Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Trodelvy 180 mg powder for concentrate for solution for infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sacituzumab govitecan may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Trodelvy is a cancer medicine that contains the active substance sacituzumab govitecan. Trodelvy is used to treat a type of breast cancer in adults called triple-negative breast cancer (TNBC). Trodelvy should only be used after patients have tried at least two other treatments for their cancer, including at least one of them for a locally advanced cancer or metastasised cancer. Trodelvy is used to treat a type of breast cancer in adults called hormone receptor -positive (HR+), human epidermal growth factor receptor 2 -negative (HER2-) breast cancer. Trodelvy should only be used after patients have tried a treatment including a hormonal anticancer treatment and at least two additional other treatments for a locally advanced cancer or metastasised cancer. Talk to your doctor or nurse if you have any questions about how Trodelvy works or why this medicine has been prescribed for you. 2.
What you need to know before you take it
Trodelvy
You must not be given Trodelvy if you are allergic to sacituzumab govitecan, to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to irinotecan. If you think you may be allergic, ask your doctor for advice. Warnings and precautions Seek urgent medical attention if you notice any of the following serious side effects whilst being given or after you are given Trodelvy: Neutropenia This is a condition where you have too few neutrophils in your blood after receiving Trodelvy, resulting in increased risk of infections. These infections can be severe, life-threatening and may lead 1
to death, mainly early on in treatment. Seek urgent medical attention if you have the following signs and symptoms that may be due to having too few neutrophils (including infections): • a fever (a temperature of 38.5°C or higher) • chills or sweating • sore throat, sores in the mouth, or a toothache • stomach pain • pain near the anus or sores around the anus • pain or burning when urinating, or urinating often • diarrhoea • a cough or shortness of breath. Your doctor will take blood samples to monitor neutrophils and may give a medicine to help prevent low neutrophil count while being treated with TRODELVY. You will not be given Trodelvy if the absolute neutrophil count is below a certain level on Day 1 or Day 8 of any cycle. If your neutrophil count is too low, your doctor may need to lower your dose of TRODELVY, give you a medicine to treat low neutrophil count, or in some cases may stop TRODELVY. Fever Seek urgent medical attention if you have the following signs and symptoms: • a temperature of 38.5°C or higher • sweating Diarrhoea Seek urgent medical attention if you suffer from severe diarrhoea, whilst receiving Trodelvy (for example, black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhoea under control within 24 hours). Contact your doctor or nurse the first time that you get diarrhoea. Your Trodelvy treatment will be postponed until your diarrhoea has improved. You will be given loperamide to treat your diarrhoea, as long as you do not have an infection. If appropriate, you may also be given fluids into your veins (intravenously). Your doctor may also give you medicine, such as atropine, to help with stomach cramps, diarrhoea, and excessive saliva in mouth before your next treatment infusion. Your diarrhoea can lead to dehydration and sudden kidney damage. Talk to your doctor if you experience dark-coloured urine or decreased urine volume. Allergic and Infusion related reactions (reactions related to your infusion of the medicine) These reactions can be severe and life-threatening and can emerge when receiving Trodelvy. Seek urgent medical attention if you have the following signs and symptoms of allergic and infusion related reactions: • itching • outbreak of swollen, pale red bumps or plaques (wheals) on the skin that appear suddenly • fever • a sudden attack of severe shivering accompanied by a feeling of coldness • excessive sweating • breathing difficulties and wheezing • chest pain, heart palpitations. You may be given some medicine before Trodelvy is administered to help relieve the symptoms. During each infusion of Trodelvy and for 30 minutes after, you will be closely monitored for these signs and symptoms of infusion-related reactions. Your doctor will slow down the infusion rate or stop it if you develop a serious infusion-related reaction. Please let your doctor, pharmacist or nurse know if you have previously experienced any problems after receiving infusions, such as dizziness, feeling of fainting, difficulty breathing, breathlessness, swelling or skin rash, swelling of your face, lips, tongue, or throat, chills or shaking chills (rigors), and fever.
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Nausea and vomiting Seek urgent medical attention if you suffer from uncontrolled nausea or vomiting whilst receiving Trodelvy. Your doctor will give you anti-sickness medicines before and after Trodelvy is administered to help relieve nausea and vomiting. You will not be given Trodelvy if you have severe nausea and vomiting and will only be given Trodelvy when the symptoms have been controlled. Talk to your doctor or nurse before you are given Trodelvy if you: • have liver problems • have kidney problems • are female and of child-bearing age (see 'Pregnancy, Breast-feeding and Fertility') • are taking medicines to treat other conditions (see 'Other medicines and Trodelvy') • have experienced any problems after receiving any infusions in the past • have been told you carry a gene for uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 Some patients are genetically more likely to have certain side effects from Trodelvy. If you have the
UGT1A1*28 gene, you are more likely to develop low white blood cell count (neutropenia), a fever
while your white blood cell count is low, low level of red blood cell count (anaemia). You may also be more likely to develop other side effects after being given Trodelvy than those who do not have the gene. See section 4. for a list of all the side effects related to Trodelvy. Children and adolescents Trodelvy must not be given to children under 18 years of age because there is no information about its use in this age group. Other medicines and Trodelvy Tell your doctor if you are taking, have recently taken or might take any other medicines, including herbal medicines while receiving Trodelvy. This is because Trodelvy or the other medicines may not work as well as expected or you may be more likely to get a side effect. This includes in particular: propofol, given as an anesthetic in surgery. ketoconazole, used to treat fungal infections. tyrosine kinase inhibitors used to treat cancer (medicines ending in nib). carbamazepine or phenytoin used to treat epilepsy. rifampicin used to treat tuberculosis. protease inhibitor antivirals used to treat HIV. Pregnancy Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to have a baby. Trodelvy must not be given if you are pregnant. Male and female contraception Women must use effective contraception during treatment with Trodelvy, and for 6 months after the last dose of Trodelvy. Men with female partners who can become pregnant must use effective contraception during treatment and for 3 months after the last dose of Trodelvy. Breast-feeding Do not breast-feed during treatment with Trodelvy and for 1 month after the last dose. It is unknown whether this medicine passes into breast milk.
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Driving and using machines You may experience side effects of Trodelvy that may affect your ability to drive and use machines. You should therefore be cautious when driving, using tools or operating machines after being given Trodelvy. 3.
How you will be given Trodelvy
Trodelvy will only be given to you by your doctor or a nurse experienced in using anti-cancer therapies. It is important that the doctor specialising in your care has confirmed you can take this medicine by carrying out a blood test prior to treatment. Medicines given before Trodelvy treatment You will be given some medicines before receiving Trodelvy to help with side effects, such as nausea and vomiting and influsion-related reactions. How much you will be given The dose you are given will depend on your weight. Your doctor will weigh you and will determine the dose you should receive. Frequency of administration You should usually receive Trodelvy twice every 3 weeks on Days 1 and 8 of a 21day treatment cycle.
How to take it
your medicine A doctor or nurse will put the medicine into your bloodstream via an intravenous infusion (a drip into your vein). First infusion: you will be given your first infusion of Trodelvy over 3 hours. Your doctor or nurse will monitor you for signs and symptoms of infusion-related reactions both during the infusion and 30 minutes after. Second and subsequent infusions: you will be given the other infusions over 1 to 2 hours, if your first infusion was uneventful. Your doctor or nurse will monitor you during and 30 minutes after your infusion. Infusion-related reactions Your doctor will slow down the infusion rate of Trodelvy if you develop an infusion-related reaction. The medicine will be stopped if the infusion reaction is life-threatening. See section 2. Dose of medicine when experiencing some side-effects Your doctor may adjust the dose or stop Trodelvy if you experience certain side effects. See section 4. If you are given more Trodelvy than you should Since the infusion is given to you by your doctor or other appropriately trained staff, an overdose is unlikely. If you inadvertently receive too much medicine, your doctor will monitor you and give you additional supportive care to prevent and treat side effects. If a dose of Trodelvy is missed If you forget or miss your appointment, contact your doctor or your treatment centre to make another appointment as soon as possible. If you stop treatment with Trodelvy You should not stop the therapy early without talking with your doctor first. The therapy for breast cancer with Trodelvy usually requires a number of treatments. The number of 4
infusions that you receive will depend on how you are responding to treatment. Therefore, you should continue to take Trodelvy even if you see your symptoms improve until your doctor recommends that Trodelvy should be stopped. If you have any further questions on the use of this medicine, ask your doctor or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Seek urgent medical attention if you get any of the following serious side effects: Very common (may affect more than 1 in 10 people) • Diarrhoea. Seek urgent medical attention if you have the following signs and symptoms: o black or bloody stools o symptoms of dehydration such as lightheadedness, dizziness, or faintness o inability to take fluids by mouth due to nausea or vomiting o inability to get diarrhoea under control within 24 hours. •
Hypersensitivity reactions (including infusion-related reactions) which may cause the following signs and symptoms: o swollen lips, tongue, eyes, throat or face o swelling or a raised, itchy, red skin rash o outbreak of swollen, pale red bumps or plaques (wheals) on the skin that appear suddenly o fever o a sudden attack of severe shivering accompanied by a feeling of coldness o excessive sweating o wheezing, chest or throat tightness, shortness of breath, dizziness, feeling of fainting, breathlessness o chest pain, heart palpitations.
Common (may affect up to 1 in 10 people) • Low neutrophil count with fever, which may cause the following signs and symptoms: o a fever, which is a temperature of 38.5°C or higher: this is called febrile neutropenia o chills or sweating o sore throat, sores in the mouth, or a toothache o stomach pain o pain or burning when urinating, or urinating often o diarrhoea o a cough or shortness of breath.
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Pneumonia (Lung infection) which may cause the following signs and symptoms: o cough, which may produce greenish, yellow or even bloody mucus o fever, sweating and shaking chills o shortness of breath o rapid, shallow breathing o sharp or stabbing chest pain that gets worse when you breathe deeply or cough o loss of appetite, low energy, and fatigue 5
Other possible side effects Other side effects are listed below. If any of these become severe or serious, tell your doctor immediately. Very common (may affect more than 1 in 10 people) • burning sensation during urination and frequent, and urgent need to urinate • shortness of breath, cough, sore throat, headache, and sneezing • looking pale and feeling tired (may be symptoms of low level of red blood cells (anaemia)) • low level of white blood cells (lymphocytes or leukocytes) • nausea (feeling sick) • vomiting (being sick) • loss of appetite • low blood level of potassium or magnesium • trouble sleeping • feeling dizzy • shortness of breath • constipation; stomach pain • hair loss; rash; general itching • back pain; joint pain • tiredness Common (may affect up to 1 in 10 people) • shiver, fever, general discomfort, pale or discolored skin, shortness of breath due to infection in bloodstream by bacteria (sepsis) • infection of the lungs (pneumonia) • blocked nose, pain in your face, runny nose, wheezing, cough (may be symptoms of bronchitis) • hacking cough which may bring up clear, yellow-grey or greenish phlegm • low number of platelets, which may lead to bleeding and brusing (thrombocytopenia) • high blood level of glucose • decreased water in the body • low blood level of phosphate, calcium or sodium • change in your sense of taste • low blood pressure • nose bleeding; cough reflex triggered by the drip down of mucus in the back of your throat • inflammation of the large bowel (colitis) • inflamed and sore mouth; pain in upper stomach area; heartburn; bloated stomach • darkening of the skin; rash; acne-like skin problem; dry skin • excess protein in urine • dehydration • chills, pain • weight loss • increase in enzymes called alkaline phosphatase or lactate dehydrogenase, abnormal blood tests related to coagulation Uncommon (may affect up to 1 in 100 people) • inflammation of the small intestine (enteritis) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 6
5.
How to store it
Trodelvy
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP. The expiry date refers to the last day of that month that the medicine can be used. Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. Once reconstituted, the infusion bag containing Trodelvy solution can be stored in a refrigerator at 2°C to 8°C for up to 24 hours protected from light. Do not use this medicine if you notice the reconstituted solution is cloudy or discoloured. Trodelvy is a cytotoxic drug. Applicable special handling and disposal procedures must be followed. Do not throw away any medicines via wastewater. The hospital pharmacist will throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Trodelvy contains The active substance is sacituzumab govitecan The other ingredients are 2-(N-morpholino)ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrate. What Trodelvy looks like and contents of the pack The medicine is an off-white to yellowish powder. It comes as 50 mL clear glass single-dose vials, with a rubber stopper and crimp-sealed with an aluminum flip-off cap. Each pack contains 1 vial. Marketing Authorisation Holder Gilead Sciences Ltd 280 High Holborn London WC1V 7EE United Kingdom Manufacturer Gilead Sciences Ireland UC IDA Business and Technology Park Carrigtohill County Cork, T45 DP77 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Gilead Sciences Ltd Tel: + 44 (0) 8000 113700 This leaflet was last revised in October 2025.
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Other sources of information Detailed information on this medicine is available on the website of the Medicines and Healthcare Regulatory Agency (MHRA) https://www.gov.uk/guidance/find-product-information-about-medicines and other websites https://www.medicines.org.uk/emc/.
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The following information is intended for healthcare professionals only: Trodelvy is a cytotoxic drug. Applicable special handling and disposal procedures have to be followed. Reconstitution • The product should be prepared in a hospital aseptic unit. • 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 0.9% solution for injection, into each 180 mg Trodelvy vial. The resulting concentration will be 10 mg/mL. • The product should only be reconstituted with 0.9% sodium chloride. • 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 Trodelvy solution for infusion. 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 sodium chloride 0.9% solution for injection, 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. • Only sodium chloride 0.9% solution for injection should be used since the stability of the reconstituted product has not been determined with other infusion-based solutions. 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 protected from light. After refrigeration, administer diluted solution at room temperature up to 25°C within 8 hours (including infusion time). Do not freeze or shake. Administration • Administer Trodelvy as an intravenous infusion. Protect infusion bag from light. • 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 0.9% solution for injection. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Frequently asked questions about Trodelvy 180 mg powder for concentrate for solution for infusion
How do I take Trodelvy 180 mg powder for concentrate for solution for infusion?
Trodelvy 180 mg powder for concentrate for solution for infusion comes as infusion containing 180mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Trodelvy 180 mg powder for concentrate for solution for infusion?
The active substance in Trodelvy 180 mg powder for concentrate for solution for infusion is sacituzumab govitecan.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Trodelvy 180 mg powder for concentrate for solution for infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Trodelvy 180 mg powder for concentrate for solution for infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sacituzumab govitecan
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
TRODELVY is 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 lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease (see section 5.1).
TRODELVY as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).
4.2. Posology and method of administration
TRODELVY must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies and should be administered in an environment where resuscitation facilities are available (see section 4.3 and 4.4).
Posology
The recommended dose of TRODELVY is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity.
Premedication
Prior to each dose of TRODELVY, premedication for prevention of infusion reactions and prevention of chemotherapy-induced nausea and vomiting (CINV) is recommended:
• Premedicate with antipyretics, and H1 and H2 blockers prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions.
• 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).
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 and 4.8).
Dose modifications for adverse reactions
Management of adverse reactions may require temporary interruption, dose reduction, or treatment discontinuation of TRODELVY. The recommended dosage reduction schedule is presented in Table 1 and the recommended dosage modifications for adverse reactions are provided in Table 2. The TRODELVY dose should not be re-escalated after a dose reduction for adverse reactions has been made.
Table 1: Dosage Reduction Schedule
Dose Reduction Schedule
Dose Level
Recommended starting dose
10 mg/kg
First dose reduction
Reduce to 7.5 mg/kg
Second dose reduction
Reduce to 5 mg/kg
Requirement for further dose reduction
Discontinue treatment
The recommended dosage modifications for adverse reactions are provided in Table 2.
Table 2: Recommended dose modifications for adverse reactions
Adverse reactions
Severity
Dose Modification
Neutropenia
• Grade 3-4 neutropenia (ANC <1000/mm3)
• Grade 3-4 febrile neutropenia (ANC <1000/mm3)
• Withhold treatment until resolved to ≤ Grade 1 (ANC ≥1500/mm3) for Day 1 dose or Grade 2 (ANC ≥1000/mm3) for Day 8 Dose [see Special warnings and precautions for use (4.4)].
• Administer G-CSF during treatment as clinically indicated.
• For subsequent Grade 3-4 febrile neutropenia events or subsequent prolonged Grade 3-4 neutropenia events, reduce one dose level with each recurrence or discontinue according to Table 1.
Nausea/Vomiting/ Diarrhoea
• Grade 3-4 nausea, vomiting or diarrhoea due to treatment that is not controlled with antiemetics and anti-diarrhoeal agents
• Withhold treatment until resolved to ≤ Grade 1 [see Special warnings and precautions for use (4.4)].
• Reduce one dose level with each occurrence or discontinue according to Table 1.
Infusion-Related Reaction
• Grade 1-3 infusion-related reactions
• Slow or interrupt the infusion rate of TRODELVY
• Grade 4 infusion-related reactions
• Discontinue treatment.
Other Toxicities
• Other Grade 3-4 toxicities of any duration despite optimal medical management
• Withhold treatment until resolved to ≤ Grade 1.
• Reduce one dose level with each occurrence or discontinue according to Table 1.
Special populations
Elderly
No dose adjustment is required in patients ≥ 65 years old. Data from TRODELVY in patients ≥ 75 years are limited.
Hepatic impairment
No adjustment to the starting dose is required when administering TRODELVY to patients with mild hepatic impairment (see section 5.2)
The safety of TRODELVY in patients with moderate or severe hepatic impairment has not been established. TRODELVY has not been studied in patients with any of the following: serum bilirubin > 1.5 ULN, AST or ALT > 3 ULN in patients without liver metastases, or AST or ALT > 5 ULN in patients with liver metastases. The use of TRODELVY is not recommended in these patients.
Renal impairment
No adjustment to the starting dose is required when administering TRODELVY to patients with mild or moderate renal impairment. TRODELVY has not been studied in patients with severe renal impairment, or end-stage renal disease.
Paediatric population
The safety and efficacy of TRODELVY in children and adolescents aged below 18 years of age have not been established. No data are available.
Method of administration
TRODELVY should only be administered as an intravenous infusion, not as an intravenous push or bolus. It must be reconstituted and diluted by a healthcare professional experienced in the handling of anti-cancer therapies.
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 the infusion and for at least 30 minutes after each infusion, for signs or symptoms of infusion-related reactions.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to previous irinotecan therapy
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Neutropenia
TRODELVY can cause severe or life-threatening neutropenia. Fatal infections in the setting of neutropenia have been observed in clinical studies with TRODELVY, primarily in the first two cycles of treatment.
Primary prophylaxis with G-CSF should be considered starting in the first cycle of treatment in patients at increased risk of febrile neutropenia, e.g., older patients (in particular aged 65 years and older), patients with previous neutropenia, poor performance status, organ dysfunction (including renal, liver or cardiovascular dysfunction), or multiple comorbid conditions. Monitor absolute neutrophil count (ANC) during treatment.
TRODELVY should not be administered if the ANC is below 1500/mm3 on Day 1 of any cycle or if the neutrophil count is below 1000/mm3 on Day 8 of any cycle. TRODELVY should not be administered in case of neutropenic fever. Dose reductions are required due to neutropenia or febrile neutropenia. Consider treating neutropenia with G-CSF and consider prophylaxis in subsequent cycles as clinically indicated (see section 4.2 and 4.8).
Diarrhoea
TRODELVY can cause severe diarrhoea. Diarrhoea in some cases was observed to have led to dehydration and subsequent acute kidney injury. TRODELVY should not be administered in case of Grade 3-4 diarrhoea at the time of scheduled treatment and treatment should only be continued when resolved to ≤ Grade 1 (see section 4.2).
Patients should be advised of the risk of diarrhoea and be closely monitored. Instruct patients to immediately contact their healthcare provider if they experience diarrhoea for the first-time during treatment.
At the onset of diarrhoea, and if no infectious cause can be identified, 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. In patients with infectious diarrhoea, initiate anti-infective treatment as clinically indicated. Additional supportive measures (e.g. fluid and electrolyte substitution) may also be employed as clinically indicated.
Instruct patients to immediately contact their healthcare provider if they experience melena, haematochezia, dehydration, an inability to tolerate oral fluids or an inability to manage diarrhoea within 24 hours.
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.
Hypersensitivity
TRODELVY can cause severe and life-threatening hypersensitivity. Anaphylactic reactions have been observed in clinical studies with TRODELVY and the use of TRODELVY is contraindicated in patients with a known hypersensitivity to TRODELVY (see section 4.3). Other hypersensitivity events observed during and within 24 hours following the infusion included dyspnoea; rash; pruritus; hypotension; wheezing; oedema including facial and tongue; urticaria; and bronchospasm. Inform patients of the risk of serious infusion reactions and anaphylaxis. Instruct patients to immediately contact their healthcare provider if they experience these signs and symptoms. Medication to treat life-threatening hypersensitivity, as well as emergency equipment, should be available for immediate use.
Infusion-related reactions
Pre-infusion medication for patients receiving TRODELVY is recommended (see section 4.2). Patients should be closely observed for infusion-related reactions during each TRODELVY infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. The infusion rate of TRODELVY should be slowed down or infusion interrupted if the patient develops an infusion-related reaction. TRODELVY should be permanently discontinued if life-threatening infusion-related reactions occur (see section 4.2).
Nausea and vomiting
TRODELVY is emetogenic. Premedication 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) is recommended for prevention of chemotherapy-induced nausea and vomiting (CINV).
TRODELVY should not be administered in case of Grade 3 nausea or Grade 3-4 vomiting at the time of scheduled treatment administration and treatment should only be continued with additional supportive measures when resolved to ≤ Grade 1 (see section 4.2).
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
Individuals who are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk of severe neutropenia, severe diarrhoea, febrile neutropenia, and anaemia and are at increased risk for other adverse reactions following initiation of TRODELVY treatment (see section 4.8). Patients with known reduced UGT1A1 activity should be closely monitored 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 activity (see section 4.2).
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. SN-38 (the small molecule moiety of sacituzumab govitecan) is primarily metabolised via UGT1A1. Inhibitors or inducers of UGT1A1 are expected to increase or decrease SN-38 exposure, respectively.
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. TRODELVY should be used with caution with UGT1A1 inhibitors (e.g. propofol, ketoconazole, EGFR tyrosine kinase inhibitors), and patients should be closely monitored.
UGT1A1 inducers
Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. TRODELVY should be used with caution with UGT1A1 inducers (e.g. carbamazepine, phenytoin, rifampicin, protease inhibitors), and patients should be closely monitored.
Based on the limited data available from patients who received UGT1A1 inhibitors (n=16) or inducers (n=5) while being treated with TRODELVY, free SN-38 exposures in these patients were comparable to those in patients who did not receive UGT1A1 inhibitor or inducer.
CYP3A
SN-38 (the small molecule moiety of sacituzumab govitecan) is primarily metabolised via UGT1A1. Inhibitors or inducers of CYP3A are not anticipated to impact SN-38 exposure.
4.6. Fertility, pregnancy and lactation
Pregnancy
Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-foetal lethality when administered during pregnancy. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. TRODELVY is not recommended during pregnancy. Advise female patients to contact their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to the foetus and potential loss of the pregnancy.
Women of Childbearing Potential / Contraception in Males and Females
Women of childbearing potential have to use effective contraception during treatment and for 6 months after the last dose. Male patients with female partners of childbearing potential have to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. The pregnancy status of women of childbearing potential should be verified prior to the initiation of TRODELVY.
Breast-feeding
It is unknown whether TRODELVY or metabolites are excreted in human milk. Breast-feeding should be discontinued during treatment with TRODELVY and for 1 month after the last dose.
Fertility
Based on findings in animals, TRODELVY may impair fertility in females of reproductive potential.
4.7. Effects on ability to drive and use machines
TRODELVY has minor influence on the ability to drive and use machines. Dizziness has been reported. Advise patients to use caution when driving or using machines.
4.8. Undesirable effects
Summary of the safety profile
The frequencies of adverse reactions are based on pooled data from three clinical studies (IMMU-132-01, IMMU-132-05 [N=258; ASCENT] and IMMU-132-09) involving 688 patients who received TRODELVY 10 mg/kg for the treatment of metastatic TNBC and HR+/HER2- breast cancer. The median exposure to TRODELVY in this data set was 4.63 months.
The most common adverse drug reactions (ADRs) (reported at a frequency of ≥20%) with TRODELVY were neutropenia (67.6%), nausea (62.6%), diarrhoea (62.5%), fatigue (61.5%), alopecia (45.6%), anaemia (40.7%), constipation (36.2%), vomiting (33.6%), decreased appetite (25.7%), dyspnoea (22.1%) and abdominal pain (20.2%).
The most common Grade 3 or higher ADRs (reported at a frequency of ≥ 2%) were neutropenia (50.7%), leukopenia (10.5%), diarrhoea (10.3%), anaemia (9.3%), fatigue (6.8%), febrile neutropenia (6.1%), hypophosphataemia (4.2%), dyspnoea (3.1%), lymphopenia (2.9%), abdominal pain (282%), nausea (2.8%), vomiting (2.5%), hypokalaemia (2.5%), pneumonia (2.3%) and aspartate aminotransferase increased (2.2%).
The most common serious adverse reactions (reported at a frequency of ≥ 2%) were febrile neutropenia (4.8%), diarrhoea (3.9%), neutropenia (2.6%), and pneumonia (2%). Fatal adverse reactions occurred in 1.2% of patients who received TRODELVY.
The most common ADRs leading to treatment interruption (reported at a frequency of ≥ 2%) were neutropenia (44.2%), leukopenia (4.7%), anaemia (3.9%), diarrhoea (3.6%), and dyspnoea (2.2%).
The most common ADRs leading to dose reduction reported (at a frequency of ≥ 2%) were neutropenia (12.4%), diarrhoea (6.5%), febrile neutropenia (2.9%), and fatigue (2.5%).
The most common ADRs leading to treatment discontinuation (reported in >1 patient) were neutropenia (0.4%), diarrhoea (0.4%), fatigue (0.4%), pneumonia (0.4%), asthenia (0.3%), and general physical health deterioration (0.3%).
Adverse reactions in patients with reduced UGT1A1 activity
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.
(See sections 4.2 and 4.4)
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.
Tabulated list of adverse reactions
Adverse reactions are classified by System Organ Class and sorted by frequencies calculated from all reported events, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) or not known (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Table 3: List of adverse reactions
System organ class (SOC)
Frequency
Adverse reactions
Infections and infestations
Very common
Urinary tract infection
Upper respiratory tract infection
Common
Sepsis
Pneumonia
Influenza
Bronchitis
Nasopharyngitis
Sinusitis
Oral herpes
Blood and lymphatic system disorders
Very common
Neutropenia1
Anaemia2
Leukopenia3
Lymphopenia4
Common
Febrile neutropenia
Thrombocytopenia5
Immune system disorders
Very common
Hypersensitivity6
Metabolism and nutrition disorders
Very common
Decreased appetite
Hypokalaemia
Hypomagnesaemia
Common
Dehydration
Hyperglycaemia
Hypophosphataemia
Hypocalcaemia
Hyponatraemia
Psychiatric disorders
Very common
Insomnia
Common
Anxiety
Nervous system disorders
Very common
Headache
Dizziness
Common
Dysgeusia
Vascular disorders
Common
Hypotension
Respiratory, thoracic and mediastinal disorders
Very common
Dyspnoea7
Cough
Common
Epistaxis
Productive cough
Rhinorrhoea
Nasal congestion
Upper airway cough syndrome
Gastrointestinal disorders
Very common
Diarrhoea
Vomiting
Nausea
Constipation
Abdominal Pain
Common
Neutropenic colitis8
Colitis
Stomatitis
Abdominal pain upper
Dyspepsia
Gastrooesophageal reflux disease
Abdominal distension
Uncommon
Enteritis
Skin and subcutaneous tissue disorders
Very common
Alopecia
Rash
Pruritus
Common
Rash maculopapular
Skin hyperpigmentation
Dermatitis acneiform
Dry skin
Musculoskeletal and connective tissue disorders
Very common
Back pain
Arthralgia
Common
Musculoskeletal chest pain
Muscle spasms
Renal and urinary disorders
Common
Haematuria
Proteinuria
Dysuria
General disorders and administration site conditions
Very common
Fatigue9
Common
Pain
Chills
Investigations
Common
Weight decreased
Blood alkaline phosphatase increased
Activated partial thromboplastin time prolonged
Blood lactate dehydrogenase increased
Injury, poisoning and procedural complications
Uncommon
Infusion related reaction
1: Includes the following preferred terms: neutropenia; neutrophil count decreased.
2: Includes the following preferred terms: anaemia; haemoglobin decreased; red blood cell count decreased.
3: Includes the following preferred terms: leukopenia; white blood cell count decreased.
4: Includes the following preferred terms: lymphopenia; lymphocyte count decreased.
5: Includes the following preferred terms: thrombocytopenia; platelet count decreased.
6: Hypersensitivity events reported up to the end of the day after treatment was administered. Includes events coded to the following preferred terms: dyspnoea; hypotension; flushing; erythema; chest discomfort; rhinitis allergic; wheezing; oedema; urticaria; anaphylactic reaction; mouth ulceration; skin exfoliation; swollen tongue; throat tightness
7: Includes the following preferred terms: dyspnoea; dyspnoea exertional
8: Includes the preferred term of neutropenic colitis and events reported as typhlitis
9: Includes the following preferred terms: fatigue, asthenia
Description of selected adverse reactions
Neutropenia
Neutropenia occurred in 67.6% (465/688) of patients treated with TRODELVY, including Grade 3-4 neutropenia in 50.7% of patients. Neutropenia was the reason for dose reduction in 12.4% of patients. Neutropenic colitis was observed in 1% (7/688) of patients.
Febrile neutropenia occurred in 6.1% (42/688) of patients treated with TRODELVY. Febrile neutropenia was the reason for dose reduction in 2.9% of patients.
G-CSF was used beyond treatment cycle 1 in 46.4% (319/688) of patients who received TRODELVY. G-CSF was used at any time during the study for prophylaxis for neutropenia by 28.2% of patients (194/688) and/or treatment of neutropenia by 32.7% of patients (225/688).
The median time to onset of neutropenia (including febrile neutropenia) following the start of the first treatment cycle was 16 days [1-435 days] and has occurred earlier in some patient populations (see Adverse reaction in patients with reduced UGT1A1 activity section). Neutropenia was reversible with a median duration of 8 days [1-200 days].
Of the patients homozygous for the UGT1A1*28 allele, the incidence of febrile neutropenia was 5.9% (16/272). No patients had febrile neutropenia leading to permanent discontinuation.
Diarrhoea
Diarrhoea occurred in 62.5% (430/688) of patients treated with TRODELVY. Grade 3 events occurred in 10.3% (71/688) of patients. Three of 688 patients (< 1%) discontinued treatment because of diarrhoea. The median time to onset of diarrhoea following the start of the first treatment cycle was 13 days [1-630 days]. The median duration of diarrhoea was 8 days [1-268 days].
Hypersensitivity
Hypersensitivity reactions reported up to the end of the day following dosing occurred in 33.0% (227/688) of patients treated with TRODELVY. Grade 3 and above hypersensitivity occurred in 1.7% (12/688) of patients treated with TRODELVY. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.1% (1/688).
Nausea and vomiting
Nausea occurred in 62.6% (431/688) of patients treated with TRODELVY, including Grade 3-4 nausea in 2.8% (19/688) of patients. Vomiting occurred in 33.6% (231/688) of patients treated with TRODELVY, including Grade 3-4 vomiting in 2.5% (17/688) of patients.
Alopecia
Alopecia occurred in 45.6% (314/688) of patients treated withTRODELVY.
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 neutralizing 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 TRODELVY; 6 of these patients (0.8% of all patients treated TRODELVY) had neutralizing antibodies against TRODELVY.
Special Populations
There was no difference in discontinuation rate due to adverse events in patients aged 65 years or older compared with younger patients with mTNBC. There was a higher discontinuation rate due to adverse reactions in patients aged 65 years or older (14%) compared with younger patients (3%) with HR+/HER2- metastatic breast cancer. There was a higher incidence rate of serious adverse events in patients aged 75 years or older (67%) compared to patients aged 65 years or older (43%) and patients younger than 65 years (24%) with HR+/HER2- metastatic breast cancer.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There is no information on overdose with TRODELVY. In clinical trials, doses of up to 18 mg/kg (approximately 1.8 times the maximum recommended dose of 10 mg/kg) 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 severe diarrhoea, and appropriate treatment instituted.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- TRODELVY 200 mg prescriptionSACITUZUMAB GOVITECAN · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- TrodelvySacituzumabum govitecanum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
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