Zilucoplan

Zilucoplan is a prescription medication indicated for generalized myasthenia gravis in adults who are acetylcholine receptor antibody positive.

• Zilucoplan is available under the following different brand names: Zilbrysq

Common side effects of Zilucoplan include:

• injection site reactions
• upper respiratory tract infection
• diarrhea
• urinary tract infection
• nausea or vomiting
• pancreatitis and pancreatic cysts

Serious side effects of Zilucoplan include:

• inflammation of the pancreas (pancreatitis) and other pancreatic problems

Rare side effects of Zilucoplan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution for SC (single-dose prefilled syringe)

• 16.6 mg/0.416 mL
• 23 mg/0.574 mL
• 32.4 mg/0.81 mL

Myasthenia gravis

Adult dosage

• Dosage based on actual body weight
• Weighing less than 56 kg: 16.6 mg SC once a day
• Weighing between 56 and 76 kg: 23 mg SC once a day
• Weighing 77 kg and more: 32.4 mg SC once a day

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Zilucoplan has no noted severe interactions with any other drugs
• Zilucoplan has no noted serious interactions with any other drugs
• Zilucoplan has no noted moderate interactions with any other drugs
• Zilucoplan has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Unresolved Neisseria meningitidis infection

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zilucoplan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zilucoplan?”

Cautions

• Serious meningococcal infections
  • Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors
  • Zilucoplan increases susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including nongroupable strains
  • Closely monitor for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected
  • Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur
  • Withhold zilucoplan in patients who are undergoing treatment for meningococcal infection until the infection resolved
• Meningococcal vaccination
  • Complete or update meningococcal vaccination (for both serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) at least 2 weeks before administering the first dose, according to current ACIP recommendations for meningococcal vaccinations in patients receiving a complement inhibitor
  • Revaccinate by ACIP recommendations considering the duration of zilucoplan therapy
  • Note: ACIP recommends an administration schedule for patients receiving complement inhibitors that differs from the prescribing information
• Urgent therapy
  • If urgent therapy is indicated in a patient who is not current with both MenACWY and MenB vaccines, administer meningococcal vaccine(s) as soon as possible and provide antibacterial drug prophylaxis
  • Various durations and regimens of antibacterial drug prophylaxis have been considered, but optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors
  • Assess the benefits and risks for treatment and the benefits and risks for antibacterial drug prophylaxis in unvaccinated or vaccinated patients compared with the known risks for meningococcal infection
• Zilbrysq REMS
  • Available only through a restricted program because of the risk for meningococcal infections
  • REMS requirements
  • Prescribers must enroll in the REMS
  • Prescribers must counsel patients about the risk for meningococcal infection
  • Prescribers must provide patients with REMS educational materials
  • Prescribers must assess patient vaccination status for both meningococcal vaccines (MenACWY and MenB) and vaccinate if needed according to current ACIP recommendations for meningococcal vaccinations in patients receiving a complement inhibitor 2 weeks before the first dose
  • Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently and the patient is not up to date with both MenACWY and MenB vaccines
  • Pharmacies that dispense zilucoplan must be certified in the REMS and must verify prescribers are certified
  • Patients must receive counseling from the prescriber about the need to receive both meningococcal vaccines (MenACWY and MenB) per ACIP recommendations, the need to take antibiotics as directed, and the signs and symptoms of meningococcal infection
  • Instruct patients to always carry the Patient Safety Card with them during and for 2 months following treatment discontinuation
  • Further information is available at www.ZILBRYSQREMS.com or 1-877-414-8353
• Other infections
  • Blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria (eg, N meningitidis, Streptococcus pneumoniae, Haemophilus influenzae, and, to a lesser extent, N gonorrhea); counsel patients about gonorrhea prevention and advise regular testing if at risk
  • Administer vaccinations for the prevention of S pneumoniae and H influenzae type b infections according to ACIP guidelines
  • People receiving zilucoplan are at an increased risk for infections owing to these bacteria, even after vaccination
  • Pancreatitis and other pancreatic conditions
  • Pancreatitis and pancreatic cysts reported
  • Obtain lipase and amylase levels at baseline before initiating treatment
  • Discontinue suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved
  • Inform patients that persistent abdominal pain, sometimes severe or radiating to the back, which may or may not be accompanied by vomiting, is a hallmark symptom of acute pancreatitis; instruct patients to contact their healthcare provider if symptoms occur to determine if therapy should be discontinued

Pregnancy and Lactation

• Human data are not available regarding the use in pregnant women to evaluate for drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • Data are not available regarding the presence of zilucoplan in human milk, its effects on breastfed infants, or its effects on milk production