TRODELVY (Sacituzumab Govitecan) – mTNBC | HongKong DengYue Medicine

TRODELVY Application Scope

TRODELVY is a Trop-2-directed antibody-drug conjugate (ADC) indicated for the treatment of adult patients with:

• Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) patients who have received two or more prior systemic therapies, at least one of them for metastatic disease.

• Locally advanced or metastatic urothelial cancer (mUC) patients who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.

  

TRODELVY Characteristics

• Ingredients: Sacituzumab govitecan-hziy

• Properties:​ Sterile, preservative-free, off-white to yellowish lyophilized powder for intravenous use

• Packaging Specification:​ 50 mL clear glass single-dose vial, 80 mg of sacituzumab govitecan-hziy

• Storage:​ Store in a refrigerator at 2°C to 8°C (36°F to 46°F)

• Expiry Date: Refer to the expiration date printed on the vial label

• Executive Standard: Complies with applicable pharmaceutical standards and regulations

• Approval Number: Refer to the regulatory agency’s database for specific approval numbers

• Date of Revision: Refer to the latest prescribing information for the most recent revision date

• Manufacturer: Gilead Sciences, Inc.

Guidelines for the Use of TRODELVY

• Dosage and Administration:

  • Recommended Dose: 10 mg/kg administered as an intravenous infusion

  • Administration: Once weekly on Days 1 and 8 of 21-day treatment cycles

  • Missed Dose:​ If a dose is missed, administer as soon as possible. If the next scheduled dose is within 3 days, skip the missed dose and resume the regular dosing schedule. Do not administer two doses on the same day.

• Adverse Reactions:

  • Common Adverse Reactions: Neutropenia, anemia, diarrhea, nausea, fatigue, alopecia

  • Serious Adverse Reactions: Febrile neutropenia, severe diarrhea, interstitial lung disease, hypersensitivity reactions

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• Contraindications: Known hypersensitivity to sacituzumab govitecan-hziy or any component of the formulation

• Precautions:

  • Neutropenia: Monitor complete blood counts regularly. Withhold treatment for neutropenia and resume at a reduced dose as appropriate.

  • Diarrhea: Initiate antidiarrheal therapy promptly. Withhold treatment for severe diarrhea and resume at a reduced dose as appropriate.

  • Interstitial Lung Disease: Monitor for signs and symptoms. Withhold treatment for new or worsening pulmonary symptoms and resume at a reduced dose as appropriate.

  • Hypersensitivity Reactions: Monitor for signs of hypersensitivity during and after infusion. Discontinue treatment for severe reactions.

TRODELVY Interactions

• UGT1A1 Inhibitors: Concurrent use with UGT1A1 inhibitors may increase the risk of neutropenia. Consider dose adjustments and monitor blood counts closely.

• Other Concomitant Medications: Inform healthcare providers of all concomitant medications to assess potential interactions.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.