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.

More than 3,200 patients strong—and counting

The PNH Registry is an international, observational, and noninterventional study collecting safety, effectiveness, and QoL data on PNH patients.

UNITE with a global community of physicians in contributing to the largest, most comprehensive PNH patient registry. Those eligible for enrollment include all patients who have been newly or previously diagnosed with PNH or have evidence of positive PNH cells.

  • All physicians managing patients with PNH, regardless of treatment approach, are encouraged to participate

CONTRIBUTE to treatment objectives, practice patterns, and best practices.

  • An invaluable opportunity to increase understanding of the natural history of PNH and the safety and efficacy of treatments

SUPPORT scientific collaboration in the PNH community.

  • Offers the international community greater insight into an uncommon disease with potentially devastating consequences1

Recent data generated by the PNH Registry advance understanding of PNH

EHA 2013:

““Improved Fatigue and Quality-of-Life in Patients With Paroxysmal Nocturnal Hemoglobinuria During Treatment With Eculizumab: Data From The Global PNH Registry”” —– Muus et al.

EHA 2013:

““Eculizumab Protects Against TE and Prolongs Survival in Patients With Paroxysmal Nocturnal Hemoglobinuria: An International PNH Registry Study” ” —–– Socié et al.

EHA 2011:

““Pediatric Diagnosis of Paroxysmal Nocturnal Hemoglobinuria in the International PNH Registry”” —– Urbano-Ispizua et al.

EHA 2010:

““Evaluation of Paroxysmal Nocturnal Hemoglobinuria Disease Burden in Patients Enrolled in the International PNH Registry” ” —– Urbano-Ispizua et al.

ASH 2010:

““Clinical Characteristics of Classic Paroxysmal Nocturnal Hemoglobinuria (PNH) in Pediatric Patients: A Comparison With Classic PNH in Adults. An International PNH Registry Study” ” —– Urbano-Ispizua et al.

ASH 2010:

““Use of Blood Transfusions in Paroxysmal Nocturnal Hemoglobinuria Patients With and Without Aplastic Anaemia Enrolled in the Global PNH Registry” ” —– Schrezenmeier et al.

ASH 2010:

““Evaluation of Paroxysmal Nocturnal Hemoglobinuria Disease Burden: The Patient’'s Perspective. A Report From the International PNH Registry”” —– Muus et al.

ASH 2009:

““A Global Registry of Patients With Paroxysmal Nocturnal Hemoglobinuria”” —– Brodsky et al.

Enroll your patients with PNH today!

For more information, visit PNHRegistry.com or call +1.215.616.3558.

PNH Long-Term Management Brochure

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

brochure
blood cells hands

Understanding Soliris

The first and only targeted complement inhibitor approved for the treatment of patients with PNH to reduce hemolysis

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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.

 
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