Zilbrysq

Generic name: Zilucoplan
Dosage form: subcutaneous injection (16.6 mg/0.416 mL, 23 mg/0.574 mL, 32.4 mg/0.81 mL.)

Usage of Zilbrysq

Zilbrysq (zilucoplan) is a complement inhibitor used to treat generalized myasthenia gravis (gMG) in patients who are AChR antibody positive (AChR-Ab+). Zilbrysq is a C5 inhibitor (complement component 5 inhibitor) that works by blocking C5, a protein in the immune system that is involved with the symptoms of generalized myasthenia gravis. Zilbrysq is the first once-daily, under-the-skin injection that can be self-administered by MG patients.

Zilbrysq became an FDA-approved medication on October 17, 2023, based on positive results from the 12-week phase 3 trial RAISE (NCT04115293). Zilbrysq is indicated for adult patients with generalized myasthenia gravis that is antiacetylcholine receptor (AChR) antibody positive. Zilbrysq showed rapid and clinically meaningful improvements in symptoms of MG, compared to a placebo, measured using the MG-ADL score.

Zilbrysq side effects

Common Zilbrysq side effects

The most common Zilbrysq side effects were diarrhea, injection site reactions, and upper respiratory tract infection (URTI), affecting 10% of patients or more.

Serious Zilbrysq side effects.

See “Warnings” above.

Other serious Zilbrysq side effects include:

Inflammation of the pancreas (pancreatitis) and other pancreatic problems. Pancreatitis and pancreatic cysts have occurred in people who use this medicine. Your healthcare provider will do blood tests (baseline lipase and amylase levels) to check your pancreas before you start treatment.

Call your healthcare provider right away if you have pain in your stomach area (abdomen) that will not go away. Your healthcare provider will tell you if you should stop using this medicine if you are having problems with you pancreas. The pain may be severe or felt going from your abdomen to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Zilbrysq. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

Before taking Zilbrysq

You should not use this medicine if you have a Neisseria meningitidis infection.

How to use Zilbrysq

The recommended adult Zilbrysq dose is based on actual body weight.

Less than 56kg = 16.mg daily

56 kg to less than 77 kg = 23 mg daily

77 kg and above = 32.4 mg.

Warnings

Zilbrysq affects part of your immune system and may lower the ability of your immune system to fight certain infections, therefore increasing 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 this medicine if you have not already had these vaccines.

If your healthcare provider decides 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 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 this medicine. 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, confusion, headache and fever, muscle aches with flu-like symptoms, headache with a stiff neck or stiff back, eyes sensitive to light, fever, and fever with a rash.

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 last dose. Your risk of meningococcal infection may continue for several weeks after your last dose of this medicine. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

Zilbrysq is only available through a program called the Zilbrysq REMS. Before you can receive this medicine, your healthcare provider must:

enroll in the Zilbrysq REMS.

counsel you about the risk of meningococcal infection.

give you the Patient Guide, including information about the signs and symptoms of meningococcal infection.

give you a Patient Safety Card about your risk of meningococcal infection, as discussed above.

make sure you are vaccinated with two types of meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccines. Ask your healthcare provider if you are unsure if you need to be revaccinated.

Zilbrysq may also increase the risk of other types of serious infections. This injection may increase your chance of getting Streptococcus pneumoniae and Haemophilus influenzae type b. Your healthcare provider will tell you if you should receive the Streptococcus pneumoniae and Haemophilus influenzae type b vaccinations.

Certain people may have an increased risk of gonorrhea infection. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and about regular testing.

Call your healthcare provider right away if you have new signs or symptoms of infection.

What other drugs will affect Zilbrysq

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Disclaimer

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