Myasthenia Gravis Treatment with Ultomiris: Understanding Its Function and Additional Information
Ultomiris (ravulizumab-cwvz), a specialized infusion treatment, is administered intravenously for managing myasthenia gravis, a chronic autoimmune condition impacting voluntary muscles. This report delivers essential information on dosages, side effects, and the drug's functioning mechanism.
Ultomiris represents a biologic belonging to the drug category called complement inhibitors. Currently, there is no available biosimilar version of this medication. For comprehensive insights, refer to our detailed Ultomiris article.
Before prescribing Ultomiris, it carries a severe Food and Drug Administration (FDA) warning. For detailed information, please read the "Before receiving Ultomiris" section.
Comprehending Myasthenia Gravis
Affecting muscle-nerve interaction, myasthenia gravis instigates rapid muscle exhaustion and weakness. This persistent condition arises when the immune system mistakenly assaults the body's own cells.
Body weight
Myasthenia Gravis Symptoms
Loading dose
Symptoms can vary among individuals, typically worsening during active periods and improving with rest. They encompass:
Maintenance dose
- drooping eyelids
- weakened limb, neck, and eye muscles
- fatigue
- blurred or double vision
- difficulties with eating, swallowing, speaking, and breathing
Prescription of Ultomiris
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
Prescribed for anti-acetylcholine receptor (AChR) antibody-positive adult patients with generalized myasthenia gravis (gMG), a healthcare provider may perform a blood test to confirm the disease's AChR antibody status before recommending Ultomiris. Your doctor can supply further information regarding suitability based on your form of myasthenia gravis.
2,400 mg
How Ultomiris Alleviates Myasthenia Gravis
3,000 mg every 8 weeks
Investigating the specific method Ultomiris employs in alleviating myasthenia gravis remains incomplete. It is believed to rely on its ability to reduce the activation of a complement system protein, C5, at the neuromuscular junction (NMJ). This action is thought to boost signals sent from nerve cells to muscles, potentially reducing fatigue and muscle weakness while improving strength.
Effectiveness of Ultomiris in Treating Myasthenia Gravis
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
In clinical trials, Ultomiris exhibited effectiveness in augmenting daily living activities among gMG patients who are AChR antibody-positive. Learning more about these studies can be found within Ultomiris's prescribing information. Your doctor or pharmacist may provide additional details regarding the drug's efficacy in these studies.
2,700 mg
Administering Ultomiris Dosages for Myasthenia Gravis
3,300 mg every 8 weeks
Key elements of Ultomiris dosage patterns are outlined below. Your doctor will determine the best dosage for your individual circumstances. Any questions you may have regarding dosage or administration should be addressed by your physician.
Ultomiris is available in three strengths:
100 kg or more (approximately 220 lb or more)
- 300 mg/30 mL
- 300 mg/3 mL
- 1,100 mg/11 mL
3,000 mg
Dosage
3,600 mg every 8 weeks
Treatment often commences with a loading dose, following which you'll continue with a maintenance dosage, usually given every eight weeks.
A dosage chart illustrating recommended Ultomiris dosages based on body weight (in kilograms) is presented below:
| | | || --- | --- | --- || Body weight | Loading dose | Maintenance dose || 40 kg to less than 60 kg | 2,400 mg | 3,000 mg every 8 weeks || 60 kg to less than 100 kg | 2,700 mg | 3,300 mg every 8 weeks || 100 kg or more | 3,000 mg | 3,600 mg every 8 weeks |
Infusion and Frequency of Ultomiris
Ultomiris
Ultomiris functions as a solution for IV infusion, with a healthcare professional overseeing your infusion sessions at an infusion center.
Vyvgart
You'll typically receive your maintenance doses every eight weeks. Two weeks will usually elapse before starting these maintenance doses, following your loading dose.
For more information about Ultomiris dosing schedules, consult our Ultomiris dosage article.
Form
Side Effects of Ultomiris
solution for IV infusion
As with any medication, the use of Ultomiris for myasthenia gravis may induce side effects, some of which can be severe. Mild side effects reported with Ultomiris treatment encompass:
solution for IV infusion
- diarrhea
- upper respiratory infections (e.g., the common cold)
- abdominal pain
- urinary tract infections (UTIs)
- back pain
- dizziness
- mild infusion reactions (such as muscle spasms and discomfort in arms or legs)
These effects may be temporary, persisting for a few days to weeks. However, if they linger or become severely bothersome, consult your doctor or pharmacist.
Dosage frequency
Serious Side Effects of Ultomiris
once every 8 weeks
Though uncommon, serious side effects have been reported with Ultomiris, such as:
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
- severe infections (e.g., COVID-19 and pneumonia)
- life-threatening infusion reactions (including considerable blood pressure fluctuations, extreme shivering, and high fever)
- an increased risk of serious meningococcal infections (see "Before Receiving Ultomiris")
If you develop serious side effects while utilizing Ultomiris, immediately contact your doctor. If the side effects seem life-threatening or medical emergencies, call 911 or your local emergency number immediately.
Drug class
Boxed Warning: Risk of Serious Meningococcal Infections
complement inhibitor
Before initiating Ultomiris treatment, it is crucial to be aware of the associated risk of serious meningococcal infections (e.g., meningitis). This warning represents the Food and Drug Administration (FDA)'s most serious alert.
neonatal Fc receptor blocker
Symptoms of meningococcal infections include:
- abrupt fever, headache, or stiff neck
- nausea and vomiting
- photosensitivity (sensitivity to light)
- confusion
- drowsiness
What to Do
Before commencing Ultomiris treatment, your doctor will ensure your meningococcal vaccinations are up-to-date. If vaccinations are required, they'll be administered at least two weeks prior to your initial infusion. In emergency situations necessitating immediate Ultomiris treatment, your doctor may prescribe antibiotics to help thwart infection for the first two weeks subsequent to your first Ultomiris infusion.
Patients must be mindful of the risk of serious meningococcal infections throughout Ultomiris treatment and for at least eight months following the last dose. Immediately contact your doctor if you suspect meningococcal infection during this period, but if symptoms seem life-threatening, call 911 or your local emergency number immediately.
Additional Precautions
In addition to the boxed warning, Ultomiris carries other precautions. If any of the following medical conditions or other factors are applicable to you, consult your doctor before receiving Ultomiris:
- active infection
- pregnancy
- breastfeeding
- alcohol consumption
- allergic reaction to Ultomiris or its components
Given the risk of serious side effects, Ultomiris is only accessible through a risk evaluation and mitigation strategy (REMS) program. As part of this program, patients must carry the Ultomiris Patient Safety Card throughout treatment and for at least eight months following the last dose. The Ultomiris REMS program details are available at the program website or by calling 1-888-765-4747.
- The Complement Inhibitor drug Ultomiris is used to manage myasthenia gravis, a chronic autoimmune condition that affects voluntary muscles by attacking the body's own cells.
- There are no available biosimilars for Ultomiris, and it is available in three strengths: 300 mg/30 mL, 300 mg/3 mL, and 1,100 mg/11 mL.
- Before prescribing Ultomiris, healthcare providers should take into account the drug's severe Food and Drug Administration (FDA) warning and consider other autoimmune disorders, neurological disorders, and medications like CBD that may interact with it.
- Ultomiris functions by reducing the activation of the complement system protein C5 at the neuromuscular junction, potentially improving muscle strength and reducing fatigue and weakness.
- There may be side effects from using Ultomiris, such as diarrhea, upper respiratory infections, abdominal pain, urinary tract infections, back pain, dizziness, and mild infusion reactions. Serious side effects include severe infections, life-threatening infusion reactions, and an increased risk of serious meningococcal infections. It is crucial to consult a doctor immediately if serious side effects occur.
