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Soliris

Generic Name: eculizumab (E kue LIZ oo mab)
Brand Names: Soliris
Soliris (eculizumab) is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, the treatment of patients with atypical hemolytic uremic syndrome and the treatment of adult patients with generalized Myasthenia Gravis.
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Drug Information:
Soliris (eculizumab) is a monoclonal antibody. Eculizumab binds to proteins in the blood that can destroy red blood cells in people with genetic conditions that affect the natural defenses of red blood cells. Soliris is used to prevent the breakdown of red blood cells in adults with paroxysmal nocturnal hemoglobinuria (PNH). Soliris is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms). Learn more

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Soliris Side Effects

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

For the Consumer

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.

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

  • Back pain
  • black, tarry stools
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • burning or stinging of the skin
  • chest pain
  • cough
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • fever
  • headache
  • joint pain
  • lower back or side pain
  • muscle ache, cramp, pain, or stiffness
  • nausea
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pale skin
  • pounding in the ears
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stuffy or runny nose
  • swollen glands or joints
  • tightness of the chest
  • troubled breathing with or without exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less common

  • Chills
  • diarrhea
  • general feeling of discomfort or illness
  • loss of appetite
  • shivering
  • sweating
  • trouble sleeping
  • vomiting

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

  • Difficulty having a bowel movement
  • pain in the arms or legs

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

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

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

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

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

Cardiovascular

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

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

Nervous system

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

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

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

General

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

Psychiatric

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

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

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

Endocrine

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

Hepatic

Uncommon (0.1% to 1%): Jaundice

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction

Uncommon (0.1% to 1%): Hypersensitivity

Local

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

Metabolic

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

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Anorexia

Ocular

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

Oncologic

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

Other

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

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

Renal

Uncommon (0.1% to 1%): Renal impairment

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Soliris (www.drugs.com/soliris.html).