Applies to basiliximab: intravenous powder for solution.

Serious side effects of Basiliximab

Along with its needed effects, basiliximab 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 Basiliximab

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