Trodelvy Dosage

Generic name: SACITUZUMAB GOVITECAN 180mg
Dosage form: injection, powder for solution
Drug class: Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Mar 31, 2025.

Important Use Information

Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38.

Recommended Dosage

The recommended dosage of TRODELVY is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity. Do not administer TRODELVY at doses greater than 10 mg/kg.

Administer TRODELVY as an intravenous infusion only. Do not administer as an intravenous push or bolus.

First infusion: Administer infusion over 3 hours. Observe patients during the infusion and for at least 30 minutes following the initial dose, for signs or symptoms of infusion-related reactions.

Subsequent infusions: Administer infusion over 1 to 2 hours if prior infusions were tolerated. Observe patients during the infusion and for at least 30 minutes after infusion.

Premedication

Prior to each dose of TRODELVY, premedication for prevention of infusion reactions and prevention of chemotherapy-induced nausea and vomiting (CINV) is recommended.

Premedicate with antipyretics, H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist, as well as other drugs as indicated).

Prophylaxis for Neutropenia

Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) is recommended starting in the first cycle for all patients at increased risk of febrile neutropenia.

Dose Modifications for Adverse Reactions

Management of adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of TRODELVY as described in Tables 1 and 2. Do not re-escalate the TRODELVY dose after a dose reduction for adverse reactions has been made.

Table 1: Dosage Reduction Levels
Dose Level	Dosage and Schedule
Recommended starting dose	10 mg/kg once weekly on Days 1 and 8 of 21-day treatment cycles
First dose reduction	Reduce to 7.5 mg/kg
Second dose reduction	Reduce to 5 mg/kg
Requirement for further dose reduction	Permanently discontinue TRODELVY

The recommended dosage modifications for adverse reactions are provided in Table 2.

Table 2: Dose Modifications for Adverse Reactions
Adverse reactions	Severity	Dose Modification
Neutropenia	Grade 3–4 neutropenia (Absolute Neutrophil Count [ANC] <1000/mm3) or febrile neutropenia	Withhold TRODELVY until ANC ≥1500/mm3 for Day 1 dose or ANC ≥1000/mm3 for Day 8 Dose Administer G-CSF during treatment as clinically indicated. Reduce one dose level for each occurrence of febrile neutropenia or prolonged Grade 3–4 neutropenia, or discontinue according to Table 1.
Nausea/Vomiting/ Diarrhea	Grade 3–4 nausea, vomiting or diarrhea that is not controlled with antiemetics or anti-diarrheal agents	Withhold TRODELVY until resolved to ≤ Grade 1 Reduce one dose level with each occurrence, or discontinue according to Table 1.
Infusion-Related Reaction	Grade 1–3 infusion-related reactions	Slow infusion rate or interrupt the infusion
Infusion-Related Reaction	Grade 4 infusion-related reactions	Discontinue TRODELVY.
Other Toxicities	Other Grade 3–4 toxicities of any duration despite optimal medical management	Withhold TRODELVY until resolved to ≤ Grade 1 Reduce one dose level with each occurrence or discontinue according to Table 1.

Preparation and Administration

Reconstitution

TRODELVY is a hazardous drug.
Follow applicable special handling and disposal procedures1.
Calculate the required dose (mg) of TRODELVY based on the patient's current body weight.
Using a sterile syringe, slowly inject 20 mL of 0.9% Sodium Chloride Injection, USP, into each 180 mg TRODELVY vial. Each vial contains overfill to compensate for liquid loss during preparation and after reconstitution, the total resulting volume delivers a concentration of 10 mg/mL.
Gently swirl vials and allow to dissolve for up to 15 minutes. Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be free of visible particulates, clear and yellow. Do not use the reconstituted solution if it is cloudy or discolored.
Use immediately to prepare a diluted TRODELVY infusion solution.

Dilution

Calculate the required amount of the reconstituted TRODELVY solution needed to obtain the appropriate dose according to the patient's body weight.
Determine the final volume of the infusion solution to deliver the appropriate dose at a TRODELVY concentration range of 1.1 mg/mL to 3.4 mg/mL.
Use 0.9% Sodium Chloride Injection, USP only since the stability of the reconstituted TRODELVY solution has not been determined with other infusion-based solutions. Use a polyvinyl chloride, polypropylene/polyethylene, polyolefin, or ethylene vinyl acetate infusion bag.
Withdraw and discard the volume of 0.9% Sodium Chloride Injection, USP from the final infusion bag that is necessary to achieve the indicated TRODELVY concentration following the addition of the calculated amount of reconstituted TRODELVY solution.
Withdraw the calculated amount of the reconstituted TRODELVY solution from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).
To minimize foaming, slowly inject the calculated amount of reconstituted TRODELVY solution into the infusion bag. Do not shake the contents.
If not used immediately, the infusion bag containing TRODELVY solution can be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours protected from light. After refrigeration, administer diluted solution at room temperature up to 25°C (77°F) within 8 hours (including infusion time).

Do Not Freeze or Shake.

Administration

Administer TRODELVY as an intravenous infusion. Protect infusion bag from light. The infusion bag should be covered during administration to the patient until dosing is complete. It is not necessary to cover the infusion tubing or to use light-protective tubing during the infusion.
An infusion pump may be used.
Do not mix TRODELVY, or administer as an infusion, with other medicinal products.
Upon completion of the infusion, flush the intravenous line with 20 mL 0.9% Sodium Chloride Injection, USP.