TRODELVY Powder for solution for infusion Ref.[28090] Active ingredients: Sacituzumab govitecan

Trodelvy must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies and administered in an environment where full resuscitation facilities are available.

Posology

The recommended dose of sacituzumab govitecan is 10 mg/kg body weight administered as an intravenous infusion once weekly on Day 1 and Day 8 of 21-day treatment cycles. Treatment should be continued until disease progression or unacceptable toxicity.

Prevention treatment

Prior to each dose of sacituzumab govitecan, treatment for prevention of infusion-related reactions and prevention of chemotherapy-induced nausea and vomiting (CINV) is recommended (see section 4.4).

Prophylaxis for Neutropenia

Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) should be considered starting in the first cycle in patients at increased risk of febrile neutropenia (see section 4.4).

Dose modifications for adverse reactions

Management of adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of sacituzumab govitecan. The recommended dosage reduction schedule is presented in Table 1 and the recommended dosage modifications for adverse reactions are provided in Table 2. The sacituzumab govitecan dose should not be re-escalated after a dose reduction for adverse reactions has been made.

Table 1. Dosage Reduction Schedule:

Table 2. Recommended dose modifications for adverse reactions:

Special populations

Elderly

No dose adjustment is required in patients ≥65 years old. Data from sacituzumab govitecan in patients ≥75 years are limited.

Hepatic impairment

No adjustment to the starting dose is required when administering sacituzumab govitecan to patients with mild hepatic impairment (bilirubin ≤1.5 upper limit of normal [ULN] and aspartate aminotransferase [AST]/alanine aminotransferase [ALT] <3 ULN).

The safety of sacituzumab govitecan in patients with moderate or severe hepatic impairment has not been established. Sacituzumab govitecan has not been studied in patients with any of the following: serum bilirubin >1.5 ULN, or AST or ALT >3 ULN in patients without liver metastases, or AST or ALT >5 ULN in patients with liver metastases. The use of sacituzumab govitecan should be avoided in these patients.

Renal impairment

No adjustment to the starting dose is required when administering sacituzumab govitecan to patients with mild or moderate renal impairment.

Sacituzumab govitecan has not been studied in patients with severe renal impairment or end-stage renal disease (Creatinine Clearance [CrCl] <15 mL/min).

Paediatric population

The safety and efficacy of sacituzumab govitecan in children aged 0 to 18 years have not been established. No data are available.

Method of administration

Sacituzumab govitecan is for intravenous use only. It must be reconstituted and diluted by a healthcare professional experienced in the handling of anti-cancer therapies. It must be administered as an intravenous infusion, not as an intravenous push or bolus.

First infusion: the infusion should be administered over a period of 3 hours.

Subsequent infusions: the infusion should be administered over a period of 1 to 2 hours if prior infusions were tolerated.

Patients have to be observed during each infusion and for at least 30 minutes after each infusion for signs or symptoms of infusion-related reactions (see section 4.4).

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

In clinical studies, doses of up to 18 mg/kg (approximately 1.8 times the maximum recommended dose of 10 mg/kg body weight) led to a higher incidence of severe neutropenia.

In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, in particular severe neutropenia, and appropriate treatment instituted.

Unopened vial:

3 years.

After reconstitution:

The reconstituted solution should be used immediately to prepare the diluted solution for infusion. If not used immediately, the infusion bag containing diluted solution can be stored in a refrigerator (2°C to 8°C) for up to 24 hours protected from light.

Store in a refrigerator (2°C-8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Type I colourless, clear glass 50 mL vial, with an elastomeric butyl stopper and sealed with an aluminum flip-off overseal containing 200 mg of sacituzumab govitecan.

Each pack contains one vial.

Trodelvy is a cytotoxic medicinal product. Applicable special handling and disposal procedures have to be followed.

Reconstitution:

• Calculate the required dose (mg) of Trodelvy based on the patient's body weight.
• Using a sterile syringe, slowly inject 20 mL of sodium chloride 9 mg/mL (0.9%) solution for injection into each vial. The resulting concentration will be 10 mg/mL.
• Gently swirl vials and allow to dissolve for up to 15 minutes. Do not shake. The product should be inspected visually for particulate matter and discoloration prior to administration. The solution should be free of visible particulates, clear and yellow. Do not use the reconstituted solution if it is cloudy or discoloured.
• Use immediately to prepare a diluted solution for infusion.

Dilution:

• Calculate the required volume of the reconstituted 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 sacituzumab govitecan concentration range of 1.1 mg/mL to 3.4 mg/mL.
• Withdraw and discard a volume of sodium chloride 9 mg/mL (0.9%) solution for injection from the final infusion bag that is equivalent to the required volume of the reconstituted solution.
• Withdraw the calculated amount of the reconstituted solution from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).
• To minimize foaming, slowly inject the required volume of reconstituted solution into a polyvinyl chloride, polyolefin (polypropylene and/or polyethylene) or ethylene vinyl acetate infusion bag. Do not shake the contents.
• If necessary, adjust the volume in the infusion bag as needed with sodium chloride 9 mg/mL (0.9%) solution for injection, to obtain a concentration of 1.1 mg/mL to 3.4 mg/mL. Only sodium chloride 9 mg/mL (0.9%) solution for injection should be used since the stability of the reconstituted product has not been determined with other infusion-based solutions.
• If not used immediately, the infusion bag containing diluted solution can be stored refrigerated 2°C to 8°C for up to 24 hours protected from light. Do not freeze. After refrigeration, administer the diluted solution at room temperature up to 25°C within 8 hours (including infusion time).

Administration:

• Administer Trodelvy as an intravenous infusion. Protect the infusion bag from light. The infusion bag should be covered during administration to the subject 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 sodium chloride 9 mg/mL (0.9%) solution for injection.

Disposal:

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.