Important Safety Information

  • WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

    Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

    • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
    • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection.
    • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

    Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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 solirisrems.com.

How Soliris Can Help

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.

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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

  1. Soliris works by blocking complement (part of your body's defense system) from attacking red blood cells that are missing an important protective protein.

  2. In clinical trials, patients saw improvements in hemolysis, blood clots*, and health-related quality of life.

  3. 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.

  4. Your LDH test results can help tell you the progress you’re making with Soliris.

  5. 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:

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  • 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

  • Confusion

  • Severe muscle aches with flu-like symptoms

  • Eye sensitivity to light

For complete Important Safety Information for Soliris, please click here.

Get Vaccinated

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.

patient safety information card
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.

Treatment Support

Alexion Nurse Case Managers are here to help you with answers to your questions about Soliris and the management of PNH

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Soliris Patient Brochure

Learn about PNH and how Soliris can work to treat it.

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Interactive Symptom Viewer

Explore the signs and symptoms of PNH

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Important Safety Information

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WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection.
  • Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 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 solirisrems.com.

Indications and Usage

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS)

Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Contraindications

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection

  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

Warnings and precautions

Other Infections

Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenza type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenza type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

Monitoring Disease Manifestations After Soliris Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing Soliris, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued Soliris treatment. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients.

Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during Soliris treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during Soliris treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during Soliris treatment.

If TMA complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.

Infusion Reactions

As with all protein products, administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction which required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infection.