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Reconstitution and Administration

Instructions for preparing and administering a TRODELVY infusion1

TRODELVY injection comes as a powder in a single-dose vial, packaged in a white carton.

TRODELVY for injection is a sterile, off-white to yellowish lyophilized powder in a single-dose vial. Each TRODELVY vial is individually boxed in a carton:

NDC 55135-132-01 contains one 180-mg vial

Store vials in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light until time of reconstitution. Do not freeze.

J-Code J9317: Injection, sacituzumab govitecan-hziy, 2.5 mg

Step-by-step instructions1

All handling, use, and storage of TRODELVY should comply with institutional guidelines and follow the clinical judgment of the managing healthcare professional. Clinical professional judgment and local practices/institutional guidelines regarding safety precautions should be used. 

TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures.

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Calculate the required dose of TRODELVY

  1. Calculate the required dose (mg) of TRODELVY based on the patient’s current body weight
    • Ensure the patient’s body weight is in kg for calculations (1 kg = 2.205 lb)
  2. Determine the number of vials needed. Each vial contains 180 mg
First step in preparing TRODELVY infusion is to calculate the required dose.

Reconstitute the vials

  1. 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
  2. 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
  3. Use immediately to prepare a diluted TRODELVY infusion solution
Second step in preparing TRODELVY infusion is to reconstitute the vitals.

Calculate the required amount of reconstituted TRODELVY and infusion solution needed for dilution

  1. Calculate the required amount of the reconstituted TRODELVY solution needed to obtain the appropriate dose according to the patient’s body weight
    • After reconstitution in step 2, each vial has a concentration of 10 mg/mL
  2. 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
    • For the infusion solution, only use 0.9% sodium chloride injection, USP, 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
Third step in preparing TRODELVY infusion is to calculate the required amount of solution.

Prepare the 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
Fourth step in preparing TRODELVY infusion is to prepare the infusion bag.

Withdraw the required dose of reconstituted TRODELVY

  • 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)
Fifth step in preparing TRODELVY infusion is to withdraw the required dose.

Add the reconstituted solution to the final infusion bag

  1. Slowly inject the calculated amount of reconstituted TRODELVY solution into the infusion bag to minimize foaming. Do not shake the contents
  2. Verify final concentration is within range of 1.1 mg/mL to 3.4 mg/mL
Sixth step in preparing TRODELVY infusion is to add the reconstituted solution to the final infusion bag.

TRODELVY 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
 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). Protect from light  
  • Do not freeze or shake 

Looking for a print version of these instructions?

Download the PDF 

Example calculations

The example calculations are based on a 154-lb (70-kg) patient prescribed TRODELVY at the recommended dose of 10 mg/kg. 

Scroll to see an example calculation for select steps of the process, or see USPI section 2.4 preparation and administration for complete information.

Reconstitution: Step 1a

Calculate the total dose of TRODELVY based on the patient’s current body weight in kg (1 kg = 2.205 lb)1

154 lb ÷ 2.205 ≈ 70 kg x 10 mg/kg =

700 mg of TRODELVY

Reconstitution: Step 1b

Determine the number of vials needed.1 Each vial contains 180 mg of TRODELVY

700 mg ÷ 180 mg per vial = approximately 4 vials of TRODELVY

4 vials needed

Reconstitution: Step 2

Reconstitute the vials by slowly adding 20 mL of 0.9% Sodium Chloride Injection, USP, into each vial1

Add 20 mL to each of the 4 vials1

Each vial contains overfill to compensate for liquid loss during preparation and after reconstitution. The total resulting volume delivers a concentration of 10 mg/mL1

Dilution: Step 3a

Calculate the required volume (number of mLs needed) of reconstituted TRODELVY solution for the required dose calculated in step 1a1

700 mg ÷ 10 mg/mL = 70 mL of reconstituted TRODELVY solution

Dilution: Step 3b

Select an infusion bag with the appropriate volume to deliver the required dose at a concentration of 1.1 mg/mL to 3.4 mg/mL1

700 mg ÷ 250 mL 0.9% sodium chloride = 2.8 mg/mL (within 1.1 – 3.4 mg/mL concentration range)

250-mL infusion bag selected

Dilution: Step 4

Withdraw and discard volume from the infusion bag equivalent to the volume of reconstituted TRODELVY solution to be added (calculated in step 3a)1

Withdraw and discard 70 mL from infusion bag. 250 mL – 70 mL = 180 mL 0.9% sodium chloride injection, USP remaining in the infusion bag

Dilution: Step 5

Withdraw the calculated dose of reconstituted TRODELVY from the vials1

Withdraw 70 mL of reconstituted TRODELVY

Dilution: Step 6a

Slowly transfer the TRODELVY solution into the infusion bag1

70 mL TRODELVY solution + 180 mL 0.9% sodium chloride injection, USP = 250 mL total volume in infusion bag

Dilution: Step 6b

Verify the final concentration is within the range of 1.1 mg/mL to 3.4 mg/mL1

700 mg ÷ 250 mL = 2.8 mg/mL is the final concentration of reconstituted TRODELVY solution in the infusion bag

Download the Ordering Information Sheet for a specialty distributor list and product details

Download the PDF

USP=United States Pharmacopoeia.

Reference: TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025.

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Indications

TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

  • ​Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior 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 received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Important Safety Information

Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.

Boxed Warning: neutropenia and diarrhea
  • ​TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
  • TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
Contraindications
  • Severe hypersensitivity reaction to TRODELVY.
Warnings and precautions

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. 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) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

Adverse Reactions

In the pooled safety population, the most common (≥25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

Drug Interactions

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.