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.

Soliris Efficacy

Soliris: The Power to Protect

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The first and only targeted complement inhibitor to reduce hemolysis and its harmful effects in patients with PNH

  • 87% reduction in hemolysis (as measured by LDH)1,2,3,4

  • 92% reduction in thrombotic events1

    • The majority of patients (63%) received concomitant anticoagulated therapy5

    • The effect of anticoagulant withdrawal during Soliris treatment has not been studied5

  • 73% reduction in the need for transfusions across all patient populations2

  • 78% clinically meaningful improvement in fatigue; significant improvement in broad range of health-related QoL measures2,3

  • Most frequently reported adverse events were similar to placebo5

Reduction in Hemolysis

87% reduction in hemolysis as measured by LDH was sustained long term with ongoing Soliris therapy2,3,4

Results observed in all patients, across all subgroups2,4,5

Long-term reduction in hemolysis with Soliris®1,4,5,6
Long-term reduction in hemolysis with Soliris
  • Reduction in hemolysis (as demonstrated by LDH) began with the first dose, was significant within the first week, and was sustained2,3,6

  • Sustained reduction in LDH demonstrated out past 5 years6

Reduction in Thrombotic Events

92% reduction in thrombotic events was observed with Soliris®1

  • Soliris significantly reduced the number of TE events during treatment compared to events during the same length of time pretreatment1

Thrombotic event reduction with Soliris1
Thrombotic event reduction with Soliris

* The majority of patients received concomitant anticoagulant therapy. The effect of anticoagulant withdrawal during Soliris treatment was not studied. Pretreatment included 272.1 patient-years; Soliris treatment included 281.0 patient-years.1

† This 52-week EXTENSION Study (which included patients from all Soliris clinical studies) also included TRIUMPH placebo-treated patients who transitioned to Soliris treatment in the phase 3 extension study.

  • Soliris significantly reduced the number of TE events during treatment compared to events during the same length of time pretreatment1

  • TE events occurred in both venous and arterial sites1

  • TE rates prior to Soliris remained elevated in patients receiving or prophylaxed with antithrombotics1

Reduction in Transfusion Units

73% reduction in mean number of units transfused across all patient subgroups2

  • 51% of Soliris patients achieved transfusion independence vs 0% of patients not on Soliris2

Median units transfused during treatment in patients with minimal-, moderate-, and high-pretreatment transfusion needs8
Median units transfused during treatment in patients with minimal-, moderate-, and high-pretreatment transfusion needs

TRIUMPH Study: 26-week, randomized, double-blind, multicenter, placebo-controlled trial of 87 transfusion-dependent patients who received either placebo or Soliris. Patients were stratified according to the median number of packed red blood cell units transfused in the 12 months pretreatment. All patients in both arms were maintained on standard-of-care therapy.

  • 51% of Soliris patients achieved transfusion independence vs 0% of patients not on Soliris2

  • 44% reduction in transfusion requirements for Soliris patients who still required some transfusions2

  • Soliris helps stabilize hemoglobin levels by protecting against PNH red blood cell lysis2,3,4,8

    • 49% maintained hemoglobin levels without transfusions over 26 weeks2

  • Patients with concomitant bone marrow dysfunction may continue to require some transfusions, because Soliris only addresses hemolysis and not RBC production issues2,4,8,9

Improvement of FACIT-fatigue scores

Rapid, clinically meaningful improvements in fatigue2,3

TRIUMPH Study: Improvement in FACIT-fatigue* scores independent of hemoglobin2,3
TRIUMPH Study: Improvement in FACIT-fatigue scores independent of hemoglobin

TRIUMPH Study: 26-week, randomized, double-blind, multicenter, placebo-controlled trial of 87 transfusion-dependent patients who received either placebo or Soliris. Fatigue was measured using the FACIT-Fatigue scale. All patients in both arms were maintained on standard-of-care therapy.

* The FACIT (Functional Assessment of Chronic Illness Therapy) Measurement System is a collection of health-related quality of life questionnaires targeted to the management of chronic illness. In this study, patients filled out the FACIT-Fatigue instrument to indicate level of fatigue over the past 7 days.10

  • Improvements in fatigue began in the induction phase and were maintained over the long term3

  • No changes from baseline in hemoglobin levels at 26 weeks2

  • Fatigue in PNH is:

    • Often disproportionate to the nominal hemoglobin level2,11

    • Due to hemolysis independent of hemoglobin level2,11

Improvement of overall health-related Quality of Life (QoL)

Sustained improvements in overall health-related QoL3

Most patients showed improvement as early as week 3 of treatment across the following measures3

Change in the QoL during treatment *2
Scale Mean change in score from baseline to week 26† Absolute difference
Placebo Soliris®
Global health status scale -8.5 10.9 19.4
Functioning scales Role -6.9 17.9 24.8
Social 2.0 16.7 14.7
Cognitive -6.1 7.9 14.0
Physical -3.5 9.4 12.9
Emotional -3.7 7.5 11.2
Symptom scales Fatigue 10.0 -16.9 26.9
Pain 5.3 -12.3 17.6
Nausea and vomiting 2.8 -0.4 3.2
Single-item measures Dyspnea 8.9 -7.9 16.8
Loss of appetite 3.3 -10.3 13.6
Insomnia 4.9 -7.9 12.8
Financial difficulties 0.0 -10.3 10.3
Constipation 0.0 -6.3 6.3
Diarrhea 5.7 4.8 0.9

* The QoL was assessed with the EORTC QLQ-C30 instrument.

† A positive value for a score on the scales for global health status and functioning indicates improvement, whereas a negative value for a score on the symptom scales and for a score on the single-item measures indicates improvement.

Soliris is indicated for treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.*

* For full adverse reactions reported in the PNH controlled clinical trial, please see Soliris Safety Profile.

PNH Registry

A global observational, noninterventional study collecting safety, effectiveness and quality of life data on PNH

Enroll Your Patients with PNH

1.888.SOLIRIS

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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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