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Pluvicto Generic Name & Formulations
Legal Class
Rx
General Description
Lutetium Lu 177 vipivotide tetraxetan 1000MBq/mL (27mCi/mL); soln for IV inj or infusion; preservative-free.
Pharmacological Class
Radioligand therapeutic agent.
How Supplied
Single-dose vial (30mL)—1
Manufacturer
Generic Availability
NO
Pluvicto Indications
Indications
In adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
Pluvicto Dosage and Administration
Adult
Select patients using Locametz or another approved PSMA-11 imaging agent based on PSMA expression in tumors. Give by IV inj 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). Administer 7.4GBq (200mCi) every 6 weeks for up to 6 doses, or until disease progression, or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Pluvicto Contraindications
Not Applicable
Pluvicto Boxed Warnings
Not Applicable
Pluvicto Warnings/Precautions
Warnings/Precautions
Should be used by physicians trained and experienced in radiopharmaceuticals.
Handle with appropriate safety measures to minimize radiation exposure during and after Pluvicto. Increased risk for cancer with long-term cumulative radiation exposure. Ensure adequate hydration. Advise patients to void frequently to reduce bladder radiation. Risk for myelosuppression, renal toxicity; withhold, reduce dose, or permanently discontinue treatment based on the severity of reactions. Obtain CBCs, renal function tests (including serum creatinine, CrCl) before and during therapy. May cause temporary or permanent male infertility with the recommended cumulative dose of Pluvicto 44.4GBq. Mild or moderate renal impairment: increased risk of toxicity; monitor renal function, adverse reactions frequently. Severe renal impairment (CrCl <30mL/min) or ESRD: not studied. Embryo-fetal toxicity. Advise males (w. female partners of reproductive potential) to use effective contraception during and for 14 weeks after the last dose. Pregnancy. Nursing mothers.
Pluvicto Pharmacokinetics
See Literature
Pluvicto Interactions
Not Applicable
Pluvicto Adverse Reactions
Adverse Reactions
Fatigue, dry mouth, nausea, anemia, decreased appetite, constipation, lab abnormalities (decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, decreased sodium); hemorrhage, musculoskeletal pain, sepsis.
Pluvicto Clinical Trials
See Literature
Pluvicto Note
Not Applicable
Pluvicto Patient Counseling
See Literature
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