Consumer medicine information

Trodelvy

Sacituzumab govitecan

BRAND INFORMATION

Brand name

Trodelvy

Active ingredient

Sacituzumab govitecan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Trodelvy.

SUMMARY CMI

TRODELVY®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details.

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?

Things you should do
  • Remind any doctor, dentist, pharmacist, or surgeon you visit that you are using TRODELVY.
  • Tell your doctor right away if you develop fever, chills or feel unwell, severe diarrhoea, have black or bloody stools, experience signs of an allergic reaction, become pregnant or think you may be pregnant.
Things you should not do
  • Do not stop your TRODELVY treatment or miss any doctor's appointments without talking to your doctor first.
  • Do not take any other medicines without first telling your doctor or consulting with a pharmacist.
Driving or using machines
  • TRODELVY may cause tiredness in some people. If you feel tired, weak or dizzy, do not drive or use machines until symptoms stop.
Drinking alcohol
  • Tell your doctor if you drink alcohol. The effects of alcohol on this medicine were not assessed as part of its registration.
Looking after your medicine
  • TRODELVY will be stored in the pharmacy or on the hospital ward in a refrigerator at a temperature between 2°C and 8°C.

For more information, see Section 5. What should I know while receiving TRODELVY? in the full CMI.

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.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.



FULL CMI

TRODELVY®

Active ingredient: sacituzumab govitecan (Sah-see-TOO-zoo-mab GOH-vih-TEE-kan)

Consumer Medicine Information (CMI)

This leaflet provides important information about using TRODELVY. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TRODELVY.

Where to find information in this leaflet:

1. Why am I being given TRODELVY?
2. What should I know before I receive TRODELVY?
3. What if I am taking other medicines?
4. How am I given TRODELVY?
5. What should I know while receiving TRODELVY?
6. Are there any side effects?
7. Product details

1. Why am I being given TRODELVY?

TRODELVY contains the active ingredient sacituzumab govitecan.

TRODELVY belongs to a group of medicines known as anti-neoplastic (anti-cancer) agents. There are different classes of anti-cancer agents.

TRODELVY is designed to work differently to traditional anti-cancer agents (e.g., chemotherapy).

TRODELVY is made up of three components:

  • a monoclonal antibody that recognises and attaches to certain cancer cells, and
  • a substance intended to kill cancer cells, and
  • a linker that links the antibody to the substance.

TRODELVY is designed to target and deliver the anti-cancer substance directly to certain cancer cells to stop the growth and spread of the cancer.

TRODELVY is used to treat adults with:

  • a type of breast cancer that is oestrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer), and
    - has spread to other parts of the body or cannot be removed by surgery, and
    - has previously been treated with at least two therapies for breast cancer.
  • a type of breast cancer that is HR positive and HER2-negative. TRODELVY may be used:
    - if you previously have received endocrine therapy (including a CDK 4/6 inhibitor) and
    - if you previously have received at least two additional systemic therapies for locally advanced or metastatic disease.

2. What should I know before I receive TRODELVY?

Warnings

Do not use TRODELVY if:

  • you are allergic to sacituzumab govitecan, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • have any other medical conditions, including:
    - liver problems
    - if you have been told you carry a gene for uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

TRODELVY may cause harm to your unborn baby. You should not become pregnant during treatment with TRODELVY.

If you are a female who can become pregnant:

  • Your doctor should do a pregnancy test before you start treatment with TRODELVY.
  • You should use effective birth control (contraception) during treatment, and for 6 months after your last dose of TRODELVY.

If you are a male with a female partner who can become pregnant:

  • You should use effective birth control during treatment, and for 3 months after your last dose of TRODELVY.

Talk to your doctor if you are breastfeeding or intend to breastfeed. You must not breastfeed during treatment with TRODELVY, and for 1 month after your last dose.

TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your doctor if fertility is a concern for you.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with TRODELVY and affect how it works.

Medicines that may increase the effect of TRODELVY include:

  • Medicines that work by inhibiting an enzyme known as UGT1A1, such as atazanavir sulfate.

Medicines that may reduce the effect of TRODELVY include:

  • Medicines that work by inducing an enzyme known as UGT1A1, such as efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, and rifampicin.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TRODELVY.

4. How am I given TRODELVY?

How much is given

  • 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.
  • You will receive the first dose of TRODELVY over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours.
  • Before each dose of TRODELVY, you will receive medicines to help prevent infusion reactions, and nausea and vomiting.
  • You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of TRODELVY.
  • Your doctor may slow down or temporarily stop your infusion of TRODELVY if you have an infusion-related reaction, or permanently stop TRODELVY if you have a life-threatening infusion-related reaction.
  • Your doctor will decide how long you will continue to receive TRODELVY.

If you miss a dose of TRODELVY

As TRODELVY is given to you under the supervision of your doctor, you are unlikely to miss a dose. However, if you forget or miss your appointment to receive TRODELVY, make another appointment as soon as possible. Do not wait until your next planned appointment. Your doctor will decide when you should be given your next dose of TRODELVY.

If you are given too much TRODELVY

As TRODELVY is given to you under the supervision of your doctor, you are unlikely to be given too much. However, if you experience any side effects after receiving TRODELVY, tell your doctor or nurse immediately.

5. What should I know while receiving TRODELVY?

Things you should do

Keep all your doctor's appointments so that your progress can be checked.

Tell your doctor or pharmacist if you feel like your condition is worsening or have new side effects while you are receiving TRODELVY.

Call your doctor straight away if you:

  • Develop any signs of infection, including fever, chills, cough, shortness of breath or a burning or pain when you urinate
  • Experience diarrhoea that lasts longer than 24 hours, or makes you feel like you are losing too much body fluid (e.g., light-headedness, dizziness, faintness)
  • Have black or bloody stools
  • Experience signs of an allergic reaction, such as swelling on the face, difficulty breathing, skin rash, chills, fever or dizziness
  • Become pregnant or think you may be pregnant.

Remind any doctor, dentist or pharmacist you visit that you are being given TRODELVY. If you are going to have surgery, tell the surgeon or anaesthetist that you are being given TRODELVY.

Things you should not do

  • Do not stop your TRODELVY treatment or miss any doctor's appointments without talking to your doctor first.
  • Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting with a pharmacist.

TRODELVY may affect your fertility

Talk to your doctor if you are planning on having children.

Low white blood cell count (neutropenia)

Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening.

Your doctor should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your doctor may need to lower your dose of TRODELVY, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY.

Your doctor may need to give you antibiotic medicines if you develop fever while your white blood cell count is low.

Call your doctor right away or go straight to the Emergency Department at your nearest hospital if you develop any of the following signs of infection during treatment with TRODELVY:

  • fever
  • chills
  • cough
  • shortness of breath
  • burning or pain when you urinate.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how TRODELVY affects you.

TRODELVY may cause tiredness in some people. If you feel tired, weak or dizzy, do not drive or use machines until symptoms stop.

Drinking alcohol

Discuss alcohol use with your doctor.

Looking after your medicine

TRODELVY will be stored in the pharmacy or on the hospital ward in a refrigerator at a temperature between 2°C and 8°C.

Getting rid of any unwanted medicine

Your doctor, nurse or pharmacist will dispose of any left-over medicine.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Stomach or bowel-related:
  • Diarrhoea
  • Nausea
  • Vomiting
  • Loss of appetite
  • Constipation
  • Stomach pain
General body-related
  • Feeling tired
  • Feeling weak or low in energy
  • Dizziness or light-headedness
  • Hair loss
  • Cold hands and feet
  • Bleeding or bruising easily
Blood test-related:
  • Lower white blood cell count
  • Lower red blood cell count
  • Lower platelet count
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergic reaction:
  • Swelling of face, lips, tongue or throat
  • Difficulty breathing or wheezing
  • Skin rash or reddening of skin
  • Hives
  • Dizziness or light-headedness
  • Chills or shaking
  • Fever
Infection related to low white blood cell count (neutropenia):
  • Fever
  • Chills
  • Cough
  • Shortness of breath or pain when taking a deep breath
  • Burning or pain when you urinate
  • Infection of the lungs (pneumonia)
Stomach or bowel-related:
  • Severe diarrhoea;
    - if you have black or bloody stools
    - if you have symptoms of losing too much body fluid (dehydration) such as light-headedness, dizziness or faintness
    - if you have nausea or vomiting that stops you from drinking fluids
    - if you are not able to get your diarrhoea under control within 24 hours
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What TRODELVY contains

Active ingredient
(main ingredient)		Sacituzumab govitecan
Other ingredients
(inactive ingredients)
  • 2-N-morpholinoethanesulfonic acid monohydrate
  • Polysorbate 80
  • Trehalose dihydrate

Do not take this medicine if you are allergic to any of these ingredients.

What TRODELVY looks like

TRODELVY is an off-white to yellowish powder which is dissolved in a solution of sodium chloride before it is given. After dissolving, the TRODELVY solution is clear and yellow.

Each TRODELVY carton contains 1 vial (AUST R 353081).

Who distributes TRODELVY

Gilead Sciences Pty Ltd
Level 28, 385 Bourke Street
Melbourne, Victoria 3000

This leaflet was prepared in June 2024.

Published by MIMS August 2024

BRAND INFORMATION

Brand name

Trodelvy

Active ingredient

Sacituzumab govitecan

Schedule

S4

 

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

4.1 Therapeutic Indications

Metastatic triple‐negative breast cancer.

Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior systemic therapies, including at least one prior therapy for locally advanced or metastatic disease.

HR+/HER2‐ metastatic breast cancer.

Trodelvy is indicated for the treatment of adult patients with 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 (including a CDK4/6 inhibitor) and at least two additional systemic therapies in the locally advanced or metastatic setting.

4.2 Dose and Method of Administration

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

Pre‐medication.

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

Prevention of infusion reactions.

Give antipyretics, H1 and H2 blockers prior to infusion; corticosteroids may be used for patients who had prior infusion reactions.

Prevention of CINV.

Give a two or three drug antiemetic combination regimen (e.g. dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist, as well as other drugs as indicated).

Dosage.

The recommended dose of Trodelvy is 10 mg/kg administered as an intravenous (IV) infusion once weekly on Days 1 and 8 of 21-day treatment cycles.
Do not administer Trodelvy at doses greater than 10 mg/kg.

Duration of treatment.

Continue treatment until disease progression or unacceptable toxicity.

Dosage adjustment for adverse events.

Infusion-related reactions.

Slow or interrupt the infusion rate of Trodelvy if the patient develops an infusion-related reaction. Permanently discontinue Trodelvy for life-threatening infusion-related reactions (see Section 4.4 Special Warnings and Precautions for Use).

Dose modifications for adverse reactions.

Withhold or discontinue Trodelvy to manage adverse reactions as described in Table 1. Do not re-escalate the Trodelvy dose after a dose reduction for adverse reactions has been made.

Special populations.

Paediatric population.

The safety and effectiveness of Trodelvy in paediatric patients have not been established.

Elderly.

No dose adjustment is necessary in older patients (see Section 4.4 Special Warnings and Precautions for Use).

Renal impairment.

No dose adjustment is necessary in patients with mild or moderate renal impairment. Trodelvy has not been studied in patients with severe renal impairment, or end-stage renal disease (CLcr < 15 mL/min) (see Section 5.2 Pharmacokinetic Properties).

Hepatic impairment.

No dose adjustment is necessary in patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN, or bilirubin > 1.0 to ≤ 1.5 ULN and AST of any level). The safety of Trodelvy in patients with moderate or severe hepatic impairment has not been established, and hepatic UGT1A1 activity could be decreased in such patients. No recommendations can be made for the starting dose in these patients (see Section 4.4 Special Warnings and Precautions for Use).

Method of administration.

Administer Trodelvy as an intravenous infusion only. Do not administer as an intravenous push or bolus.
Trodelvy is a cytotoxic drug. Follow applicable special handling and disposal procedures. The product is for use in one patient on one occasion only. Discard any unused portion.
Only 0.9% Sodium Chloride Injection, USP, should be used for reconstitution and dilution as the stability of the reconstituted product has not been determined with other infusion-based solutions.
Reconstitution. Calculate the required dose (mg) of Trodelvy based on the patient's body weight at the beginning of each treatment cycle (or more frequently if the patient's body weight changed by more than 10% since the previous administration) (see Section 4.2 Dose and Method of Administration).
Allow the required number of vials to warm to room temperature.
Using a sterile syringe, slowly inject 20 mL of 0.9% Sodium Chloride Injection, USP, into each 180 mg Trodelvy vial. The resulting concentration will be 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 discoloured.
Use immediately to prepare a diluted Trodelvy infusion solution.
Dilution. Calculate the required volume of the reconstituted Trodelvy solution needed to obtain the appropriate dose according to patient's body weight. Withdraw this amount from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).
Adjust the volume in the infusion bag as needed with 0.9% Sodium Chloride Injection, USP, to obtain a concentration of 1.1 mg/mL to 3.4 mg/mL.
Slowly inject the required volume of reconstituted Trodelvy solution into a polyvinyl chloride, polyolefin (polypropylene and/or polyethylene) or ethylene vinyl acetate infusion bag to minimise foaming. Do not shake the contents.
Use the diluted solution in the infusion bag immediately. If not used immediately, the infusion bag containing Trodelvy solution can be stored refrigerated at 2°C to 8°C for up to 24 hours.
After refrigeration, administer diluted solution at room temperature up to 25°C within 8 hours (including infusion time).
Do not freeze or shake. Protect from light.
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.

First infusion.

Administer infusion over 3 hours.

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 each infusion for signs or symptoms of infusion-related reactions (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Trodelvy is contraindicated in patients who have experienced a severe hypersensitivity reaction to Trodelvy (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Neutropenia.

Trodelvy can cause severe or life-threatening neutropenia. Fatal infections in the setting of neutropenia have been observed in clinical trials with Trodelvy. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever. Dose modifications may be required due to neutropenia. Administer G-CSF as clinically indicated (see Section 4.2 Dose and Method of Administration).
Neutropenia occurred in 68% (465/688) of patients treated with Trodelvy, including Grade 3-4 neutropenia in 51% of patients. Neutropenia was the reason for dose reduction in 12% (65/688) of patients. Neutropenic colitis was observed in 1% (7/688) of patients.
Febrile neutropenia occurred in 6% (42/688) of patients treated with Trodelvy.
The median time to first onset of neutropenia (including febrile neutropenia) was 16 days and has occurred earlier in some patient populations (see Section 4.4, Use in patients with reduced UGT1A1 activity).

Diarrhoea.

Trodelvy can cause severe diarrhoea. Withhold Trodelvy for Grade 3-4 diarrhoea at the time of scheduled treatment administration and resume when resolved to ≤ Grade 1 (see Section 4.2 Dose and Method of Administration).
At the onset of diarrhoea, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhoea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhoea 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 with Trodelvy (e.g. abdominal cramping, diarrhoea, salivation, etc.) can receive appropriate premedication (e.g. atropine) for subsequent treatments.
Diarrhoea occurred in 63% (430/688) of all patients treated with Trodelvy. Grade 3 diarrhoea occurred in 10% (71/688) of all patients treated with Trodelvy. Three of 688 patients (< 1%) discontinued treatment because of diarrhoea. Diarrhoea in some cases was observed to have led to dehydration and subsequent acute kidney injury.

Hypersensitivity.

Trodelvy can cause severe and life-threatening hypersensitivity. Severe signs and symptoms include cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Anaphylactic reactions have been observed in clinical trials with Trodelvy (see Section 4.3 Contraindications).
Hypersensitivity reactions within 24 hours of dosing occurred in 33% (227/688) of patients treated with Trodelvy. Grade 3 and above hypersensitivity occurred in 2% (12/688) of patients treated with Trodelvy. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.1% (1/688).
Pre-infusion medication for patients receiving Trodelvy is recommended. Observe patients closely for infusion-related reactions during each Trodelvy infusion and for at least 30 minutes after completion of each infusion (see Section 4.2 Dose and Method of Administration). Medication to treat such reactions, as well as emergency equipment, should be available for immediate use.

Nausea and vomiting.

Trodelvy is emetogenic. Nausea occurred in 63% of all patients treated with Trodelvy and was grade 3-4 severity in 4% of patients. Vomiting occurred in 34% of all patients treated with Trodelvy and was Grade 3-4 severity in 3% of patients.
Premedicate with a two or three drug combination regimen (e.g. dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 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 at the time of scheduled treatment administration and resume with additional supportive measures when resolved to ≤ Grade 1 (see Section 4.2 Dose and Method of Administration).
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.

Use in patients with reduced UGT1A1 activity.

Individuals who are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are potentially at increased risk for neutropenia, febrile neutropenia, and anaemia and may be at increased risk for other adverse reactions when treated with Trodelvy.
The incidence of Grade 3-4 neutropenia was 60.6% (43/71) in patients homozygous for the UGT1A1*28 allele, 52.9% (144/272) in patients heterozygous for the UGT1A1*28 allele, and 49.1% (140/285) in patients homozygous for the wild-type allele. The incidence of Grade 3-4 febrile neutropenia was 14.1% (10/71) in patients homozygous for the UGT1A1*28 allele, 5.9% (16/272) in patients heterozygous for the UGT1A1*28 allele, and 4.6% (13/285) in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anaemia was 15.5% (11/71) in patients homozygous for the UGT1A1*28 allele, 7.4% (20/272) in patients heterozygous for the UGT1A1*28 allele, and 8.1% (23/285) in patients homozygous for the wild-type allele.
Compared to patients homozygous for the wild-type allele, earlier median onset of neutropenia and anaemia was observed in patients homozygous for the UGT1A1*28 allele and in patients heterozygous for the UGT1A1*28 allele.
Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate UGT1A1 reduced function (see Section 4.2 Dose and Method of Administration).

Embryo‐fetal toxicity.

Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant person. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells (see Section 5.1 Pharmacodynamic Properties). Advise patients who are pregnant, 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 (see Section 4.6 Fertility, Pregnancy and Lactation).

Use in hepatic impairment.

No adjustment to the starting dose is required when administering Trodelvy to patients with mild hepatic impairment.
The exposure of Trodelvy in patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN, or bilirubin > 1.0 to ≤ 1.5 ULN and AST of any level; n=257) was similar to patients with normal hepatic function (bilirubin and AST ≤ ULN; n=526).
The safety of Trodelvy in patients with moderate or severe hepatic impairment has not been established. Trodelvy has not been tested in patients with any of the following: serum bilirubin > 1.5 ULN, patients with AST or ALT > 3 ULN in the absence of liver metastases, or patients with AST or ALT > 5 ULN in the presence of liver metastases.
The safety of Trodelvy in patients with moderate or severe hepatic impairment has not been established. No recommendations can be made for the starting dose in these patients.

Use in the elderly.

Of the 366 patients with TNBC treated with Trodelvy, 19% of patients were 65 years and older and 3% were 75 years and older. No overall differences in safety and effectiveness were observed between patients ≥ 65 years of age and younger patients.
Of the 322 patients with HR+/HER2- breast cancer treated with Trodelvy, 26% of patients were 65 years and older and 6% were 75 years and older. No overall differences in effectiveness were observed between patients ≥ 65 years of age and younger patients. There was a higher discontinuation rate due to adverse reactions in patients aged 65 years or older (14%) compared with younger patients (3%).

Paediatric use.

Safety and effectiveness of Trodelvy have not been established in paediatric patients.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No formal drug-drug interaction studies were conducted with sacituzumab govitecan or its components.

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 (see Section 4.4 Special Warnings and Precautions for Use; Section 5.2 Pharmacokinetic Properties). Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 inducers.

Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers (see Section 4.4 Special Warnings and Precautions for Use; Section 5.2 Pharmacokinetic Properties). Avoid administering UGT1A1 inducers with Trodelvy.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility studies with sacituzumab govitecan have not been conducted. Based on findings in animals, Trodelvy may impair fertility in females of reproductive potential.
In a repeat-dose toxicity study in cynomolgus monkeys, intravenous administration of sacituzumab govitecan resulted in endometrial atrophy, uterine haemorrhage, increased follicular atresia of the ovary, and atrophy of vaginal epithelial cells at doses ≥ 60 mg/kg (1.9 times the recommended human dose of 10 mg/kg based on body surface area; and > 29 times the plasma exposure to free SN-38, based on clinical AUC at the recommended human dose).
(Category D)
Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant person. There are no available clinical data on the use of Trodelvy in pregnancy to inform the associated risk. Trodelvy contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells (see Section 5.1 Pharmacodynamic Properties).
Verify the pregnancy status of females of reproductive potential prior to the initiation of Trodelvy.
Advise patients who are pregnant, 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. Because of the potential for genotoxicity, 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.

Animal data.

There were no reproductive and developmental toxicology studies conducted with sacituzumab govitecan.
 There is no information regarding the presence of sacituzumab govitecan or SN-38 in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment and for 1 month after the last dose of Trodelvy.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration. The effects of reported adverse reactions such as fatigue and asthenia are unknown, therefore, caution is advised when driving or operating machines.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions are discussed in greater detail in Section 4.4 Special Warnings and Precautions for Use: neutropenia, diarrhoea, hypersensitivity, nausea and vomiting.

Adverse effects across clinical trials.

The data described in Section 4.4 Special Warnings and Precautions for Use reflect exposure to Trodelvy as a single agent at the recommended dose for the treatment of metastatic TNBC and HR+/HER2- breast cancer, in 688 patients across three studies: IMMU-132-01, IMMU-132-05 (ASCENT) and IMMU-132-09 (TROPiCS-02). The median duration of treatment in this pooled safety population was 4.63 months, and the most common (> 20%) adverse reactions were neutropenia, nausea, diarrhoea, fatigue, alopecia, anaemia, constipation, vomiting, decreased appetite and abdominal pain.

Adverse effects in ASCENT (TNBC).

The ASCENT study (IMMU-132-05, NCT02574455) was an international, randomised, active-controlled, open-label trial in patients with mTNBC who had previously received a taxane and at least two prior therapies. Patients were randomised (1:1) to receive either Trodelvy (n=258) or physician's choice of single agent chemotherapy (n=224) until disease progression or unacceptable toxicity (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
All patients received standard prophylaxis and treatment for chemotherapy-induced nausea and vomiting (CINV) with a 2- or 3-drug combination regimen, and take-home medications for CINV and diarrhoea.
The median duration of treatment was 4.4 months for Trodelvy (range: 0 to 23 months) and 1.3 months for single agent chemotherapy (range: 0 to 15 months).
Serious adverse reactions occurred in 27% of patients receiving Trodelvy. The most common (> 1%) serious adverse reactions in the Trodelvy group were neutropenia (7%), diarrhoea (3%), and pneumonia (3%). Fatal adverse reactions occurred in 0.8% of patients who received Trodelvy, including respiratory failure (0.4%). Adverse reactions leading to permanent discontinuation of Trodelvy occurred in 5% of patients. The most common adverse reactions leading to permanent discontinuation were pneumonia (0.8%) and fatigue (0.8%).
Adverse reactions leading to a dose reduction of Trodelvy occurred in 22% of patients. The most frequent (≥ 4%) adverse reactions leading to a dose reduction were neutropenia (11%) and diarrhoea (5%).
Adverse reactions leading to a treatment interruption of Trodelvy occurred in 63% of patients. The most frequent (≥ 5%) adverse reactions leading to a treatment interruption were neutropenia (47%), diarrhoea (5%), respiratory infection (5%) and leukopenia (5%).
Granulocyte-colony stimulating factor (G-CSF) was used in 47 of patients who received Trodelvy.
Tables 2 and 3 summarise the most common adverse reactions and haematological laboratory abnormalities, respectively, in the ASCENT study.

Adverse effects in TROPiCS‐02 (HR+/HER2‐).

The TROPiCS-02 study (IMMU-132-09) was an international, randomised, open-label trial in patients with unresectable locally advanced or metastatic HR-positive, HER2-negative (IHC 0, IHC1+, or IHC 2+/ISH-) breast cancer whose disease has progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane; patients received at least two prior chemotherapies in the metastatic setting (one of which could be in the neoadjuvant or adjuvant setting if progression or recurrence occurred within 12 months). Patients were randomised (1:1) to receive either Trodelvy or Single Agent Chemotherapy (SAC) until disease progression or unacceptable toxicity (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The median duration of treatment was 4.11 months for Trodelvy and 2.33 months for the SAC group overall.
Serious adverse reactions occurred in 28% of patients receiving Trodelvy. Serious adverse reactions in > 1% of patients receiving Trodelvy included diarrhoea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia and vomiting (each 2%). Fatal adverse reactions occurred in 2% of patients who received Trodelvy, including arrhythmia, pneumonia, COVID-19 pneumonia, septic shock, nervous system disorder, and pulmonary embolism (each 0.4%).
Adverse reactions leading to permanent discontinuation of Trodelvy occurred in 6% of patients. The most common adverse reactions leading to permanent discontinuation were neutropenia, asthenia, and general physical health deterioration (each 0.7%).
Adverse reactions leading to a dose reduction of Trodelvy occurred in 34% of patients. The most frequent (≥ 3%) adverse reactions leading to a dose reduction were neutropenia (16%), diarrhoea (8%), and febrile neutropenia and fatigue (each 3%).
Adverse reactions leading to a treatment interruption of Trodelvy occurred in 66% of patients. The most frequent (≥ 3%) adverse reactions leading to a treatment interruption were neutropenia (50%), leukopenia, anaemia and diarrhoea (each 3%).
Tables 4 and 5 summarise the most common adverse reactions and haematological laboratory abnormalities, respectively, in the TROPiCS-02 study.
Other clinically significant adverse reactions in TROPiCS-02 (≤ 10%) include: pain (5%), rhinorrhea (5%), hypocalcemia (3%), nasal congestion (3%), skin hyperpigmentation (3%), colitis or neutropenic colitis (2%), hyponatremia (2%), pneumonia (2%), proteinuria (1%), enteritis (0.4%).

Immunogenicity.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralising antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies may be misleading.
Across clinical studies in patients treated with Trodelvy, 9 (1.1%) of 785 patients developed antibodies to sacituzumab govitecan; 6 of these patients (0.8% of all patients treated with Trodelvy) had neutralizing antibodies against sacituzumab govitecan. There are insufficient data to determine the impact of immunogenicity on sacituzumab govitecan efficacy, safety, or pharmacokinetics.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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

5.1 Pharmacodynamic Properties

Trodelvy exposure-response relationships and a pharmacodynamic time-course for efficacy have not been fully characterised.

Mechanism of action.

Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate. Sacituzumab is a humanised antibody that recognises Trop-2. The small molecule, SN-38, is a topoisomerase I inhibitor, which is covalently attached to the antibody by a linker. Pharmacology data suggest that sacituzumab govitecan binds to Trop-2-expressing cancer cells and is internalised with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase I and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. Sacituzumab govitecan decreased tumour growth in mouse xenograft models of triple-negative breast cancer.

Cardiac electrophysiology.

The effect of Trodelvy on the QTc interval was assessed in a PK-ECG substudy (n=17) of the Phase 3 ASCENT study (Study IMMU-132-05). The maximum mean change from baseline was 9.7 msec (with a two-sided 90% confidence interval upper bound of 16.8 msec) at the recommended dose. A positive exposure-response relationship was observed between QTc increases and SN-38 concentrations.

Clinical trials.

Locally advanced or metastatic triple-negative breast cancer (ASCENT).

The ASCENT study (IMMU-132-05; NCT02574455) was an international Phase 3, multicentre, open-label, randomised study conducted in 529 patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who had relapsed after at least two prior chemotherapies (one of which could be in the neoadjuvant or adjuvant setting provided progression occurred within 12 months of adjuvant therapy). All patients had received previous taxane treatment in either the adjuvant, neoadjuvant, or advanced setting unless there was a contraindication or intolerance to taxanes during or at the end of the first taxane cycle. Poly-ADP ribose polymerase (PARP) inhibitors were allowed as one of the two prior chemotherapies for patients with a documented germline BRCA1/BRCA2 mutation.
Patients with previously-treated, stable brain metastases were allowed to enrol (up to a predefined maximum of 15% of the trial population). Patients with known or suspected brain metastases were required to have a brain MRI (magnetic resonance imaging) prior to enrolment. Patients with known Gilbert's disease or bone-only disease were excluded.
Patients were randomised 1:1 to receive Trodelvy 10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21-day cycle (n=267) or physician's choice of single agent chemotherapy (n=262). Single agent chemotherapy was selected by the investigator before randomisation from one of the following single-agent regimens: eribulin (n=139), capecitabine (n=33), gemcitabine (n=38), or vinorelbine (except if patient had ≥ Grade 2 neuropathy, n=52).
Patients were treated until disease progression or unacceptable toxicity. The primary efficacy endpoint was progression-free survival (PFS) in patients without brain metastases at baseline (the BM-neg subgroup) as measured by blinded, independent, centralised review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Secondary efficacy endpoints included PFS for the full population (all randomised patients, with and without brain metastases) and overall survival (OS).
The full population (n=529) was 99.6% female; 79% White; 12% Black/African American; and had a median age of 54 years (range: 27-82 years), with 81% younger than 65 years. All patients had an ECOG performance status of 0 (43%) or 1 (57%). Forty-two percent of patients had hepatic metastases; 8% were BRCA1/BRCA2 mutational status positive, and 70% were TNBC at diagnosis. Baseline brain metastases were present in 12% of patients (n=61; 32 in the Trodelvy arm and 29 in the single agent chemotherapy arm). The median number of prior systemic therapies was 4, and for 29% of patients this included an anti-PD-(L)1 agent. Thirteen percent of patients in the Trodelvy group in the full population received only 1 prior line of systemic therapy in the metastatic setting.
Efficacy results for ASCENT are summarised in Table 6, Figure 1, and Figure 2.
Efficacy results for the subgroup of patients who had received only 1 prior line of systemic therapy in the metastatic setting (in addition to having disease recurrence or progression within 12 months of neoadjuvant/adjuvant systemic therapy) were consistent with those who had received at least two prior lines in the metastatic setting.
An exploratory analysis of PFS in 61 patients with previously treated, stable brain metastases showed a stratified HR of 0.65 (95% CI: 0.35, 1.22). The median PFS in the Trodelvy arm was 2.8 months (95% CI: 1.5, 3.9) and the median PFS with single agent chemotherapy was 1.6 months (95% CI: 1.3, 2.9). Exploratory OS analysis in the same population showed a stratified HR of 0.87 (95% CI: 0.47, 1.63). The median OS in the Trodelvy arm was 6.8 months (95% CI: 4.7, 14.1) and the median OS with single agent chemotherapy was 7.5 months (95% CI: 4.7, 11.1).

Locally advanced or metastatic HR‐positive, HER2‐negative breast cancer (TROPiCS‐02).

The efficacy of Trodelvy was evaluated in a multicentre, open-label, randomised study TROPiCS-02 (IMMU-132-09) conducted in 543 patients with unresectable locally advanced or metastatic HR-positive, HER2-negative (IHC 0, IHC1+, or IHC 2+/ISH-) breast cancer whose disease has progressed after the following in any setting: a CDK 4/6 inhibitor, endocrine therapy, and a taxane; patients received at least two prior chemotherapies in the metastatic setting (one of which could be in the neoadjuvant or adjuvant setting if progression or recurrence occurred within 12 months).
Patients were randomised (1:1) to receive Trodelvy 10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21-day cycle (n=272) or SAC (n=271). SAC was determined by the investigator before randomisation from one of the following single-agent regimens: eribulin (n=130), vinorelbine (n=63), gemcitabine (n=56), or capecitabine (n=22). Randomisation was stratified based on prior chemotherapy regimens for metastatic disease (2 vs. 3-4), visceral metastasis (yes vs. no), and endocrine therapy in the metastatic setting for at least 6 months (yes vs. no).
Patients were treated until disease progression or unacceptable toxicity. Administration of Trodelvy was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. The primary efficacy outcome measure was PFS as determined by BICR per RECIST v1.1. Additional efficacy outcome measures were OS, ORR by BICR, and DOR by BICR.
The median age of the study population was 56 years (range: 27-86 years), and 26% of patients were 65 years or over. Almost all patients were female (99%). The majority of patients were White (67%); 4% were Black, 3% were Asian, and 26% were of unknown race. Patients received a median of 7 (range: 3 to 17) prior systemic regimens in any setting and 3 (range: 0 to 8) prior systemic chemotherapy regimens in the metastatic setting. Approximately 42% of patients had 2 prior chemotherapy regimens for metastatic disease compared to 58% of patients who had 3 to 4 prior chemotherapy regimens. Patients had an ECOG performance status of 0 (44%) or 1 (56%). Ninety-five percent of patients had visceral metastases. Most patients received endocrine therapy in the metastatic setting for ≥ 6 months (86%).
Trodelvy demonstrated a statistically significant improvement in PFS by BICR and OS versus SAC. The improvement in PFS by BICR and OS was generally consistent across pre-specified subgroups. Efficacy results are summarized in Table 7 and Figures 3 and 4.

5.2 Pharmacokinetic Properties

The serum pharmacokinetics of sacituzumab govitecan and SN-38 were evaluated in the ASCENT study in a population of mTNBC patients who received sacituzumab govitecan as a single agent at a dose of 10 mg/kg. The pharmacokinetic parameters of sacituzumab govitecan and free SN38 are presented in Table 8.

Distribution.

Based on population pharmacokinetic analysis, the central volume distribution of sacituzumab govitecan is 3.58 L.

Metabolism.

No metabolism studies with sacituzumab govitecan have been conducted. SN-38 (the small molecule moiety of sacituzumab govitecan) is metabolised via UGT1A1.

Excretion.

The median elimination half-life (t1/2) of sacituzumab govitecan and of free SN-38 in patients with metastatic breast cancer was 23.4 and 17.6 hours, respectively. Based on population pharmacokinetic analysis, the clearance of sacituzumab govitecan is 0.128 L/h.

Pharmacokinetics in special populations.

Age and race.

Pharmacokinetic analyses in patients treated with Trodelvy (n=789) did not identify an effect of age or race, and mild or moderate renal impairment on the pharmacokinetics of sacituzumab govitecan.

Renal impairment.

Pharmacokinetic analyses in patients treated Trodelvy did not identify an effect of mild or moderate renal impairment on the pharmacokinetics of sacituzumab govitecan. Renal elimination is known to contribute minimally to the excretion of SN-38, the small molecule moiety of sacituzumab govitecan. There are no data on the pharmacokinetics of sacituzumab govitecan in patients with severe renal impairment, or end-stage renal disease (CrCl < 15 mL/min).

Hepatic impairment.

The exposure of sacituzumab govitecan is similar in patients with mild hepatic impairment (bilirubin ≤ ULN and AST > ULN, or bilirubin > 1.0 to ≤ 1.5 ULN and AST of any level; n=257) to patients with normal hepatic function (bilirubin and AST ≤ ULN; n=526).
Sacituzumab govitecan and free SN-38 exposures are unknown in patients with moderate or severe hepatic impairment.

UGT1A1 gene variants.

SN-38 is metabolised via UGT1A1. Genetic variants of the UGT1A1 gene such as the UGT1A1*28 allele lead to reduced UGT1A1 enzyme activity. Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia, febrile neutropenia, and anaemia from Trodelvy (see Section 4.4 Special Warnings and Precautions for Use). Approximately 20% of the Black or African American population, 10% of the White population, and 2% of the East Asian population are homozygous for the UGT1A1*28 allele. Decreased function alleles other than UGT1A1*28 may be present in certain populations.

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

6.1 List of Excipients

2-N-morpholinoethanesulfonic acid monohydrate, polysorbate 80, trehalose dihydrate.

6.2 Incompatibilities

Do not mix Trodelvy, or administer as an infusion, with other medicinal products.
For reconstitution and dilution, only 0.9% Sodium Chloride Injection, USP, should be used since the stability of the reconstituted product has not been determined with other infusion-based solutions.

6.3 Shelf Life

Shelf life of unopened vials.

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Shelf life of reconstituted solution.

The reconstituted solution should be used immediately to prepare a diluted Trodelvy infusion solution.

Shelf life of diluted infusion solution.

The diluted solution in the infusion bag should be used immediately. If not used immediately, the infusion bag containing Trodelvy solution can be stored refrigerated (2°C to 8°C) for up to 24 hours. Protect from light and do not freeze.

6.4 Special Precautions for Storage

Store at 2°C to 8°C (Refrigerate. Do not freeze). Store in carton to protect from light.

6.5 Nature and Contents of Container

Trodelvy is supplied in single-use clear glass vials, with a rubber stopper and crimp-sealed with an aluminium flip-off cap, in a pack size of 1 vial.

6.6 Special Precautions for Disposal

Trodelvy is a cytotoxic drug. Follow applicable special handling and disposal procedures.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


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