Trodelvy® (sacituzumab govitecan-hziy)
Preparation for Administration
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Gilead Sciences, Inc. is providing this document to you, a US Healthcare Professional, in response to your unsolicited request for medical information.
Trodelvy® (sacituzumab govitecan-hziy)
Preparation for Administration
Some data may be outside of the US FDA-approved Prescribing Information. In providing this data, Gilead Sciences, Inc. is not making any representation as to its clinical relevance or to the use of any Gilead product(s). For information about the approved conditions of use of any Gilead drug product, please consult the FDA approved prescribing information.
The full indication, important safety information, and boxed warnings for neutropenia and diarrhea are available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.
Summary
- SG is supplied as a single-dose 180 mg vial. Store vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light until time of reconstitution. Do not freeze.
- Calculate the required dose (mg) of SG based on the patient’s current body weight.
- Please note that the reconstitution and dilution instructions provided in the SG US FDA-approved Prescribing Information should be followed. Gilead cannot support the use of SG under circumstances where reconstitution and/or dilution are not consistent with the US FDA-approved Prescribing Information.
Additional Preparation for Administration Information2
• An example of dose preparation calculations for a sample patient are shown below.
Product Labeling1
Please note that the reconstitution and dilution instructions provided in the SG US FDA-approved Prescribing Information should be followed. Gilead cannot support the use of SG under circumstances where reconstitution and/or dilution are not consistent with the US FDA-approved Prescribing Information.
Dosage and Administration
Recommended Dosage
Administer SG as an intravenous infusion only. Do not administer as an intravenous push or bolus.
Preparation and Administration
Reconstitution
• SG is a hazardous drug.
• Follow applicable special handling and disposal procedures.
• Calculate the required dose (mg) of SG 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 SG 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 SG infusion solution.
Dilution
• Calculate the required amount of the reconstituted SG 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 SG 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 SG 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 SG concentration following the addition of the calculated amount of reconstituted SG solution.
• Withdraw the calculated amount of the reconstituted SG 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 SG solution into the infusion bag. Do not shake the contents.
• If not used immediately, the infusion bag containing SG 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.
How Supplied/Storage and Handling
SG for injection is a sterile, off-white to yellowish lyophilized powder in a single-dose vial. Each SG 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.
SG is a hazardous drug. Follow applicable special handling and disposal procedures.
Additional Preparation for Administration Information2
Table 1 below illustrates SG dose preparation for a sample subject as an example for illustration purposes only. All handling, use, and storage of SG should comply with institutional guidelines and follow the clinical judgment of the managing healthcare professional. Clinical professional judgement and local practices/Institutional guidelines regarding safety precautions should be used.
Table 1. Sample SG Dose Preparation: Sample Patient (58 kg), Reconstituted Vial Containing 10 mg/mL and Using a 250-mL Infusion Bag2
Sample Preparation for 10mg/kg Dosing (Sample Patient Weighing 58 kg) | |||
| Action | Example | Result |
Step 1 | Calculate total dose | 58 kg × 10 mg/kg | 580 mg dose |
Step 2 | Reconstitute the required number of vials by adding 20 mL normal saline to each | Add 20 mL to each vial |
Approximately 20 mL of 10 mg/mL reconstituted SG solution in each vial |
Step 3 | Calculate required volume (number of mL’s needed) of reconstituted SG solution to equal desired dose | 580 mg dose ÷ 10 mg/mL | 58 mL |
Step 4 | Select sterile normal saline infusion bag of appropriate volume | 250 mL for 580 mg dose (within 1.1–3.4 mg/mL ratio) | 250 mL infusion bag selected |
Step 5 | Withdraw volume from the infusion bag equivalent to the volume of reconstituted SG solution to be added | Remove 58 mL from 250 mL normal saline infusion bag | 192 mL normal saline remaining in the infusion bag |
Step 6 | Slowly transfer the calculated amount of reconstituted SG solution into the infusion bag and gently mix | 58 mL SG solution + 192 mL normal saline |
250 mL total volume |
Step 7 | Verify final concentration is within the range of 1.1–3.4 mg/mL | 580 mg ÷ 250 mL | 2.32 mg/mL |
Abbreviations: normal saline=0.9% Sodium Chloride Injection, USP.
References
2. Gilead Sciences Inc. Data on File.
Product Label
For the full indication, important safety information, and boxed warning(s), please refer to the Trodelvy US Prescribing Information available at:
www.gilead.com/-/media/files/pdfs/medicines/oncology/trodelvy/trodelvy_pi.
Follow-Up
For any additional questions, please contact Gilead Medical Information at:
☎1‐888-983-4668 or www.askgileadmedical.com
Adverse Event Reporting
Please report all adverse events to:
Gilead Global Patient Safety ☎ 1-800-445-3235, option 3 or
www.gilead.com/utility/contact/report-an-adverse-event
FDA MedWatch Program by ☎ 1-800-FDA-1088 or MedWatch, FDA, 5600 Fishers Ln, Rockville, MD 20852 or www.accessdata.fda.gov/scripts/medwatch
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