Note: This document contains side effect information about lutetium lu 177 vipivotide tetraxetan. Some dosage forms listed on this page may not apply to the brand name Pluvicto.
Applies to lutetium lu 177 vipivotide tetraxetan: intravenous solution.
Serious side effects of Pluvicto
Along with its needed effects, lutetium lu 177 vipivotide tetraxetan (the active ingredient contained in Pluvicto) 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 lutetium lu 177 vipivotide tetraxetan:
More common
- Black, tarry stools
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- bloody or cloudy urine
- difficult, burning, or painful urination
- lower back or side pain
- pale skin
- pinpoint red spots on the skin
- rapid weight gain
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Anxiety
- chest pain or tightness
- chills
- confusion
- coughing up blood
- difficulty in breathing or swallowing
- dizziness
- fainting
- fast heartbeat
- fever
- headache
- increased menstrual flow or vaginal bleeding
- lightheadedness
- nosebleeds
- paralysis
- prolonged bleeding from cuts
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
Rare
- Blurred vision
- dark-colored urine
- irregular heartbeat
- light-colored stools
- nausea and vomiting
- stomach pain, continuing
- yellow eyes or skin
Other side effects of Pluvicto
Some side effects of lutetium lu 177 vipivotide tetraxetan 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
- Change in taste
- constipation
- decreased appetite
- diarrhea
- dry mouth
- loss of taste
For Healthcare Professionals
Applies to lutetium lu 177 vipivotide tetraxetan: intravenous solution.
General
The most common adverse reactions reported with this drug (plus best standard of care) were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation; the most common laboratory abnormalities that worsened from baseline were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. Serious adverse reactions included hemorrhage, musculoskeletal pain, sepsis, anemia, urinary tract infection, acute kidney injury, pneumonia, pancytopenia, pyrexia, spinal cord compression, and pulmonary embolism; fatal adverse reactions included sepsis, pancytopenia, hepatic failure, intracranial hemorrhage, subdural hematoma, ischemic stroke, coronavirus disease 2019 (COVID-19), and aspiration pneumonia.[Ref]
Hematologic
Very common (10% or more): Decreased lymphocytes (up to 85%), decreased hemoglobin (up to 63%), decreased leukocytes (up to 56%), decreased platelets (up to 45%), anemia (up to 32%), decreased neutrophils (up to 28%), thrombocytopenia (up to 17%)
Frequency not reported: Pancytopenia (including bicytopenia), leukopenia (including neutropenia)[Ref]
In clinical trials, Grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with this drug. Grade 3 or higher pancytopenia (including 2 fatal events) occurred in 1.1% of patients treated with this drug. There were 2 deaths (0.4%) due to intracranial hemorrhage and subdural hematoma associated with thrombocytopenia and 1 death due to sepsis and concurrent neutropenia in patients who received this drug.[Ref]
Other
Very common (10% or more): Fatigue (up to 43%); decreased calcium (up to 39%), decreased sodium (up to 33%), increased potassium (up to 24%), weight decreased (up to 11%), increased sodium (up to 11%)
Common (1% to 10%): Peripheral edema (included peripheral edema, fluid retention, fluid overload), pyrexia, sepsis[Ref]
Gastrointestinal
Very common (10% or more): Dry mouth (included dry mouth, aptyalism, dry throat; up to 39%), nausea (up to 35%), constipation (up to 20%), vomiting (included vomiting, retching; up to 19%), diarrhea (up to 19%), abdominal pain (included abdominal pain, upper abdominal pain, abdominal discomfort, lower abdominal pain, abdominal tenderness, gastrointestinal pain; up to 11%)[Ref]
Hepatic
Very common (10% or more): Increased AST (up to 28%)
Frequency not reported: Hepatic failure[Ref]
Renal
In clinical trials, Grade 3 or 4 acute kidney injury and increased creatinine occurred in 3% and 0.9% of patients treated with this drug, respectively.[Ref]
Very common (10% or more): Increased creatinine (up to 24%)
Common (1% to 10%): Acute kidney injury (included blood creatinine increased, acute kidney injury, renal failure, blood urea increased)[Ref]
Metabolic
Very common (10% or more): Decreased appetite (up to 21%)[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection (included urinary tract infection, cystitis, bacterial cystitis; up to 12%)[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache, dysgeusia (included dysgeusia, taste disorder), spinal cord compression
Frequency not reported: Vertigo, intracranial hemorrhage, subdural hematoma, ischemic stroke[Ref]
Cardiovascular
Common (1% to 10%): Hemorrhage[Ref]
Musculoskeletal
Common (1% to 10%): Musculoskeletal pain[Ref]
Respiratory
Common (1% to 10%): Pneumonia, pulmonary embolism
Frequency not reported: COVID-19, aspiration pneumonia[Ref]
Ocular
Frequency not reported: Dry eye[Ref]
