Treatment of Myasthenia Gravis with Ultomiris: Insights into Its Functioning and Additional Details
Bold and Italics Ultomiris (ravulizumab): An intravenous infusion for those battling myasthenia gravis. Here's a lowdown on how it works, its side effects, and dosage.
Ultomiris is an IV infusion solution that a healthcare professional administers. It's a biologic belonging to the complement inhibitors drug class, with no biosimilar version available. For more details, check out this Ultomiris deep-dive.
Warning: Ultomiris carries a certified warning from the Food and Drug Administration (FDA) - the most serious kind. To learn what that's about, skip ahead to "Before receiving Ultomiris."
Myasthenia Gravis Decoded
Myasthenia gravis is a chronic, autoimmune condition that messes with muscle-nerve communication, causing your voluntary muscles to tire easily and weaken. Here's a breakdown of its symptoms and who Ultomiris is typically prescribed for:
Body weight
Myasthenia Gravis Symptoms
Loading dose
Not everyone experiences myasthenia gravis symptoms in the same way, but common ones include:
Maintenance dose
- Drooping eyelids
- Weak muscles in limbs, neck, and eyes
- Tiredness
- Blurry or double vision
- Difficulty chewing, swallowing, speaking, and breathing
Ultomiris Users
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Ultomiris is meant for adult sufferers of generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. This means their immune system is attacking their own cells, blocking acetylcholine receptors – neurotransmitters that aid in muscle contraction.
2,400 mg
Before prescribing Ultomiris, your doctor might order a blood test to determine if your myasthenia gravis is AChR antibody positive. Consult your doctor to understand better if Ultomiris could help you manage your myasthenia gravis.
3,000 mg every 8 weeks
How Ultomiris Tackles Myasthenia Gravis
If your doctor recommends Ultomiris, you might be curious about how it works. Here's a simplified explanation:
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
The Mechanism Behind Ultomiris
2,700 mg
Though the exact mechanism isn't fully understood, Ultomiris blocks the activity of a complement system protein called C5 at the neuromuscular junction (NMJ) – the area where nerve cells communicate with muscles. By curbing C5 activity at the NMJ, Ultomiris helps signals from nerve cells reach your muscles, potentially reducing fatigue and muscle weakness while enhancing muscle strength.
3,300 mg every 8 weeks
Ultomiris' Effectiveness for Myasthenia Gravis
Ultomiris proved effective in improving the ability to perform daily living activities in clinical trials for gMG patients who were AChR antibody-positive. For more information on these studies, you can read the Ultomiris prescribing information. Your doctor or pharmacist can also provide details about the study results.
100 kg or more (approximately 220 lb or more)
Receiving Ultomiris for Myasthenia Gravis
3,000 mg
Here's what you need to know about the typical Ultomiris dosages for treating myasthenia gravis. Your doctor will determine the best dosage for you. Be sure to ask questions if you have doubts about your Ultomiris dosage or administration.
3,600 mg every 8 weeks
Ultomiris comes in three strengths:
- 300 milligrams (mg)/30 milliliters (mL)
- 300 mg/3 mL
- 1,100 mg/11 mL
Dosage
Based on your body weight in kilograms (kg), Ultomiris treatment typically begins with a loading dose, followed by a maintenance dose, usually every 8 weeks.
Ultomiris
| Body weight | Loading dose | Maintenance dose || --- | --- | --- || 40 kg to less than 60 kg | 2,400 mg | 3,000 mg every 8 weeks || 60 kg to less than 100 kg | 2,700 mg | 3,300 mg every 8 weeks || 100 kg or more | 3,000 mg | 3,600 mg every 8 weeks |
Vyvgart
Note: In addition to treating myasthenia gravis, Ultomiris can be used for other conditions. Keep this in mind as the dosage may differ for other disorders. Talk to your doctor for more information.
How Your Ultomiris Is Given
Form
Ultomiris is an infusion solution that a healthcare professional will administer at an infusion center.
solution for IV infusion
How Often Ultomiris Is Given
solution for IV infusion
You'll typically receive your maintenance doses every 8 weeks. You'll start receiving these doses 2 weeks after your loading dose.
For more information about Ultomiris dosing schedules, check out this Ultomiris dosage article.
Dosage frequency
Ultomiris Side Effects
once every 8 weeks
The usage of Ultomiris may induce side effects that are minor or severe. Remember that the following lists are not exhaustive, and it's essential to discuss other potential side effects with your doctor or pharmacist.
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Mild Side Effects of Ultomiris
Mild side effects reportedly include:
Drug class
- Diarrhea
- Upper respiratory infections, such as the common cold
- Abdominal pain
- Urinary tract infections (UTI)
- Back pain
- Dizziness
- Mild infusion reactions, including
- Muscle spasms
- Discomfort in your arms or legs
complement inhibitor
These side effects could be temporary, lasting a few days to a couple of weeks. But if they persist, worsen, or become severe, consult your doctor or pharmacist.
neonatal Fc receptor blocker
Serious Side Effects of Ultomiris
Though rare, serious side effects have been reported with Ultomiris, including:
- Serious infections, including COVID-19 and pneumonia
- Severe infusion reactions, including
- Increased or decreased blood pressure
- Severe shivering, chills, and fever
- Risk of serious meningococcal infections (see "Before receiving Ultomiris")
Contact your doctor right away if you develop serious side effects while using Ultomiris. In an emergency, call 911 or your local emergency number immediately.
Before Receiving Ultomiris
Before you receive Ultomiris, consider these crucial details:
Boxed Warning: Risk of severe meningococcal infections
Ultomiris carries a boxed warning for the risk of severe meningococcal infections, including meningitis. These infections can be life-threatening. Symptoms include:
- Sudden fever, headache, or stiff neck
- Nausea and vomiting
- Sensitivity to light
- Confusion
- Drowsiness
What to Do
Before you start Ultomiris treatment, your doctor will make sure you're up-to-date with meningococcal vaccines. If not, they'll give you the needed vaccines at least 2 weeks before Ultomiris treatment begins. If time is of the essence, your doctor may start treatment sooner than 2 weeks after meningococcal vaccination. In this case, they'll likely prescribe antibiotics to prevent infections, which you'll take for 2 weeks following your first Ultomiris infusion.
The risk of severe meningococcal infections applies during treatment with Ultomiris and for at least 8 months after your last dose. If you feel you have symptoms of a meningococcal infection, contact your doctor immediately. Get emergency help (dial 911 or your local emergency number) if symptoms feel life-threatening.
Due to this risk, Ultomiris is only available under 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. Learn more about the Ultomiris REMS program at the program website or by calling 1-888-765-4747.
Other Warnings
Besides the boxed warning, Ultomiris has other warnings. If any of the following apply to you, talk to your doctor before receiving Ultomiris:
- Active infection
- Pregnancy
- Breastfeeding
- Alcohol consumption
- Allergic reaction to Ultomiris or any of its ingredients
Frequently Asked Questions
Below are answers to some frequently asked questions about Ultomiris for treating myasthenia gravis:
How does Ultomiris compare to Vyvgart?
Ultomiris and Vyvgart (sutimlimab-jmeb) are prescribed to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Here's a comparison between these medications for the treatment of gMG:
| | || --- | --- || Ultomiris | Vyvgart || Form | solution for IV infusion | solution for IV infusion || Dosage frequency | once every 8 weeks | once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms || Drug class | complement inhibitor | neonatal Fc receptor blocker |
Ultomiris is also approved to treat other conditions, whereas Vyvgart is only approved for gMG. Your doctor or pharmacist can offer more information on how Ultomiris and Vyvgart compare.
Can I receive Ultomiris infusions at home?
It may be possible. Your doctor might be able to prescribe Ultomiris for home infusion. With home infusion services, a healthcare professional visits your home to administer the medication infusion.
Talk to your doctor to understand whether this solution is available and suitable for you.
Ultomiris Cost
The cost of Ultomiris depends on factors like your treatment regimen, insurance plan, and location. Ultomiris is a brand-name biologic drug with no biosimilar version available. Biologics can't be exactly copied, while generics are exact copies of brand-name drugs.
A program called the Alexion OneSource CoPay Program is available for Ultomiris. For more information and to find out if you're eligible for support, call 888-765-4747 or visit the program website.
- Ultomiris is a solution for intravenous infusion, belonging to the complement inhibitors drug class, typically prescribed for adult sufferers of generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, as it helps manage this autoimmune neurological disorder.
- The immune system, in the context of myasthenia gravis, attacks its own cells, blocking acetylcholine receptors – neurotransmitters that aid in muscle contraction.
- Other autoimmune disorders and additional medical-conditions, especially neurological disorders, may benefit from Ultomiris, as the drug class it belongs to is under research for treatment applications.
- Science and health-and-wellness professionals work together to improve our understanding of myasthenia gravis and develop effective treatments, like Ultomiris, to alleviate its symptoms and manage the disease.
- The immune system plays a crucial role in overall health, but when dysfunctional, as in the case of myasthenia gravis, it can cause chronic conditions like this one, leading to fatigue, muscle weakness, and compromised quality of life.
