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.

What are the Signs and Symptoms of PNH?

The signs and symptoms of PNH can be similar to those of other diseases. It is important to discuss all of your symptoms with your doctor. It is an unpredictable disease that everyone can experience differently, even from day to day. There is no one sign, symptom, or lab result that defines PNH, but there is a test that can identify it. PNH can be diagnosed using high-sensitivity flow cytometry – a minimally invasive and relatively inexpensive peripheral blood test that your doctor can order.

Sometimes symptoms you can see or feel are a clue to things that are going on beneath the surface — serious signs you may not always be able to see or feel. You may feel fine, even when your lab results show potential problems. That is how PNH is like an iceberg — what you cannot see or feel can hurt you the most.

It’s important for you and your doctor to track your signs, symptoms and lab results, and to treat your PNH early and aggressively before serious problems occur.

iceberg

Symptoms you can see or feel.

  • Fatigue.Tiredness, difficulty performing daily activities, trouble concentrating, dizziness, weakness.
  • Pain.Stomach pain, leg pain or swelling, chest pain, back pain.
  • Other signs and symptoms.Dark-colored urine, shortness of breath, difficulty swallowing, yellowing of the skin and eyes, erectile dysfunction (ED).
iceberg

Signs you may not always see or feel.

  • Blood clots
  • Kidney disease
  • Damage to your organs
  • Stroke
  • Heart attack

Even though you can’'t see or feel it, hemolysis is always happening in your body. Hemolysis is the main cause of major health problems in people with PNH.

Serious health risks can take you by surprise. If left untreated, PNH can lead to:

  • Life-threatening blood clots

    Formed when parts of the blood clump together, blood clots can block veins and arteries and lead to heart attack, stroke, and organ damage, as well as other problems. They can occur at any time, even in patients with a small percentage of PNH cells in their blood. Blood clots are one of the most serious, life-threatening conditions in patients with PNH.

  • Kidney damage

    Almost 2/3 of people with PNH have chronic kidney disease.

  • Chronic fatigue

    Hemolysis affects the way oxygen gets delivered throughout your body. This can make you feel weak and tired to the point where once-normal, everyday activities become a struggle.

    In PNH, there are actually two causes of fatigue: hemolysis itself, which is the main cause of fatigue, and the anemia that’s caused by hemolysis.

    Fatigue is often worse than the amount of anemia you have, as measured by your hemoglobin level.

  • Serious lung problems

    Lung problems can be caused by pulmonary hypertension. This can lead to shortness of breath and other serious health problems.

Speak with your doctor about treating PNH and reducing hemolysis— — with Soliris.

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.