ZILBRYSQ- zilucoplan injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

zilucoplan (UNII: YG391PK0CC) (zilucoplan - UNII:YG391PK0CC)

Available from:

UCB, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZILBRYSQ is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ is contraindicated in patients with unresolved Neisseria meningitidis infection [see Warnings and Precautions (5.1)] . Risk Summary There are no available data on ZILBRYSQ use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Administration of zilucoplan to pregnant monkeys resulted in increases in embryofetal death at maternal exposures similar to those in humans at therapeutic doses (see Animal Data) . All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Subcutaneous administration of zilucoplan (0, 1, 2, or 4 mg/kg/day) to pregnant monkeys throughout gestation resulted in an increase in embryofetal death at all doses, in the absence of maternal toxicity. A no effect dose for adverse developmental effects in monkeys was not identified. The lowest dose tested was associated with maternal exposures (AUC) similar to that in humans at the maximum recommended human dose of 32.4 mg/day. Data from an ex vivo human placental transfer model demonstrated transfer of zilucoplan into the fetal compartment at a rate of 0.5% at a steady state plasma concentration of 10 µg/mL zilucoplan, which corresponds to a therapeutic dose of 0.3 mg/kg. The clinical significance of these data in human pregnancies is unknown. Risk Summary There are no data on the presence of zilucoplan in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ZILBRYSQ and any potential adverse effects on the breastfed infant from ZILBRYSQ or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Clinical studies of ZILBRYSQ did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adult patients. ZILBRYSQ® (ZIL-brisk) (zilucoplan) injection, for subcutaneous use Single-Dose Prefilled Syringe This Instructions for Use contains information on how to inject ZILBRYSQ. Understanding Your ZILBRYSQ Prefilled Syringe Read this Instructions for Use before using the ZILBRYSQ prefilled syringe. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. See the Medication Guide that comes with ZILBRYSQ for important information. Your healthcare provider should show you how to prepare and inject ZILBRYSQ prefilled syringe properly before you use it for the first time. Do not inject yourself or someone else until you have been shown how to inject ZILBRYSQ correctly. Keep this Instructions for Use and refer to it as needed until you have used all of the ZILBRYSQ prefilled syringes in the packaging. For general questions or help, please call your healthcare provider or UCBCares at 1-844-599-CARE (2273). How Should I Store ZILBRYSQ Prefilled Syringes? - Store ZILBRYSQ prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date on the carton. Do not freeze ZILBRYSQ. - ZILBRYSQ prefilled syringes may be stored at room temperature up to 86°F (30°C) in the original carton for a single period of up to 3 months. Write the date you removed the prefilled syringes from the refrigerator in the space provided on the carton. After ZILBRYSQ prefilled syringes have been stored at room temperature, do not place them back in the refrigerator. Throw them away if not used within 3 months or if the expiration date has passed, whichever occurs first. - Keep the ZILBRYSQ prefilled syringes in the original carton before use. - Keep ZILBRYSQ prefilled syringes and all medicines out of the reach of children. Important Information You Need to Know Before You Inject ZILBRYSQ - Do not use ZILBRYSQ if the expiration date on the packaging has passed or the carton seals have been broken. - Do not reuse the ZILBRYSQ prefilled syringe. The prefilled syringe is for 1-time (single use) only. You may get an infection. - Do not inject ZILBRYSQ more than 1 time per day. - Do not miss any doses of ZILBRYSQ. If you miss your ZILBRYSQ dose, inject a dose as soon as possible. Then, inject the next dose at your scheduled time. Do not inject more than 1 dose each day. - Do not use the ZILBRYSQ prefilled syringe if it has been dropped. - Do not remove the needle cap from the ZILBRYSQ prefilled syringe until you are ready to inject. - Do not insert the needle into the skin more than 1 time because this may bend or break the needle, causing trauma to the tissue. - Do not pull back on the ZILBRYSQ prefilled syringe plunger head at any time because this can break the prefilled syringe. - Do not touch the needle guard activation clips at any time because this can cause the early activation of the needle guard. ZILBRYSQ Prefilled Syringe Guide to Parts (Figure A): Preparing for Injection Step 1: Take out the ZILBRYSQ prefilled syringe If the ZILBRYSQ prefilled syringes are stored in the refrigerator: - Take the ZILBRYSQ prefilled syringes carton out of the refrigerator and remove 1 prefilled syringe from the carton. Grasp the prefilled syringe body. Carefully lift the prefilled syringe straight up out of the tray (Figures B.1 and B.2) . Put the rest of the prefilled syringes in the carton back in the refrigerator. - Before you inject ZILBRYSQ, let the prefilled syringe warm up to room temperature on a clean flat surface for 30 to 45 minutes . This will help to reduce discomfort when injecting. - Do not warm the ZILBRYSQ prefilled syringe in any other way (for example in a microwave, in hot water, or in direct sunlight). - Do not remove the needle cap from the prefilled syringe until you are ready to inject. If the ZILBRYSQ prefilled syringes are stored at room temperature: - Remove 1 ZILBRYSQ prefilled syringe from the carton. Grasp the prefilled syringe body. Carefully lift the prefilled syringe straight up out of the tray (Figures B.1 and B.2 ). Any remaining prefilled syringes in the carton should not be placed in the refrigerator after it has been stored at room temperature. Figure B.1 Figure B.2 Step 2: Inspect the ZILBRYSQ prefilled syringe - Check the prefilled syringe for damage (Figure C) . - Do not use if any part of the prefilled syringe appears to be cracked, leaking, or broken. - Check that the needle cap is not cracked or broken and attached to the prefilled syringe (Figure C) . - Do not use if the needle cap is missing or not securely attached. - Check the expiration date and medicine name (ZILBRYSQ) on the prefilled syringe label (Figure C) . - Do not use if the expiration date printed on the prefilled syringe has passed. - Do not use if the word ZILBRYSQ does not appear on the prefilled syringe. - Check the dose appearing on the label (Figure C) and make sure it matches your prescribed dose. - Do not use if the dose does not match your prescribed dose. - Check the medicine inside the prefilled syringe (Figure C) . The medicine should be clear to almost clear and colorless. It is normal to see air bubbles in the prefilled syringe. - Do not use if the medicine is cloudy, discolored, or contains floating particles. Figure C Step 3: Gather supplies Wash your hands with soap and water and dry them with a clean towel. Gather the following supplies on a clean, flat surface (Figure D) : - 1 ZILBRYSQ prefilled syringe - 1 alcohol wipe (not supplied) - 1 cotton ball or gauze pad (not supplied) - 1 adhesive bandage (not supplied) - 1 sharps disposal or puncture-resistant container (not supplied). See Step 12 for instructions on throwing away the syringe. Figure D Step 4: Choose your injection site Choose an injection site from the following areas (Figures E.1 and E.2) : - The stomach (abdomen), except for the 2-inch area around the belly button (navel) (Figure E.1) - The front of the thighs (Figure E.1) Figure E.1 – abdomen and thighs - The back of the upper arms (only if someone else is giving you the injection) (Figure E.2) Figure E.2 – upper arms Choose a different site each time you give yourself an injection. If you want to use the same injection site, make sure it is at least 1-inch from a spot you used before. Do not inject ZILBRYSQ into an area that is red, tender, bruised, swollen, hard or that has scars or stretch marks. Step 5: Clean your injection site Clean the injection site using an alcohol wipe (Figure F) . Let the skin dry for 10 seconds before injecting. Do not touch the injection site again before giving your injection. Injecting the Medicine Step 6: Remove the needle cap Hold the body of the ZILBRYSQ prefilled syringe with one hand and pull the needle cap straight off with your other hand (Figure G) . Throw away (discard) the needle cap into your household trash or a sharps disposal container. Do not touch the needle or let it touch anything. Do not recap the needle at any time to avoid injury. Do not try to remove any air bubbles from the ZILBRYSQ prefilled syringe. Air bubbles will not affect your dose and will not harm you. This is normal. You can continue to take your injection. Step 7: Pinch your injection site Use your other hand to pinch the area of cleaned skin and hold it firmly (Figure H) . Step 8: Insert the needle Insert the entire needle into the pinched skin at a 45° to 90° angle. When the needle is fully inserted, hold the ZILBRYSQ prefilled syringe in place (Figure I) . Do not pull back on the plunger head at any time because this could break the prefilled syringe. Do not touch the needle guard activation clips. Step 9: Release the pinched skin When the needle is fully inserted, hold the ZILBRYSQ prefilled syringe in place and release the pinched skin (Figure J) . Do not reinsert the needle into the skin if the needle is pulled out when releasing the skin. If this happens, safely throw away (dispose of) the syringe in a sharps disposal container and get a new ZILBRYSQ prefilled syringe to give the injection. Step 10: Inject the medicine Push the plunger head all the way down while holding onto the finger grip to inject all the medicine (Figure K) . Step 11: Release the plunger head Slowly release the plunger head by lifting your thumb. After a complete injection, the needle guard will cover the needle and you may hear a click (Figure L) . Step 12: Throw away (dispose of) the used ZILBRYSQ prefilled syringe Throw away (dispose of) the used ZILBRYSQ prefilled syringe into a sharps disposal container (Figure M) right away. Do not throw away (dispose of) the ZILBRYSQ prefilled syringe in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labelled to warn of hazardous waste inside the container. Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Always keep the sharps disposal container out of the reach of children. Step 13: Examine the injection site Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds (Figure N) . Do not rub the injection site. You may have slight bleeding. This is normal. Apply an adhesive bandage if needed (Figure O). The injection is complete. For more information or help, contact your healthcare provider. If you have any questions, call UCBCares at 1-844-599-CARE (2273) or visit www.AskUCBCares.com. Manufactured for: UCB, Inc. Smyrna, GA 30080 This Instructions for Use has been approved by the U.S. Food and Drug Administration.        Issued: 10/2023

Product summary:

ZILBRYSQ (zilucoplan) injection prefilled syringe contains a sterile, preservative-free, clear to slightly opalescent, colorless solution. Each single-dose prefilled syringe consists of a 1 mL glass syringe with a 29-gauge ½ inch needle, a needle safety guard, and a needle cover. The ZILBRYSQ prefilled syringe components are not made with natural rubber latex. ZILBRYSQ is available as follows: Pharmacy Prior to Dispensing Store ZILBRYSQ prefilled syringes refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton until dispensing. Do not freeze. Storage for Patients or Caregivers After Dispensing Storage conditions after dispensing by pharmacist are summarized in Table 4:

Authorization status:

New Drug Application

Patient Information leaflet

UCB, Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Issued: 10/2023
MEDICATION GUIDE
ZILBRYSQ® (ZIL-brisk)
(zilucoplan)
injection, for subcutaneous use
What is the most important information I should know about ZILBRYSQ?
ZILBRYSQ is a medicine that affects part of your immune system.
ZILBRYSQ may lower the ability of
your immune system to fight certain infections.
•
ZILBRYSQ increases your chance of getting serious and life-threatening
meningococcal
infections. Meningococcal infections may become life-threatening or
fatal if not recognized and
treated early.
•
You must complete or update two types of meningococcal vaccines (for
both serogroup B
infections and serogroup A, C, W, and Y infections) at least 2 weeks
before your first dose
of ZILBRYSQ if you have not already had these vaccines.
•
If your healthcare provider decided that urgent treatment with
ZILBRYSQ is needed, you
should receive meningococcal vaccination(s) as soon as possible.
•
If you have not completed or updated vaccinations for meningococcal
infections at least 2
weeks before your first ZILBRYSQ dose and ZILBRYSQ therapy must be
started right
away, you must also receive antibiotics.
•
If you had a meningococcal vaccine in the past, you might need
additional vaccination
before starting ZILBRYSQ. Your healthcare provider will decide if you
need additional
meningococcal vaccination.
•
Meningococcal vaccines do not prevent all meningococcal infections.
Call your healthcare
provider or get emergency medical care right away if you get any of
these signs and
symptoms of a meningococcal infection:
•
headache with nausea or vomiting
•
headache and fever
•
headache with a stiff neck or stiff back
•
fever
•
fever and a rash
•
confusion
•
muscle aches with flu-like symptoms
•
eyes sensitive to light
Your healthcare provider will give you a Patient Safety Card about the
risk of meningococcal infection.
Carry it with you at all times during treatment and for 2 months after
your la

Summary of Product characteristics

ZILBRYSQ- ZILUCOPLAN INJECTION, SOLUTION
UCB, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZILBRYSQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZILBRYSQ.
ZILBRYSQ (ZILUCOPLAN) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2023
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LIFE-THREATENING AND FATAL MENINGOCOCCAL INFECTIONS HAVE OCCURRED IN
PATIENTS TREATED
WITH COMPLEMENT INHIBITORS; ZILBRYSQ IS A COMPLEMENT INHIBITOR. (4,
5.1)
MENINGOCOCCAL INFECTION MAY BECOME RAPIDLY LIFE-THREATENING OR FATAL
IF NOT RECOGNIZED
AND TREATED EARLY. (5.1)
COMPLETE OR UPDATE MENINGOCOCCAL VACCINATION AT LEAST 2 WEEKS PRIOR TO
ADMINISTERING THE FIRST DOSE OF ZILBRYSQ, UNLESS THE RISK OF DELAYING
THERAPY
OUTWEIGHS THE RISK OF DEVELOPING A MENINGOCOCCAL INFECTION. COMPLY
WITH THE MOST
CURRENT ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)
RECOMMENDATIONS FOR
MENINGOCOCCAL VACCINATIONS IN PATIENTS RECEIVING A COMPLEMENT
INHIBITOR. (5.1)
PERSONS RECEIVING ZILBRYSQ ARE AT INCREASED RISK FOR INVASIVE DISEASE
CAUSED BY _N._
_MENINGITIDIS_, EVEN IF THEY DEVELOP ANTIBODIES FOLLOWING VACCINATION.
MONITOR PATIENTS
FOR EARLY SIGNS OF MENINGOCOCCAL INFECTIONS AND EVALUATE IMMEDIATELY
IF INFECTION IS
SUSPECTED. (5.1)
ZILBRYSQ IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED
ZILBRYSQ REMS. (5.2)
INDICATIONS AND USAGE
ZILBRYSQ is a complement inhibitor indicated for the treatment of
generalized myasthenia gravis (gMG) in
adult patients who are anti-acetylcholine receptor (AChR) antibody
positive. (1)
DOSAGE AND ADMINISTRATION
Obtain baseline amylase and lipase. (2.2)
For subcutaneous injection only. (2.3)
Recommended dosage (2.3):
BODY WEIGHT
ONCE DAILY DOSAGE
PLUNGER ROD COLOR OF PREFILLED
SYRINGE
Less than 56 kg
16.6 mg
RUBINE RED
56 kg to less than 77 kg
23 mg
ORANGE
77 kg and above
32.4 mg
DARK BLUE
See Full Prescribing Information for instructions on dosage,
preparation, and a