Well-Established Safety Profile1

Data from 20 clinical studies, 610 patients and 4 indications1

Adverse Reactions

Adverse Reactions Reported in 610 Patients Included in Overall SOLIRIS®
Clinical Trials, Including Patients with PNH, atypical HUS, gMG and NMOSD

MedDRA system
organ class		 Very Common
(≥1/10)		 Common
(≥1/100 to <1/10)		 Uncommon
(≥1/1,000 to <1/100)
Infection and infestations Nasopharyngitis,
Upper respiratory tract infection,
Urinary tract infection,
Influenza		 Bronchitis,
Sinusitis,
Viral infection,
Oral herpes,
Pneumonia,
Cystitis,
Lower respiratory tract infection,
Cellulitis,
Infection,
Fungal infection,
Gastrointestinal infection,
Tooth infection,
Sepsis		 Meningococcal infection,a
Gingivitis,
Septic shock,
Abscess,
Haemophilus infection,
Peritonitis,
Genitourinary tract gonococcal
infection,
Impetigo
Neoplasms benign, malignant and unspecified (including cysts and polyps) Malignant melanoma,
Myelodysplastic syndrome
Blood and lymphatic system disorders Anemia,
Leukopenia,
Hemolysis,
Thrombocytopenia,
Lymphopenia		 Coagulopathy,
Abnormal clotting factor,
Red blood cell agglutination
Immune system disorders Hypersensitivity
Endocrine disorders Basedow's disease
Metabolism and nutrition disorders Decreased appetite
Psychiatric disorders Insomnia,
Depression,
Anxiety		 Sleep disorder,
Abnormal dreams,
Mood swings
Nervous system disorders Headache,
Dizziness		 Paresthesia,
Syncope,
Dysgeusia		 Tremor
Eye disorders Vision blurred Conjunctival irritation
Ear and labyrinth disorders Vertigo,
Tinnitus
Cardiac disorders Palpitations
Vascular disorders Hypertension,
Hematoma,
Hypotension		 Hot flush,
Accelerated hypertension,
Vein disorder
Respiratory, thoracic and mediastinal disorders Cough,
Oropharyngeal pain		 Epistaxis,
Dyspnea,
Rhinorrhea,
Nasal congestion,
Throat irritation
Gastrointestinal disorders Diarrhea,
Nausea,
Vomiting,
Abdominal pain		 Constipation,
Dyspepsia,
Abdominal distension,
Gastroesophageal reflux disease		 Gingival pain
Hepatobiliary disorders Jaundice
Skin and subcutaneous tissue disorders Rash,
Pruritus,
Alopecia,
Dry skin,
Erythema,
Urticaria,
Dermatitis,
Hyperhidrosis,
Petechiae		 Skin depigmentation
Musculoskeletal and connective tissue disorders Back pain,
Arthralgia,
Pain in extremity,
Myalgia		 Muscle spasms,
Neck pain,
Joint swelling,
Bone pain		 Trismus
Renal and urinary disorders Renal impairment,
Dysuria,
Hematuria
Reproductive system and breast disorders Menstrual disorder,
Spontaneous penile erection
General disorders and administration site conditions Pyrexia,
Fatigue		 Influenza like illness,
Chest pain,
Asthenia,
Chills,
Chest discomfort,
Edema		 Feeling hot,
Infusion site pain,
Extravasation,
Injection site paresthesia
Investigations Alanine aminotransferase increased Gamma-glutamyl transferase increased,
Hemoglobin decreased,
Aspartate aminotransferase increased,
Hematocrit decreased
Injury, poisoning and procedural complication Infusion related reaction
aMeningococcal infection includes the following group of PTs: Meningococcal sepsis, Meningococcal meningitis, Neisseria infection
Consistent Safety Profile

Common adverse reactions reported in the REGAIN trial were consistent with those previously reported1

ADVERSE REACTIONS REPORTED IN ≥5% OF SOLIRIS®-TREATED PATIENTS IN THE REGAIN STUDY AND AT A GREATER FREQUENCY THAN IN PLACEBO-TREATED PATIENTS1

SOLIRIS®
(n=62)
n (%)		 Placebo
(n=63)
n (%)
Gastrointestinal disorders
Abdominal pain 5 (8) 3 (5)
General disorders and administration site conditions
Peripheral edema 5 (8) 3 (5)
Pyrexia 4 (7) 2 (3)
Infections and Infestations
Herpes simplex virus infections 5 (8) 1 (2)
Injury, Poisoning, and Procedural Complications
Contusion 5 (8) 2 (3)
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal pain 9 (15) 5 (8)
Rates of common adverse events in the OLE
were consistent with the REGAIN study2
See how consistent dosing with Soliris works

Abbreviations: AChR+= anti-acetylcholine receptor antibody-positive; gMG=generalized myasthenia gravis; MG=myasthenia gravis; OLE=open-label extension; QoL=quality of life

REGAIN was a 6-month randomized, placebo-controlled study of the efficacy and tolerability of SOLIRIS® in adults with refractory* AChR+ gMG who continued their established IST regimens with no changes permitted.1,2

During the REGAIN OLE, all participants received open-label SOLIRIS® and adjustments of concomitant IST regimens were permitted at the investigators' discretion (although they were not required by the study protocol).1

*Refractory is defined as an inadequate response to ISTs, requirement for maintenance intravenous immunoglobulin or plasma-exhange treatment, or experience of intolerable IST-associated adverse events

SOLIRIS® (eculizumab) is indicated in adult patients with generalized Myasthenia Gravis (gMG).

SOLIRIS® was studied in clinical trials in patients who were anti-acetylcholine receptor (AChR) antibody positive and refractory, defined as failure of treatment with two or more immunosuppressive therapies (ISTs) either in combination or as monotherapy, or failed at least one IST and required chronic plasmapheresis, plasma exchange (PE), or intravenous immunoglobulin (IVIg) to control symptoms. Patients continued to receive standard therapy throughout the pivotal clinical trial.

SOLIRIS® should be administered by a qualified healthcare professional.

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Cases of serious or fatal meningococcal infections have been reported in patients treated with SOLIRIS®. Meningococcal infections may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current National Advisory Committee on Immunization (NACI) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • All patients must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating SOLIRIS®, unless the risks of delaying SOLIRIS® therapy outweigh the risks of developing a meningococcal infection; revaccinate according to current medical guidelines for vaccine use.
  • All patients must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.

Vaccination may not prevent all meningococcal infections.

Contraindications

Do not initiate SOLIRIS® therapy in patients:

  • With unresolved Neisseria meningitidis infection.
  • Who are not currently vaccinated against Neisseria meningitidis (unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination).
1. SOLIRIS® Product Monograph. Alexion Pharmaceuticals Inc. March 25, 2021.
2. Nowak RJ, et al. Concomitant immunosuppressive therapy use in eculizumab-treated adults with generalized myasthenia gravis during the REGAIN open-label extension study. Front Neurol. 2020;11:556104.