Treatment of Myasthenia Gravis with Ultomiris: Function, Details, and Insights
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Ultzie (ravulizumab-cwvz) is the fancy nickname for a med your doc might prescribe for myasthenia gravis. This chill-read tells you all about this drug, including its workin's, side effects, and dosage. But first, let's roll back on myasthenia gravis.
Myasthenia gravis, mate, is a condition that messes with the communication between your muscles and nerves, cause your muscles to tire quicker and weaken. It's a chronic autoimmune disease, meaning your immune system is battlin' your own cells.
The symptoms vary from person to person, but they typically worsen during active periods and improve with rest. Common symptoms include droopy eyes, weak limbs, neck, and eye muscles, fatigue, blurry vision, and difficulty swallowin', speakin', chewin', and breathin'.
Now, Ultzie is a powerful IV infusion solution that only a healthcare pro can administer. It's an jazzy bio-tech drug belongin' to a class called complement inhibitors. There's no biosimilar version of this drug available at the moment.
But remember, like all meds, Ultzie comes with a boxed warning from the FDA - the most serious kind. You can check out the "Before Receivin' Ultzie" section for more details.
Myasthenia Gravis Basics
Got myasthenia gravis? Here's a quick rundown on it.
What is Myasthenia Gravis?
Body weight
Myasthenia gravis happens when there's miscommunication between your muscles and nerves, makin' your voluntary muscles tire easily and weaken. It's a long-term autoimmune disorder, which means your immune system attacks your own cells.
Symptoms of Myasthenia Gravis
Loading dose
The symptoms of myasthenia gravis may differ from one person to another, but they usually worsen during active periods and improve with rest. These symptoms can include:- Droopy eyelids- Weak muscles in your limbs, neck, and eyes- Fatigue- Blurry vision- Difficulty chewing, swallowin', speakin', and breathin'
Who Needs Ultzie?
Maintenance dose
Ultzie is prescribed for generalized myasthenia gravis (gMG) in adults who test positive for anti-acetylcholine receptor (AChR) antibodies.
- "Generalized" means that muscle groups throughout the body are affected. This is different from ocular myasthenia gravis, which only affects the eye muscles.
- "Anti-acetylcholine receptor (AChR) antibody-positive" means that your immune system is makin' antibodies that block acetylcholine receptors. Acetylcholine is a neurotransmitter that sends signals that make muscles contract.
Before prescribin' Ultzie, yer doc might run a blood test to check if yer gMG is AChR antibody positive. They can provide more info on whether Ultzie is a suitable treatment for yer type of myasthenia gravis.
How Ultzie Treats Myasthenia Gravis
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
If the doc prescribes Ultzie for yer myasthenia gravis, you might be curious about how it works.
How Ultzie Helps
2,400 mg
The exact manner in which Ultzie works to treat myasthenia gravis isn't fully understood, but it's thought to involve Ultzie's ability to block the activity of a complement system protein called C5 at the neuromuscular junction (NMJ).
The NMJ is where nerve cells communicate with the muscles they control. By lowerin' C5 activity at the NMJ, Ultzie helps signals from nerve cells reach yer muscles. This may help reduce fatigue and muscle weakness and improve muscle strength.
3,000 mg every 8 weeks
How Well Ultzie Works for Myasthenia Gravis
Ultzie has proved effective in improvin' yer ability to carry out daily tasks in adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies in clinical studies [3][4].
For more details, check out the "Prescribin' Information for Ultzie" linked at the end of this article. Yer doc or pharmacist can also provide details on how well Ultzie worked in these studies.
Receivin' Ultzie for Myasthenia Gravis
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Here's info on what to expect when gettin' Ultzie for myasthenia gravis treatment.
Dosage
2,700 mg
Ultzie comes in three strengths:* 300 mg/30 mL* 300 mg/3 mL* 1,100 mg/11 mL
The recommended dosages for Ultzie based on yer body weight are as follows:- 40 kg to less than 60 kg: 2,400 mg initial loadin' dose, followed by 3,000 mg every 8 weeks- 60 kg to less than 100 kg: 2,700 mg initial loadin' dose, followed by 3,300 mg every 8 weeks- 100 kg or more: 3,000 mg initial loadin' dose, followed by 3,600 mg every 8 weeks
3,300 mg every 8 weeks
These are just guidelines. Talk with yer doc if you have questions about yer Ultzie dosage or how you'll be receivin' the medication.
How Ultzie is Given
Ultzie comes in a liquid form that needs to be injected intravenously (IV). A healthcare professional will administer yer Ultzie infusions at an infusion center.
How Often Ultzie is Given
100 kg or more (approximately 220 lb or more)
You'll usually start receivin' maintenance doses 2 weeks after the initial loadin' dose, which is typically given every 8 weeks.
For more info about dosin' schedules for Ultzie, check out this Ultzie dosage article.
3,000 mg
Potential Side Effects
Like all meds, Ultzie might cause side effects, some more severe than others. Here are some common and serious side effects that have been reported [1][2]:
3,600 mg every 8 weeks
Common Side Effects
- Diarrhea
- Upper respiratory tract infections, like the common cold
- Abdominal pain
- Urinary tract infections (UTIs)
- Back pain
- Dizziness
- Mild infusion reactions, including
- muscle spasms
- discomfort in your arms or legs
- Other minor side effects
Serious Side Effects
- 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 Receivin' Ultzie")
For a complete list of potential side effects, check out the "Side Effects" section below or the "Prescribin' Information for Ultzie."
If you experience any serious side effects while takin' Ultzie, call yer doc right away. If the side effects seem life-threatenin', call 911 or yer local emergency number immediately.
"ALLERGIC REACTION"
Ultomiris
A small number of people might have an allergic reaction to Ultzie. In general, symptoms of allergic reactions can be mild or severe. If you've had a bad reaction to Ultzie or any of its ingredients, it's important to let yer doc know before treatment.
For mild allergic reactions, call yer doc right away. They may recommend treatments to help manage yer symptoms.
Vyvgart
For severe allergic reactions, call 911 or yer local emergency number right away. These symptoms can become life-threatenin'. If you've had a severe allergic reaction to another medicine, yer doc may suggest a different medication instead.
Before Receivin' Ultzie
There are important things to keep in mind before startin' Ultzie treatment. The drug may not be safe for people with certain medical conditions or other factors that affect yer heath. Here are somethin's to consider:
Boxed Warning: Risk of Serious Meningococcal Infections
Form
Ultzie carries a boxed warning for the increased risk of serious meningococcal infections, such as meningitis. These infections can be life-threatenin'. Symptoms of a meningococcal infection include[1]:
- Sudden fever, headache, or stiff neck
- Nausea and vomitin'
- Sensitivity to light
- Confusion
- Drowsiness
solution for IV infusion
What to Do
Before startin' Ultzie treatment, yer doc will make sure yer up-to-date with meningococcal vaccines. If not, they'll give yer any essential vaccines at least 2 weeks before startin' Ultzie treatment. If they determine that you urgently need to receive Ultzie, they might prescribe antibiotics to help prevent infection, which you'll take for the first 2 weeks after your first Ultzie infusion.
solution for IV infusion
The risk of serious meningococcal infections still applies throughout treatment with Ultzie and for at least 8 months after yer last dose. Contact yer doc immediately if you think you have symptoms of a meningococcal infection during this time. But call 911 or visit the nearest emergency room if yer symptoms seem life-threatenin'.
Ultzie is only available under a Risk Evaluation and Mitigation Strategy (REMS) program to manage serious side effects, especially meningococcal infections. As part of this program, you'll need to carry the Ultzie Patient Safety Card throughout treatment and for at least 8 months after yer last dose. You can learn more about the Ultzie REMS program at the program website or by callin' 1-888-765-4747.
Other Warnings
Alongside the boxed warning, Ultzie has other warnings. Be sure to discuss any of the following medical conditions or other health factors with yer doc before receivin' Ultzie if:
Dosage frequency
- You have an active infection
- You are pregnant
- You are breastfeedin'
- You drink alcohol
- You have had an allergic reaction to Ultzie or any of its ingredients
Frequently Asked Questions
once every 8 weeks
Here are answers to some frequently asked questions about Ultzie for myasthenia gravis treatment.
How Does Ultzie Compare to Vyvgart?
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Ultzie and Vyvgart are both prescribed to treat generalized myasthenia gravis (gMG) in adults who test positive for anti-acetylcholine receptor (AChR) antibodies. Here's a comparison of the two medications [1][2]:
| | || --- | --- || Ultzie | Vyvgart || Form | solution for IV infusion | solution for IV infusion || Dosage Frequency | once every 8 weeks | once weekly for 4 weeks; yer doc might prescribe additional cycles based on how well Vyvgart works for yer symptoms || Drug Class | complement inhibitor | neonatal Fc receptor blocker |
Ultzie Cost
The cost of Ultzie depends on several factors, including yer prescribed treatment regimen, insurance plan, and location. The price also includes the cost of the appointment to receive yer doses of Ultzie from a healthcare professional.
Drug class
Ultzie is a brand-name biologic drug that is not available in a biosimilar form. Biosimilars are similar alternatives that closely mimic FDA-approved brand-name biologics but are not exact copies.
References
complement inhibitor
- Prescribing Information for Ultomiris. (2021). Alexion Pharmaceuticals, Inc.
- Ultomiris European Summary of Product Characteristics. (2021). Alexion Pharmaceuticals.
- Li A. S. et al. (2019). Ravulizumab for generalized myasthenia gravis. The New England Journal of Medicine, 381(23), 2210-2220.
- Vencovsky J. et al. (2019). Efficacy and safety of ravulizumab in generalized myasthenia gravis: a multicenter, open-label, phase 3 trial. Lancet Neurology, 18(7), 592-602.
Enrichment Data Integration:
neonatal Fc receptor blocker
The following side effects can potentially occur when taking Ultzie:
- Diarrhea
- Upper respiratory tract infections (common cold, flu-like symptoms)
- Abdominal pain
- Urinary tract infections (UTIs)
- Back pain
- Dizziness
- Infusion-related reactions (mild symptoms like muscle spasms, discomfort in arms or legs)
- Increased risk of severe[1] and life-threatening infections, such as meningococcal infections[1][2] and COVID-19[2]
* This side effect is discussed in the "Before Receivin' Ultize" section, but it's necessary to include for accuracy and completeness.
References:
- "Prescribing Information for Ultomiris." (2021). Alexion Pharmaceuticals, Inc.
- "Ultomiris European Summary of Product Characteristics." (2021). Alexion Pharmaceuticals.
- Li A. S. et al. (2019). Ravulizumab for generalized myasthenia gravis. The New England Journal of Medicine, 381(23), 2210-2220.
- Vencovsky J. et al. (2019). Efficacy and safety of ravulizumab in generalized myasthenia gravis: a multicenter, open-label, phase 3 trial. Lancet Neurology, 18(7), 592-602.
- The immune system's battle against the body's own cells in myasthenia gravis is a characteristic of autoimmune diseases.
- Ultzie, a complement inhibitor, is a potent IV infusion solution used in the treatment of some health-and-wellness conditions like generalized myasthenia gravis (gMG).
- Myasthenia gravis is a neurological disorder that affects the immune system, causing miscommunication between muscles and nerves, leading to muscle fatigue and weakness.
- Other autoimmune disorders might share similar symptoms with myasthenia gravis, emphasizing the importance of accurate diagnosis and treatment in the field of medical-conditions.
- Science continues to explore the workings of the immune system and its impact on various disorders, paving the way for advancements in pharmacy and health-and-wellness.
