Lutetium Lu 177 Vipivotide Tetraxetan Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 28, 2024.

Applies to lutetium lu 177 vipivotide tetraxetan: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 14 weeks after the last dose. If you think your partner has become pregnant while using this medicine, tell your doctor right away.

While receiving this medicine, you will be exposed to radiation and increase risk of cancer. If you have any questions about this, talk to your doctor.

Lutetium Lu 177 vipivotide tetraxetan will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious kidney problems. Check with your doctor right away if you have agitation, blood in the urine, coma, confusion, decreased urine output, depression, dizziness, headache, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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:

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:

For healthcare professionals

Applies to lutetium lu 177 vipivotide tetraxetan: intravenous solution.

General adverse events

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]

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]

See also:

Further information

Lutetium lu 177 vipivotide tetraxetan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer