Zilbrysq: Uses, Side Effects and Dosage

What is ZILBRYSQ used for?

ZILBRYSQ is used to treat adults with a certain type of disease affecting the muscles called generalized myasthenia gravis (gMG).

How does ZILBRYSQ work?

ZILBRYSQ belongs to a group of medicines known as “Complement C5 inhibitors”. It works by attaching and blocking a certain protein (i.e., C5 complement protein) part of the immune system that causes

Serious Warnings and Precautions

inflammation. This helps prevent the immune system from attacking and damaging signals between the nerves and muscles in the body.

What are the ingredients in ZILBRYSQ?

Medicinal ingredient: zilucoplan sodium.

Non-medicinal ingredients: dibasic sodium phosphate, anhydrous; monobasic sodium phosphate, monohydrate; sodium chloride; and water for injection.

ZILBRYSQ comes in the following dosage forms:

Solution, 40 mg/mL of zilucoplan (as zilucoplan sodium) in single-dose pre-filled syringes with needle safety device containing:

• 16.6 mg in 0.416 mL (syringes with rubine red plungers);
• 23 mg in 0.574 mL (syringes with orange plungers); and
• 32.4 mg in 0.81 mL (syringes with dark blue plungers).

Do not use ZILBRYSQ if:

• you are allergic to zilucoplan sodium or to any other ingredients in ZILBRYSQ.
• you have an untreated infection from a bacteria called “Neisseria meningitidis”, which can cause meningitis. Ask your healthcare professional if you are unsure.
• you have not received a meningococcal vaccine prior to, or at the time of, initiating ZILBRYSQ treatment.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ZILBRYSQ. Talk about any health conditions or problems you may have, including if you:

• are pregnant, think you may be pregnant, or are planning to have a baby. Ask your healthcare professional for advice before using this medicine. This is because it is not known if ZILBRYSQ can harm your unborn baby.

• are breastfeeding or planning to breastfeed. It is not known if ZILBRYSQ passes into your breast milk.

Other warnings you should know about:

Testing and Check-Ups: Your healthcare professional may do certain tests before and during your treatment with ZILBRYSQ. These tests may assess the levels of certain pancreas proteins (i.e., lipase and amylase) and white blood cells (i.e., “eosinophils”) in your body.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ZILBRYSQ:

• rituximab, a medicine typically used to treat certain types of cancer and arthritis.

How to take ZILBRYSQ:

• Take ZILBRYSQ exactly as directed by your healthcare professional. Check with your healthcare professional if you are unsure.
• Before you take ZILBRYSQ, make sure your healthcare professional goes through the important information with you and/or your caregiver and shows you how to properly prepare and inject ZILBRYSQ. Your healthcare professional may also prepare and inject ZILBRYSQ for you.
• ZILBRYSQ is to be injected under the skin (i.e., “subcutaneous” or “SC”) at suitable injection sites. Suitable injection sites include front of the thighs, abdomen, and the back of the upper arms. You should choose a different injection site for each injection. Do not inject ZILBRYSQ into an area that is red, tender, bruised, hard, or that has scars or stretch marks.
• Always take your daily dose at approximately the same time every day.

Read the “Instructions for use” at the end of this leaflet before using ZILBRYSQ. This leaflet includes additional important details for the safe and proper use of ZILBRYSQ.

Usual dose:

Your healthcare professional will decide the right dose of ZILBRYSQ for you. The usual dose is 0.3 mg/kg given as a once daily subcutaneous injection, which corresponds to the following table:

Overdose:

Missed Dose:

If you miss or forget a dose, contact your healthcare professional right away for advice. If you did not inject your dose at the usual time, inject as soon as you realize it on the same day and then continue with your normal dosing schedule the next day. Do not take more than one dose per day.

What are possible side effects from using ZILBRYSQ?

These are not all the possible side effects you may have when taking ZILBRYSQ. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of ZILBRYSQ may include:

• injection site reactions (e.g., pain, redness, bruising, itchiness, or swelling at injection site);
• upper respiratory tract infection (e.g., runny or stuffy nose, sore throat, cough, body aches, headache, sneezing, fever, or generally feeling unwell);
• urinary tract infection (e.g., pain or burning sensation while urinating, frequent urination, strong smelling or cloudy urine);
• diarrhea;
• discoloured and hardened areas of the skin (morphea).

You may also have elevated levels of certain pancreas proteins (i.e., lipase and amylase) and white blood cells (i.e., “eosinophils”).

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store ZILBRYSQ in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Store the pre-filled syringes in the original carton to protect from light.

• ZILBRYSQ may also be stored at room temperature (up to 30°C or 86° F) in the original carton for up to 3 months, within the expiration date of the product.

  • Write the date removed from the refrigerator in the space provided on the carton.
  • Do not place ZILBRYSQ back in refrigerator after it has been stored at room temperature.
  • Throw away the product if not used within 3 months at room temperature, or when the expiry date is reached, whichever occurs first.
• Do not use ZILBRYSQ after the expiration date shown on the outer carton.
• Keep out of reach and sight of children.

If you want more information about ZILBRYSQ:

• Talk to your healthcare professional.
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.ucb-canada.ca), or by calling 1-866-709-8444.

Last Revised: JUL 11, 2024

ZILBRYSQ^TM is a trademark of Ra Pharmaceuticals, Inc.

INSTRUCTIONS FOR USE

^PrZILBRYSQ^TM

(zil-brisk)

zilucoplan injection

Pre-filled Syringe

Read this “Instructions for Use” leaflet carefully before using the ZILBRYSQ pre-filled syringe.

Important information

• Keep this “Instructions for Use” leaflet and refer to this as needed until you have used all of the ZILBRYSQ pre-filled syringes in the packaging.
• Your healthcare professional should show you or a caregiver how to prepare and inject ZILBRYSQ using pre-filled 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 the right way.
• For general questions or help, please call your healthcare professional.

How should I store ZILBRYSQ pre-filled syringe?

• Store ZILBRYSQ in the refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton. Protect from light. Do not freeze.
• ZILBRYSQ may also be stored at room temperature (up to 30°C or 86° F) in the original carton for up to 3 months, within the expiration date of the product. Protect from light. Do not place ZILBRYSQ back in refrigerator after it has been stored at room temperature.
• Keep ZILBRYSQ pre-filled syringes and all medicines out of the reach and sight of children.

ZILBRYSQ pre-filled syringe parts (see Figure A):

For each daily ZILBRYSQ injection, you will need:

• 1 ZILBRYSQ pre-filled syringe.

Not provided in the ZILBRYSQ pre-filled syringe carton:

• 1 alcohol wipe,

• 1 cotton ball or gauze pad,
• 1 adhesive bandage,
• 1 puncture-resistant sharps container. See “Dispose of (throw away) the used ZILBRYSQ pre-filled syringe” at the end of this Instructions for Use.

Follow the steps below each time you use the ZILBRYSQ pre-filled syringe.

Step 1: Setting up your ZILBRYSQ injection

1. a) If the pre-filled syringes are stored in the refrigerator:

Take 1 ZILBRYSQ pre-filled syringe out of the refrigerator and let it sit on a clean, flat surface at room temperature for 30 to 45 minutes before injecting to warm it to room temperature. This will help to reduce discomfort when injecting.

• Do not warm in any other way (for example in a microwave, in hot water, or in direct sunlight). Put the rest of the carton back in the refrigerator and proceed to Step 1b below.

If the pre-filled syringes are stored at room temperature: Take 1 ZILBRYSQ pre-filled syringe out of the carton. Any remaining syringes from the carton should not be placed in the refrigerator once stored at room temperature.

The pre-filled syringe must always be lifted straight up out of the tray (see Figures A.1 and A.2). Do not touch the needle guard activation clips.

1. b) Gather the supplies for your injection and place them on a clean flat, well-lit surface, like a table.
2. c) Inspect the pre-filled syringe (see Figure B)
3. •

   Check the pre-filled syringe for damage.

   1. • Do not use if any part of the pre-filled syringe appears to be cracked, leaking, or broken.
   2. • Do not use if the needle cap is cracked or broken, missing or not securely attached to the pre-filled syringe.

• Check if the name ZILBRYSQ and the expiration date appear on the pre-filled syringe label. Do not use if the expiration date of the pre-filled syringe has passed.
• Check the medicine (solution) inside the pre-filled syringe. The medicine should be clear to slightly opalescent and colorless. It is normal to see air bubbles in the syringe. Do not use if the medicine is cloudy, discolored, or contains floating particles.

• Check the dose on the label. Do NOT use if the dose does not correspond to your prescription.

  

Step 2: Choose your injection site and prepare your injection

1. a) Choose your injection site

Choose an injection site from the following areas:

• The stomach (abdomen), except for the 5 cm or 2-inch area around the belly button (navel) (see Figure C.1).
• The front of the thighs (see Figure C.1).

• The back of the upper arms (only if someone else is giving you the injection) (see Figure C.2).

  

  

Choose a different site for each injection. If you want to use the same injection site, make sure it is at least 2.5 cm / 1-inch from a spot you used the last time.

Do not inject ZILBRYSQ into an area that is red, tender, bruised, swollen, hard or that has scars or stretch marks.

1. b) Wash your hands well with soap and water and dry with a clean towel.
2. c) Prepare your skin:
3. • Clean the injection site using an alcohol wipe.
4. • Let the skin dry for 10 seconds before injecting.
5. • Do not touch the injection site again before giving your injection.

Step 3: Giving your ZILBRYSQ injection

1. a) Remove the needle cap:

Hold the body of the pre-filled syringe with one hand and pull the needle cap straight off with your other hand (see Figure D). Do not recap the needle at any time. After the cap is removed, a few drops of liquid on the tip of the needle may appear. This is normal.

Throw away the needle cap into your household trash or a sharps container (see Step 4 “Dispose of (throw away) the used ZILBRYSQ pre-filled syringe”).

• Do not touch the needle or let it touch any surface.
• Do not recap the needle at any time to avoid injury.
• Do not try to remove any air bubbles from the syringe. Air bubbles will not affect your dose and will not harm you. This is normal. You can continue to take your injection.
• Do not use if syringe has been dropped or looks damaged.
• Pinch your injection site:

Use your other hand to gently pinch the area of cleaned skin and hold it firmly (see Figure E).

1. c) Insert the needle:

Insert the entire needle into the pinched skin at a 45° to 90° angle (see Figure F).

• Do not pull back on the plunger at any time because this could break the syringe.

• Do not touch the needle guard activation clips.

  

• Release the pinched skin:

When the needle is pushed all the way in, hold the pre-filled syringe in place and release the pinched skin (see Figure G).

• Figure F

• 45°

  90°

• Do not reinsert the needle into the skin if the needle is pulled out when releasing the skin because this may bend or break the needle, causing trauma to the tissue. If this happens, safely throw away the syringe in a sharps container, and get a new syringe to give the injection.
• Inject the medicine:

Push the plunger all the way down while holding onto the finger grip to inject all the medicine (see Figure H). All the medicine is injected when you cannot push the plunger head any further.

1. f) Release the plunger:

Slowly release the plunger by lifting your thumb. After a complete injection, the needle guard will cover the needle and you may or may not hear a click (see Figure I).

1. g) Examine the injection site:

Press a cotton ball or gauze pad over the injection site and hold it for 10 seconds.

Do not rub the injection site. You may have slight bleeding, this is normal. Apply an adhesive bandage if needed.

Step 4: Throw away (dispose of) the used ZILBRYSQ syringe

Put the used ZILBRYSQ pre-filled syringe in sharps container right away after use (see Figure J).

Do not throw away (dispose of) the ZILBRYSQ pre-filled syringe in your household trash.

• When your sharps disposal container is almost full, contact your healthcare professional for disposal information.

  Do not recycle your used sharps disposal container.

  Always keep the sharps disposal container out of the reach and sight of children.