Consumer medicine information

1. Why am I being given TRODELVY?

TRODELVY contains the active ingredient sacituzumab govitecan. TRODELVY is used to treat adults with a type of breast cancer known as triple-negative breast cancer, that has spread to other parts of the body or cannot be removed by surgery, and that has previously been treated with at least two therapies for breast cancer. TRODELVY is also used to treat adults with a type of breast cancer known as hormone receptor (HR)-positive and human epidermal growth factor 2 (HER2)-negative, that has previously been treated by endocrine therapy (including a CDK 4/6 inhibitor) and at least two additional other therapies for locally advanced or metastasised cancer. For more information, see Section 1. Why am I being given TRODELVY? in the full CMI.

2. What should I know before I receive TRODELVY?

Do not use if you have ever had an allergic reaction to TRODELVY or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I receive TRODELVY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TRODELVY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given TRODELVY?

TRODELVY is prepared by a healthcare professional and will be given to you in a hospital or clinic by a doctor or nurse.
Your doctor will give you TRODELVY into your vein through an intravenous (IV) line. You will receive TRODELVY once per week, on Day 1 and on Day 8 of a 21-day treatment cycle. Your doctor will decide how long you will continue to receive TRODELVY.
More instructions can be found in Section 4. How am I given TRODELVY? in the full CMI.

5. What should I know while receiving TRODELVY?

6. Are there any side effects?

The most common side effects you may feel while receiving TRODELVY include diarrhoea, nausea, constipation, vomiting, hair loss, and feeling tired. Serious side effects can include infections caused by a low white blood cell count. Call your doctor right away if you experience fever, chills, cough, shortness of breath, or burning or pain when you urinate. Other serious side effects can include allergic reactions and severe diarrhoea or vomiting that causes you to become dehydrated.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Sacituzumab govitecan.

2 Qualitative and Quantitative Composition

Each single-dose vial of Trodelvy delivers 180 mg sacituzumab govitecan.
Reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP, results in a concentration of 10 mg/mL with a pH of 6.5 (see Section 4.2 Dose and Method of Administration). The product is for use in one patient on one occasion only. Discard any unused portion.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Trodelvy is an off-white to yellowish lyophilised powder. Following reconstitution, the solution is clear and yellow.

4 Clinical Particulars

4.9 Overdose

There is no information on overdose in human clinical trials. In a clinical trial, planned doses of up to 18 mg/kg (approximately 1.8 times the maximum recommended dose of 10 mg/kg) of Trodelvy were administered. In these patients, a higher incidence of severe neutropenia was observed.
Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. SN-38 was clastogenic in an in vitro mammalian cell micronucleus test in Chinese hamster ovary cells and was not mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Carcinogenicity. Carcinogenicity studies have not been conducted with sacituzumab govitecan.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSACGOV.gif Sacituzumab govitecan is a Trop-2 directed antibody and topoisomerase inhibitor conjugate, composed of the following three components:
the humanised monoclonal antibody, hRS7 IgG1κ (also called sacituzumab), which binds to Trop-2 (the trophoblast cell-surface antigen-2);
the drug SN-38, a topoisomerase inhibitor;
a hydrolysable linker (called CL2A), which links the humanised monoclonal antibody to SN-38.
The recombinant monoclonal antibody is produced by mammalian (murine myeloma) cells, while the small molecule components SN-38 and CL2A are produced by chemical synthesis. Sacituzumab govitecan contains on average 7 to 8 molecules of SN-38 per antibody molecule. Sacituzumab govitecan has a molecular weight of approximately 160 kilodaltons.
CAS number. 1491917-83-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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