Myasthenia Gravis Treatment with Ultomiris: Insights and Details Explained
Ultomiris Remixed
Hey there! Let's knock this one outta the park and take a gander at Ultomiris, the brand name treatment for myasthenia gravis. We'll cover the nitty-gritty details like side effects, dosage, and how it works. You'll also find some suggestions on additional reading.
Ultomiris, also known as ravulizumab-cwvz, is an IV infusion that your doc will administer. It's a biologic drug, belongin' to the complement inhibitor family, and ain't got no biosimilar version.
If you're curious to learn more about Ultomiris, don't hesitate to check out this in-depth article on the topic.
Ultomiris carries a boxed warning, the most serious warning from the Food and Drug Administration (FDA). Want to find out more? Jump to the section called "Before Receiving Ultomiris" for the details.
Myasthenia Gravis: The Lowdown
Myasthenia gravis is a chronic autoimmune disorder where muscle and nerve communication goes kaput, causin' your voluntary muscles to tire quickly and weaken. Folks with myasthenia gravis are susceptible to periods of increased activity that worsen their symptoms and rest that improves 'em.
Common symptoms of myasthenia gravis include:
- droopy eyelids
- weak muscles in your limbs, neck, and eyes
- tiredness
- blurry or double vision
- difficulty swallowin', chewing, speakin', and breathin'
Body weight
Ultomiris: Who Gets It?
Ultomiris is prescribed to treat generalized myasthenia gravis (gMG) in adults who are antibody-positive for acetylcholine receptor (AChR). This means their immune system produces antibodies that block acetylcholine receptors, thus preventin' proper communication between muscles and nerves.
Loading dose
Before your doc writes you a prescription for Ultomiris, they might order a blood test to check if your gMG is AChR antibody-positive. If you're curious 'bout Ultomiris suitability for your form of myasthenia gravis, chat with your doc for more information.
How Ultomiris Works for Myasthenia Gravis
Maintenance dose
If your doc prescribes Ultomiris to deal with your myasthenia gravis, you might want to understand how it works. The precise mechanism of action isn't totally clear, but it's believed to involve inhibition of the activity of a complement system protein called C5 at the neuromuscular junction (NMJ).
The NMJ is the spot where nerve cells connect to control the muscles they regulate. By lowerin' C5 activity at the NMJ, Ultomiris helps signals from nerve cells reach the muscles, potentially reducing tiredness and muscle weakness while improvin' muscle strength.
How Well Ultomiris Works for Myasthenia Gravis
In clinical studies, Ultomiris effectively improved the ability to perform daily activities in adults with gMG who were AChR antibody-positive. Saunter over to the "Prescribing Information for Ultomiris" to learn more about these studies. Your doctor or pharmacist can also provide details on how Ultomiris fared in these studies.
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Receiving Ultomiris for Myasthenia Gravis
Wonderin' what to expect when receivin' Ultomiris? Here's the lowdown on dosage and how Ultomiris is administered. Your doc will recommend the correct dosage for you. If you have questions 'bout your Ultomiris dosage or the method of administration, consult your doc.
2,400 mg
Ultomiris is available in three strengths:
- 300 mg/ml
- 300 mg/3 ml
- 1,100 mg/11 ml
3,000 mg every 8 weeks
Dosage
Ultomiris dosages for treatin' myasthenia gravis are based on body weight in kilograms (kg). For example, 1 kg equals about 2.2 pounds (lb).
Ultomiris treatment typically begins with a loadin' dose. Two weeks post loadin' dose, you'll receivin' maintenance doses, usually every 8 weeks.
Check out the chart below for recommended Ultomiris dosages based on body weight:
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
| | | || --- | --- | --- || 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 |
How Ultomiris is administered
2,700 mg
Ultomiris is an IV infusion solution, which your healthcare professional will administer.
How often Ultomiris is administered
3,300 mg every 8 weeks
You typically receive your Ultomiris maintenance doses every 8 weeks. You'll likely receive maintenance doses 2 weeks post loadin' dose.
For more information 'bout dosage schedules for Ultomiris, saunter on over to this Ultomiris dosage article. Your doc or pharmacist can provide additional details, too.
Ultomiris Side Effects
The usage of Ultomiris for myasthenia gravis may lead to mild or severe side effects.
100 kg or more (approximately 220 lb or more)
Keep in mind that Ultomiris is also approved for other conditions. Side effects may vary depending on the condition it's used to treat.
Mild side effects reported with Ultomiris include:
3,000 mg
- diarrhea
- upper respiratory infections (such as cold)
- abdominal pain
- urinary tract infections (UTIs)
- back pain
- dizziness
- mild infusion reactions, such as:
- muscle spasms
- uncomfortable feelings in arms or legs
These side effects may be temporary, fade after a few days or weeks. If they persist or bother you, chat with your doctor or pharmacist.
3,600 mg every 8 weeks
Serious side effects of Ultomiris
Though uncommon, serious side effects have been reported with Ultomiris. These include:
- severe infections, like COVID-19 and pneumonia
- severe infusion reactions, such as:
- extreme increases or decreases in blood pressure
- intense shivering, chills, and fever
- increased risk of severe meningococcal infections
Contact your doc right away if you develop serious side effects while usin' Ultomiris. In case the side effects feel life threatening, call 911 or your local emergency number immediately.
Before Receivin' Ultomiris
Before you start receivin' Ultomiris, there are some important details to know. Ultomiris may not be a safe option if you've got certain medical conditions or other factors that affect your overall health. The following highlights some of these.
Boxed Warning: Risk of Severe Meningococcal Infections
Ultomiris has a boxed warning for the risk of severe meningococcal infections.
Ultomiris
Treatment with Ultomiris boosts the risk for severe meningococcal infections, such as meningitis. These infections can be fatal. Symptoms of a meningococcal infection include:
- sudden fever, headache, or stiff neck
- nausea and vomiting
- sensitivity to light
- confusion
- drowsiness
Vyvgart
What to do
Before you start Ultomiris treatment, your doc will ensure you've had up-to-date meningococcal vaccines. If not, they'll provide you with needed vaccines at least 2 weeks before Ultomiris treatment. If your doc determines an urgent need for Ultomiris, they may have you start treatment sooner than 2 weeks post-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.
The risk of serious meningococcal infections applies throughout treatment with Ultomiris and for at least 8 months after your last dose. Contact your doc immediately if think you've got symptoms of a meningococcal infection during this time. In case symptoms feel life threatening, call 911 or go to the closest emergency room.
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 post-treatment. You can learn more about the Ultomiris REMS program at the program website or by callin' 1-888-765-4747.
Form
Other Warnings
Besides the boxed warnings, Ultomiris has other warnings.
solution for IV infusion
If any of the following medical conditions or other health factors apply to you, chat with your doc before receivin' Ultomiris:
- active infection
- pregnancy
- breastfeedin'
- drinkin' alcohol
- had an allergic reaction to Ultomiris or any of its ingredients
solution for IV infusion
Frequently Asked Questions
Below are answers to some frequently asked questions about Ultomiris for treatin' myasthenia gravis.
How does Ultomiris compare vs. Vyvgart?
Ultomiris and Vyvgart are prescribed to treat generalized myasthenia gravis (gMG) in adults who are antibody-positive for acetylcholine receptor (AChR). The following table compares these medications for treatin' this condition.
Dosage frequency
| | || --- | --- || Ultomiris | Vyvgart || Form | IV infusion solution | IV infusion solution || Dosage frequency | once every 8 weeks | weekly for 4 weeks; your doc may prescribe additional cycles based on how well Vyvgart works for your symptoms || Drug class | complement inhibitor | neonatal Fc receptor blocker |
Unlike Vyvgart, Ultomiris is also approved for other conditions.
once every 8 weeks
Your doc or pharmacist can offer more information on how Ultomiris and Vyvgart compare.
Can I receive Ultomiris infusions at home?
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
It's possible. Your doc may be able to prescribe Ultomiris for home infusion. With home infusion services, a healthcare professional visits your home to administer the medication.
Contact your doc to learn more about whether this solution is available and suitable for you.
neonatal Fc receptor blocker
Ultomiris Cost
The cost of Ultomiris varies depending on factors such as your treatment regimen, insurance plan, and location.
Drug class
Ultomiris is a brand-name biologic drug and is not available in a biosimilar form.
A program called the Alexion OneSource CoPay Program is available for Ultomiris. For info and to find out if you're eligible for support, call 888-765-4747 or visit the program website.
complement inhibitor
Remember: Always consult a healthcare professional before takin' any medication. The info herein is intended for educational purposes only and should not be used as a substitute for professional advice. The drug info contained herein might change and is not intended to cover all possible uses, precautions, warnings, adverse effects, or drug interactions. The absence of warnings or other info for a given drug doesn't imply that the drug or drug combination is safe, effective, or appropriate for all patients or situations.
- Ultomiris, also known as ravulizumab-cwvz, is a biologic drug that belongs to the complement inhibitor family and is used to treat generalized myasthenia gravis (gMG) in adults who are antibody-positive for acetylcholine receptor (AChR).
- It's an IV infusion solution and doesn't have a biosimilar version.
- Before receiving Ultomiris, it's important to check if you have certain medical conditions or other factors that could affect your overall health, such as active infection, pregnancy, breastfeeding, alcohol consumption, allergic reaction to Ultomiris or its ingredients, and more.
- Ultomiris carries a boxed warning from the Food and Drug Administration (FDA) due to the risk of severe meningococcal infections.
- Before starting Ultomiris treatment, you should have up-to-date meningococcal vaccines, and your doctor will prescribe antibiotics for the first two weeks following your first Ultomiris infusion.
- Ultomiris is typically administered every 8 weeks, with a loading dose followed by maintenance doses. Dosages are based on body weight, with recommendations in the chart provided.
- Mild side effects of Ultomiris include diarrhea, upper respiratory infections, abdominal pain, urinary tract infections, back pain, dizziness, and mild infusion reactions. Serious side effects include severe infections, severe infusion reactions, and increased risk of severe meningococcal infections.
- In addition to myasthenia gravis, Ultomiris is also approved for other conditions, so side effects may vary depending on the condition it's used to treat. It's important to consult a healthcare professional for more information.
