Myasthenia Gravis Treatment with Ultomiris: Insights, Mechanisms, and Additional Details
Ultomiris: The Life-Threatening Catch
Ultomiris, also known as ravulizumab-cwvz, is a medicine often prescribed for myasthenia gravis. This article dives into its side effects, dosage, and how it functions. But remember, there's a grave risk you should know about.
Grab a cold one (or a cup of coffee, no judgment here) and let's dive in.
The IV infusion fate awaits
Ultomiris is an IV infusion solution that gets administered by a healthcare professional. It's classed as a biologic, part of the drug category known as complement inhibitors. There's no biosimilar version of Ultomiris available.
Want to learn more about Ultomiris? Check out this in-depth Ultomiris article.
The deadliest warning: Meningococcal infections
Ultomiris wears the most serious warning - a boxed warning - from the Food and Drug Administration (FDA). What's this all about? It's about serious meningococcal infections, such as meningitis, which can be downright lethal.
Looking for more details? Head to the "Before receiving Ultomiris" section for the grimy details.
Body weight
Myasthenia gravis explained
Myasthenia gravis is a chronic (long-term) condition that messes with muscle and nerve communication. Your voluntary muscles tire easily and weaken due to autoimmune reactions.
Loading dose
Symptoms of myasthenia gravis
Symptoms of myasthenia gravis vary. They worsen during periods of increased activity and improve with rest. These symptoms include:
Maintenance dose
- drooping eyelids
- weak muscles in your limbs, neck, and eyes
- fatigue
- blurry or double vision
- difficulty chewing, swallowing, speaking, and breathing
Who Ultomiris is prescribed for
Ultomiris is mainly prescribed for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
- "Generalized" means your entire body's muscle groups are affected, different from ocular myasthenia gravis, which only messes with the eye muscles.
- "Anti-acetylcholine receptor (AChR) antibody-positive" means your immune system produces antibodies that block acetylcholine receptors. Acetylcholine is a neurotransmitter that leaves you with muscle contractions.
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Before prescribing Ultomiris, your doctor might order a blood test to check if your gMG is AChR antibody positive. Your doctor can help you better understand if Ultomiris is suitable for your type of myasthenia gravis.
How Ultomiris works its magic
2,400 mg
If your doctor prescribes Ultomiris for treating myasthenia gravis, you probably want to understand how it works.
The workings of Ultomiris
3,000 mg every 8 weeks
The exact method Ultomiris uses to treat myasthenia gravis isn't entirely clear. But it's believed that it inhibits 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 reducing C5 activity at the NMJ, Ultomiris helps nerve cell signals reach your muscles. This may decrease fatigue and muscle weakness and potentially boost muscle strength.
How well does Ultomiris perform for myasthenia gravis
In clinical studies, Ultomiris successfully improved the ability to handle daily activities in adults with generalized myasthenia gravis (gMG) who were anti-acetylcholine receptor (AChR) antibody-positive.
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Want more deets about these studies? Check out the prescribing information for Ultomiris. Your doctor or pharmacist can fill you in on the nitty-gritty.
Receiving Ultomiris
2,700 mg
Here's the lowdown on typical Ultomiris dosages for myasthenia gravis. Your doctor will recommend the ideal dosage for you. If you've got questions about your dosage or how you'll get the medication, reach out to your doctor.
Ultomiris comes in three strengths:
3,300 mg every 8 weeks
- 300 milligrams (mg)/30 milliliters (mL)
- 300 mg/3 mL
- 1,100 mg/11 mL
Dosage
Ultomiris treatment usually starts with a loading dose. Two weeks after the loading dose, you move to the maintenance dose, which you typically receive every 8 weeks.
The following chart details recommended Ultomiris dosages based on body weight:
100 kg or more (approximately 220 lb or more)
| | | || --- | --- | --- || 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 |
Note: Ultomiris has other uses. Keep in mind that the drug's dosage may differ when treating other conditions. Chat with your doctor for more details.
3,000 mg
Giving the Ultomiris treatment
Ultomiris comes as an infusion solution for IV use. A healthcare professional will administer your Ultomiris infusions at an infusion center.
3,600 mg every 8 weeks
When to get your Ultomiris fix
You usually receive your Ultomiris maintenance doses every 8 weeks. You'll likely start receiving maintenance doses 2 weeks after your loading dose.
"For more information about dosing schedules for Ultomiris, check out this Ultomiris dosage article."
Ultomiris side effects
The use of Ultomiris for myasthenia gravis may bring side effects, mild to severe.
Ultomiris is approved to treat other conditions. Importantly, side effects from Ultomiris may differ based on the condition it's used to treat.
Here's a list of some main side effects associated with Ultomiris, but it's always wise to consult your doctor or pharmacist about other potential side effects. For more deets, check out the side effect article about Ultomiris or the prescribing information.
Mild side effects of Ultomiris
Ultomiris
Mild side effects reported with Ultomiris include:
- diarrhea
- upper respiratory infection (like the common cold)
- abdominal pain
- urinary tract infection (UTI)
- back pain
- dizziness
- mild infusion reactions, including:
- muscle spasms
- arm or leg discomfort
Vyvgart
These side effects of Ultomiris may be temporary, lingering a few days to weeks. But if they last longer than this, bother you, or become severe, it's smart to talk with your doctor or pharmacist.
Serious side effects of Ultomiris
Though rare, serious side effects have been reported with Ultomiris. These include:
- serious infections, including COVID-19 and pneumonia
- serious infusion reactions, including:
- increased or decreased blood pressure
- severe shivering, chills, and fever
- potential for serious meningococcal infections (see "Before receiving Ultomiris")
Form
Call your doctor right away if you develop serious side effects while using Ultomiris. If the side effects seem life-threatening or you think you're having a medical emergency, call 911 or your local emergency number immediately.
ALLERGIC REACTION
solution for IV infusion
For some people, Ultomiris can lead to an allergic reaction.
In general, symptoms of allergic reactions can be mild or severe.
solution for IV infusion
Ways to manage mild allergic reaction symptoms
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to alleviate your symptoms. They'll also let you know whether you should keep taking the medication.
Coping with severe allergic reaction symptoms
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms need immediate medical care as they can become life-threatening. If you've had a severe allergic reaction to Ultomiris, your doctor may recommend a different medication instead.
Dosage frequency
Before receiving Ultomiris
Before you dive into Ultomiris, it's essential to know some vital information. The drug may not be the best option if you have specific medical conditions or other factors affecting your health. Here are some of these:
once every 8 weeks
Boxed warning: Risk of serious meningococcal infections
Ultomiris boasts a boxed warning for the risk of serious meningococcal infections. This is the FDA's most serious warning.
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Treatment with Ultomiris increases the risk for serious meningococcal infections, like meningitis. These infections can be life-threatening. Symptoms of a meningococcal infection include:
- sudden fever, headache, or neck stiffness
- nausea and vomiting
- sensitivity to light
- confusion
- drowsiness
What to do
Before initiating treatment, your doctor will ensure you're up to date with meningococcal vaccines. If not, they'll hook you up with the necessary jabs at least 2 weeks before starting Ultomiris. If urgent treatment is needed, they may prescribe antibiotics for the first 2 weeks following the initial infusion to prevent infections. If this applies to you, they'll also likely prescribe antibiotics for the first 2 weeks after the first infusion to help ward off infection.
Drug class
The risk of serious meningococcal infections applies 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, contact your doctor, but call 911 or go to the closest emergency room if your symptoms feel life-threatening.
Due to this risk, Ultomiris is only available through a risk evaluation and mitigation strategy (REMS) program. With this program, you'll receive a Patient Safety Card, which you'll carry throughout treatment and for at least 8 months after your last dose. This card contains signs, symptoms, and emergency contact information for meningococcal infections. You can learn more about the Ultomiris REMS program at the program website or by calling 1-888-765-4747.
complement inhibitor
Other warnings
Besides boxed warnings, Ultomiris has other warnings.
neonatal Fc receptor blocker
If any of the following medical conditions or other health factors apply to you, talk with your doctor before receiving Ultomiris if:
- you have an active infection
- you're pregnant
- you're breastfeeding
- you drink alcohol excessively
- you've had an allergic reaction to Ultomiris or any of its ingredients
Disclaimer: Medical News Today has made every effort to ensure that all information is correct, comprehensive, and up to date. However, this article should not replace the knowledge and expertise of a licensed healthcare professional. Always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
[1] FDA: Ultomiris warnings and precautions - https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ultomiris-ravulizumab[2] Ultomiris (ravulizumab-cwvz) prescribing information - https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761003s021lbl.pdf[3] Ultomiris REMS program: https://www.alexion.com/us/rems-safety-programs/ultomiris/home.html
- Ultomiris is an IV infusion solution that is administered by a healthcare professional, making it part of the 'IV infusion' system.
- The drug class of Ultomiris falls under biologics and within the category of complement inhibitors; there's no biosimilar version of Ultomiris available.
- Ultomiris is prescribed primarily for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive; acetylcholine being a neurotransmitter that provides muscle contractions, and the immune system producing antibodies blocking acetylcholine receptors causing the immune system disorder.
- Ultomiris works by inhibiting the activity of a complement system protein, C5, at the neuromuscular junction (NMJ), helping nerve cell signals reach muscles, potentially decreasing fatigue and muscle weakness, and boosting muscle strength.
- Along with potential benefits, Ultomiris may lead to side effects such as diarrhea, mild infusion reactions, upper respiratory infections, abdominal pain, urinary tract infections, back pain, dizziness, and other mild symptoms.
- Meningococcal infections, a serious side effect of Ultomiris, are life-threatening and can occur with its use, making it crucial to get meningococcal vaccines before starting treatment with Ultomiris.
- The risk for serious meningococcal infections remains through the treatment with Ultomiris and for at least 8 months after the last dose, highlighting the importance of monitoring for symptoms during this period.
