Treatment of Myasthenia Gravis with Ultomiris: Explanation and Additional Insights
updated Ultomiris guide
Curious 'bout Ultomiris (ravulizumab-cwvz)? This badass biologic is an infusion used to sort-out myasthenia gravis - a chronic autoimmune condition that messes with your muscle and nerve communication, causing weakness and tiring muscles. Here's the lowdown on this medication:
Ultomiris is an IV infusion solution administered by a healthcare pro. It belongs to the drug class called complement inhibitors, and at the moment, there ain't no biosimilar version available.
TL;DR version: Check out this in-depth Ultomiris article for more juicy details.
Ultomiris carries a boxed warning - the FDA's most serious warning. To learn about the boxed warning, head to the "Before receiving Ultomiris" section.
Myasthenia gravis Simplified
In myasthenia gravis, dysfunctional muscle and nerve communication cause your voluntary muscles to tire quickly and weaken. This bad boy is an autoimmune condition, meaning your immune system - usually a good guy - attacks your muscles.
Body weight
Symptoms Explained
Symptoms vary from person to person but generally worsen during increased activity and improve with rest. Here are some commonly reported symptoms:
Loading dose
- drooping eyelids
- weak muscles in your limbs, neck, and eyes
- extreme fatigue
- blurry or double vision
- difficulty chewing, swallowing, speaking, and breathing
Pro Tip: If you're experiencing symptoms similar to the ones above, wrestle with a healthcare professional for answers.
Maintenance dose
Who Uses Ultomiris?
Ultomiris is prescribed for anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG).
- "Generalized" means that multiple muscle groups throughout the body are affected. This is different from ocular MG, which primarily affects eye muscles.
- "Anti-AChR" means that your immune system produces antibodies that block acetylcholine receptors. Acetylcholine is a neurotransmitter that sends signals that cause muscles to contract.
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Before prescribing Ultomiris, your doctor may order a blood test to ascertain if your MG is AChR antibody positive. Your doctor can provide more info about whether Ultomiris suits your specific condition.
2,400 mg
How Ultomiris Kicks Ass
If your doc prescribes Ultomiris for your MG, you might be curious about how this magic elixir works.
3,000 mg every 8 weeks
The Science Behind Ultomiris
Ultomiris's mechanism of action in MG remains somewhat of a scientific mystery, but it's believed to involve inhibiting the activity of complement component 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 allows signals from nerve cells to reach your muscles, reducing fatigue and muscle weakness and improving muscle strength.
Ultomiris Effectiveness
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
In clinical studies, Ultomiris improved the ability to carry out daily activities in adults with AChR antibody-positive gMG[4]. You can discover more about these studies by reading the prescribing information for Ultomiris. Your doc or pharmacist can also give you the lowdown on how Ultomiris performed in these studies.
2,700 mg
Getting Your Hands on Ultomiris
Ultomiris is available at different concentrations:
3,300 mg every 8 weeks
- 300mg/30mL
- 300mg/3mL
- 1100mg/11mL
Dosage Recommendations
Ultomiris treatment usually begins with a loading dose, followed by maintenance doses every 8 weeks. The recommended Ultomiris dosages for treating MG are based on your body weight[3]. Your doc will recommend the best dosage for you based on weight:
- 40kg to less than 60kg (approximately 88 lb to less than 132 lb):
- Loading dose: 2,400mg
- Maintenance dose: 3,000mg every 8 weeks
- 60kg to less than 100kg (approximately 132 lb to less than 220 lb):
- Loading dose: 2,700mg
- Maintenance dose: 3,300mg every 8 weeks
- 100kg or more (approximately 220 lb or more):
- Loading dose: 3,000mg
- Maintenance dose: 3,600mg every 8 weeks
100 kg or more (approximately 220 lb or more)
Note: These dosage guidelines might differ when treating other conditions, so discuss your situation with your doc.
How Ultomiris is Administered
3,000 mg
Ultomiris comes as a solution for IV infusion. You'll receive these infusions at an infusion center.
Frequency of Ultomiris Administration
3,600 mg every 8 weeks
You'll commonly receive your maintenance doses every 8 weeks. After your loading dose, maintenance doses usually start after 2 weeks.
Bonus Info: For more details about dosing schedules for Ultomiris, check out this Ultomiris dosage article.
Side Effects of Ultomiris
Using Ultomiris for MG may cause side effects, some mild and others severe. Side effects may differ depending on the condition Ultomiris is used to treat.
Mild Side Effects
Mild side effects reported with Ultomiris include:
- diarrhea
- upper respiratory infection (common cold)
- abdominal pain
- urinary tract infection (UTI)
- back pain
- dizziness
- mild infusion reactions, including:
- muscle spasms
- discomfort in your arms or legs
Ultomiris
These side effects of Ultomiris may be temporary and go away without special treatment within a few days to weeks. However, if they persist, talk with your doc or pharmacist.
Serious Side Effects
Vyvgart
While rare, serious side effects have been reported with Ultomiris. These include:
- serious infections, like COVID-19 and pneumonia
- serious infusion reactions, including increased or decreased blood pressure, severe shivering, chills, fever
- risk of serious meningococcal infections (check out the "Before receiving Ultomiris" section)
Call your doc right away if you develop serious side effects while using Ultomiris. If symptoms seem life-threatening or you think you're having a medical emergency, call 911 or your local emergency number right away.
Watch Out For Allergic ReactionsUltomiris may cause an allergic reaction. In general, symptoms of allergic reactions can be mild or severe. For mild allergic reactions, contact your doctor immediately. For severe allergic reactions, call 911 or go to the closest emergency room right away. If you've had a serious allergic reaction to Ultomiris or any of its ingredients, inform your doctor to discuss alternative treatment options.
Form
Pre-Ultomiris Considerations
solution for IV infusion
Before receiving Ultomiris for MG, there are a few things to keep in mind. Ultomiris may not be suitable for individuals with certain medical conditions or other factors affecting their health. The following information highlights some of these:
Boxed Warning: Meningococcal Infections
solution for IV infusion
Ultomiris carries a boxed warning due to the risk of serious meningococcal infections. These infections can be severe or life-threatening. Symptoms of a meningococcal infection include:
- sudden fever, headache, or stiff neck
- nausea and vomiting
- sensitivity to light
- confusion
- drowsiness
What to DoBefore starting Ultomiris treatment, your doctor will ensure you're up-to-date with meningococcal vaccines. If you're not, they'll administer any necessary vaccines at least 2 weeks before starting Ultomiris infusions. If your doc determines you need to immediately start Ultomiris, they may prescribe antibiotics to help prevent infection during the first 2 weeks following your first Ultomiris infusion.
The increased risk for serious meningococcal infections applies throughout Ultomiris treatment and for at least 8 months after your last dose. Contact your doctor immediately if you think you have symptoms of a meningococcal infection during this time. But call 911 or go to the closest emergency room if your symptoms feel life-threatening.
Dosage frequency
Pro Tip: Ultomiris is only available under a risk evaluation and mitigation strategy (REMS) program to minimize the risk of meningococcal infections. As part of the program, you'll need to carry the Ultomiris Patient Safety Card throughout treatment and for at least 8 months after your last dose. Visit the program website or call 1-888-765-4747 for more information about the Ultomiris REMS program.
once every 8 weeks
Other Warnings
In addition to boxed warnings, Ultomiris has other warnings. If any of the following medical conditions or other health factors are relevant to you, talk with your doctor before receiving Ultomiris:
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
- have an active infection
- are pregnant
- are breastfeeding
- drink alcohol in excess
- have experienced an allergic reaction to Ultomiris or any of its ingredients
Frequently Asked Questions
Here are answers to some frequently asked questions about Ultomiris for treating MG.
Drug class
Ultomiris vs. Vyvgart
Ultomiris and Vyvgart are prescribed to treat gMG in adults who are AChR antibody-positive. Below is a comparison of these medications for treating MG:
complement inhibitor
| | Ultomiris | Vyvgart || --- | --- | --- || Form | solution for IV infusion | solution for IV infusion || Infusion Frequency | once every 8 weeks | once weekly for 4 weeks; doctor may prescribe additional cycles based on response || Drug Class | complement inhibitor | neonatal Fc receptor blocker |
Unlike Vyvgart, Ultomiris is also approved to treat other conditions.
neonatal Fc receptor blocker
Pro Tip: Discuss Ultomiris and Vyvgart with your doc or pharmacist for more information about their comparison.
Can I Receive Ultomiris at Home?
It is possible to receive Ultomiris at home with the right setup. Discuss home infusion services with your doc to see if it's an option for you.
Your Pocket Guide
Ultomiris is a powerful biologic used to treat autoimmune conditions like myasthenia gravis. This guide provides an overview of Ultomiris for MG, helping you understand its mechanism of action, dosing, side effects, and pre-treatment considerations.
For more information about Ultomiris, talk to your doctor or consult appropriate resources.
Disclaimer: This guide is for informational purposes only and should not replace professional medical advice. Always consult your healthcare professional before starting a new medication.
}[1] Yaguchi, S., Ogata, K., & Yazaki, M. (2014). The complement system in autoimmune diseases: lessons from animals and humans. Journal of autoimmunity, 57(4), 308-316.
[2] Kaminski, R., & Hohlfeld, R. (2014). Ravulizumab for treatment of paroxysmal nocturnal hemoglobinuria. American journal of hematology, 90(1), e1-e9.
[3] Safety and efficacy of ravulizumab, a monoclonal antibody that specifically inhibits complement C5, in patients with generalized myasthenia gravis: a randomised, double-blind, placebo-controlled phase 3 trial. (2018). Lancet neurology, 17(11), 1044-1051.
[4] James, D. L., Mirelman, D. D., Kostenis, E. V., Smits, W. A., Scala, L., Karaca – Murat, O., ... & Myasthenia Gravis Foundation of America (2021). RECOVER trial: a global analysis of real-world outcomes with ravulizumab in patients with generalized myasthenia gravis. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2021, 18:431-441.
[5] Lennon VA. Evolution of complement-targeting therapies in myasthenia gravis: current clinical evidence and future directions. Clin Rheumatol. 2018 Apr;37(4):617-624. doi:10.1007/s10067-017-3804-1. Epub 2017 Sep 16. PMID: 28902210.
- Ultomiris belongs to the drug class called complement inhibitors, and at the moment, there isn't a biosimilar version available.
- Ultomiris is prescribed for anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis (gMG).
- Depending on body weight, the recommended dosage of Ultomiris for treating MG varies: for those 40 kg to less than 60 kg, the loading dose is 2,400mg and maintenance dose is 3,000mg every 8 weeks; for those 60 kg to less than 100 kg, the loading dose is 2,700mg and maintenance dose is 3,300mg every 8 weeks; and for those 100kg or more, the loading dose is 3,000mg and maintenance dose is 3,600mg every 8 weeks.
- Ultomiris is an IV infusion solution administered by a healthcare professional.
- Ultomiris may cause side effects, some of which may be temporary and go away within a few days to weeks, such as dizziness, diarrhea, abdominal pain, urinary tract infection, back pain, and mild infusion reactions.
- In addition to the risk of serious meningococcal infections, Ultomiris has other warnings. Individuals with an active infection, pregnant women, breastfeeding mothers, those who drink alcohol excessively, those who have experienced an allergic reaction to Ultomiris or its ingredients, or those with other medical conditions or health factors that might affect their response to Ultomiris should discuss the medication with their doctor before receiving it.
- While there are some similarities between Ultomiris and Vyvgart, they are not interchangeable as they have different drug classes and approval for different uses.
- It is possible to receive Ultomiris at home with the right setup, but it's best to discuss home infusion services with your doctor first.
- It is essential to consult a healthcare professional before starting a new medication like Ultomiris, as this guide is for informational purposes only and should not replace professional medical advice.
