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 to Expect During Treatment

Receiving Soliris Therapy

Soliris is delivered through a vein — an intravenous, or I.V., infusion — usually over 35 minutes. If you have an allergic reaction during your Soliris infusion, your doctor may decide to give Soliris more slowly or stop your infusion.

You will usually receive a Soliris infusion by your doctor:

  • weekly for five weeks, then

  • every 2 weeks

After each infusion, you should be monitored for one hour for allergic reactions. Serious allergic reactions can happen, so 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

Infusions must be given by trained healthcare professionals, usually at a doctor’s office, health clinic, or infusion center. You must receive a meningococcal vaccine at least 2 weeks before your first dose of Soliris unless you have already had this vaccine.

If you forget or miss a Soliris infusion, call your doctor right away. Your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris. Stopping treatment with Soliris may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: drop in the number of your red blood cell count, drop in your platelet count, confusion, chest pain, kidney problems, blood clots, and difficulty breathing.

Seeing Results With Soliris

By 1 week, patients experienced less hemolysis as measured by LDH, and they reported feeling less tired. By 3 weeks, patients noticed less shortness of breath and improved health-related quality of life.

From 6 months on, patients have needed fewer transfusions and continued to experience reduced hemolysis and fatigue, improved health-related quality of life, and stabilized hemoglobin levels. These improvements and others have continued to 4 years and beyond.

PNH symptoms can differ widely from person to person, so the improvements you see in your health may differ from others’.

Individual results may vary and may be different if you have AA or MDS. It’s important to ask your doctor about different treatment options for AA or MDS.

In clinical trials, blood clots were reduced

In 1 week

  • Less hemolysis as measured by LDH

  • Feeling less tired

Between 2 and 3 weeks

  • Improved health-related quality of life (QoL)

  • Improvement in breathing

Between 2 and 6 months

  • Fewer blood transfusions (if you need them)

  • Stabilized hemoglobin levels

After 6 months

  • Continued improvement in health-related QoL

  • Near normal levels of hemolysis as measured by LDH

  • Continued improvements in fatigue

  • Even less need for blood transfusions

  • Continued stabilization in hemoglobin levels

At 3 years and up to 4 1/2 years

  • Continued reduction in hemolysis

  • Reduction in blood clots maintained

  • Commonly reported side effects related to Soliris were mostly mild to moderate

In clinical trials, blood clots were reduced

flowchart

What to expect with Soliris

  • Soliris needs to be taken regularly for you to get the most out of treatment

  • You will need to get vaccinated against meningococcal infection at least 2 weeks before your first infusion

  • Soliris offers results— — both right away and over time

  • OneSource can help with insurance and support and to answer your questions about PNH and Soliris

  • It is possible to live a long, full life with PNH with ongoing Soliris therapy


A Measure of Success: LDH

One way for a doctor to check your progress with Soliris is through a simple blood test that checks the level of LDH in your blood. LDH is a measure of hemolysis, so when there’s less of it in your blood, it means Soliris is working. Soliris can lower LDH levels in people with PNH right away and can maintain those levels over time.

Some patients have bone marrow production problems and will continue to require transfusions, since Soliris addresses hemolysis and not red blood cell production issues. You can measure how Soliris is working by measuring LDH, however platelet counts, hemoglobin, and transfusion dependency may never fully resolve and therefore these markers are not an accurate measure of your response to Soliris.


Call an Alexion Nurse Case Manager at 1.888.SOLIRIS (1.888.765.4747) to learn more.

Treatment Support

Alexion Nurse Case Managers are here to help you and your patients

nurse

PNH Long-Term Management Brochure

Learn how to help control the ongoing signs, symptoms, and health-related risks of PNH long-term.

brochure
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Important Safety Information

CLOSE

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.

 
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