Lutetium (177Lu) vipivotide tetraxetan

What is Lutetium (177Lu) vipivotide tetraxetan?

• Lutetium (177Lu) vipivotide tetraxetan (Pluvicto) is a radioligand therapeutic agent used to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies.

177Lu vipivotide tetraxetan -177LU-PSMA-617

What are the uses of this medicine?

• Lutetium (177Lu) vipivotide tetraxetan (Pluvicto) is used for the treatment of adult patients 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.

How does this medicine work?

• Lutetium Lu 177 vipivotide tetraxetan is a radioligand therapeutic agent.
• The active moiety of lutetium Lu 177 vipivotide tetraxetan is the radionuclide lutetium-177 which is linked to a moiety that binds to PSMA, a transmembrane protein that is expressed in prostate cancer, including mCRPC.
• Upon binding of lutetium Lu 177 vipivotide tetraxetan to PSMA-expressing cells, the beta-minus emission from lutetium-177 delivers radiation to PSMA-expressing cells, as well as to surrounding cells, and induces DNA damage which can lead to cell death.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.

Is this medicine FDA approved?

• Lutetium (177Lu) vipivotide tetraxetan was approved for medical use in the United States in March 2022.

How should this medicine be used?

• Select patients with previously treated mCRPC for treatment with Pluvicto using LOCAMETZ or another approved PSMA-11 imaging agent based on PSMA expression in tumors.

Recommended dosage:

• The recommended Pluvicto dosage is 7.4 GBq (200 mCi) intravenously every 6 weeks for up to 6 doses, or until disease progression, or unacceptable toxicity.

Administration:

• The recommended dosage of Pluvicto may be administered intravenously as an injection using a disposable syringe fitted with a syringe shield (with or without a syringe pump), as an infusion using the gravity method (with or without an infusion pump), or as an infusion using the vial (with a peristaltic infusion pump).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 1,000 MBq/mL (27 mCi/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Pluvicto

What side effects can this medication cause?

The most common side effects of this medicine include:

• fatigue
• dry mouth
• nausea
• anemia
• decreased appetite
• constipation

Most common laboratory abnormalities are:

• decreased lymphocytes
• decreased hemoglobin
• decreased leukocytes
• decreased platelets
• decreased calcium
• decreased sodium

What special precautions should I follow?

• Pluvicto 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 during and after treatment with Pluvicto consistent with institutional good radiation safety practices and patient treatment procedures. Ensure patients increase oral fluid intake and advise patients to void as often as possible to reduce bladder radiation.
• Pluvicto can cause severe and life-threatening myelosuppression, including anemia, thrombocytopenia, leukopenia, and neutropenia. Perform complete blood counts. Withhold, reduce dose, or permanently discontinue Pluvicto and clinically treat based on severity.
• Pluvicto can cause severe renal toxicity. Advise patients to remain well hydrated and to urinate frequently. Perform kidney function laboratory tests. Withhold, reduce dose, or permanently discontinue Pluvicto based on severity.
• The safety and efficacy of Pluvicto have not been established in females. Based on its mechanism of action, Pluvicto can cause fetal harm. Advise male patients with female partners of reproductive potential to use effective contraception.
• Pluvicto may cause temporary or permanent infertility. The recommended cumulative dose of 44.4 GBq of Pluvicto results in a radiation absorbed dose to the testes within the range where Pluvicto may cause temporary or permanent infertility.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of administration of a radiation overdosage with Pluvicto, reduce the radiation absorbed dose to the patient by increasing the elimination of the radionuclide from the body by frequent micturition or by forced diuresis and frequent bladder voiding.
• Estimate the effective radiation dose that was applied and treat with additional supportive care measures as clinically indicated.

Can this medicine be used in pregnancy?

• The safety and efficacy of Pluvicto have not been established in females.
• Based on its mechanism of action, Pluvicto can cause fetal harm.
• There are no available data on Pluvicto use in pregnant females.

Can this medicine be used in children?

• The safety and effectiveness of Pluvicto in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• lutetium lu-177 vipivotide tetraxetan

Inactive ingredients:

• acetic acid
• sodium acetate
• gentisic acid
• sodium ascorbate
• pentetic acid
• water

Who manufactures and distributes this medicine?

Distributed by:

• Advanced Accelerator Applications USA, Inc.
• Millburn, NJ

What should I know about storage and disposal of this medication?

• Store below 30°C (86°F).
• Do not freeze.
• Store in the original package to protect from ionizing radiation (lead shielding).
• Store Pluvicto in accordance with local and federal laws on radioactive materials.
• Do not use Pluvicto after the expiration date and time which are stated on the label.
• Dispose of any unused medicinal product or waste material in accordance with local and federal laws.

• Dailymed label info on Lutetium (177Lu) vipivotide tetraxetan
• FDA Lutetium (177Lu) vipivotide tetraxetan