Myasthenia Gravis Treatment with Ultomiris: Understanding Its Mechanism and Additional Information
Rewritten Article:
Chillax, Man! We're diving into the deets about Ultomiris, the sick infusion that treats your myasthenia gravis. (Yea, that chronic autoimmune bizness where your muscles tire super fast.) This no-holds-barred guide covers the down-low on side effects, dosage, and how the hell this badass drug works. Plus, we'll hook you up with some bonus info if you're down.
First things first, Ultomiris is an intravenous (IV) infusion that a pro pulls straight into your veins. It's a biologic and part of the drug class called complement inhibitors. There ain't no biosimilar option for this bad boy.
Wanna learn more about this lit treatment? Grab a seat and continue reading.
Ultomiris sports a boxed warning – the most serious one from the Food and Drug Administration (FDA). Read up on this section before you start your treatment.
Myasthenia Gravis Simplified
Myasthenia gravis messes with your voluntary muscles, causing them to weaken and tire easily because of flawed communication between muscles and nerves. It's a long-term autoimmune condition, meaning your immune system's all "I'ma attack my own cells!"
Symptoms for MG
Symptoms vibe from one person to the next, but they usually worsen during active times and improve when you chill. Look out for:
Body weight
- droopy peepers
- weak muscles in your limbs, neck, and eyes
- fatigue
- blurry or double vision
- breathing, chewing, or swallowing troubles
Who's Prescribed Ultomiris?
Loading dose
Ultomiris is for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
"Generalized" means multiple muscle groups are involved. gMG ain't the same as ocular myasthenia gravis, which only affects eye muscles.
Maintenance dose
"AChR antibody-positive" means your immune system generates antibodies that block AChR receptors. AChR receptors dope neurotransmitters called acetylcholine into action, allowing for muscle contractions.
Before your doc prescribes Ultomiris, they may order a blood test to check if your gMG is AChR antibody-positive. Your doc can spill the beans on whether Ultomiris is a suitable treatment for your specific MG variant.
How Ultomiris Treats MG
If your doctor tanks you with Ultomiris to handle your MG, you might be curious about how this miracle drug does its thing.
40 kg to less than 60 kg (approximately 88 lb to less than 132 lb)
The Science Behind Ultomiris
Scientists ain't got the full scoop on how Ultomiris works, but it's thought to centrally involve its ability to curb the activity of a complement system protein called C5 at the neuromuscular junction (NMJ).
2,400 mg
The NMJ is the area where nerve cells holler at the muscles they control. Ultomiris lowers C5 activity at the NMJ, helping nerve signals reach your muscles. This could reduce tiredness and muscle weakness, potentially enhancing muscle strength.
How Well Ultomiris Works for MG
3,000 mg every 8 weeks
In studies, Ultomiris effectively improved the ability to jive through daily tasks in adults with generalized myasthenia gravis (gMG) who were anti-acetylcholine receptor (AChR) antibody-positive.
Curious about these studies? Your doc or pharmacist can pepper you with more deets or you can check out the prescribing information for Ultomiris.
Receiving Ultomiris for MG
Check out this lowdown on Ultomiris dosages for MG. Your doc will customize a plan that's right for you. If you've got questions about your Ultomiris dosage or how you'll cop it, don't hesitate to hit up your doc.
60 kg to less than 100 kg (approximately 132 lb to less than 220 lb)
Ultomiris comes in three strengths:
- 300 mg/30 mL
- 300 mg/3 mL
- 1,100 mg/11 mL
2,700 mg
Dosage
Ultomiris treatment kicks off with a loading dose. After two weeks, you'll continue with a maintenance dose, typically every 8 weeks.
3,300 mg every 8 weeks
Here's a chart that breaks down recommended Ultomiris dosages based on your weight:
| | | || --- | --- | --- || 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 |
Pro Tip: Keep in mind that the Ultomiris dosage may vary when treating different conditions. Check with your doc if you want to learn more.
How Ultomiris Is Administered
100 kg or more (approximately 220 lb or more)
Ultomiris is an IV solution that a pro gives you at an infusion center.
How Often Ultomiris Is Given
3,000 mg
You usually receive your maintenance doses every 8 weeks. You'll likely start receiving maintenance doses 2 weeks after your loading dose.
Dose Schedules: To find out more about Ultomiris dosing schedules, peep this Ultomiris Dosage article.
3,600 mg every 8 weeks
Side Effects of Ultomiris
Using Ultomiris for MG may trigger side effects that could be mild or serious. Remember that symptoms ain't the same for everyone!
Ultomiris is also used to treat:
- paroxysmal nocturnal hemoglobinuria (PNH)
- atypical hemolytic uremic syndrome (aHUS)
- neuromyelitis optica spectrum disorder (NMOSD)
Side effects from Ultomiris may differ depending on the condition it's prescribed for.
The following lists tackle some common side effects that have been reported with Ultomiris:
Mild Side Effects of Ultomiris
Mild side effects include:
Ultomiris
- diarrhea
- upper respiratory infection (common cold)
- stomach pain
- urinary tract infection (UTI)
- back pain
- dizziness
- minor infusion reactions (like muscle spasms or irritation in your arms or legs)
Serious Side Effects of Ultomiris
Vyvgart
While they're not common, serious side effects have been reported with Ultomiris. They include:
- serious infections, such as COVID-19 and pneumonia
- serious infusion reactions (with symptoms like high or low blood pressure, severe shivering, fever, and chills)
- a risk of serious meningococcal infections (see "Before receiving Ultomiris")
Call your doc immediately if you experience serious side effects while taking Ultomiris. If things seem life-threatening, dial 911 or your local emergency number ASAP.
Allergic Reactions to Ultomiris
Form
For some, Ultomiris can spark an allergic reaction.
In general, allergic reaction symptoms can range from mild to severe.
solution for IV infusion
Dealing with Mild Allergic Reaction Symptoms
For minor allergic reaction symptoms like a rash, chat with your doc right away. They might suggest treatments to help ease your symptoms. They'll also let you know whether you should continue using the med.
solution for IV infusion
Handling Severe Allergic Reaction Symptoms
Severe allergic reaction symptoms, such as swelling or trouble breathing, require immediate medical care. Call 911 or your local emergency number immediately if these symptoms crop up. Your doctor may recommend a different medication if you've had a severe allergic reaction to Ultomiris.
Before You Receive Ultomiris
Here are important facts to keep in mind before starting Ultomiris treatment. It's crucial to discuss any medical conditions or other factors that may affect your health with your doctor.
Dosage frequency
Boxed Warning: Risk of Serious Meningococcal Infections
Ultomiris has a boxed warning for the risk of serious meningococcal infections. This is the most severe warning from the Food and Drug Administration (FDA).
once every 8 weeks
Treatment with Ultomiris elevates the risk of serious meningococcal infections, such as meningitis. These infections can be deadly. Symptoms of a meningococcal infection include:
- sudden fever, headaches, or neck stiffness
- nausea and vomiting
- sensitivity to light
- confusion
- drowsiness
once weekly for 4 weeks; your doctor may prescribe additional cycles based on how well Vyvgart works for your symptoms
What To Do
Before you start receiving Ultomiris, your doc will ensure you're caught up on meningococcal vaccines. If not, they'll administer any necessary vaccines at least two weeks before starting Ultomiris treatment. If your doctor deems immediate treatment essential, they might have you begin treatment sooner than two weeks after meningococcal vaccination. In this case, they'll likely prescribe antibiotics to help ward off infections during the initial two weeks post-first Ultomiris infusion.
The risk of serious meningococcal infections prolongs through Ultomiris treatment and for at least 8 months following your last dose. Contact your doc pronto if you suspect meningococcal infection symptoms during this window. If symptoms feel life-threatening, dial 911 or rush to the closest emergency room.
Since this risk exists, Ultomiris is only available under a risk evaluation and mitigation strategy (REMS) program. As part of this program, you must carry the Ultomiris Patient Safety Card throughout treatment and for at least eight months after your final dose. Find more info about the Ultomiris REMS program on the program website or by calling 1-888-765-4747.
Drug class
Other Warnings
Apart from the boxed warning, Ultomiris has other caveats. If any of the following medical conditions or other health factors apply to you, chat with your doc before receiving Ultomiris if you:
complement inhibitor
- have an active infection
- are pregnant
- are breastfeeding
- partake in the sauce (alcohol)
- have had an allergic reaction to Ultomiris or any of its ingredients
Top FAQs About Ultomiris
neonatal Fc receptor blocker
Below are answers to some frequently asked questions about Ultomiris for treating myasthenia gravis.
Ultomiris vs. Vyvgart
Ultomiris and Vyvgart are prescribed to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Check out the comparison table below:
| | || --- | --- || Ultomiris | Vyvgart || Form | solution for IV infusion | solution for IV infusion || Dosage frequency | once every 8 weeks | once weekly for 4 weeks; your doc may prescribe additional cycles based on the efficacy of Vyvgart for alleviating your symptoms || Drug class | complement inhibitor | neonatal Fc receptor blocker |
Unlike Vyvgart, Ultomiris is also approved to treat other conditions.
Talk to your doc or pharmacist for additional insights on how Ultomiris and Vyvgart stack up.
Can I Receive Ultomiris Infusions at Home?
There's a chance your doctor might be able to prescribe Ultomiris for home infusion. With this arrangement, a pro heads to your crib to administer the treatment. Get the lowdown from your doc to learn more about this option. Happy treatments!
Ultomiris Cost
The Ultomiris cost varies based on several factors, such as your treatment regime, insurance coverage, and location. Keep in mind that the price also depends on the expense of the appointment to receive Ultomiris doses from a doctor.
For medication cost assistance, check out the Alexion OneSource program. To find out if you're eligible, dial 888-765-4747 or visit the program website.
Disclaimer: Medical News Today's information should not be used as a substitute for professional medical advice. Always consult your doctor or another healthcare professional before taking any medication. They'll provide you with accurate and tailored medical advice based on your unique needs. The drug information presented here is general and may not apply to every patient or all possible uses.
Enrichment Data:
The Alexion OneSource Copay Program for Ultomiris eligibility determination involves the following steps:
- The patient or caregiver can contact the program directly by calling the dedicated phone number (888-765-4747) or through the Alexion OneSource program website to obtain information and initiate the eligibility assessment.
- Eligibility criteria consider factors such as insurance coverage, financial need, and prescription for Ultomiris. However, specific eligible requirements are handled by the program itself.
- The program may require documentation from the healthcare provider or patient to verify diagnosis and insurance details.
- Approved patients can receive copay assistance to help manage out-of-pocket expenses related to Ultomiris.
For individual eligibility assessment, the process begins by reaching out to Alexion OneSource through their phone number or website, with program representatives guiding patients through the application and qualification process based on their unique circumstances.
- Ultomiris is used to treat myasthenia gravis, a chronic autoimmune disorder that causes muscles to tire easily due to flawed communication between muscles and nerves.
- It is an intravenous (IV) infusion that involves no biosimilar options since it belongs to the drug class called complement inhibitors.
- Myasthenia gravis has a significant risk of serious meningococcal infections, necessitating meningococcal vaccines before treatment and carrying the Ultomiris Patient Safety Card throughout the treatment period and for eight months following the last dose.
- Dizziness, upper respiratory infection, stomach pain, urinary tract infection, back pain, and minor infusion reactions may occasionally occur as mild side effects.
- Serious side effects are not common but may include serious infections, severe infusion reactions, and the risk of meningococcal infections.
- Before receiving Ultomiris, it's important to discuss any other autoimmune disorders, active infections, pregnancy, breastfeeding, alcohol consumption, and allergic reactions to Ultomiris or its ingredients with your healthcare provider.
- Whether prescribed for myasthenia gravis, paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, or neuromyelitis optica spectrum disorder, the side effects of Ultomiris may vary depending on the condition it's used to treat.
- Other medical conditions or other health factors should also be discussed with your healthcare provider before receiving Ultomiris. Discussions should cover factors such as complement inhibitors, pregnancy, breastfeeding, and alcohol consumption.
