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Soliris Side Effects

Generic name: eculizumab

Medically reviewed by Drugs.com. Last updated on Nov 30, 2023.

Note: This document contains side effect information about eculizumab. Some dosage forms listed on this page may not apply to the brand name Soliris.

Applies to eculizumab: intravenous solution.

Warning

Intravenous route (Solution)

Meningococcal infections, which may rapidly become life-threatening or fatal if not recognized and treated early, have been reported in patients treated with eculizumab. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of eculizumab, unless the risks of delaying eculizumab therapy outweigh the risk of developing a meningococcal infection. Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Eculizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the eculizumab REMS prescribers must enroll in the program. Enrollment in the eculizumab REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at solirisrems.com.

Serious side effects of Soliris

Along with its needed effects, eculizumab (the active ingredient contained in Soliris) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking eculizumab:

More common

Less common

Other side effects of Soliris

Some side effects of eculizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

More common

For Healthcare Professionals

Applies to eculizumab: intravenous solution.

Immunologic

Common (1% to 10%): Meningococcal sepsis, aspergillus infection, arthritis bacterial, oral herpes, viral infection

Uncommon (0.1% to 1%): Meningococcal meningitis, Neisseria infection, sepsis, septic shock, fungal infection, Haemophilus influenza infection, abscess, cellulitis, influenza, cystitis, gingival infection, impetigo, tooth infection

Rare (0.01% to 0.1%): Aspergillus infection, bacterial arthritis, impetigo[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, bronchitis, dyspnea, cough, nasal congestion, pharyngolaryngeal pain, rhinorrhea, pneumonia

Uncommon (0.1% to 1%): Lower respiratory tract infection, sinusitis, epistaxis, throat irritation[Ref]

Musculoskeletal

Very common (10% or more): Back pain (15%), arthralgia (17%)

Common (1% to 10%): Myalgia, muscle spasms, bone pain, neck pain, pain in extremity

Uncommon (0.1% to 1%): Trismus, joint swelling[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal pain, constipation, dyspepsia

Uncommon (0.1% to 1%): Gastrointestinal infection, peritonitis, gastroesophageal reflux disease, abdominal distension, gingival pain

Rare (0.01% to 0.1%): Gingivitis[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia, leukopenia, anemia, hemolysis

Uncommon (0.1% to 1%): Coagulopathy, red blood cell agglutination, abnormal clotting factor, anemia, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hematocrit decreased, hemoglobin decreased, thrombocytopenia, lymphopenia

Rare (0.01% to 0.1%): Hemolysis, abnormal clotting factor, red blood cell agglutination, coagulopathy[Ref]

Cardiovascular

Very common (10% or more): Hypertension (33%), hypotension (17%)

Uncommon (0.1% to 1%): Palpitation, accelerated hypertension, hematoma, hot flush, vein disorder[Ref]

Nervous system

Very common (10% or more): Headache (41%)

Common (1% to 10%): Dizziness, dysgeusia

Uncommon (0.1% to 1%): Syncope, tremor, paresthesia[Ref]

General

The most common adverse reaction was headache (occurred mostly in the initial phase) and the most serious adverse reaction was meningococcal sepsis.[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression, anxiety, insomnia, sleep disorder, abnormal dreams, mood swings[Ref]

Genitourinary

Common (1% to 10%): Proteinuria, urinary tract infection

Uncommon (0.1% to 1%): Hematuria, dysuria, spontaneous penile erection, menstrual disorder

Rare (0.01% to 0.1%): Genitourinary tract gonococcal infection[Ref]

Dermatologic

Very common (10% or more): Rash (15%), pruritus (10%)

Common (1% to 10%): Alopecia

Uncommon (0.1% to 1%): Urticaria, dermatitis, erythema, petechiae, skin depigmentation, hyperhidrosis, dry skin[Ref]

Endocrine

Uncommon (0.1% to 1%): Grave's disease[Ref]

Hepatic

Uncommon (0.1% to 1%): Jaundice[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Local

Uncommon (0.1% to 1%): Infusion site paresthesia, infusion site pain, extravasation[Ref]

Metabolic

Very common (10% or more): Hypokalemia (18%)

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Anorexia[Ref]

Ocular

Uncommon (0.1% to 1%): Vision blurred, conjunctival irritation[Ref]

Oncologic

Uncommon (0.1% to 1%): Malignant melanoma, myelodysplastic syndrome[Ref]

Other

Common (1% to 10%): Edema, chest discomfort, pyrexia, chills, fatigue, asthenia, influenza like illness

Uncommon (0.1% to 1%): Tinnitus, vertigo, feeling hot[Ref]

Renal

Uncommon (0.1% to 1%): Renal impairment[Ref]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. Soliris (eculizumab). Alexion Pharmaceuticals Inc. 2007.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.