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Pluvicto

Pluvicto

Manufacturer:

Novartis

Distributor:

Global Medical Solutions
Concise Prescribing Info
Contents
Lutetium (177Lu) vipivotide tetraxetan
Indications/Uses
In combination w/ androgen deprivation therapy w/ or w/o androgen receptor (AR) pathway inhibition for the treatment of progressive prostate-specific membrane antigen (PSMA) +ve metastatic castration-resistant prostate cancer (mCRPC) in adults who have been treated w/ AR pathway inhibition & taxane-based chemotherapy.
Dosage/Direction for Use
IV Recommended treatment regimen: 7,400 MBq every 6 wk (±1 wk) for up to a total of 6 doses, unless there is disease progression or unacceptable toxicity.
Contraindications
Special Precautions
Risk from radiation exposure. Risk of myelosuppression & renal toxicity. Perform lab tests (haematology, kidney/liver function) before & during treatment. Patients should remain well hydrated & urinate frequently before & after treatment administration. Contains up to 3.9 mmol (88.75 mg) Na per vial. Minor influence on ability to drive & use machines. Not recommended in patients w/ moderate to severe renal impairment w/ baseline CrCl <50 mL/min or ESRD. Has not been studied in patients w/ moderate or severe hepatic impairment. Not indicated for use in females. Potential to cause foetal harm when administered to a pregnant woman. Potential toxic effects on male gonads & spermatogenesis. Male patients are advised not to father a child & to use a condom for intercourse during treatment & for 14 wk after the last dose. No relevant use in paed population.
Adverse Reactions
Anaemia, thrombocytopenia, leukopenia, lymphopenia; dry mouth, nausea, constipation, vomiting, diarrhoea, abdominal pain; UTI; fatigue, decreased appetite/wt. Pancytopenia; dizziness, headache, dysgeusia; dry eye; vertigo; acute kidney injury; peripheral oedema, pyrexia.
MIMS Class
Targeted Cancer Therapy
ATC Classification
V10XX05 - lutetium (177Lu) vipivotide tetraxetan ; Belongs to the class of various therapeutic radiopharmaceuticals.
Presentation/Packing
Form
Pluvicto soln for inj/infusion 1,000 MBq/mL
Packing/Price
1's
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