PNH can be a scary disease. But, you don’t have to see it that way. Soliris is a drug that works to reduce ongoing hemolysis, the cause of the signs, symptoms, and health risks associated with PNH.
Soliris is indicated for the treatment of patients with PNH to reduce hemolysis.
In global clinical programs, Soliris lowered hemolysis in everyone who took it. Just as the effects of PNH symptoms on everyday life can differ from person to person, results with Soliris may vary.
In clinical trials, people with PNH taking Soliris experienced the following
92% fewer blood clots — one of the serious health problems of PNH.
Of the 195 patients tested, only three blood clots occurred while people were on Soliris, while 39 had occurred in the same time period before Soliris was started *
In Soliris clinical trials for PNH, most people also received blood-thinning medicine. The effect of stopping blood-thinning medicine during treatment with Soliris has not been studied.
73% reduction in the number of blood transfusions.
Over half of those tested no longer needed transfusions after taking Soliris
87% less hemolysis as measured by LDH.
All patients who took Soliris saw less hemolysis
Soliris reduced hemolysis both right away and over time
Improved energy and overall health-related quality of life.
Patients saw improvement in fatigue after starting Soliris, with significant improvement after 3 weeks of treatment
Soliris improved health-related quality of life after 3 weeks of treatment
The most common side effects reported during PNH clinical trials were headaches, runny nose and colds, sore throat, back pain, and nausea.
Call your doctor if you have any of these side effects. These are not all the side effects with Soliris. For more information, ask your doctor or pharmacist. You may report side effects to the FDA at 1-800-FDA-1088.
Download a complete copy of the Soliris Medication Guide.
Full indication and dosing information for PNH and aHUS is available here.
Quick facts about Soliris
Soliris works by blocking complement (part of your body's defense system) from attacking red blood cells that are missing an important protective protein.
In clinical trials, patients saw improvements in hemolysis, blood clots*, and health-related quality of life.
If you decide to begin treatment, you will need to get vaccinated against meningococcal infection first. It is important that you stay up-to-date with all recommended vaccinations during Soliris treatment.
Your LDH test results can help tell you the progress you’re making with Soliris.
Remember, you and your doctor should consider all of your signs, symptoms, and lab results for a complete picture of your PNH.
What is the most important information I should know about Soliris?
Soliris works by blocking a part of your immune system, which can increase your chance of contracting some types of serious and life-threatening meningococcal infections.
Soliris can lower the ability of your immune system to fight meningococcal infection, which requires immediate medical attention. This infection may quickly become life threatening and cause death if not recognized and treated early.
To help protect against such infections, you will need a meningococcal vaccine before beginning treatment with Soliris.
You must receive a meningococcal vaccine at least 2 weeks before your first dose of Soliris
If your doctor decides that you need Soliris immediately, you should be vaccinated as soon as possible after starting Soliris therapy
If you had a meningococcal vaccine in the past, you might need a booster dose before starting Soliris. Your doctor will decide if you need another dose of a meningococcal vaccine.
A meningococcal vaccine does not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
Headache with nausea or vomiting
Headache and a fever
Headache with a stiff neck or stiff back
Fever of 103° F (39.4° C) or higher
Fever and a rash
Severe muscle aches with flu-like symptoms
Eye sensitivity to light
For complete Important Safety Information for Soliris, please click here.
Soliris may also increase the risk of other types of serious infections. If your child is treated with Soliris, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilus influenza type b (Hib).
Who Should Not Receive Soliris?
Do not receive Soliris if you:
have a meningococcal infection
have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with Soliris is needed
What should I tell my doctor before receiving Soliris?
Before receiving Soliris, tell your doctor if you:
have an infection or fever
are pregnant or plan to become pregnant. It is not known if Soliris will harm your unborn baby
are breastfeeding or plan to breastfeed. It is not known if Soliris passes into your breast milk
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medications you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
Soliris Patient Safety Information Card — Carry it at all times
Download and print the Patient Safety Information card with information about the risk of meningococcal infection and discuss it with your PNH primary care doctor. Carry it with you at all times during treatment and for 3 months after your last Soliris dose. Your risk of meningococcal infection may continue for several weeks after your last dose of Soliris. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.
The Patient Safety Information card contains Important Safety Information that you should know while receiving Soliris therapy. Because Soliris may reduce your natural resistance to infections, it is important to recognize the signs and symptoms of infections, including those of meningitis. This card includes a list of the signs and symptoms of these infections, so you can recognize an infection, including meningitis, and seek IMMEDIATE medical attention.
* In Soliris clinical trials for PNH, the majority of patients also received blood-thinning medicine. The effect of stopping blood-thinning medicine during treatment with Soliris has not been studied.