Myasthenia Gravis Treatment with Ultomiris: Insights and Details
Loosen Up on Ultomiris: What You Need to Know
Ultimiz, a brand name infusion, tackles myasthenia gravis - but beware, it's no walk in the park. We've got the lowdown on this medication's side effects, dosage, and how it works.
Ultimiz is an intravenous (IV) solution given by a healthcare professional. It's a biological drug, belonging to the complement inhibitors class, and ain't got no biosimilar alternative. Curious? Read on!
Ultimiz has a big, bad, and serious warning from the Food and Drug Administration (FDA) - a boxed warning, to be exact. Want the deets? Head to the "Before Receiving Ultimiz" section.
Myasthenia Gravis Explained
Body weight
When the communication between muscles and nerves gets all jumbly, you've got myasthenia gravis. This long-lasting (or chronic) autoimmune condition happens when your immune system starts attacking your own cells. Sounds fun, right?
Loading dose
Symptoms of Myasthenia Gravis
Maintenance dose
The symptoms of myasthenia gravis vary from one person to another. They tend to worsen during periods of activity and improve during rest. Here's what to watch out for:
- droopy eyelids
- limbs, neck, and eyes displaying weakness
- extreme fatigue
- weak vision (blurry or double)
- difficulty chewing, swallowing, speaking, or breathing.
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Who Ultimiz is Prescribed For
2,400 mg
Ultimiz is prescribed for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies. "Generalized" means various muscle groups are affected, different from ocular myasthenia gravis, which solely targets the eye muscles.
3,000 mg every 8 weeks
How Ultimiz Treats Myasthenia Gravis
Wondering how Ultimiz works its magic? The specific way it does so isn't entirely clear, but we've got a theory: Ultimiz supposedly blocks the activity of a complement system protein named C5 at the neuromuscular junction (NMJ).
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
The NMJ is the place where nerve cells communicate with the muscles they control. By reducing C5 activity at the NMJ, Ultimiz helps nerve signals reach your muscles, potentially lessening fatigue and muscle weakness while boosting muscle strength.
2,700 mg
How Well Ultimiz Works for Myasthenia Gravis
3,300 mg every 8 weeks
In clinical studies, Ultimiz showed it could boost the ability to perform daily tasks in adults with gMG who tested positive for AChR antibodies. Keen to learn more? Check out the "How Ultimiz is Given" section for more info.
Receiving Ultimiz for Myasthenia Gravis
100 kg or more (approximately 220 lb or more)
Here's what you need to know about Ultimiz dosages for myasthenia gravis:
3,000 mg
- Ultimiz comes in three strengths: 300 milligrams (mg)/30 milliliters (mL), 300 mg/3 mL, and 1,100 mg/11 mL.
- Your doctor will decide your best dosage based on your body weight in kilograms (kg). One kilogram is roughly 2.2 pounds (lb).
- Ultimiz treatment kicks off with a loading dose, followed by a maintenance dose every 8 weeks.
3,600 mg every 8 weeks
How Ultimiz is Given
Ultimiz is dispensed as an IV infusion - just ask your healthcare provider.
How Often Ultimiz is Given
You typically receive your maintenance doses every 8 weeks after your loading dose.
Ultomiris
For more details on Ultimiz's dosing regimen, check out this Ultimiz dosage article.
Vyvgart
Ultimiz Side Effects
Using Ultimiz for myasthenia gravis treatment may lead to side effects, both mild and severe.
Form
- Note: Ultimiz's side effects may differ depending on the condition it's used to treat.
solution for IV infusion
Mild Side Effects of Ultimiz
solution for IV infusion
- diarrhea
- upper respiratory infection (common cold)
- abdominal pain
- urinary tract infection (UTI)
- back pain
- dizziness
- minor infusion reactions (muscle spasms or discomfort in arms/legs).
These side effects of Ultimiz might be temporary, lasting a few days to weeks. But if they persist or worsen, let your doctor know.
Dosage frequency
Serious Side Effects of Ultimiz
once every 8 weeks
Although infrequent, severe side effects have been reported with Ultimiz. Look out for:
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
- serious infections (like COVID-19 or pneumonia)
- serious infusion reactions (including severe shivering, fever, increased/decreased blood pressure)
- increased risk of serious meningococcal infections (see "Before Receiving Ultimiz" section).
Call your doctor right away if you experience serious side effects while using Ultimiz. If they seem life-threatening or you believe you're having a medical emergency, call 911 or your local emergency number immediately.
Drug class
Before Receiving Ultimiz
complement inhibitor
Before receiving Ultimiz, be aware of the following:
neonatal Fc receptor blocker
Boxed Warning: Risk of Serious Meningococcal Infections
Ultimiz has a serious warning for the increased risk of meningococcal infections. Treatment with Ultimiz raises the risk of these infections significantly. Symptoms include:
- sudden fever or headache
- nausea and vomiting
- light sensitivity
- confusion
- drowsiness.
What to Do
Before starting Ultimiz treatment, your doctor will ensure your vaccination status is up-to-date and administer any needed vaccines at least 2 weeks before starting treatment if needed. In urgent cases, they may prescribe antibiotics to help prevent infection within the first 2 weeks following your first Ultimiz infusion.
The increased risk of serious meningococcal infections continues throughout Ultimiz treatment 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 head to the closest emergency room if you believe your symptoms seem life-threatening.
For more information, visit the Ultimiz REMS program website or contact 1-888-765-4747.
Other Warnings
Apart from the boxed warning, Ultimiz has other warnings for people with certain medical conditions or health factors that could affect its use. If any of these are relevant, discuss them with your doctor before receiving Ultimiz:
- active infections
- pregnancy
- breastfeeding
- excessive alcohol consumption.
- Ultimiz is a biological drug in the complement inhibitors class that targets myasthenia gravis, a chronic autoimmune condition where the immune system attacks one's own cells, causing symptoms like droopy eyelids, limb weakness, extreme fatigue, and difficulty speaking or breathing.
- Ultimiz is primarily prescribed for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies. This drug comes in three strengths, and the dosage is determined based on body weight.
- While patients may experience temporary side effects such as diarrhea, upper respiratory infections, abdominal pain, urinary tract infections, back pain, dizziness, and minor infusion reactions, severe side effects like serious infections, infusion reactions, and increased risk of meningococcal infections have also been reported.
- There's a serious boxed warning for the increased risk of meningococcal infections when using Ultimiz, which requires patients to update their vaccine status, receive necessary vaccines, and consider antibiotics if needed within the first two weeks of treatment.
- Note that Ultimiz treatment might also be contraindicated for those with certain medical conditions, like active infections, pregnancy, breastfeeding, or excessive alcohol consumption, and it's important to discuss these issues with a doctor before starting treatment.
