LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN

Other

Brand names: PLUVICTO

Intravenous

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

and are considered appropriate to delay taxane-based chemotherapy

or have received prior taxane-based chemotherapy. ( 1 )

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk From Radiation Exposure : Minimize radiation exposure during and after treatment with PLUVICTO consistent with institutional good radiation safety practices and patient treatment procedures
1 Risk From Radiation Exposure 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
One death occurred due to bone marrow failure during long-term follow-up in a patient who received PLUVICTO

Known Side Effects

4 documented side effects by frequency

Fatigue

0.1-1%

Nausea

0.1-1%

General Unwellness

0.1-1%

Diarrhea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous