Myasthenia Gravis Treatment with Ultomiris: Insights and Additional Information
A Streetwise Guide to Ultomiris: An Infusion for Myasthenia Gravis
Hey there! Here's the lowdown on Ultomiris (ravulizumab-cwvz), a brand-name medicine often prescribed to treat myasthenia gravis.
Ultomiris comes as an intravenous (IV) infusion solution, administered by healthcare professionals. It's a biologic drug, classified under complement inhibitors, and isn't available as a biosimilar at the moment.
Curious about the nitty-gritty? Check out this in-depth Ultomiris article.
Important Warning: Ultomiris carries a boxed warning, the Food and Drug Administration's (FDA's) most serious warning. For details, hop to the "Before Receiving Ultomiris" section.
Body weight
Myasthenia Gravis: A Quick Rundown
Loading dose
Myasthenia gravis is a chronic condition resulting from dysfunctional communication between your muscles and nerves. It causes your voluntary muscles to weaken and tire quickly. This is an autoimmune disorder, meaning your immune system mistakenly attacks your own cells.
Maintenance dose
Symptoms Galore!
Symptoms of myasthenia gravis vary greatly from person to person, but they typically worsen during periods of activity and improve with rest. Here are some common symptoms:
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
- Fatigue
- Drooping eyelids
- Weak muscles in your limbs, neck, and eyes
- Blurry or double vision
- Difficulty chewing, swallowing, speaking, and breathing
2,400 mg
Who's Taking Ultomiris?
3,000 mg every 8 weeks
Ultomiris is primarily prescribed to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
- "Generalized" implies that muscle groups throughout the body are affected. gMG differs from ocular myasthenia gravis, which only impacts eye muscles.
- "Anti-acetylcholine receptor (AChR) antibody-positive" means your immune system produces antibodies that obstruct acetylcholine receptors. Acetylcholine is a neurotransmitter that controls muscle contractions.
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Before prescribing Ultomiris, your doctor might order a blood test to determine whether your gMG is AChR antibody-positive. They can help you figure out if Ultomiris is right for your specific form of myasthenia gravis.
2,700 mg
How Ultomiris Does Its Thang
3,300 mg every 8 weeks
Wanna know more about how Ultomiris works its magic?
Activating Your Muscles
100 kg or more (approximately 220 lb or more)
Ultomiris blocks 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 signals reach your muscles, potentially decreasing fatigue and muscle weakness and enhancing muscle strength.
3,000 mg
So, How Effective is Ultomiris?
3,600 mg every 8 weeks
In clinical studies, Ultomiris demonstrated considerable improvement in daily functioning for adults with generalized myasthenia gravis (gMG) who were AChR antibody-positive[2].
Got more questions? Chat with your doctor, pharmacist, or see the prescribing information for Ultomiris.
Receiving Your Ultomiris Fix
Here's the skinny on Ultomiris dosing based on body weight and frequency. However, your doctor will determine the best dosage for your situation. If you have questions about your dosage or administration, chat with your doc!
Ultomiris
Ultomiris is available in three strengths:
Vyvgart
- 300 milligrams (mg)/30 milliliters (mL)
- 300 mg/3 mL
- 1,100 mg/11 mL
Dot the T's and Cross the I's
Form
The recommended Ultomiris dosages for treating myasthenia gravis depend on your body weight in kilograms (kg).
solution for IV infusion
Ultomiris treatment typically consists of a loading dose followed by a maintenance dose. You usually receive the maintenance dose every 8 weeks, starting 2 weeks after the loading dose[2].
solution for IV infusion
Ultomiris Side Effects to Watch Out For
Mild Side Effects
Dosage frequency
Mild side effects reported with Ultomiris include:
once every 8 weeks
- Diarrhea
- Upper respiratory infections, such as the common cold
- Abdominal pain
- Urinary tract infections (UTIs)
- Back pain
- Dizziness
- Infusion reactions, including mild muscle spasms and discomfort in your arms or legs
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Serious Side Effects
While less common, serious side effects have been reported with Ultomiris. These include:
Drug class
- Serious infections, including COVID-19 and pneumonia
- Serious infusion reactions
- Risk of serious meningococcal infections
complement inhibitor
Contact your doctor right away if you experience serious side effects while using Ultomiris. If the side effects seem life-threatening, call 911 or your local emergency number immediately.
neonatal Fc receptor blocker
Before Receiving Ultomiris
Before getting Ultomiris, there are some important factors to consider, such as medical conditions and other health factors.
Boxed Warning: Meningococcal Infections
Ultomiris has a boxed warning for the risk of serious meningococcal infections. These infections can be life-threatening. Symptoms include:
- Sudden fever, headache, or stiff neck
- Nausea and vomiting
- Sensitivity to light
- Confusion
- Drowsiness
What to Do
Before starting Ultomiris, your doctor will ensure you've received appropriate meningococcal vaccines. If not, they'll give you any needed vaccines at least 2 weeks before beginning Ultomiris treatment[1].
If your doctor determines you urgently require Ultomiris treatment, they may have you start it sooner than 2 weeks after meningococcal vaccination. In this case, they'll likely prescribe antibiotics to combat infection for the first 2 weeks following your first Ultomiris infusion.
Remember, the risk of serious meningococcal infections persists 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 immediately, but call 911 or go to the closest emergency room if symptoms feel life-threatening.
Ultomiris is only available under a risk evaluation and mitigation strategy (REMS) program due to this risk[1]. 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[1]. You can find more information about the Ultomiris REMS program at the program website or by calling 1-888-765-4747[1].
- The intravenous (IV) infusion solution of Ultomiris, a drug primarily prescribed for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, is a type of biologic system involved in complement inhibitors and isn't available as a biosimilar at the moment.
- This drug is classified under the medical-conditions called neurological-disorders, specifically autoimmune disorders that affect the immune system and lead to other autoimmune disorders.
- Besides Ultomiris, health-and-wellness professionals may also prescribe drugs addressing other symptoms or complications, such as antibiotics for serious infections, vaccine boosters for preventing meningococcal infections, and drugs for managing adverse effects like diarrhea and headache.
- Science and research play a crucial role in understanding Ultomiris's effect on the immune system, neurological disorders, and body weight-specific dosage requirements, as well as its potential side effects and interactions with other health conditions.
- Since Ultomiris comes with a boxed warning for the risk of meningococcal infections, pharmacists and other medical professionals are vigilant in ensuring necessary safety measures, vaccinations, and monitoring are in place during the entire treatment cycle and for at least 8 months after the last dose.
