Zilbrysq
Zilbrysq (zilucoplan) is the first FDA‑approved at-home self injection that's used to treat certain adults with generalized myasthenia gravis (gMG). The dose, based on your weight, is injected once a day. Common side effects of this medication include injection site reactions, diarrhea, and upper respiratory tract infections (e.g., cough, stuffy nose). Zilbrysq (zilucoplan) is available only through the FDA’s Zilbrysq REMS program because of the risk for serious meningococcal infections.
What is Zilbrysq (zilucoplan)?
What is Zilbrysq (zilucoplan) used for?
- Generalized myasthenia gravis (gMG) in adults with anti-AChR antibodies
How Zilbrysq (zilucoplan) works
Zilbrysq (zilucoplan) is a complement inhibitor. The exact way that the medication works isn't clear, but it's thought to prevent breakdown of complement proteins. These complement proteins, which are part of the immune system, are activated by harmful antibodies (anti-Ach antibodies) to disrupt communication between nerves and muscles. By blocking these proteins, Zilbrysq (zilucoplan) helps to ease gMG symptoms and improve the ability to perform daily living, like walking or speaking.
Drug facts
Side effects of Zilbrysq (zilucoplan)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Injection site reactions (29%)
- Upper respiratory tract infections (cough, runny nose; 14%)
- Diarrhea (11%)
- Urinary tract infection (8%)
- Nausea or vomiting (8%)
Less Common Side Effects
- Higher levels of lipase
- Higher levels of amylase
- Hardening and discoloration of the skin
Zilbrysq (zilucoplan) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Meningococcal infections: headache, stiff neck or back, muscle ache, nausea, vomiting, fever, flu-like symptoms, sensitivity to bright light, confusion, rash
- Pancreatitis: stomach pain that won't go away, pain radiating to the back, nausea, or vomiting
The following Zilbrysq (zilucoplan) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion, which may be signs of meningitis
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Cough
- Diarrhea
- Pain, redness, or irritation at injection site
- Runny or stuffy nose
- Sore throat
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Pros and cons of Zilbrysq (zilucoplan)
Pros
- First self-injected, once-daily, medication for gMG
- Works well to improve symptoms of daily living in some adults with gMG
- Can be stored in the refrigerator or at room temperature
Cons
- Can raise the risk of serious infections
- Can only receive it from specific pharmacies enrolled in the REMS program
- Unknown if it's safe in pregnancy or breastfeeding
Pharmacist tips for Zilbrysq (zilucoplan)
- Review the Instructions for Use for Zilbrysq (zilucoplan) to make sure you know how to prepare and inject a dose. Your care team will show you how to do your first injection.
- It's best to get your Zilbrysq (zilucoplan) injections around the same time every day. Wash your hands before giving yourself an injection to prevent infection.
- Zilbrysq (zilucoplan) can raise your risk of meningococcal infections. Before starting this medication, your prescriber will check if you've received your meningococcal vaccines at least 2 weeks before treatment.
- If you haven't completed your vaccinations for meningococcal infections at least 2 weeks before your first Zilbrysq (zilucoplan) treatment, you might need to receive these vaccinations as soon as possible and take antibiotics to help prevent infections.
- Zilbrysq (zilucoplan) can raise your risk of other serious infections, such as pneumonia and gonorrhea. Discuss with your care team about different ways to prevent these infections.
- Tell your prescriber right away if you experience severe stomach pain that doesn't go away. This can be a symptom of an inflamed pancreas (pancreatitis).
- Make sure to get your routine blood tests done on time before and while you’re receiving Zilbrysq (zilucoplan). This helps your care team make sure the medication is safe for you.
- You can store Zilbrysq (zilucoplan) in the refrigerator or at room temperature. If in the refrigerator, the medication is good up to the expiration date. If at room temperature, it's good for up to 3 months. Keep Zilbrysq (zilucoplan) in its original container to protect it from light.
- If you choose to store Zilbrysq (zilucoplan) in the refrigerator, take one prefilled syringe out and let it reach room temperature for 30 to 45 minutes before injecting a dose. Don't use the medication if it's cloudy or has particles.
- You'll be given a Zilbrysq Patient Safety Information Card by your care team. Carry it with you at all times so you know when to get emergency medical help. Continue to carry this card for 2 months after stopping Zilbrysq (zilucoplan) treatment, because you can still develop an infection during that time.
- Don't share or reuse needles or syringes. Doing so can put you at risk for getting or transmitting infections. Throw away your needles and syringes in a sharps disposal container after each use.
Common questions about Zilbrysq (zilucoplan)
Although Zilbrysq (zilucoplan) can start working within a week, you might not feel the full effects until a few months later. So make sure you continue to inject the medication every day and let your neurologist know how it's working for you.
You can inject Zilbrysq (zilucoplan) at any time of the day, but it's important to be consistent. Try to inject the medication at the same time every day. This will help the medication work best.
It can. Zilbrysq (zilucoplan) can cause pancreatitis, or inflammation of the pancreas, and pancreatic cysts. To lower your risk, your prescriber will order blood tests to check your pancreas before you start the medication. Let your prescriber know if you experience symptoms of pancreatic problems like stomach pain that won't go away, pain radiating to the back, nausea, or vomiting.
In a study, Zilbrysq (zilucoplan) helped to lessen muscle weakness and improve the ability to talk, swallow, and breathe compared to placebo after 12 weeks of daily injections. Talk to your neurologist if you have questions on how well this medication will work for you.
Zilbrysq (zilucoplan) can be injected under the skin on the belly and thighs. Make sure to avoid the area 2 inches within the belly button. If you're giving the injection to someone else, you can also inject under the skin on the underside of the upper arms. Change the injection site often to prevent skin irritation and allow Zilbrysq (zilucoplan) to be absorbed. Don't inject the medication into skin that's bruised, red, tender, or hard.
Make sure you review the Instructions for Use before you inject Zilbrysq (zilucoplan). Firstly, wash your hands and clean the injection site with an alcohol wipe. After taking the cap off the syringe, pinch an area of your skin and insert the needle into your skin at a 45 to 90 degree angle. Release the pinch and push the plunger down all the way to inject the medication. After you complete the injection, release the plunger to activate the needle guard. Remove the syringe and throw it away in a sharps container right away.
Zilbrysq (zilucoplan) hasn’t been studied in human pregnancies or those who are nursing. But, animal studies showed that this medication caused harm to babies when used during pregnancy. While animal studies aren’t always representative of what happens in humans, it’s possible that Zilbrysq (zilucoplan) can cause serious problems to unborn babies. Talk with your care team to discuss the benefits and risks of using this medication if you're pregnant or nursing.
No, Zilbrysq (zilucoplan) isn't an immunosuppressant. Even though it's not considered an immunosuppressant, Zilbrysq (zilucoplan) can put you at risk for infections because it affects certain parts of your immune system. Let your care team know if you have symptoms of an infection like sore throat, runny nose, or fever. Zilbrysq (zilucoplan) can also raise your risk for certain serious infections, such as meningococcal infections. You'll be required to get certain vaccines before starting this medication to lower your risk of getting meningitis during treatment.
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Risks and warnings for Zilbrysq (zilucoplan)
Zilbrysq (zilucoplan) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious meningococcal infections
Zilbrysq (zilucoplan) can lower your ability to fight off infections. This can raise the risk for serious infections, especially meningococcal infections.
Before you start Zilbrysq (zilucoplan), your prescriber will check that you're up to date on your meningococcal vaccines. If not, you might have to receive the meningococcal vaccine right away on top of preventative antibiotics. This helps to lower your risk for serious meningococcal infections. But it's important to note that even people who have received these vaccinations might still get an infection. Call your care team right away if you have any signs of infection, like fever, body aches, nausea, vomiting, and severe headache.
Because of the risk for serious meningococcal infections, Zilbrysq (zilucoplan) is only available through a restricted program called Zilbrysq Risk Evaluation and Mitigation Strategy (REMS). Your neurologist must be enrolled in this program to prescribe the medication to you. They'll also talk with you about the risk for meningococcal infections and how to best protect against them.
Other infections
Zilbrysq (zilucoplan) can lower your ability to fight off other infections too. These infections include pneumonia, Haemophilus influenzae diseases, and gonorrhea. Your prescriber will make sure you're vaccinated against certain types of bacteria that can cause infection. Let your prescriber know if you have symptoms such as trouble breathing, cough, chills, fever, fatigue, chest pain, and headache.
Pancreas problems
Though rare, few people who received Zilbrysq (zilucoplan) have reported having inflammation of the pancreas (pancreatitis) or pancreatic cysts. Make sure to get your routine blood work done before treatment. This is so your care team can make sure Zilbrysq (zilucoplan) is safe for you. Stop using this medication and let your care team know right away if you experience symptoms of an inflamed pancreas, such as stomach pain that won't go away, pain radiating to the back, nausea, or vomiting.
Zilbrysq (zilucoplan) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 28 prefilled syringes of 16.6mg/0.416ml | 1 carton | $22,602.53 | $22,602.53 |
| 28 prefilled syringes of 23mg/0.574ml | 1 carton | $31,300.23 | $31,300.23 |
| 28 prefilled syringes of 32.4mg/0.81ml | 1 carton | $44,092.91 | $44,092.91 |
Typical dosage for Zilbrysq (zilucoplan)
Zilbrysq (zilucoplan) is an injection under the skin that's given under the supervision of a healthcare professional until you've received training. Dosage depends on your body weight, and your care team will decide the appropriate dose for you each time.
- Adults weighing less than 123 lbs (56 kg): The typical dose is 16.6 mg injected under the skin once daily.
- Adults weighing between 123 to 168 lbs (56-76 kg): The typical dose is 23 mg injected under the skin once daily.
- Adults weighing 169 lbs (77 kg) and more: The typical dose is 32.4 mg injected under the skin once daily.
How much does Zilbrysq (zilucoplan) cost?
$22,602.53
Zilbrysq (zilucoplan) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Zilbrysq (zilucoplan) will not be safe for you to take.
- Active meningococcal infection
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