Note: This document contains side effect information about sipuleucel-T. Some dosage forms listed on this page may not apply to the brand name Provenge.
Applies to sipuleucel-T: intravenous suspension.
Serious side effects of Provenge
Along with its needed effects, sipuleucel-T (the active ingredient contained in Provenge) 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 sipuleucel-T:
More common
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- body aches or pain
- chest pain
- chills
- confusion
- cough
- diarrhea
- difficult, burning, or painful urination
- difficulty with breathing
- difficulty with speaking
- double vision
- ear congestion
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- inability to move the arms, legs, or facial muscles
- inability to speak
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- nasal congestion
- nausea
- pale skin
- rapid weight gain
- runny nose
- shivering
- shortness of breath
- slow speech
- sneezing
- sore throat
- sweating
- tightness in the chest
- tingling of the hands or feet
- trouble sleeping
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- wheezing
Other side effects of Provenge
Some side effects of sipuleucel-T 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
- Back pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased weight
- dizziness
- feeling of warmth
- lack or loss of strength
- loss of appetite
- muscle ache
- muscle or bone pain
- muscle spasms
- neck pain
- rash
- redness of the face, neck, arms, and occasionally, upper chest
- sleeplessness
- sudden sweating
- unable to sleep
- weight loss
Less common
- Shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
For Healthcare Professionals
Applies to sipuleucel-T: intravenous suspension.
Other
Very common (10% or more): Acute infusion reactions (71.2%), chills (53.1%), fatigue (41.1%), fever (31.3%)
Common (1% to 10%): Influenza-like illness, peripheral edema, hot flush
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Myocardial infarction
Postmarketing reports: Hypotension, thromboembolic events (deep vein thrombosis and pulmonary embolism)[Ref]
Musculoskeletal
Very common (10% or more): Back pain (29.6%), joint ache (19.6%), extremity pain (12.1%)
Common (1% to 10%): Musculoskeletal pain, muscle spasms, bone pain, musculoskeletal chest pain, neck pain[Ref]
Gastrointestinal
Very common (10% or more): Nausea (21.5%), vomiting (13.3%), constipation (12.3%), oral paresthesia (12.3%), diarrhea (10%)[Ref]
Nervous system
Very common (10% or more): Headache (18.1%), paresthesia (14.1%), dizziness (11.8%), muscle ache (11.8%), asthenia (10.8%)
Common (1% to 10%): Insomnia, tremor, cerebrovascular events (hemorrhagic and ischemic strokes)
Postmarketing reports: Transient ischemic attack, syncope[Ref]
Metabolic
Very common (10% or more): Citrate toxicity (14.8%)
Common (1% to 10%): Anorexia, decreased weight
Hematologic
Very common (10% or more): Anemia (12.5%)
Common (1% to 10%): Hematuria[Ref]
Respiratory
Common (1% to 10%): Dyspnea, upper respiratory tract infection, cough[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Dermatologic
Common (1% to 10%): Rash, sweating[Ref]
