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 Eculizumab
Along with its needed effects, eculizumab 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
- blindness
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning or stinging of the skin
- burning, dry, or itching eyes
- chest pain or tightness
- chills
- cough
- cough producing mucus
- diarrhea
- difficult, burning, or painful urination
- difficulty breathing or swallowing
- difficulty with moving
- dizziness
- ear congestion
- fast heartbeat
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- joint pain or swelling
- loss of appetite
- loss of voice
- 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
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- shivering
- slow or fast heartbeat
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- sweating
- swollen glands
- trouble breathing
- trouble sleeping
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- General feeling of discomfort or illness
- hoarseness
- itching, pain, redness, swelling, tenderness, or warmth on the skin
Other side effects of Eculizumab
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
- Bone pain
- constipation
- difficulty having a bowel movement
- difficulty in moving
- mouth or throat pain
- pain in the arms or legs
More common
- Bruise
- hair loss or thinning of hair
- lack or loss of strength
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]
