Applies to siltuximab: intravenous powder for solution.
Serious side effects of Siltuximab
Along with its needed effects, siltuximab 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 siltuximab:
More common
- Black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody urine
- blurred vision
- body aches or pain
- chills
- confusion
- cough
- decreased frequency or amount of urine
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- ear congestion
- fever
- full or bloated feeling
- headache
- increased thirst
- loss of appetite
- loss of voice
- lower back or side pain
- nasal congestion
- nausea
- pinpoint red spots on the skin
- pressure in the stomach
- rapid weight gain
- runny nose
- sneezing
- sore throat
- stomach pain
- sweating
- swelling of the abdominal or stomach area
- tingling of the hands or feet
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
Less common
- Back pain
- chest pain or discomfort
- dizziness
- dry mouth
- fainting
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- flushing or redness of the skin
- lightheadedness
- rapid breathing
- redness of the face, neck, arms, and occasionally, upper chest
- sunken eyes
- unusually warm skin
- wrinkled skin
Rare
- Difficulty with swallowing
- hives, itching, or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
Other side effects of Siltuximab
Some side effects of siltuximab 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
- difficulty with moving
- joint pain, stiffness, or swelling
- muscle pain or stiffness
- rash with flat lesions or small raised lesions on the skin
Less common
- Darkening of the skin
- decreased appetite
- dry skin
- skin rash, encrusted, scaly, and oozing
For Healthcare Professionals
Applies to siltuximab: intravenous powder for injection.
General
The most common adverse reactions were pruritus, weight gain, rash, hyperuricemia, and upper respiratory tract infection.[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (63%), nasopharyngitis (13%)
Common (1% to 10%): Lower respiratory tract infection, oropharyngeal pain[Ref]
Dermatologic
Very common (10% or more): Rash (28%), pruritus (28%), eczema
Common (1% to 10%): Skin hyperpigmentation, psoriasis, dry skin[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (32%), abdominal pain/abdominal distention (12%), oropharyngeal pain, nausea, vomiting, constipation, gastroesophageal reflux disease, mouth ulceration
Frequency not reported: Gastrointestinal perforation[Ref]
Metabolic
Very common (10% or more): Weight gain (19%), hyperuricemia (11%), localized edema
Common (1% to 10%): Hypertriglyceridemia, hypercholesterolemia, decreased appetite, dehydration[Ref]
Cardiovascular
Very common (10% or more): Edema (26%), hypertension
Common (1% to 10%): Hypotension[Ref]
Hypersensitivity
Common (1% to 10%): Anaphylactic reaction[Ref]
Other
Very common (10% or more): Fatigue (21%)[Ref]
Musculoskeletal
Very common (10% or more): Pain in extremities (21%), arthralgia (21%)[Ref]
Renal
Common (1% to 10%): Renal impairment[Ref]
Hematologic
Very common (10% or more): Thrombocytopenia, neutropenia[Ref]
Nervous system
Very common (10% or more): Headache, dizziness[Ref]
Immunologic
Uncommon (0.1% to 1%): Positive test for anti-siltuximab antibodies[Ref]
Local
Common (1% to 10%): Infusion related reactions (e.g., back pain, chest pain/discomfort, nausea, vomiting, flushing, erythema, palpitations)[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection[Ref]
