What are the precautions for Sacituzumab govitecan?

In four studies of sacituzumab govitecan (IMMU-132-01, ASCENT, TROPiCS-02, and TROPHY), warnings and precautions such as neutropenia, diarrhea, allergic and infusion-related reactions, nausea and vomiting, reduced uridine diphosphate-glucuronosyltransferase activity, and embryo-fetal toxicity emerged.

1. Neutropenia: Severe, life-threatening, or fatal neutropenia may occur; discontinue gosatuzumab if the absolute neutrophil count falls below 1500/mm3 on day 1 of any cycle or if the neutrophil count falls below 1000/mm3 on day 8 of any cycle. Suppresses neutropenic fever. Dosage adjustments may be necessary due to neutropenia.

For patients with severe neutropenia, the dose of gosatuzumab can be tapered and granulocyte colony-stimulating factor (G-CSF) can be administered. If administration is delayed for more than 3 weeks during planned treatment, gosatuzumab treatment should be discontinued. For patients with severe non-neutropenic toxicity who develop nausea, vomiting, or diarrhea lasting more than 48 hours, the dose of gosatuzumab should be tapered and delayed for 2 or 3 weeks, and gosatuzumab treatment should be discontinued.

2. Diarrhea: Severe diarrhea can lead to excessive fluid loss (dehydration) and kidney problems. For Grade 3-4 diarrhea, discontinue T-gosatuzumab at the scheduled treatment dosing time and continue when remission is to Grade ≤ 1. During an episode of diarrhea, assess for infectious causes and, if negative, initiate loperamide immediately, 4 mg initially, then 2 mg with each subsequent diarrhea episode, up to a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (such as fluid and electrolyte replacement) may also be used if clinically indicated. Patients who exhibit an exaggerated cholinergic response to gosatuzumab treatment (e.g., abdominal cramps, diarrhea, salivation, etc.). Appropriate premedication (e.g., atropine) may be accepted for subsequent treatment.

3. Allergy and infusion-related reactions: including life-threatening allergic reactions. Severe signs and symptoms include cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonia, and skin reactions. It is recommended that patients receiving gosatuzumab take the drug before experiencing an infusion reaction. Have immediately available medications and first aid equipment to treat infusion-related reactions, including anaphylaxis, while taking gosatuzumab.

4. Nausea and vomiting: Gosatuzumab is a type of emetic, and patients use a combination of two or three drugs before surgery(e.g., dexamethasone with a 5-HT3 receptor antagonist or NK1 receptor antagonist and other drugs as indicated) to prevent chemotherapy-induced nausea and vomiting (CINV). For Grade 3 nausea or Grade 3-4 vomiting, withhold the dose of gosatuzumab at the scheduled treatment administration time and resume additional supportive measures upon resolution to grade ≤1. Additional antiemetics and other supportive measures may also be used if clinically indicated, and all patients should receive take-home medications with clear instructions for preventing and treating nausea and vomiting.

5. uridine diphosphate-Glucuronosyltransferase (UGT1A1) activity is reduced: patients homozygous for the UGT1A1*28 allele have an increased risk of neutropenia, febrile neutropenia, and anemia; and may increase the risk of other adverse reactions when treated with gosatuzumab. Monitor patients with known reduced UGT1A1 activity closely for adverse reactions.

6. Embryonic-Fetotoxicity: Based on its mechanism of action, gosatuzumab can cause teratogenesis and/or embryo-fetal lethality when administered to pregnant women. Gosatuzumab contains a genotoxic component, SN-38, which acts on rapidly dividing cells. Inform pregnant women and women of reproductive potential of the potential risks to the fetus. Advise females of childbearing potential to use effective contraception during drug treatment and for 6 months after the last dose. Due to the potential for genotoxicity, advise male patients with a female partner of reproductive potential to use effective contraception during drug treatment and for 3 months after the last dose.

Gosatuzumab The original drug has been launched in China, but it has not yet been included in the medical insurance. The price of a 100mg bottle may be around 10,000 yuan, which is relatively expensive. Gosatuzumab Original drug marketed overseas has three versions: European version, American version, and Singapore version. SpecificationsThe price of each 100 mg bottle may be around RMB 10,000-35,000 (the price may fluctuate due to exchange rates). The ingredients of gosatuzumab sold domestically and abroad are basically the same. There is currently no generic version of gosatuzumab available on the market. For specific prices and drug information, please consult your medical consultant.