Lutetium Lu 177 Vipivotide Tetraxetan

Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent indicated for the treatment of men with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

• Lutetium Lu 177 vipivotide tetraxetan is available under the following different brand names: Pluvicto

Common side effects of lutetium Lu 177 vipivotide tetraxetan include:

• fatigue
• dry mouth
• nausea
• anemia
• decreased appetite
• constipation
• weight loss
• swelling of extremities
• fever
• vomiting
• diarrhea
• abdominal pain 
• urinary tract infection
• acute kidney injury
• dizziness
• headache
• changes in taste
• decreased lymphocytes, hemoglobin, leukocytes, platelets, calcium, and sodium

Serious side effects of lutetium Lu 177 vipivotide tetraxetan include:

• unusual tiredness or weakness
• pale skin
• dizziness
• shortness of breath
• unusual bleeding or bruising
• fever, chills, sore throat, or other signs of infection
• mouth sores
• increased or decreased urination
• swelling of the arms, hands, feet, ankles, or lower legs

Rare side effects of lutetium Lu 177 vipivotide tetraxetan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, solution for IV use

• 1000 MBq/mL (27 mCi/mL) single-dose vial

CRPC

Adult dosage

• 7.4 GBq (200 mCi) IV every 6 weeks for up to six doses, or until disease progression, or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Lutetium Lu 177 vipivotide tetraxetan has no noted severe interactions with any other drugs
• Lutetium Lu 177 vipivotide tetraxetan has no noted serious interactions with any other drugs
• Lutetium Lu 177 vipivotide tetraxetan has no noted moderate interactions with any other drugs
• Lutetium Lu 177 vipivotide tetraxetan has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lutetium Lu 177 vipivotide tetraxetan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lutetium Lu 177 vipivotide tetraxetan?”

Cautions

• Can cause fetal harm based on its mechanism of action
• May cause temporary or permanent infertility in men
• Radiation exposure
  • Contributes to a patient's overall long-term cumulative radiation exposure
  • Long-term cumulative radiation exposure is associated with an increased risk for cancer
  • Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment
  • Ensure that patients increase oral fluid intake, and advise patients to void as often as possible to reduce bladder radiation
  • Before a patient is released, explain the necessary radioprotection precautions to follow to minimize radiation exposure to others
  • Advise patients to limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days
  • Advise patients to refrain from sexual activity for 7 days and to sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days
• Myelosuppression
  • My cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia
  • Perform complete blood cell counts before and during treatment
  • Withhold, reduce dose, or permanently discontinue and clinically treat patients based on the severity of myelosuppression
  • Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression (eg, tiredness, weakness, pale skin, shortness of breath, bleeding or bruising more easily than normal, or difficulty to stop bleeding) or frequent infections with signs, such as fever, chills, sore throat, or mouth ulcers
• Renal toxicity
  • Can cause severe renal toxicity
  • Advise patients to remain well hydrated and to urinate frequently before and after administration
  • Perform kidney function laboratory tests, including serum creatinine and calculated creatinine clearance, before and during treatment
  • Withhold, reduce dose, or permanently discontinue based on the severity of renal toxicity

Pregnancy and Lactation

• Data are not available for use in pregnant women; can cause fetal harm based on its mechanism of action
• No animal studies have been conducted to evaluate its effect on women's reproduction and embryo-fetal development; however, all radiopharmaceuticals have the potential to cause fetal harm
• Contraception
  • Based on its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 14 weeks after the last dose
• Infertility
  • Cumulative dose of 44.4 GBq results in a radiation-absorbed dose to the testes within the range that may cause temporary or permanent infertility
• Lactation
  • There are no data on the presence of human milk or its effects on breastfed children or milk production