Myasthenia Gravis Treatment with Ultomiris: Insights and Additional Information
Rewritten Article:
Ultimosh (ravulizumab-cwvz) is the brand name of an infusion treatment for myasthenia gravis, a chronic autoimmune condition that interferes with muscle and nerve communication. This write-up covers key aspects such as side effects, dosage, and the mechanism behind Ultimosh.
Ultimosh comes in the form of an intravenous (IV) infusion, which is given by a healthcare professional. This biologic falls under the drug class called complement inhibitors, and currently, there's no biosimilar version available.
Want to learn more? Check out this detailed Ultimosh article.
Ultimosh carries a boxed warning, the Food and Drug Administration's most serious warning, due to the potential risk of serious meningococcal infections. For more details, see the "Preparing for Ultimosh" section.
Body weight
Myasthenia Gravis – An Explanation
Loading dose
Myasthenia gravis is characterized by faulty communication between muscles and nerves, leading to quick fatigue and muscle weakness. This long-term autoimmune disorder occurs when your immune system attacks your own cells.
Maintenance dose
Symptoms of Myasthenia Gravis
Symptoms of myasthenia gravis vary from person to person and tend to worsen during active periods and improve with rest. Common symptoms include:
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
- drooping eyelids
- weakened limbs, neck, and eye muscles
- fatigue
- blurred or double vision
- difficulty in chewing, swallowing, speaking, and breathing
2,400 mg
Who Ultimosh is Prescribed for
3,000 mg every 8 weeks
Ultimosh is prescribed to treat adult patients with generalized myasthenia gravis (gMG) that's AChR antibody-positive (the immune system makes antibodies that block acetylcholine receptors).
Before prescribing Ultimosh, your doctor might order a blood test to determine if your gMG is AChR antibody-positive. Your doctor can explain whether Ultimosh suits your specific case of myasthenia gravis.
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
How Ultimosh Treats Myasthenia Gravis
2,700 mg
If prescribed Ultimosh for myasthenia gravis, you might wonder about its working mechanism.
3,300 mg every 8 weeks
The Working Mechanism of Ultimosh
Though the exact way Ultimosh works isn't fully understood, it's thought to involve the medication's ability to reduce 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 the activity of C5 at the NMJ, Ultimosh helps neurotransmitters reach your muscles effectively. This could possibly reduce fatigue and muscle weakness while improving muscle strength.
100 kg or more (approximately 220 lb or more)
Ultimosh's Clinical Results
3,000 mg
In clinical trials, Ultimosh significantly improved the ability to perform daily activities in adults with gMG who were AChR antibody-positive.
3,600 mg every 8 weeks
Learn more about these trials by reading Ultimosh's prescribing information, or ask your doctor or pharmacist for details.
Receiving Ultimosh
Here's what you need to know about receiving Ultimosh dosages for myasthenia gravis:
Ultimosh is given as an IV infusion at an infusion center by a healthcare professional.
Ultomiris
Ultimosh is available in three strengths:
Vyvgart
- 300mg/30mL
- 300mg/3mL
- 1,100mg/11mL
Ultimosh Dosage
Form
The recommended dosages for Ultimosh depend on your weight in kilograms:
solution for IV infusion
| Weight Range (kg) | Loading Dose | Maintenance Dose ||---------------------------|--------------|------------------|| 40-60 (approx. 88-132 lbs) | 2,400mg | 3,000mg every 8 weeks || 60-100 (approx. 132-220 lbs) | 2,700mg | 3,300mg every 8 weeks || 100 or more (approx. 220 lbs or more) | 3,000mg | 3,600mg every 8 weeks |
solution for IV infusion
Note: In addition to treating myasthenia gravis, Ultimosh may be used for other conditions. Consult your doctor for further details.
Side Effects of Ultimosh
Dosage frequency
The use of Ultimosh for myasthenia gravis may cause mild or severe side effects.
once every 8 weeks
Ultimosh is also prescribed for other conditions, and the side effects may vary depending on the condition it's used to treat.
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
Learn about common and severe side effects in the "Ultimosh Side Effects" section or refer to Ultimosh's prescribing information.
Remember, if you observe any side effects while taking Ultimosh, sharing your experience with the Food and Drug Administration can help make medication safer for everyone. You can submit your experience through MedWatch or call 800-FDA-1088.
Drug class
In general, mild symptoms may be temporary and last for a few days to weeks. If they continue, worsen, or become severe, talk to your doctor or pharmacist.
complement inhibitor
Preparing for Ultimosh
neonatal Fc receptor blocker
Before receiving Ultimosh, it's crucial to be aware of certain factors:
Boxed Warning: Risk of Serious Meningococcal Infections
Ultimosh carries a boxed warning because it increases the risk of serious meningococcal infections, such as meningitis. These infections can be life-threatening.
To minimize this risk, your doctor will make sure you're up-to-date with meningococcal vaccines before prescribing Ultimosh. If needed, your doctor may administer vaccines at least 2 weeks before you start Ultimosh treatment. In emergency situations, your doctor may have you start treatment sooner than 2 weeks after meningococcal vaccination.
In such cases, your doctor might give antibiotics for the first 2 weeks following your first Ultimosh infusion to help prevent infections.
The risk of serious meningococcal infections applies throughout treatment with Ultimosh and for at least 8 months after your last dose. Report any symptoms of meningococcal infections to your doctor immediately. However, if the symptoms appear to be life-threatening, call 911 or your local emergency number.
Due to the risk of meningococcal infections, Ultimosh is only available under a risk evaluation and mitigation strategy (REMS) program. During treatment and for at least 8 months after your last dose, you need to carry the Ultimosh Patient Safety Card.
Other Important Factors
Other factors to consider before receiving Ultimosh include:
- Active infections
- Pregnancy
- Breastfeeding
- Alcohol consumption
- Allergic reactions to Ultimosh or its components
Discuss these factors with your doctor before receiving Ultimosh to ensure safe treatment.
- Ultimosh, a treatment for myasthenia gravis, is administered as an intravenous (IV) infusion by healthcare professionals and belongs to the drug class called complement inhibitors.
- Myasthenia gravis is a chronic autoimmune disorder marked by faulty communication between muscles and nerves, leading to symptoms such as drooping eyelids, weakened limbs, fatigue, blurred vision, and difficulty in chewing, swallowing, speaking, and breathing.
- Ultimosh is prescribed to adult patients with generalized myasthenia gravis (gMG) that's AChR antibody-positive, and its working mechanism involves reducing the activity of a complement system protein called C5 at the neuromuscular junction.
- In clinical trials, Ultimosh significantly improved the ability to perform daily activities in adults with gMG who were AChR antibody-positive.
- Besides treating myasthenia gravis, Ultimosh may be used for other conditions, including other autoimmune disorders, chronic diseases, neurological disorders, and health-and-wellness applications like the use of CBD.
- Ultimosh carries a boxed warning due to the potential risk of serious meningococcal infections, and to minimize this risk, patients need to be updated with meningococcal vaccines before prescribing Ultimosh and carry the Ultimosh Patient Safety Card during treatment and for at least 8 months after the last dose.
