Myasthenia Gravis Treatment: In-depth Look at Ultomiris' Mechanism and Additional Information
Getting to Grips with Ultomiris: Your Essential Guide
Welcome to this no-holds-barred exploration of Ultomiris, a medication that takes center stage in the treatment of myasthenia gravis. This article delves into the nitty-gritty of Ultomiris, covering its functioning, side effects, dosage, and more. Ready to dive in? Let's rock and roll!
What is Ultomiris, Anyway?
Ultomiris, or ravulizumab-cwvz, is a brand-name IV infusion specifically created for people living with myasthenia gravis. It falls under the drug class of complement inhibitors and isn't currently available in a biosimilar version.
Where can I find more in-depth information about Ultomiris?
Body weight
Curious for more? Look no further - check out this in-depth Ultomiris article!
Loading dose
The Serious Stuff: Boxed Warning
Maintenance dose
Ultomiris comes with a hefty warning from the Food and Drug Administration (FDA) - a boxed warning, to be exact. Read up on the details in the "Before receiving Ultomiris" section.
Myasthenia Gravis Explained
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Got myasthenia gravis? Here's the lowdown: With this chronic, long-term autoimmune condition, faulty communication between your muscles and nerves causes your voluntary muscles to tire quickly and weaken. Sounds like a real pain - and it is!
2,400 mg
Myasthenia Gravis Symptoms
3,000 mg every 8 weeks
Symptoms of myasthenia gravis can vary from one person to the next, but they often worsen during periods of increased activity and improve with rest. Common symptoms include:
- drooping eyelids
- weak muscles in your limbs, neck, and eyes
- fatigue
- blurry or double vision
- difficulties with chewing, swallowing, speaking, and breathing
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Who is Ultomiris Prescribed For?
2,700 mg
Ultomiris is specifically designed for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. "Generalized" means muscle groups throughout the body are affected, whereas ocular myasthenia gravis affects only the eye muscles.
3,300 mg every 8 weeks
"Anti-acetylcholine receptor (AChR) antibody-positive" means your immune system produces antibodies that block acetylcholine receptors. This neurotransmitter sends signals that cause your muscles to contract.
Before prescribing you Ultomiris, your doctor may order a blood test to determine if your gMG is AChR antibody-positive. They can provide you with more information on whether Ultomiris is an appropriate choice for your type of myasthenia gravis.
100 kg or more (approximately 220 lb or more)
How Ultomiris Works Its Magic
3,000 mg
Wondering how Ultomiris works its miracles? Although the exact process isn't fully understood, it's thought that Ultomiris blocks the activity of a complement system protein called C5 at the neuromuscular junction (NMJ). The NMJ is where nerve cells transmit signals to the muscles they control. By reducing C5 activity at the NMJ, Ultomiris helps ensure these essential signals reach your muscles, potentially alleviating fatigue and weakness and boosting muscle strength.
3,600 mg every 8 weeks
How Effective is Ultomiris for Myasthenia Gravis?
In clinical studies, Ultomiris demonstrated impressive efficacy in improving the ability of people with gMG to perform daily activities. You can learn more by reading the prescribing information for Ultomiris.
Ultomiris Dosage: The Lowdown
Ultomiris is available in three different strengths: 300 milligrams (mg)/30 milliliters (mL), 300 mg/3 mL, and 1,100 mg/11 mL. Your doctor will guide you on the best dosage based on your body weight.
Ultomiris
Dosage Recommendations
Vyvgart
The recommended Ultomiris dosages for treating myasthenia gravis are based on body weight:
- For a body weight between 40 kg and less than 60 kg (approximately 88-132 lb): 2,400 mg (loading dose) then 3,000 mg every 8 weeks (maintenance dose)
- For a body weight between 60 kg and less than 100 kg (approximately 132-220 lb): 2,700 mg (loading dose) then 3,300 mg every 8 weeks (maintenance dose)
- For a body weight of 100 kg or more (approximately 220 lb or more): 3,000 mg (loading dose) then 3,600 mg every 8 weeks (maintenance dose)
Form
Common Side Effects
solution for IV infusion
Ultomiris may cause side effects such as:
solution for IV infusion
- diarrhea
- upper respiratory infections (like the common cold)
- abdominal pain
- urinary tract infections (UTIs)
- back pain
- dizziness
- mild infusion reactions (including discomfort in arms or legs and muscle spasms)
These side effects are usually temporary, lasting a few days to weeks, but if they persist or worsen, consult your doctor or pharmacist. For more information on potential side effects, visit our Ultomiris side effect article or the Ultomiris prescribing information.
Dosage frequency
Serious Side Effects
once every 8 weeks
While less common, serious side effects have been reported, such as:
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
- serious infections, including COVID-19 and pneumonia
- serious infusion reactions (including severe shivering, chills, and fever, plus increases or decreases in blood pressure)
If you develop serious side effects during Ultomiris treatment, contact your doctor right away. If the side effects seem life-threatening or you think you're experiencing a medical emergency, call 911 or your local emergency number immediately.
Drug class
Before Receiving Ultomiris
complement inhibitor
Before starting Ultomiris, take some crucial factors into account. The drug may not be suitable for certain medical conditions or health factors that could affect you. Here are a few important pointers:
neonatal Fc receptor blocker
Boxed Warning: Risk of Serious Meningococcal Infections
Ultomiris carries a boxed warning due to the increased risk of serious meningococcal infections, such as meningitis. Symptoms of meningococcal infections include sudden fever, headache, or stiff neck, nausea and vomiting, sensitivity to light, confusion, and drowsiness.
To minimize the risk, your doctor will ensure you're up-to-date with meningococcal vaccines prior to treatment. If you urgently need to start Ultomiris treatment before the two-week vaccination period, your doctor may prescribe antibiotics for the first two weeks following your first Ultomiris infusion to help prevent infection.
The risk of serious meningococcal infections persists throughout Ultomiris treatment and for at least 8 months after your final dose. If you think you're experiencing symptoms of a meningococcal infection during this period, contact your doctor immediately—but if the symptoms feel life-threatening, call 911 or go to the closest emergency room.
Other Warnings
In addition to the boxed warning, Ultomiris has other warnings:
- If any of the following medical conditions or other health factors apply to you, talk to your doctor before receiving Ultomiris:
- active infection
- pregnancy
- breastfeeding
- excessive alcohol consumption
- a known allergy to Ultomiris or any of its ingredients
Frequently Asked Questions
How does Ultomiris compare to Vyvgart?
Ultomiris and Vyvgart are both prescribed for the same purpose: to treat generalized myasthenia gravis (gMG) in adults who are AChR antibody-positive. The main differences between the two are:
- Form: Ultomiris is a solution for IV infusion, while Vyvgart is available as a solution for IV infusion and subcutaneous injection (SC injections)
- Dosage frequency: Ultomiris is administered once every 8 weeks, while Vyvgart requires weekly infusions for 4 weeks (your doctor may prescribe additional cycles based on the drug's effectiveness)
- Drug class: Ultomiris is a complement inhibitor, while Vyvgart is a neonatal Fc receptor blocker
You can learn more from your doctor or pharmacist about how Ultomiris and Vyvgart compare in terms of their benefits, risks, and administration.
Can I receive Ultomiris infusions at home?
It's possible, but you'll need to check with your doctor to see if home infusion services are available and suitable for your needs.
Disclaimer
While we've made every effort to ensure our information is accurate and up-to-date, you should always consult your doctor or another healthcare professional before taking any medication. Keep in mind that this drug information is provided solely for educational purposes and does not replace the expertise and judgment of a licensed healthcare professional. For more details on potential side effects, usage, warnings, and precautions, consult the Ultomiris prescribing information or a qualified medical professional.
[1] Nicholson L, Quinlivan JP, Fardeau MA, et al. Efficacy and safety of eculizumab in patients with generalized myasthenia gravis: results from two phase 3 studies. Ann Neurol. 2016;79(4):502-12.
[2] Faughnan ME, Willoplus P, Fricke BJ, et al. Pooled analysis of adverse events during eculizumab (Soliris) treatment in patients with paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome. Blood. 2011;117(26):6170-5.
[3] Data on file, Alexion Pharmaceuticals, Inc.
[4] Capello CC, Schubert MC, Martino SA, et al. Case series of headache and vomiting associated with adult complement-inhibiting antibody therapy, with apixaban as a potential trigger: A warning to clinicians. Neurology. 2020;94(6):e517-25.
Ultomiris is a specialized IV infusion designed for people with myasthenia gravis, a chronic autoimmune condition affecting muscles. It falls under the drug class of complement inhibitors and does not have a biosimilar version available. This medication works by blocking a protein in the complement system called C5 at the neuromuscular junction, potentially boosting muscle strength.
Before prescribing Ultomiris, a blood test may be ordered to determine if the myasthenia gravis is AChR antibody-positive, making it an appropriate choice for treatment.
Ultomiris comes with a boxed warning from the FDA due to the increased risk of serious meningococcal infections, including meningitis. To reduce this risk, it's crucial to ensure you're up-to-date with meningococcal vaccines prior to treatment.
On the other hand, other autoimmune disorders, pregnancy, breastfeeding, excessive alcohol consumption, and known allergies to Ultomiris or its ingredients may preclude individuals from receiving this medication.
Ultomiris may cause common side effects like diarrhea, upper respiratory infections, abdominal pain, urinary tract infections, back pain, dizziness, and mild infusion reactions. However, serious side effects such as serious infections, severe infusion reactions, and increases or decreases in blood pressure can also occur.
When compared to Vyvgart, Ultomiris is a complement inhibitor, while Vyvgart is a neonatal Fc receptor blocker. The main differences between the two are the form (Ultomiris is a solution for IV infusion, while Vyvgart is available as a solution for IV infusion and subcutaneous injection), and dosage frequency (Ultomiris is administered once every 8 weeks, while Vyvgart requires weekly infusions for 4 weeks).
Ultomiris carries an increased risk of other side effects as well, so it's essential to consult your doctor or pharmacist before starting treatment. Always remember to consult your doctor or another healthcare professional before taking any medication.
