Patient Assistance & Copay Programs for Soliris Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines and copay programs to low income or uninsured and under-insured people who meet specific guidelines. Eligibility requirements vary for each program.
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How do I get certified under the Soliris REMS program?
Under the SOLIRIS REMS, prescribers must enroll in the program. HCPs who prescribe SOLIRIS must be specifically certified. Certification consists of reviewing REMS educational materials and enrolling in the SOLIRIS REMS. Click below to get certified or to learn more.
What should I know about Soliris before taking it?
Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk.
What are the possible complications of Soliris?
Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.
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 is Soliris supplied?
DOSAGE FORMS AND STRENGTHS Soliris is supplied as 300 mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free eculizumab solution.
Does Soliris treat myasthenia gravis?
Summary: Alexion Pharmaceuticals announced Oct. 23, 2017, that the U.S. Food and Drug Administration (FDA) has approved eculizumab (brand name Soliris) as a treatment for adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor antibody-positive.
How long do you take Soliris?
If you are an adult, you will usually receive a SOLIRIS infusion by your doctor: o weekly for five weeks, then o every 2 weeks • If you are less than 18 years of age, your doctor will decide how often you will receive SOLIRIS depending on your age and body weight • After each infusion, you should be monitored for one ...
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.
How often is Soliris given?
It is usually given every 7 days for 5 weeks, then every 14 days. The dosage is based on your medical condition. For children, the dosage is also based on the weight. Infusion reactions may occur while you are receiving this medication.
Is eculizumab a chemo drug?
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.
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 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.
Does Soliris suppress the immune system?
Eculizumab is a medication that suppresses the immune system. Sometimes, it is prescribed for individuals with autoimmune myasthenia gravis (MG). It is manufactured as a solution for intravenous infusion under the brand name Soliris®.
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.
How is Soliris administered?
Only administer as an intravenous infusion. Do not administer as an intravenous push or bolus injection. Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion Page 7 7 pump.
How is Solaris given?
This medication is given by injection into a vein by a health care professional as directed by your doctor. It is usually given every 7 days for 5 weeks, then every 14 days. The dosage is based on your medical condition. For children, the dosage is also based on the weight.
How do you infuse Soliris?
Dilute to a final concentration of 5 mg/mL prior to administration. Administer by intravenous infusion over 35 minutes. mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free solution (3). not initiate Soliris therapy in patients: • with unresolved serious Neisseria meningitidis infection (4).
Is Soliris approved in Canada?
SOLIRIS is also approved by Health Canada as safe and effective for use in children and adults with atypical HUS to inhibit complement-mediated thrombotic microangiopathy (TMA). More recently, SOLIRIS has also been approved by Health Canada for use in adult patients with generalized Myasthenia Gravis (gMG).
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.
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.
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.
Does soliris affect the immune system?
SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. 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.
Is Soliris a boxed medicine?
Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.
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.
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 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.
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.
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.
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.
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.
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. ...
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.
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 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. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections.
How does Soliris work in NMOSD?
While the exact way SOLIRIS works in NMOSD is unknown, it is thought to prevent deposition of the terminal complement complex C5b-9. 1
Is Soliris a serious infection?
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS. Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.
Is NMOSD relapse recurrent?
NMOSD relapses are unpredictable and tend to be severe and recurrent 5-7. Over time, relapses have been shown to be inevitable for the majority of patients with NMOSD. 5,6,8. Risk of Relapse.
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.
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 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. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections.
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 Soliris require REMS?
All SOLIRIS prescribers must enroll in the REMS program and counsel patients about the risks of meningococcal infection according ly.
Does Alexion OneSource pay for out of pocket?
Find details about the Alexion OneSource™ CoPay Program, which may help patients pay for eligible out-of-pocket medication and infusion costs.
Is Soliris a serious infection?
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS. Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.