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Sacituzumab (certolizumab lyophilized powder injection) instruction manual
[Trademark]: Trodelvy
[Chinese name]: sacituzumab govitecan-hziy
[English name]: sacituzumab govitecan-hziy injection
[Specification]: 180mg/dose
[Properties]: Sterile, preservative-free off-white to light yellow freeze-dried powder, for intravenous infusion, packed in a 50ml transparent glass single-dose bottle, equipped with a rubber stopper and crimped and sealed with an aluminum flip-top.
【Storage】: Store together with the original dosage bottle in the refrigerator at 2°C to 8°C (36°F to 46°F). Please store in closed light. Do not freeze or shake.
[Trodelvy (sacituzumab govitecan-hziy) indications and uses]
For adult patients with metastatic triple-negative breast cancer (mTNBC) who have been previously treated with at least two therapies.
[Trodelvy (sacituzumab govitecan-hziy) dosage and administration]
1. This drug is a prescription drug and an intravenous infusion; it needs to be prepared and administered by professional medical staff.
2. Give this medicine once a week on the 1st and 8th day of the 21-day treatment cycle.
3. The infusion time of the first dose should exceed 3 hours. If the patient can tolerate the first dose well, the subsequent infusion time can be controlled to 1 to 2 hours.
4. Before each administration, drug treatment is required to prevent infusion reactions, such as nausea and vomiting.
5. Patients need to be monitored for adverse reactions during and for at least 30 minutes after each infusion.
6. If the patient has an infusion-related reaction, medical staff need to slow down the infusion speed or temporarily stop the infusion; if a life-threatening infusion reaction occurs, treatment with this drug may be permanently stopped.
7. The length of treatment is determined by medical staff.
[Trodelvy (sacituzumab govitecan-hziy) dosing preparation]
1. Calculate the required volume of the drug solution to obtain an appropriate dose based on the patient's weight. Use a syringe to remove this amount from the vial. Discard any unused portion remaining in the vial.
2. Slowly inject the required volume of Trodelvy (sacituzumab govitecan-hziy) solution into the polypropylene (PP) infusion bag to minimize foaming. Do not shake.
3. Use 0.9% Sodium Chloride Injection (USP) to adjust the volume in the infusion bag as needed to obtain a concentration of 1.1 mg/mL to 3.4 mg/mL (the total volume should not exceed 500 mL). For patients weighing more than 170 kg, divide the total dose of this drug evenly between two 500 mL infusion bags and administer them sequentially by slow infusion.
4. Only 0.9% Sodium Chloride Injection (USP) may be used because the stability of the reconstituted product has not been established with other infusion-based solutions. Use diluted solution immediately. If not used immediately, infusion bags containing Trodelvy (sacituzumab govitecan-hziy) solution can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours. After refrigeration, use diluent within 4 hours (including infusion time).
[Trodelvy (sacituzumab govitecan-hziy) contraindications]
Patients allergic to any component of this drug are prohibited
[Trodelvy (sacituzumab govitecan-hziy) govitecan-hziy) Adverse reactions]
Common adverse reactions include: fatigue; reduced red blood cell count; hair loss; constipation; rash; decreased appetite; stomach area (abdominal) pain, etc.
This drug can cause serious adverse reactions, such as:
1. Neutropenia, symptoms may include: fever, cold, cough, shortness of breath, burning or pain during urination
2. Severe diarrhea
3. Severe and life-threatening allergic reactions: swelling of the face, lips, tongue, or throat; hives; rash or flushing of the skin; difficulty breathing or wheezing; dizziness, feeling weak, or fainting; chills or shaking with chills; fever, etc.
4. Nausea and vomiting
[Trodelvy (sacituzumab govitecan-hziy) warnings and precautions]
1. Neutropenia: This adverse reaction is very common and can lead to infection or even life-threatening in severe cases. During treatment, medical staff should monitor the patient's blood cell count and adjust the patient's dosage of this drug or add antibiotics in a timely manner according to the situation. Advise patients to contact their healthcare provider immediately if they develop any of the following signs of infection during treatment: fever, chills, cough, shortness of breath, burning or pain when urinating.
2. Severe diarrhea: This adverse reaction is very common. Medical staff need to monitor patients' diarrhea and take timely measures to control diarrhea, such as replenishing body fluids and electrolytes, reducing the dose of this drug or even stopping the use of this drug. Patients are advised to contact medical staff immediately if the following diarrhea conditions occur during treatment: diarrhea for the first time during treatment; black or bloody stools; symptoms of excessive loss of body fluids and salts (dehydration), such as dizziness or fainting; inability to take liquids by mouth due to nausea or vomiting; inability to control diarrhea within 24 hours, etc.
3. Serious and life-threatening allergic reactions: If any allergic reaction symptoms occur during treatment (see [Trodelvy (sacituzumab govitecan-hziy) Adverse Reactions]), advise patients to tell their medical staff immediately.
4. Nausea and vomiting: This adverse reaction is common and sometimes even serious. Therefore, drugs need to be given before each intravenous infusion to prevent nausea and vomiting. If uncontrollable nausea and vomiting occurs, the dose of this drug needs to be reduced or treatment terminated.
5. This medicine may cause female fertility problems and affect fertility.
6. Advise patients to actively inform medical staff of their medical diagnosis, including:
7. Carrying the gene of uridine diphosphate glucuronosyltransferase A1 (UGT1A1)*28. People who carry this gene are at higher risk of side effects, especially low white blood cell counts.
8. Liver problems.
9. Pregnant or planning to become pregnant. This medicine may harm an unborn baby. Healthcare professionals should check patients to see if they are pregnant before starting treatment.
① Female patients of childbearing potential should use effective contraception during treatment and for 6 months after the last dose.
② Men who have a female partner of childbearing potential should take effective contraceptive measures during treatment and within 3 months after the last injection. ③ If you unfortunately become pregnant during treatment, advise the patient to tell the medical staff immediately.
10. Currently breastfeeding or planning to breastfeed. It is not known whether this medicine passes into breast milk and could harm the baby. Do not breastfeed during treatment and for 1 month after the last dose.
[Trodelvy (sacituzumab govitecan-hziy) drug interactions]
1. UGT1A1 inhibitors: The combined use of this drug and UGT1A1 inhibitors may increase the amount of systemic exposure in patients and the incidence of adverse reactions caused by potential exposure. Avoid use with UGT1A1 inhibitors.
2. UGT1A1 inducers: Patients receiving UGT1A1 enzyme inducers at the same time can greatly reduce the in vivo exposure of this drug. Coadministration with UGT1A1 inducers should be avoided.
[Trodelvy (sacituzumab govitecan-hziy) is used in special populations]
1. It is currently unclear whether this drug is safe and effective in patients with moderate or severe liver disease.
2. It is not yet clear whether this medicine is safe and effective for children.
3. Women with childbearing potential: It may cause female fertility problems and affect fertility. This medicine may harm an unborn fetus. For details, see [Trodelvy (sacituzumab govitecan-hziy) Warnings and Precautions]
4. Breastfeeding: It is not clear whether this drug will pass into breast milk and harm the baby. Do not breastfeed during treatment and for 1 month after the last dose.
[General description of Trodelvy (sacituzumab govitecan-hziy)]
The active pharmaceutical ingredient of Trodelvy is sacituzumab Govitecan, a new and first-in-class antibody drug conjugate (ADC) drug, is conjugated from a humanized IgG1 antibody targeting the TROP-2 antigen and SN-38, the metabolic active product of the chemotherapy drug irinotecan (a topoisomerase I inhibitor). TROP-2 is a cell surface glycoprotein expressed in more than 90% of TNBC.
Metastatic triple-negative breast cancer (mTNBC) is an invasive breast cancer that specifically refers to breast cancer that expresses negative expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER-2). It is an invasive cancer with a very poor prognosis. It progresses rapidly, has an extremely poor prognosis, and has a 5-year survival rate of less than 15%. Treatment options other than traditional chemotherapy are extremely limited.
[Mechanism of action of Trodelvy (sacituzumab govitecan-hziy)]
Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate. This conjugate drug can bind to the TROP-2 antigen expressed on most breast cancer cells through antibodies, and deliver chemotherapy drugs directly to the tumor cell microenvironment.