IntravenousMetastatic castration-resistant prostate cancerAdult: In patients with prostate-specific membrane antigen (PSMA)-positive cases who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy: 7,400 megabecquerel every 6 weeks (±1 week) for up to 6 doses, or until disease progression or unacceptable toxicity occurs. Doses are given via slow IV push over approx 1-10 minutes using a disposable syringe fitted with syringe shield (with or without syringe pump), via IV infusion using gravity method (with or without infusion pump), or via IV infusion using the vial (with peristaltic infusion pump). Dose reduction, dosing interruption or discontinuation may be required according to the severity of adverse reactions. Reduced doses following an adverse reaction must be given only by the syringe method or vial method. Refer to detailed product guidelines for further information on dose adjustments and administration instructions.
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Not indicated for use in women. Mild to moderate renal impairment.
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Significant: Renal toxicity (e.g. increased blood creatinine, acute kidney injury); increased risk for cancer (long-term cumulative radiation exposure); temporary or permanent infertility in males (at cumulative dose of 44,400 megabecquerel).
Ear and labyrinth disorders: Vertigo.
Eye disorders: Dry eye.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, dysgeusia, dry mouth, abdominal pain.
General disorders and administration site conditions: Fatigue, fever, peripheral oedema.
Investigations: Weight loss, decreased serum Ca, increased serum K, decreased or increased serum Na, increased AST.
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: UTI.
Potentially Fatal: Severe myelosuppression (e.g. pancytopenia, anaemia, thrombocytopenia, leucopenia, neutropenia).
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Ensure to increase fluid intake and to urinate frequently. Minimise exposure to others after receiving treatment, limit close contact (<1 metre) with household contacts for 2 days or with children and pregnant women for 7 days; refrain from sexual activity for 7 days; sleep in a separate room from household contacts for 3 days, from children for 7 days or from pregnant women for 15 days. Men with partners of reproductive potential must use condoms for intercourse during therapy and for 14 weeks after the last dose.
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Identify patients using an approved PSMA imaging before treatment. Monitor CBC, kidney function (CrCl and serum creatinine), and LFTs (AST, ALT, alkaline phosphatase, blood serum albumin and total blood bilirubin) before and during treatment. Observe hydration status and for signs or symptoms of myelosuppression and infection.
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Description:
Mechanism of Action: Lutetium (177Lu) vipivotide tetraxetan is a radioligand therapeutic agent that contains the radioactive nuclide lutetium-177 which is linked to a small molecule that targets prostate-specific membrane antigen (PSMA), a transmembrane protein that is highly expressed in prostate cancer cells. Once lutetium (177Lu) vipivotide tetraxetan binds to PSMA-expressing cells, the β-minus emission from lutetium-177 delivers radiation to the targeted cells, as well as to surrounding cells, leading to DNA damage and subsequent cell death.
Pharmacokinetics:
Distribution: Distributed in the gastrointestinal tract, heart wall, kidneys, liver, lungs, bone marrow and salivary glands within 2.5 hours of administration. Volume of distribution: 123 L. Plasma protein binding: 60-70%.
Excretion: Mainly via kidneys. Elimination half-life: 41.6 hours.
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Store below 30°C. Do not freeze. Store in the original container to protect from ionising radiation. This is a radiopharmaceutical agent, follow applicable procedures for storing, receiving, handling, administration, and disposal in accordance with national guidelines.
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V10XX05 - lutetium (177Lu) vipivotide tetraxetan ; Belongs to the class of various therapeutic radiopharmaceuticals.
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Lutetium Lu 177 Vipivotide Tetraxetan. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 03/05/2024. Lutetium Lu 177 Vipivotide Tetraxetan. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 03/05/2024. Pluvicto 1,000 MBq/mL Solution for Injection/Infusion (Advanced Accelerator Applications [UK & Ireland] Limited). MHRA. https://products.mhra.gov.uk. Accessed 03/05/2024. Pluvicto Injection, Solution (Advanced Accelerator Applications USA, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 03/05/2024. Pluvicto Solution for Injection/Infusion 1,000 MBq/mL (Novartis Pharmaceuticals [HK] Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 03/05/2024.
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