Myasthenia Gravis Treatment with Ultomiris: Insights and Explanations
Toxic Tumble: All About Ultomiris
Ever heard of Ultomiris? It's a brand name solution that's pumped into your veins by a healthcare pro to manage myasthenia gravis. This article covers the nitty-gritty, like its side effects, dosage, and how it works.
Ultomiris is an IV infusion solution, considered a biologic, belonging to the drug class called complement inhibitors. It's exclusive, as it doesn't have a biosimilar version in the market.
might wanna know more about Ultomiris? Let's dive in!
Ultomiris carries a boxed warning from the Food and Drug Administration (FDA), the most serious advisory. Check out the "WARNING: Before you get your Ultomiris infusion" section for more details.
Body weight
Myasthenia Gravis: The Anti-cooperative Condition
Loading dose
Myasthenia gravis is a chronic (long-term) disorder that messes with muscle and nerve communication. Your voluntary muscles exhaust easily and weaken, thanks to dysfunctional communication between your muscles and nerves. This condition is caused by an overactive immune system, which mistakenly attacks your own cells.
Maintenance dose
Symptoms of Myasthenia Gravis
Symptoms of myasthenia gravis vary, but commonly worsen during periods of increased activity and improve with rest. Here's what you might experience:
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
- drooping eyelids
- weak muscles in your limbs, neck, and eyes
- fatigue
- blurry or double vision
- trouble chewing, swallowing, speaking, and breathing
2,400 mg
Who Gets Ultomiris?
3,000 mg every 8 weeks
Ultomiris is prescribed to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. You might be wondering what that means:
- "Generalized" means your whole body, not just specific regions, is affected. gMG is different from ocular myasthenia gravis, which only impacts eye muscles.
- "Anti-acetylcholine receptor (AChR) antibody-positive" means your immune system manufactures antibodies that block the acetylcholine receptors. Acetylcholine is a neurotransmitter that helps your nerves signal to your muscles to contract.
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Before prescribing Ultomiris, your doctor may run a blood test to check if your gMG is AChR antibody-positive. Your doctor can provide more insights on whether Ultomiris is suitable for your type of myasthenia gravis.
2,700 mg
Ultomiris To The Rescue!
3,300 mg every 8 weeks
If Ultomiris is prescribed to treat your myasthenia gravis, you're probably curious about how it helps.
The Science Behind Ultomiris
100 kg or more (approximately 220 lb or more)
The exact way Ultomiris works to treat myasthenia gravis is a mystery, but it's thought to involve blocking the activity of a complement system protein called C5 at the neuromuscular junction (NMJ). The NMJ is where nerve cells talk to the muscles they control. Lowering C5 activity at the NMJ helps signals from nerve cells reach your muscles. This could reduce fatigue and muscle weakness, improving muscle strength.
3,000 mg
How Well Does Ultomiris Work?
3,600 mg every 8 weeks
In clinical studies, Ultomiris effectively enhanced the ability for people with generalized myasthenia gravis (gMG) to carry out daily activities.You can learn more about these studies in the Clinical Research on Ultomiris section. Your doctor or pharmacist can also fill you in on how well Ultomiris worked in these studies.
Receiving Your Ultomiris Infusion
Here's what you need to know about dosing and receiving your Ultomiris infusions:
Ultomiris Availability
Ultomiris
Ultomiris is available in three strengths:
Vyvgart
- 300 milligrams (mg)/30 milliliters (mL)
- 300 mg/3 mL
- 1,100 mg/11 mL
Dosage
Form
Ultomiris treatment begins with a loading dose. Two weeks post-loading dose, you'll continue treatment with a maintenance dose, usually every 8 weeks. Body weight determines the recommended Ultomiris dosages.
solution for IV infusion
Check out the table below for recommended dosages based on body weight:
solution for IV infusion
| | | || --- | --- | --- || 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 |
How Ultomiris is Administered
Dosage frequency
Ultomiris is an IV infusion solution. A healthcare professional handles your Ultomiris infusions at an infusion center.
once every 8 weeks
How Often Ultomiris is Administered
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
You typically receive your maintenance doses every 8 weeks. After completing the loading dose, you'll likely start receiving maintenance doses 2 weeks later.
For more information about dosing schedules for Ultomiris, head over to the Ultomiris Dosage Frequently Asked Questions section.
Drug class
Ultomiris Side Effects: Mild and Serious
complement inhibitor
The use of Ultomiris for myasthenia gravis might cause side effects, ranging from mild to serious.
neonatal Fc receptor blocker
Ultomiris is also approved for other conditions:
- paroxysmal nocturnal hemoglobinuria (PNH)
- atypical hemolytic uremic syndrome (aHUS)
- neuromyelitis optica spectrum disorder (NMOSD)
It's important to know that side effects from Ultomiris may differ depending on the condition it's being used for.
Below is a list of some common and serious side effects reported with Ultomiris. For more information about other potential side effects, chat with your doctor or pharmacist. You can also check out our Side Effects of Ultomiris article.
WARNING: Risk of Serious Meningococcal Infections
Treatment with Ultomiris increases the risk for serious meningococcal infections, which can be life-threatening.
Symptoms of a meningococcal infection include:
- sudden fever, headache, or stiff neck
- nausea and vomiting
- sensitivity to light
- confusion
- drowsiness
Contact your doctor IMMEDIATELY if you think you have symptoms of a meningococcal infection during treatment with Ultomiris, and dial 911 or your local emergency number if your symptoms feel life-threatening. Details about managing this risk can be found in the "WARNING: Before you get your Ultomiris infusion" section.
Mild Side Effects of Ultomiris
Mild side effects reported with Ultomiris treatment include:
- diarrhea
- upper respiratory infection (common cold)
- abdominal pain
- urinary tract infection (UTI)
- back pain
- dizziness
- muscle spasms and discomfort in your arms or legs during infusion
These side effects might be temporary and last for a few days to weeks. If they worsen, bother you, or persist longer than this, reach out to your doctor or pharmacist.
Serious Side Effects of Ultomiris
Though not common, serious side effects have been reported with Ultomiris, such as:
- serious infections, including COVID-19 and pneumonia
- serious infusion reactions, including increased or decreased blood pressure and severe shivering, chills, fever
- risk of severe meningococcal infections (refer to the "WARNING: Risk of Serious Meningococcal Infections" section)
If you develop serious side effects while using Ultomiris, contact your doctor right away. If your symptoms feel life-threatening or you believe you're experiencing a medical emergency, call 911 or your local emergency number immediately.
Before You Get Your Ultomiris Infusion
Before you receive Ultomiris, keep the following in mind:
WARNING: Risk of Serious Meningococcal Infections
Ultomiris has a boxed warning for the risk of serious meningococcal infections. These infections can be life-threatening if left untreated.
Management of Meningococcal Infection Risk
To manage this risk:
- Menngiococcal Vaccination: Before starting Ultomiris, you must receive meningococcal vaccinations. Ideally, these vaccinations should be administered at least 2 weeks before initiating treatment.
- Antibiotic Prophylaxis: If completing the meningococcal vaccination series 2 weeks before treatment is not possible, you may receive 2 weeks of antibiotic prophylaxis to prevent infections.
- Monitoring and Education: Throughout treatment and for at least 8 months post-treatment, you must carry an Ultomiris Patient Safety Card. This card explains the risks associated with the drug and provides guidance on recognizing symptoms.
- Risk Evaluation and Mitigation Strategy (REMS) Program: Ultomiris is available only under a Risk Evaluation and Mitigation Strategy (REMS) program, which mandates healthcare provider enrollment and patient education on the drug's risks.
Frequently Asked Questions
Here are answers to some frequently asked questions about Ultomiris for treating myasthenia gravis.
How Does Ultomiris Compare to Vyvgart?
Both Ultomiris and Vyvgart are prescribed to treat generalized myasthenia gravis (gMG) in adults who are AChR antibody-positive. Here's the gist of their differences:
- Form: Ultomiris and Vyvgart are both IV infusions.
- Dosage Frequency: Ultomiris is usually given once every 8 weeks, while Vyvgart is administered once weekly for 4 weeks, followed by additional cycles based on symptom response.
- Drug Class: Ultomiris is a complement inhibitor while Vyvgart belongs to the neonatal Fc receptor blocker class.
Your doctor or pharmacist can provide more information on how Ultomiris and Vyvgart compare.
Can I Get My Ultomiris Infusions at Home?
Perhaps, depending on your doctor's discretion. Home infusion services may be an option, allowing a healthcare professional to administer infusions in your home. Talk with your doctor to learn more about the possibility of receiving Ultomiris infusions at home.
- Ultomiris, a complement inhibitor, is used in managing myasthenia gravis, an immune system disorder that affects muscle and nerve communication.
- Other autoimmune disorders may also be treated with similar drugs, highlighting the importance of health-and-wellness and medical-conditions in relation to the immune system and pharmaceutical science.
- The pharmacy industry plays a crucial role in providing Ultomiris and other therapies-and-treatments, ensuring they're available for patients needing them.
- Myasthenia gravis patients must understand the potential side effects of Ultomiris, such as mild ones like diarrhea and back pain, and the more serious ones like meningococcal infections.
- Meningococcal infections pose a significant risk with Ultomiris, and it's important for patients to follow the recommendations outlined in the REMS (Risk Evaluation and Mitigation Strategy) program to minimize this risk, including vaccination, antibiotic prophylaxis, and carrying an Ultomiris Patient Safety Card.
