Lutetium lu 177 vipivotide tetraxetan Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 6, 2023.

Applies to lutetium lu 177 vipivotide tetraxetan: intravenous solution.

Serious side effects

Along with its needed effects, lutetium lu 177 vipivotide tetraxetan 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

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

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]

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]