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Is Ultomiris right for me?
Ask your doctor if ULTOMIRIS could be right for you. What is the most important information I should know about ULTOMIRIS? ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
What are the side effects of Ultomiris for aHUS?
The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory tract infection and headache. The most common side effects of ULTOMIRIS in people treated for aHUS are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.
What is Ultomiris (Ravulizumab)?
Ultomiris (ravulizumab) is a member of the selective immunosuppressants drug class and is commonly used for Hemolytic Uremic Syndrome, and Paroxysmal Nocturnal Hemoglobinuria. The cost for Ultomiris intravenous solution (100 mg/mL) is around $6,695 for a supply of 3 milliliters, depending on the pharmacy you visit.
What patient assistance programs are available under Rems?
Insurance benefits, claims assistance, or other reimbursement help is offered. Health care providers must enroll in the REMS program prior to submitting the Patient Assistance Program Application Co-payment assistance, and patient assistance programs are available for eligible patients.
What is ultomiris used for?
What are the side effects of ultomiriris?
How long should you be on antibiotics for ultomiris?
How long do you have to monitor for ahus?
Can you get ultomiris through a rems?
Does ultomiris lower the immune system?
Can you breastfeed after taking ultomiris?
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What does Ultomiris cost?
Ultomiris has a list price of $6,404 per vial, compared with $6,543 per vial for Soliris, which accounts for more than 80% of Alexion's total sales. On average, the annual cost for Ultomiris maintenance doses is about $458,000, a discount of about 33% to the labeled maintenance dose of Soliris in aHUS, Alexion noted.
What type of medication is Ultomiris?
ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat: adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS).
How do I order Ultomiris?
For inquiries on orders or to enroll in the ULTOMIRIS REMS program, please call 1-888-765-4747.
How long is Ultomiris infusion?
Official answer. In general, minimum infusion times for Ultomiris (ravulizumab) can range from 0.4 hours to 3.8 hours. The infusion time is based on the patient's weight, the prescribed dose and if it is a loading dose or maintenance dose. Ultomiris is given through a vein as an intravenous (IV) infusion.
How often do you take Ultomiris?
Loading dose of ULTOMIRIS should be administered 2 weeks after the last eculizumab infusion. Maintenance doses are administered once every 4 or 8 weeks (depending on body weight), starting 2 weeks after the loading dose.
Is Ultomiris hazardous?
Ultomiris affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or your eyes are more sensitive to light.
What is a REMS program?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
What is the J code for Ultomiris?
Enter the appropriate HCPCS/CPT codes and modifiers; eg, − J1303 Injection, ravulizumab-cwvz per 10 mg − 96365 for drug administration Box 24G Units: Enter the appropriate number of units of service; eg, ULTOMIRIS 300 mg is reported with “30” units.
Is Ultomiris better than Soliris?
Both product are classified as C5 complement inhibitors, but Ultomiris has a longer half-life, meaning it stays in your blood longer and does not have to be dosed as often. View dosing here. In studies for PNH evaluated by the FDA, the efficacy of Ultomiris was found to be “non-inferior” to Soliris.
Is Ultomiris used for myasthenia gravis?
Ultomiris (ravulizumab-cwvz) has been approved in the US for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people living with the disease.
When was myasthenia gravis Ultomiris approved?
April 28, 2021– Today the Muscular Dystrophy Association celebrates the approval by the US Food and Drug Administration (FDA) to ravulizumab (Ultomiris) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody.
Is ULTOMIRIS better than Soliris?
Both product are classified as C5 complement inhibitors, but Ultomiris has a longer half-life, meaning it stays in your blood longer and does not have to be dosed as often. View dosing here. In studies for PNH evaluated by the FDA, the efficacy of Ultomiris was found to be “non-inferior” to Soliris.
Is ULTOMIRIS approved for myasthenia gravis?
Ultomiris (ravulizumab) has been approved in Europe as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
What is Vyvgart used to treat?
The U.S. Food and Drug Administration today approved Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody.
What is Ravulizumab used to treat?
Ravulizumab-cwvz injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.
ULTOMIRIS (ravulizumab-cwvz) | Financial Assistance
*The Alexion OneSource CoPay Program is not valid for costs eligible to be reimbursed by government insurance programs or other federal or state programs (including any state prescription drug assistance programs), including Medicaid, Medicare (including Medicare Part D), Medicare Advantage Plans, Medigap, Veterans Affairs, Department of Defense or TRICARE.
ULTOMIRIS
ULTOMIRIS REMS (Risk Evaluation and Mitigation Strategy) What is ULTOMIRIS REMS? A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA) to manage known or potential serious risks associated with a drug product
What is ultomiris used for?
ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
What are the side effects of ultomiriris?
The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.
How long should you be on antibiotics for ultomiris?
If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
How long do you have to monitor for ahus?
If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke.
Can you get ultomiris through a rems?
ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.
Does ultomiris lower the immune system?
ULTOMIRIS is a medicine that affects your immune systemand can lower the ability of your immune system to fight infections.
Can you breastfeed after taking ultomiris?
It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.
Education
Providing your patients with educational resources and materials related to generalized myasthenia gravis (gMG)
Ongoing support
Personalized support for your patients in maintaining therapy during their major life events, such as a change in job, insurance status, provider, or relocation
Community connections
Alexion Access Navigator is a dedicated resource website for US Healthcare Professionals and their offices that contains downloadable access and reimbursement materials for ULTOMIRIS in gMG.
Resources include
ULTOMIRIS gMG Sample Letter of Medical Necessity: A template for responding to a request from a patient’s insurance company to provide a letter of medical necessity when prescribing ULTOMIRIS in gMG
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
Life-threatening meningococcal infections/sepsis have occurred in patients treated with ULTOMIRIS. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.
Education
Providing your patients with educational resources and materials related to atypical-HUS
Continuity of care
Personalized support for maintaining therapy during your patients’ major life events, such as a change in job, insurance status, provider, or location
Alexion OneSource CoPay Program
As part of the Alexion OneSource suite of services, a program is available for eligible patients to support them with financial needs.
How to order ULTOMIRIS
Find out how to get access to all of the tools necessary to get your patients started on ULTOMIRIS, including how to place an order.
Tools for the journey
Find additional resources and support information to help get your patients started on ULTOMIRIS.
What is Ultomiris used for?
Ultomiris (ravulizumab) is a member of the selective immunosuppressants drug class and is commonly used for Hemolytic Uremic Syndrome, and Paroxysmal Nocturnal Hemoglobinuria.
Is Ultomiris valid with insurance?
Prices are for cash paying customers only and are not valid with insurance plans. This Ultomiris price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
Does Ultomiris offer coupons?
Ultomiris Coupons and Rebates. Ultomiris offers may be in the form of a printable coupon, rebate, savings card, trial offer, or free samples. Some offers may be printed right from a website, others require registration, completing a questionnaire, or obtaining a sample from the doctor's office.
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What is the most important information I should know about ULTOMIRIS? ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
What is the most important information I should know about ULTOMIRIS? ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
How to report ultomiris?
These are not all the possible side effects of ULTOMIRIS. For more information, ask your doctor or pharmacist. Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How long should you be on antibiotics for ultomiris?
If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
Does OneSource cover PNH?
OneSource: available at no cost to people living with PNH, you can get one-on-one support from an Alexion Case Manager. OneSource can help you learn about PNH, co-verify your insurance coverage, and identify helpful resources for people living with PNH and those who care for them.
What is a bone marrow organization?
A nonprofit organization that supports, connects, and educates patients, caregivers, and health professionals on bone marrow failure diseases worldwide. It promotes and invests in collaborative clinical research to accelerate the discovery of better treatments and cures for AA and MDS.
Is ultomiris safe for children?
ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
Can you breastfeed after taking ultomiris?
It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.
Can ultomiris cause death?
ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognize d and treated early.
What is the purpose of ULTOMIRIS?
The purpose of the ULTOMIRIS REMS is to mitigate the occurrence and morbidity associated with meningococcal infections by informing healthcare providers and patients about the: Increased risk of meningococcal infections with ULTOMIRIS. Early signs of invasive meningococcal infections, and.
Is ULTOMIRIS a restricted program?
ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). HCPs who prescribe ULTOMIRIS must be specifically certified. Certification consists of review of REMS educational materials and enrollment in the ULTOMIRIS REMS program.
2 – Transfer Prescription to AmeriPharma
We process your prescription by working with your previous pharmacy or prescriber, making the transition quick and easy.
3 – Prior Authorization
Our team of specialists obtains approval from your insurance companies within 24 to 72 hours.
4 – Copay Assistance & Financial Aid
We secure financial aid and decrease copays, out-of-pocket expenses, and high deductibles. To date, AmeriPharma Specialty Care has secured $55 million in financial assistance for our patients.
5 – Nursing Care Coordination
AmeriPharma puts your schedule and home environment first when scheduling and coordinating one of our specialized nurses for your in-home infusions.
6 – Delivery Coordination
Medications are always delivered in strict compliance with the specific requirements for immune globulin shipping. Next-day and overnight cold-chain deliveries are coordinated around your schedule.
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We accept Medicare, Medi-Cal and most private insurances. Call us to find out more about your coverage.
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We accept Medicare, Medi-Cal and most private insurances. Call us to find out more about your coverage.
What is ultomiris used for?
ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.
What are the side effects of ultomiriris?
The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.
How long should you be on antibiotics for ultomiris?
If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
How long do you have to monitor for ahus?
If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke.
Can you get ultomiris through a rems?
ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.
Does ultomiris lower the immune system?
ULTOMIRIS is a medicine that affects your immune systemand can lower the ability of your immune system to fight infections.
Can you breastfeed after taking ultomiris?
It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.
