Description
Uses of medication:
Trodelvy (Sacituzumab govitecan-hziy) is a Trop-2-directed ADC and topoisomerase inhibitor conjugate approved to treat adults with:
- Unresectable locally advanced or mTNBC (metastatic triple-negative breast cancer) who have previously been treated with two or more systemic therapies, at least one of them for metastatic disease.
- Unresectable locally advanced or metastatic hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have been treated with endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
- Locally advanced or metastatic urothelial cancer (mUC) who have previously been treated with platinum-containing chemo and either PD-1 (which stands for programmed death receptor-1) or PDL1 (which stands for programmed death-ligand 1 inhibitor).
Dosage: The recommended dose of Trodelvy (Sacituzumab govitecan-hziy) injection is 10 mg/kg given as an IV infusion once a week on Days 1 & 8 of 21-day therapy cycles until disease progression or in case of unacceptable toxicity. Do not administer doses of Trodelvy more than 10 mg per kg. Trodelvy needs to be administered as an intravenous (IV) infusion only. Avoid administering as an intravenous (IV) push or bolus.
First infusion: Administer intravenous (IV) infusion over three hours. Observe patients throughout the infusion and for at least 30 minutes after the initial dose in order to notice/see any sign or symptom of infusion-related reactions.
Subsequent infusions: Administer intravenous (IV) infusion over 1 to 2 hours if previous infusions were tolerated. Observe patients throughout the IV infusion and for at least 30 minutes following the IV infusion.
Treatment Reactions: The most commonly reported side effects of Trodelvy 180 mg injection are:
- decreased white blood cell
- decreased red blood cell counts
- feeling tired or weak
- hair loss
- constipation
- increased sugar levels in the blood
- decreased protein levels (albumin) in the blood
- decreased appetite
- changes in kidney function test
- increased levels of alkaline phosphatase enzyme in the blood (test for liver or bone problems)
- reduced levels of sodium, potassium, and magnesium in the blood.
Warnings and Precautions:
- Prior to Trodelvy 180 mg therapy, pre-medicate patients prevent infusion reactions and prevent chemo-induced nausea and vomiting (CINV). Premedicate with H1/H2 blockers, antipyretics prior to IV infusion, and use corticosteroids in all those with a history of infusion reactions.
- Severe, deadly, or fatal neutropenia may occur in those treated with Trodelvy. Withhold Trodelvy treatment for absolute neutrophil count (ANC) less than 1500/mm3 on Day 1 of any treatment cycle or neutrophil count less than 1000/mm3 on Day 8 of any cycle. Modifications in Trodelvy doses may be needed because of neutropenia.
- Trodelvy 200 mg treatment can cause serious diarrhea. If diarrhea occurs, evaluate for infectious causes and if negative, quickly start loperamide, 4 mg at the beginning followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide twelve hours after the diarrhea resolves.
- Critical hypersensitivity reactions including deadly anaphylactic reactions may occur in patients treated with Trodelvy. Closely assess patients for infusion-related and hypersensitivity reactions during each infusion and for at least 30 minutes after each infusion.
- Trodelvy 200 mg is emetogenic. It may cause nausea and vomiting. Additional antiemetics as well as other supportive measures may also be considered as clinically required. Patients should be given take-home drugs with clear words to prevent and treat nausea and vomiting.
