Myasthenia Gravis Treatment with Ultomiris: Insights and Details
Revised Article:
Holla! Let's chat about Ultomiris, a treatment for myasthenia gravis. This bad boy is an intravenous infusion solution that'sprescribed for those battling this chronic condition.
Ultomiris belongs to a class of drugs called complement inhibitors, and it's a biologic medication, meaning it's made using living cells and organisms. It ain't got no biosimilar version, so it's unique in that sense.
This article'll fill you in on the deets about side effects, dosage, and how Ultomiris kicks myasthenia gravis to the curb. To get even more info, check out our in-depth Ultomiris article.
Ultomiris carries a boxed warning, the FDA's most serious warning. Go back to the "Before receiving Ultomiris" section to learn more.
Body weight
Myasthenia Gravis Demystified
Loading dose
Myasthenia gravis is a funky autoimmune condition that screws up communication between muscles and nerves, causing your voluntary muscles to tire quickly and weaken. It's a long-term deal, and your immune system mistakes your own cells for invaders.
Maintenance dose
Symptoms of Myasthenia Gravis
Symptoms can vary, but they typically worsen during increased activity and improve with rest. Here's what you might experience:
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
- drooping eyelids
- weak muscles in your limbs, neck, and eyes
- fatigue (you'll feel worn out, mate)
- blurry or double vision*Difficulty chewing, swallowing, speaking, and breathing (serious stuff, so don't ignore it)
2,400 mg
Who gets Ultomiris?
3,000 mg every 8 weeks
Ultomiris is prescribed for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies.
- "Generalized" means your whole body is affected, not just your eye muscles.
- "Anti-acetylcholine receptor (AChR) antibody-positive" means your immune system produces antibodies that block acetylcholine receptors. Acetylcholine is a neurotransmitter that allows muscles to contract.
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Before prescribing Ultomiris, your doctor may order a blood test to check if your gMG is AChR antibody positive. Your doc can give you the lowdown on whether Ultomiris is right for your type of myasthenia gravis.
2,700 mg
How Ultomiris vanquishes Myasthenia Gravis
3,300 mg every 8 weeks
If your doc tells you to take Ultomiris, it's natural to wonder how it works. Here's the lowdown:
The Mode of Action
100 kg or more (approximately 220 lb or more)
The exact way Ultomiris works isn't fully understood, but it's thought to interfere with a complement system protein called C5. This protein plays a role in immune responses and is active at the neuromuscular junction, where nerve cells communicate with the muscles they control.
3,000 mg
Ultomiris blocks C5 activity at the neuromuscular junction, helping signals from nerve cells reach your muscles. This may reduce fatigue and muscle weakness, improving muscle strength.
3,600 mg every 8 weeks
How Effective is Ultomiris?
In clinical trials, Ultomiris improved patients' ability to carry out daily tasks in adults with gMG who were AChR antibody positive. Visit the prescribing information for Ultomiris for more details. Your doctor or pharmacist can also provide insights on how well Ultomiris worked in these studies.
Receiving Ultomiris
Ready for the dosage details? Here's the skinny:
Ultomiris
Ultomiris comes in three strengths:
Vyvgart
- 300 mg/30 mL
- 300 mg/3 mL
- 1,100 mg/11 mL
Dosage
Form
General dosing recommendations for myasthenia gravis based on body weight are as follows:
solution for IV infusion
- 40 to 60 kg (about 88 to 132 lb): 2,400 mg loading dose followed by 3,000 mg maintenance dose every 8 weeks
- 60 to 100 kg (about 132 to 220 lb): 2,700 mg loading dose followed by 3,300 mg maintenance dose every 8 weeks
- 100 kg or more (about 220 lb or more): 3,000 mg loading dose followed by 3,600 mg maintenance dose every 8 weeks
solution for IV infusion
Your doc will determine the best dosage for you, so hit 'em up if you have questions.
Administration
Dosage frequency
Ultomiris comes as a solution for IV infusion. You'll receive your treatments at an infusion center.
once every 8 weeks
Frequency
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Maintenance doses are usually given every 8 weeks after the initial loading dose.
For more info on dosing schedules, check out this Ultomiris dosage article.
Drug class
Side Effects of Ultomiris
complement inhibitor
Using Ultomiris for myasthenia gravis may cause mild to serious side effects.
neonatal Fc receptor blocker
Here are some common side effects you might experience:
- diarrhea
- upper respiratory infection (common cold)
- abdominal pain
- urinary tract infection (UTI)
- back pain
- dizziness
- mild infusion reactions (muscle spasms, discomfort in arms or legs)
Serious side effects that have been reported include:
- serious infections, including COVID-19 and pneumonia
- serious infusion reactions, including increased or decreased blood pressure, severe shivering, chills, and fever
- risk of serious meningococcal infections (see "Before receiving Ultomiris")
If you develop serious side effects, contact your doctor immediately. If symptoms seem life-threatening, call 911 or your local emergency number.
Allergic Reaction
Ultomiris can cause allergic reactions in some people. Mild symptoms include a rash, which you should report to your doctor. For severe allergic reactions, such as swelling or trouble breathing, call 911 or your local emergency number right away.
Before Receiving Ultomiris
Before you receive Ultomiris, there are some important tidbits to think about. Ultomiris may not be a safe choice if you have certain medical conditions or lifestyle factors that affect your health. Here are some things to consider:
Boxed Warning: Risk of Serious Meningococcal Infections
Ultomiris carries a boxed warning for the risk of serious meningococcal infections. Meningococcal infections can be life-threatening.
Symptoms of a meningococcal infection include:
- sudden fever, headache, or stiff neck
- nausea and vomiting
- sensitivity to light
- confusion
- drowsiness
What to Do
Before beginning Ultomiris treatment, your doctor will ensure you're up-to-date with meningococcal vaccines. If not, they'll give you any needed vaccines at least 2 weeks before you start Ultomiris treatment. If your doctor determines you need immediate treatment, they may prescribe antibiotics to help prevent infection, which you'll take for the first 2 weeks following your first Ultomiris infusion.
The risk of serious meningococcal infections lasts throughout treatment with Ultomiris and for at least 8 months after your last dose. If you think you have symptoms of a meningococcal infection during this time, reach out to your doctor immediately. But call 911 or go to the closest emergency room if your symptoms seem 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. You can learn more about the Ultomiris REMS program at the program website or by calling 1-888-765-4747.
Other Warnings
In addition to boxed warnings, Ultomiris has other cautions. If any of the following medical conditions or other health factors apply to you, discuss them with 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 some frequently asked questions about Ultomiris for treating myasthenia gravis.
How does Ultomiris Compare to Vyvgart?
Ultomiris and Vyvgart are prescribed for treating generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Here's a comparison:
| | Ultomiris | Vyvgart || --- | --- | --- || Form | solution for IV infusion | solution for IV infusion || Dosage frequency | once every 8 weeks | once weekly for 4 weeks, with additional cycles based on symptom improvement || Drug class | complement inhibitor | neonatal Fc receptor blocker |
Ultomiris is also approved for other indications, unlike Vyvgart. Your doctor or pharmacist can provide more details on how these meds stack up.
Can I receive Ultomiris infusions at home?
It's possible, but it depends on your doctor's recommendations and specific circumstances. To learn more, chat with your healthcare provider.
Ultomiris Cost
The cost of Ultomiris varies, depending on factors like your treatment regimen, insurance coverage, and location. Ultomiris is a brand-name biologic drug that isn't available in a biosimilar form.
A program called the Alexion OneSource CoPay Program is available for Ultomiris. Visit the program website or call 1-888-765-4747 to learn more about it and see if you're eligible for support.
Disclaimer: Our content isn't intended to replace the advice of a licensed healthcare professional. Always consult your doctor or pharmacist before taking any medication. This article may not cover all possible uses, side effects, warnings, drug interactions, allergic reactions, or adverse effects of Ultomiris. For comprehensive information, consult the prescribing information and speak with your healthcare provider.
Enrichment Data:Ultomiris (ravulizumab-cwvz) treats myasthenia gravis by targeting the complement system, specifically by binding to and blocking the complement protein C5. The complement system is part of the immune system involved in attacking harmful cells, but it can also damage the body's own cells in autoimmune diseases like myasthenia gravis. In patients with myasthenia gravis, autoantibodies cause harmful activation of the complement system, contributing to the destruction or dysfunction of the neuromuscular junction. Ultomiris binds with high affinity to the C5 protein in the complement cascade, preventing its cleavage into C5a and C5b, which are crucial for further activation of downstream complement components. By blocking C5, Ultomiris inhibits the formation of the membrane attack complex and prevents complement-mediated damage to the neuromuscular junction, helping preserve neuromuscular transmission and alleviate muscle weakness associated with myasthenia gravis.[1][2][5]
- In people with myasthenia gravis, Ultomiris targets the immune system, specifically the complement system, to assist in alleviating muscle weakness.
- Its mode of action involves binding to and blocking the complement protein C5, preventing the harmful activation of the complement system that occurs in autoimmune conditions such as myasthenia gravis.
- Ultomiris may have side effects, some of which include diarrhea, upper respiratory infections, abdominal pain, urinary tract infections, back pain, dizziness, and mild infusion reactions.
- Serious side effects such as serious infections, meningococcal infections, serious infusion reactions, and allergic reactions can occur with Ultomiris use; if you experience such symptoms, contact your doctor immediately.
- The risk of serious meningococcal infections continues throughout treatment with Ultomiris and for at least 8 months after the last dose, so it's important to maintain awareness of this risk and receive necessary vaccines before starting treatment.
