Full Answer
How do I enroll in Soliris Rems?
Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS ( 1-888-765-4747) or at www.solirisrems.com. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).
How much does Soliris cost?
The cost for Soliris intravenous solution (10 mg/mL) is around $6,820 for a supply of 30 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans. This Soliris price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
Are there any risks in taking Soliris?
Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections ( Aspergillus) may occur if you take SOLIRIS and have a weak immune system or a low white blood cell count.
How do I contact Soliris?
Visit MedWatch, or call 1-800-FDA-1088. What is SOLIRIS? SOLIRIS is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
Can SOLIRIS be given at home?
SOLIRIS is a treatment that is given by intravenous (IV) infusion. Some people visit an infusion center to receive SOLIRIS while others prefer to have a visiting nurse administer their infusion at home. The location in which you receive your infusion can depend on your insurance and where you live.
How much does SOLIRIS cost per year?
At a cost of more than $500,000 per year, Soliris is one of the most expensive drugs in the world. And rightfully so: Not only is it the first of its kind, but it is extremely effective at treating certain rare diseases once thought to be fatal.
How long does it take SOLIRIS to work?
Individuals who respond to eculizumab often see improvement in the first one to two months. However, it may take up to 12 weeks for some people with MG to see improvement.
How effective is SOLIRIS for myasthenia gravis?
A 2019 analysis indicated that — after a median treatment duration of 22.7 months — nearly three out of four participants experienced clinical improvements compared with the start of REGAIN, and over half had minimal manifestations of the disease.
Is there a generic for Soliris?
Eculizumab is the generic name for the trade chemotherapy drug Soliris. In some cases, health care professionals may use the trade name Soliris when referring to the generic drug name eculizumab.
Which is the costliest drug in the world?
It's Zolgensma (generic name: onasemnogene abeparvovec-xioi), a life-saving gene therapy approved in May 2019 to treat pediatric Spinal Muscular Atrophy (SMA). Zolgensma's total cost is $2.125 million, according to Novartis, the manufacturer. It's considered the world's most expensive single-dose drug.
What happens if you stop Soliris?
Things you should not do If you forget or miss a Soliris infusion, call your doctor immediately. If you have PNH, stopping treatment with Soliris may cause a sudden and serious breakdown of your red blood cells. If you experience any of these symptoms, contact your doctor immediately.
How long does Soliris stay in your system?
Eculizumab can effect your body for up to 3 months. You may need medical tests for 8 to 12 weeks if you stop using this medicine. Make sure any doctor who treats you knows that you've used Soliris.
How long is Soliris treatment?
For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: 900 mg weekly for the first 4 weeks, followed by. 1200 mg for the fifth dose 1 week later, then. 1200 mg every 2 weeks thereafter.
What is the new myasthenia gravis drug?
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.
Is there any new medicine for myasthenia gravis?
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 disease does Soliris treat?
SOLIRIS is a prescription medicine used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS).
How does Soliris work for aHUS?
SOLIRIS is a first-in-class terminal complement inhibitor discovered, developed, and commercialized by Alexion. SOLIRIS works by selectively inhibiting activation of specific proteins in the complement system (C5a and C5b), which play a role in the pathophysiology of multiple rare diseases.
What diseases does Soliris treat?
SOLIRIS® is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive, as well as have paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (aHUS), and myasthenia gravis.
What are the side effects of Soliris?
What Are Side Effects of Soliris?headache,tiredness,nausea,vomiting,diarrhea,muscle pain,back pain, or.cold symptoms such as stuffy nose, sneezing, or sore throat.
Is soliris an immunosuppressant?
SOLIRIS® (Eculizumab) Immunosuppressant.
How long do you have to carry a patient safety card?
Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly.
What is a OneSource case manager?
OneSource Case Managers have anti-AChR Ab+ gMG disease education and health insurance expertise. One will be assigned to you to provide complimentary one-on-one education and support. You may also contact your OneSource Case Manager to request a gMG Treatment Journal to use along your journey.
What are the side effects of gmg?
The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain.
How to report side effects of Soliris?
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088. Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.
How long should you take antibiotics before taking Soliris?
It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.
Does gmg hurt with soliris?
The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain. Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist.
Can you pass out from a soliris infusion?
SOLIRIS can cause serious side effects including serious infusion-related reactions. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain; trouble breathing or shortness of breath; swelling of your face, tongue, or throat; and feel faint or pass out.
How to report side effects of Soliris?
These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.
What is the most important information about Soliris?
What is the most important information I should know about SOLIRIS? SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
How long do you have to carry a patient safety card?
Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly.
Does Soliris help with NMOSD?
Soliris may be able to help reduce your risk of relapse. Whether you are newly diagnosed or have had multiple relapses, see how it may be able to help you control your NMOSD.
Does Soliris lower the immune system?
SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
Does soliris cause gonorrhea?
SOLIRIS may also increase the risk of other types of serious infections. Certain people may be at risk of serious infections with gonorrhea. Certain fungal infections ( Aspergillus) may occur if you take SOLIRIS and have a weak immune system or a low white blood cell count.
Is Soliris a boxed warning?
Please see the accompanying full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.
What is Soliris used for?
Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
What is the Alexion OneSource program?
IMPORTANT NOTICE: The Alexion OneSource™ Copay Program (“Program”) pays for eligible out-of-pocket medication and infusion costs associated with SOLIRIS ® (eculizumab) up to $15,000 US dollars per calendar year. The Program is not valid for costs eligible to be reimbursed, in whole or in part, by Medicaid, Medicare (including Medicare Part D), Medicare Advantage Plans, Medigap, Veterans Affairs, Department of Defense or TRICARE, or other federal or state programs (including any state prescription drug assistance programs). No claim for reimbursement of any out-of-pocket expense amount covered by the Program may be submitted to any third-party payer, whether public or private. This offer cannot be combined with any other rebate/coupon, free trial, or similar offer. Patients residing in Massachusetts, Minnesota, and Rhode Island are eligible for assistance with medication costs, but are not eligible for assistance with infusion costs. Alexion reserves the right to rescind, revoke, or amend this program without notice. By participating in the Program, participants acknowledge that they understand and agree to comply with the complete terms and conditions, available at https://alexiononesource.com/copay.
How to enroll in Soliris?
Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS ( 1-888-765-4747) or at www.solirisrems.com.
What are the most common adverse reactions to NMOSD?
The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.
Can Soliris cause anaphylaxis?
Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.
Does Alexion OneSource pay for out of pocket?
The Alexion OneSource TM CoPay Program may help patients pay for eligible out-of-pocket medication and infusion costs.
Is Neisseria a serious infection?
Serious infections with Neisseria species (other than N. meningitidis ), including disseminated gonococcal infections, have been reported. Patients may have increased susceptibility to infections, especially with encapsulated bacteria.
What is Soliris used for?
Soliris (eculizumab) is a member of the selective immunosuppressants drug class and is commonly used for Hemolytic Uremic Syndrome, Myasthenia Gravis, Neuromyelitis Optica, and others.
How much does Soliris cost?
The cost for Soliris intravenous solution (10 mg/mL) is around $6,820 for a supply of 30 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
What is FDA approved diagnosis?
FDA-approved diagnosis. Must be treated by US licensed healthcare provider. 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 This program also provides copay assistance.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
How many patients were in the Soliris trial?
In the main clinical trial of Soliris, 61 patients in the Soliris treatment arm (98%) and 62 patients in the placebo arm (98%) were receiving 2 or more treatments prior to the start of the clinical trial.
How to contact MedWatch for Soliris?
Visit MedWatch, or call 1-800-FDA-1088. Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. Enter.
How long do you have to carry a patient safety card?
Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly.
How long should you take antibiotics before taking Soliris?
It is important that you have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, and stay up-to-date with all recommended vaccinations during treatment with SOLIRIS.
Can you pass out from a soliris infusion?
SOLIRIS can cause serious side effects including serious infusion-related reactions. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain; trouble breathing or shortness of breath; swelling of your face, tongue, or throat; and feel faint or pass out.
Can a soliris cause death?
SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
Does Soliris lower the immune system?
SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
What are the symptoms of a soliris?
headache with a stiff neck or stiff back. fever. fever and a rash. confusion. muscle aches with flu-like symptoms. eyes sensitive to light. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. ...
How long do you have to be on antibiotics for soliris?
If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS.
Can you take Soliris with breast milk?
It is not known if SOLIRIS passes into your breast milk. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects. It is important that you:
Does soliris affect the immune system?
SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
Can soliris cause gonorrhea?
SOLIRIS may also increase the risk of other types of serious infections. Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
Can you get a reaction to a soliris?
Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain. trouble breathing or shortness of breath. swelling of your face, tongue, or throat. feel faint or pass out.
Is Soliris safe for children?
SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. It is not known if SOLIRIS is safe and effective in children with NMOSD.
