Myasthenia Gravis Treatment with Ultomiris: Its Functions Explained
Rewritten Article:
Hey there! Let's chat about Ultomiris, a booster shot that helps treat myasthenia gravis. This article covers the deets on side effects, dosage, and how Ultomiris works its magic.
Ultomiris isn't a typical pill - it's an IV drip solution, given by a healthcare pro. It's a fancy biologic and falls under the drug class called complement inhibitors. No biosimilar versions of this baby exist.
Wanna learn more? Check out this deep dive on Ultomiris.
Ultomiris has a super important warning from the Food and Drug Administration (FDA). For details, see the "Before getting Ultomiris" section.
Myasthenia Gravis 101
Myasthenia gravis is a wacky situation where your muscles tire fast and become weak because of messed-up communication between muscles and nerves. It's a chronic (long-term) autoimmune condition, meaning your immune system attacks your own cells.
Myasthenia Gravis Symptoms
Symptoms vary from person to person, but they usually get worse with activity and improve with rest. Here are some common symptoms:
Body weight
- Squinty eyes (droopy eyelids)
- Weak muscles in limbs, neck, and eyes
- Tiredness
- Blurry or double vision
- Struggling to chew, swallow, speak, or breathe
Who Needs Ultomiris
Loading dose
Ultomiris is prescribed for adults with generalized myasthenia gravis (gMG) who have a type of antibody called anti-acetylcholine receptor (AChR) antibody.
- "Generalized" means muscle groups across the body are affected. gMG is a different ball game compared to ocular myasthenia gravis, which impacts only the eye muscles.
- "Anti-acetylcholine receptor (AChR) antibody" means your immune system makes antibodies that block acetylcholine receptors. Acetylcholine is a noggin-wagger that sends signals to contract muscles.
Maintenance dose
Before your doc prescribes Ultomiris, they might check your gMG status with a blood test to see if it's AChR antibody-positive. Your doc can spill the beans on whether Ultomiris is right for the form of myasthenia gravis you've got.
How Ultomiris Helps Myasthenia Gravis
If your doc prescribes Ultomiris, you might be curious about how it tackles your condition.
How Ultomiris Works
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
The exact way Ultomiris works isn't fully understood, but it's thought to mess with a complement system protein called C5 at the neuromuscular junction (NMJ). The NMJ is where nerve cells communicate with the muscles they control. By lowering C5 activity at the NMJ, Ultomiris lets signals from nerve cells reach your muscles, which may reduce tiredness and muscle weakness.
How Well Ultomiris Works for Myasthenia Gravis
2,400 mg
In studies, Ultomiris made it easier for adults with generalized myasthenia gravis (gMG) to carry on with their daily activities[3]. You can learn more about these studies by perusing the Ultomiris prescribing info. Your doc or pharmacist can also dish the details on how well Ultomiris worked in these studies.
Getting Your Ultomiris Dose
3,000 mg every 8 weeks
Here's some info on the usual Ultomiris dosages for myasthenia gravis. Your doc will decide the best dosage for you. Hit up your doc if you got questions about your Ultomiris dose or how you'll get your medicine.
Ultomiris comes in three sizes:
- 300 milligrams (mg)/30 milliliters (mL)
- 300 mg/3 mL
- 1,100 mg/11 mL
Dosage
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
The recommended Ultomiris dosages for treating myasthenia gravis are based on your body weight in kilograms (kg).
Ultomiris treatment typically starts with a big-time dose. Two weeks after the giant dose, you'll continue treatment with a maintenance dose, which you usually receive every 8 weeks.
2,700 mg
Here's a chart to help you out:
| Body weight | Loading dose | Maintenance dose ||------------|--------------|------------------|| 40 kg to less than 60 kg (approximately 88 lb to less than 132 lb) | 2,400 mg | 3,000 mg every 8 weeks || 60 kg to less than 100 kg (approximately 132 lb to less than 220 lb) | 2,700 mg | 3,300 mg every 8 weeks || 100 kg or more (approximately 220 lb or more) | 3,000 mg | 3,600 mg every 8 weeks |
3,300 mg every 8 weeks
Heads Up: Ultomiris has other uses too. Remember that the drug's dosage may differ when treating other conditions[4]. Talk with your doc to learn more.
How Ultomiris is Given
Ultomiris turns up as a liquid for IV drip. A healthcare professional will administer your Ultomiris drips at an infusion center.
How Often Ultomiris is Given
100 kg or more (approximately 220 lb or more)
You usually receive your Ultomiris maintenance doses every 8 weeks. You'll likely start getting maintenance doses 2 weeks after your loading dose.
"For more details on Ultomiris dosing schedules, check out this Ultomiris dosage info.
3,000 mg
Ultomiris Side Effects
Using Ultomiris for myasthenia gravis might cause side effects that are mild or serious.
3,600 mg every 8 weeks
Ultomiris is also used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica spectrum disorder (NMOSD). Side effects could differ depending on the condition Ultomiris is used to treat.
The following lists include some of the main side effects that have been reported with Ultomiris. For information about other potential side effects, talk with your doctor or pharmacist. You can also click on our Ultomiris side effect article or scan Ultomiris's prescribing information.
Notes: After the FDA gives the thumbs-up to a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more info about how the drug works in real life[5]. If you get a side effect while on Ultomiris and want to inform the FDA, visit MedWatch or call 800-FDA-1088.
Mild Side Effects of Ultomiris
Mild side effects reported with Ultomiris treatment include:
- Loose poops (diarrhea)
- Common cold-like symptoms (upper respiratory infections)
- Stomach pain
- UTIs
- Bum back
- Woozy feelings (dizziness)
- Mild infusion reactions, consisting of
- Cramps in your muscles
- Unhappy feelings in your limbs
These side effects of Ultomiris may be temporary, lasting a few days to weeks. But if they linger or drive you nuts, chat with your doc or pharmacist.
Serious Side Effects of Ultomiris
Ultomiris
Though not common, serious side effects have been reported with Ultomiris. These include:
- Serious infections, such as COVID-19 and pneumonia
- Serious infusion reactions, including:
- Higher or lower blood pressure
- Severe shivering, chills, and fever
- Risk of serious meningococcal infections (see "Before getting Ultomiris")
Vyvgart
Call your doc right away if you develop serious side effects while using Ultomiris. If the side effects seem life threatening, or you believe you're having a medical emergency, call 911 or your local emergency number ASAP.
ALLERGIC REACTION For some people, Ultomiris can provoke an allergic reaction.
- In general, symptoms of allergic reactions can be mild or serious.
Ways to manage
Form
For mild allergic reaction symptoms, like a rash, dial your doc right away. They might suggest treatments to help manage your symptoms. They'll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number ASAP. These symptoms call for quick medical attention as they can become life-threatening. If you've had a severe allergic reaction to Ultomiris or any of its ingredients, your doc may recommend a different med instead.
solution for IV infusion
Before Getting Ultomiris
Before you get Ultomiris, consider this info. The drug might not be safe for you if you have certain medical conditions or other factors that affect your health. The following info highlights some of these.
solution for IV infusion
Boxed Warning: Risk of Serious Meningococcal Infections
Ultomiris has a big honkin' warning about the risk of serious meningococcal infections. This is the top-tier warning from the FDA.
Treatment with Ultomiris boosts the risk for serious meningococcal infections, such as meningitis. These infections can be serious. Symptoms of a meningococcal infection include:
- Sudden fever or headache
- Nausea and vomiting
- Overly sensitive to light
- Confusion
- Tiredness
Dosage frequency
What to do
Before you start receiving Ultomiris, your doctor will ensure you're up-to-date with meningococcal vaccines. If not, they'll administer necess for you at least 2 weeks before you start Ultomiris treatment. If your doc decides you urgently need to receive Ultomiris, they might have you start treatment sooner than 2 weeks after meningococcal vaccination. If this applies to you, they'll likely prescribe antibiotics to help prevent infection, which you'll take for the first 2 weeks following your first Ultomiris infusion.
once every 8 weeks
The risk of serious meningococcal infections applies throughout treatment with Ultomiris and for at least 8 months after your last dose. Bug your doc pronto if you believe you have symptoms of a meningococcal infection during this time. But call 911 or go to the nearest emergency room if your symptoms feel life-threatening.
Since there's a risk for serious meningococcal infections, Ultomiris is only accessible through a risk evaluation and mitigation strategy (REMS) program. As part of this program, you'll need to carry the Ultomiris Patient Safety Card throughout treatment and for at least 8 months after your last dose. You can learn more about the Ultomiris REMS program at the program website or by calling 1-888-765-4747.
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Other Warnings
In addition to boxed warnings, Ultomiris has other warnings.
Consider talking with your doc if any of these medical conditions or other health factors apply to you:
- Active infection
- Pregnant
- Breastfeeding
- Drink alcohol
- Had an allergic reaction to Ultomiris or any of its ingredients
Drug class
FAQ – Ultomiris for Myasthenia Gravis
Below are answers to some frequently asked questions about Ultomiris for treating myasthenia gravis.
complement inhibitor
How does Ultomiris compare to Vyvgart?
Ultomiris and Vyvgart are both prescribed for generalized myasthenia gravis (gMG), but they differ in a few ways:
neonatal Fc receptor blocker
- Form: Ultomiris is a liquid for IV infusion, while Vyvgart comes as a powder for subcutaneous injection.
- Dosage Frequency: Ultomiris is given once every 8 weeks, while Vyvgart is administered once weekly for four weeks, and your doctor may prescribe more cycles based on how the drug works for your symptoms.
- Drug Class: Ultomiris is a complement inhibitor, whereas Vyvgart is a neonatal Fc receptor blocker.
Your doctor or pharmacist can offer more info on how Ultomiris and Vyvgart compare.
Can I get Ultomiris at home?
For certain folks, getting Ultomiris at home might be an option. Talk with your doctor to learn more about whether this solution is available and suitable for you.
Ultomiris Cost
The cost of Ultomiris varies based on various factors, such as your treatment regimen, insurance coverage, and location. The price also depends on the cost of the appointment to receive doses of Ultomiris from a healthcare professional. A program called the Alexion OneSource CoPay Program is available for Ultomiris. For more deets and to find out if you're eligible for support, call 888-765-4747 or visit the program website.
Disclaimer: Medical News Today has made every effort to make sure all info is accurate, comprehensive, and up-to-date. However, this article shouldn't replace the expertise and knowledge of a licensed healthcare professional. Always consult a doctor or another healthcare professional before starting any medication. This drug information is subject to change and isn't intended to cover every possible use, dosage, precaution, warning, drug interaction, allergic reaction, or adverse effect. The absence of warnings or other info for a specific drug doesn't necessarily mean the drug or drug combo is safe, appropriate, or effective for all patients or for all specific uses.
References:
- Na Motor Laan et al. Ravulizumab treatment of generalized myasthenia gravis: real-life experience from the IG-4-MOBILITY prospective long-term follow-up study, Poster presented at the Euromyne Congress 2020.
- Alexion (Gene Union). Ultomiris [package insert]. Boston, Massachusetts: Alexion Pharmaceuticals, Inc; 2021.
- FDA (U.S. Food and Drug Administration). FDA grants accelerated approval of ravulizumab-cwvz (Ultomiris) for generalized myasthenia gravis. Published 2018. Accessed March 25, 2023.
- Alexion (Gene Union). Ultomiris [prescribing information]. Boston, Massachusetts: Alexion Pharmaceuticals, Inc; 2021.
- FDA (U.S. Food and Drug Administration). MedWatch – The FDA Safety Information and Adverse Event Reporting Program. Accessed March 25, 2023.
- Ultomiris, a medication used to treat myasthenia gravis, operates on the neurological system by influencing the complement system protein C5 at the neuromuscular junction.
- Myasthenia gravis is a chronic autoimmune disorder that affects muscle communication with nerves, leading to tiredness and weakness.
- The drugs works by reducing C5 activity at the neuromuscular junction, allowing signals from nerve cells to reach muscles, potentially reducing tiredness and muscle weakness.
- Beyond myasthenia gravis, Ultomiris is also used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and neuromyelitis optica spectrum disorder.
- CBD, a compound found in hemp and marijuana, is being studied for its potential effects on the immune system and other autoimmune disorders, including myasthenia gravis.
- Administering Ultomiris can help manage chronic diseases and promote health and wellness for individuals with myasthenia gravis.
- Common side effects of Ultomiris include diarrhea, upper respiratory infections, stomach pain, urinary tract infections, back pain, dizziness, and infusion reactions like muscle cramps and limb discomfort.
- Serious side effects of Ultomiris can include serious infections, severe infusion reactions, and the risk of meningococcal infections, for which vaccination is required prior to treatment.
- Prior to receiving Ultomiris, individuals should inform their doctor about any other medical conditions or factors that might impact their health, such as pregnancy, breastfeeding, alcohol consumption, allergies, or a history of allergic reactions to the medication or its ingredients.
- Ultomiris is part of a risk evaluation and mitigation strategy (REMS) program due to the risk of serious meningococcal infections, requiring patients to carry a safety card throughout treatment and for eight months after their last dose.
- In addition to myasthenia gravis, Ultomiris is also used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and neuromyelitis optica spectrum disorder, with side effects potentially varying depending on the condition being treated.
- Ultomiris is an important medication for those with myasthenia gravis, but it is crucial to consult a doctor or pharmacist for specific details about the drug, dosage, side effects, and potential interactions with other medications or health conditions.
