBRYSQ prefilled syringe after use. Do not reuse.
• Instruct the patient that the daily dose should be administered at approximately the same time each day.
• If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. Do not administer more than 1 dose per day.