Note: This document contains side effect information about basiliximab. Some dosage forms listed on this page may not apply to the brand name Simulect.
Applies to basiliximab: intravenous powder for solution.
Warning
Intravenous route (Powder for Solution)
Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe basiliximab. The physician responsible for basiliximab administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
Serious side effects of Simulect
Along with its needed effects, basiliximab (the active ingredient contained in Simulect) 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 as soon as possible if any of the following side effects occur while taking basiliximab:
More common
- Abdominal pain
- back pain
- coughing
- dizziness
- fever or chills
- loss of energy or weakness
- painful urination
- shortness of breath
- sore throat
- swelling of the ankles, body, face, feet or lower legs
- trembling or shaking of the hands or feet
- vomiting
- white patches in the mouth or throat or on the tongue
Less common
- Abnormal vision
- agitation
- anxiety
- bleeding, tender, or enlarged gums
- blood in the stool
- bruising
- chest pain
- depression
- difficulty in urinating
- fatigue
- itching
- numbness or pain in the legs
- skin rash
- sores in the mouth
- “stocking and gloves” sensation of the hands or feet
- tingling
Other side effects of Simulect
Some side effects of basiliximab 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
- Acne
- constipation
- diarrhea
- headache
- heartburn
- nausea
- trouble in sleeping
- weight gain
Less common
- Excessive hair growth
- joint pain
- muscle pain
For Healthcare Professionals
Applies to basiliximab: intravenous powder for injection.
Cardiovascular
Very common (10% or more): Peripheral edema (29%), hypertension (27%), general edema (21%)
Common (1% to 10%): Chest pain, face edema, leg edema, abnormal heart sounds, angina pectoris, cardiac failure, hypotension, arrhythmia, atrial fibrillation, tachycardia
Postmarketing reports: Capillary leak syndrome[Ref]
Hematologic
Very common (10% or more): Anemia (26%)
Common (1% to 10%): Hematoma, hemorrhage, purpura, thrombocytopenia, thrombosis, polycythemia, leukopenia
Hypersensitivity
Postmarketing reports: Severe acute hypersensitivity reactions (including anaphylaxis)
Immunologic
Very common (10% or more): Infection, sepsis
Postmarketing reports: Cytokine release syndrome
Musculoskeletal
Common (1% to 10%): Arthralgia, arthropathy, back pain, bone fracture, cramps, hernia, myalgia, leg pain
Ocular
Common (1% to 10%): Cataract, conjunctivitis, abnormal vision
Metabolic
Very common (10% or more): Hyperkalemia (22%), hypercholesterolemia (11%), hypokalemia, hyperglycemia, hypophosphatemia, hyperuricemia
Common (1% to 10%): Acidosis, dehydration, diabetes mellitus, fluid overload, hyperlipidemia, hypertriglyceridemia, hypocalcemia, hypoglycemia, hypomagnesemia, hypoproteinemia, weight increase
Psychiatric
Very common (10% or more): Insomnia (24%)
Common (1% to 10%): Agitation, anxiety, depression
Genitourinary
Very common (10% or more): Urinary tract infection (46%)
Common (1% to 10%): Unspecified bladder disorders, genital edema, impotence, ureteral disorder, urinary retention, oliguria
Respiratory
Very common (10% or more): Upper respiratory tract infection (20%), rhinitis, dyspnea
Common (1% to 10%): Bronchitis, bronchospasm, abnormal chest sounds, coughing, pharyngitis, pneumonia, pulmonary disorder, pulmonary edema, rhinitis, sinusitis
Postmarketing reports: Respiratory failure
Other
Very common (10% or more): Pain (42%), fever (20%)
Common (1% to 10%): Asthenia, malaise
Nervous system
Very common (10% or more): Headache (24%), tremor (19%)
Common (1% to 10%): Rigors, dizziness, neuropathy, paresthesia, hypoesthesia
Renal
Common (1% to 10%): Albuminuria, bladder disorder, dysuria, frequent micturition, hematuria, increased non-protein nitrogen, abnormal renal function, renal tubular necrosis
Dermatologic
Very common (10% or more): Hypertrichosis, surgical wound complication, acne
Common (1% to 10%): Cyst, herpes simplex, herpes zoster, hypertrichosis, pruritus, rash, skin disorder, skin ulceration
Endocrine
Common (1% to 10%): Increased glucocorticoids
Gastrointestinal
Very common (10% or more): Constipation (48%), nausea (34%), abdominal pain (21%), diarrhea (21%), vomiting (20%), dyspepsia
Common (1% to 10%): Enlarged abdomen, esophagitis, flatulence, GI disorder, gastroenteritis, GI hemorrhage, gum hyperplasia, melena, moniliasis, ulcerative stomatitis
