Prospect: information for the patient

Trodelvy 200 mg powder for concentrate for solution for infusion

sacituzumab govitecan

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before you are administered this medicine, because it contains important information for you.

• Keep this prospectus, as you may have to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are adverse effects that do not appear in this prospectus. See section 4.

Trodelvy is a cancer medication that contains the active ingredient sacituzumab govitecan. One part of the medication is a monoclonal antibody that specifically binds to a protein on the surface of certain breast cancer cells called Trop-2. The other active part of Trodelvy is SN-38, a substance that can destroy cancer cells. Once the medication has bound to cancer cells, SN-38 enters the cancer cells and destroys them, which helps to combat cancer.

Trodelvy is used to treat a type of breast cancer in adults called triple-negative breast cancer.

The medication is used when it is not possible to remove the cancer with surgery, because the cancer has spread to areas outside the breast (locally advanced) or has spread to other parts of the body (metastatic). Trodelvy should only be used after patients have received at least two different treatments for their cancer, including at least one for locally advanced or metastatic cancer.

Consult your doctor or nurse if you have any questions about how Trodelvy works or why you have been prescribed this medication.

Do not administerTrodelvyif you areallergictosacituzumab govitecanor to any of the othercomponentsof this medication (listed in section 6). If you think you may be allergic, consult your doctor.

Warnings and precautions

Infusion-related reactions

Trodelvy is administered through an intravenous infusion. Some people may experience infusion-related reactions that can be severe or potentially life-threatening.Seek immediate medical attentionif you experience any of the following signs and symptoms ofinfusion-related reactions:

• hives
• sudden appearance of raised, pale red patches (hives) on the skin
• fever
• sudden onset of intense chills accompanied by a feeling of coldness
• excessive sweating
• difficulty breathing and wheezing
• chest pain, palpitations

Your doctor may administer medications before Trodelvy to help alleviate symptoms. During each infusion and for 30 minutes afterward, you will be closely monitored for signs and symptoms of infusion-related reactions. Your doctor will reduce the infusion rate or stop it if you experience a severe infusion-related reaction.

Neutropenia

This medication may cause neutropenia, a condition in which there are very few neutrophils in the blood, increasing the risk of infections. These infections can be severe and potentially life-threatening.Seek immediate medical attentionif you experience any of the following signs and symptoms ofneutropenia or infections:

• fever (temperature of 38.5°C or higher)
• chills or sweating
• sore throat, mouth sores, or tooth pain
• abdominal pain
• pain near the anus
• pain or burning sensation while urinating or urinating more frequently
• diarrhea or sores around the anus
• cough or shortness of breath

Your doctor will take blood samples to monitor your neutrophil levels. Trodelvy will not be administered if your neutrophil levels are below a certain threshold on day 1 or day 8 of any treatment cycle.

Your doctor will adjust the amount of medication administered if you have severe neutropenia.

Dys diarrhea

Seek immediate medical attentionif you experiencesevere diarrheawhile receiving Trodelvy.

Your treatment with Trodelvy will be postponed until your diarrhea has improved. Loperamide will be administered to treat diarrhea, unless you have an infection. If necessary, you will also receive fluids.

Your doctor may also prescribe medications, such as atropine, to help resolve stomach cramps, diarrhea, and excessive saliva in your mouth before the next infusion of treatment.

Nausea and vomiting

This medication may cause nausea and vomiting.Seek immediate medical attentionif you experiencesevere nausea and vomitingwhile receiving Trodelvy.

Your doctor will give you medications before cancer treatment and between infusion sessions to help alleviate nausea and vomiting. Trodelvy will not be administered if you have severe nausea and vomiting, and it will only be administered when your symptoms have been controlled.

Patients with the UGT1A1*28 gene

Some patients are more prone to certain medication side effects due to their genetic makeup. If you have the UGT1A1*28 gene, your body breaks down the medication more slowly. This means you are more likely to experience certain side effects (such as neutropenia, with or without fever, and low red blood cell counts (anemia) compared to those who do not have the gene. Your doctor will closely monitor you.

Consult your doctor or nurse before receiving Trodelvy if:

• you have liver problems
• you have kidney problems
• you are a fertile woman (see “Pregnancy”, “Contraception in men and women” and “Breastfeeding”)
• you are taking medications to treat other conditions (see “Other medications and Trodelvy”)
• you have had any problems after receiving infusions in the past.

While receiving Trodelvy, your doctor will closely monitor you for side effects. If you experience a severe side effect, your doctor may prescribe other medications to treat it, adjust the amount of Trodelvy you receive, or stop administering Trodelvy altogether.

See section 4 for a list of all possible side effects related to Trodelvy.

Children and adolescents

Trodelvy should not be administered to children and adolescents under 18 years of age because there is no information on how it works in this age group.

Other medications and Trodelvy

Inform your doctor if you are taking, have taken recently, or may need to takeany other medication. Some medications may affect how Trodelvy works and may increase the concentration of the active ingredient in Trodelvy in the blood, increasing the risk of side effects. These include:

• propofol, administered as an anesthetic during surgical procedures.
• ketoconazole, used to treat fungal infections.
• tyrosine kinase inhibitors, used to treat cancer (medications that end in -nib).

Some medications may decrease the concentration of the active ingredient in Trodelvy in the blood, reducing its effects:

• carbamazepineorphenytoin, used to treat epilepsy.
• rifampicin, used to treat tuberculosis.
• ritonavir or tipranavir, used to treat HIV.

Pregnancy

Trodelvyshould not be usedduring pregnancy because it may harm the baby. Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become pregnant.

Contraception in men and women

Women who may become pregnant should use effective contraception during Trodelvy treatment and for 6 months after the last dose of Trodelvy.

Males who have female partners who may become pregnant should use effective contraception during treatment and for 3 months after the last dose of Trodelvy.

Breastfeeding

Do not breastfeedduring Trodelvy treatment and for 1 month after the last dose. It is unknown whether this medication passes into breast milk and may affect the baby.

Driving and operating machinery

Trodelvy may affect your ability to drive and operate machinery, such as dizziness, fatigue. Therefore, you should exercise caution when driving, using tools, or operating machinery after receiving Trodelvy.

Trodelvy will only be administered by your doctor or a nurse experienced in the use of cancer treatments.

It is essential that your doctor or the nurse specialized in your care has confirmed that you can receive this medication by performing a blood test before treatment.

Medications administered before treatment with Trodelvy

You will be given some medications before receiving Trodelvy to help prevent reactions related to infusion and nausea and vomiting. Your doctor will decide which medications you may need and how much to administer.

How much Trodelvy will be administered

The treatment for your cancer is repeated in cycles of 21 days (3 weeks). The recommended dose of Trodelvy is10 mg per kilogram of body weightat the start of each cycle (day 1 of each cycle) and again a week later (day 8 of each cycle).

How the medication will be administered

A doctor or nurse will administer the medication through intravenous infusion (drip in the vein).

First infusion:The first infusion of the medication will be administered over 3 hours.Second infusion and subsequent:Other infusions will be administered over 1 to 2 hours if the first infusion proceeded without incident.

Your doctor or nurse will monitor you during the infusion and for 30 minutes after each one to detect signs and symptoms of infusion-related reactions.

Infusion-related reactions

Your doctor will reduce the infusion rate of the medication if you experience an infusion-related reaction. The administration of the medication will be interrupted if the infusion-related reaction is potentially life-threatening. See section 2.

Medication dose when experiencing some adverse effects

Your doctor may modify the dose or interrupt administration if you experience certain adverse effects. See section 4.

If you are given more Trodelvy than you should

Since the infusion is administered by your doctor or another properly trained person, it is unlikely that an overdose will occur. If you receive too much medication by accident, your doctor will monitor you and administer additional treatment as needed.

If you forget a dose of Trodelvy

If you forget or miss your appointment, call your doctor or treatment center to schedule another appointment as soon as possible. Do not wait until your next scheduled visit. It is very important that you do not miss any doses for the treatment to be completely effective.

If you interrupt treatment with Trodelvy

You should not interrupt treatment prematurely without consulting your doctor first.

Trodelvy treatment for breast cancer generally requires a number of treatments. The number of infusions you receive will depend on how you are responding to treatment. Therefore, you should continue receiving Trodelvy even if you observe that your symptoms improve and until your doctor decides that you should stop treatment with Trodelvy. If treatment is interrupted too soon, your symptoms may return.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Seek urgent medical help if you experience any of the following severe side effects that are very common(may affect more than 1 in 10 people):

• fever, which is a body temperature of 38.5 °C or higher: this is calledneutropenic fever
• chills or sweating
• sore throat, mouth sores, or toothache
• stomach pain
• pain or discomfort near the anus or sores around the anus
• pain or burning when urinating or frequent urination
• diarrhea
• cough or shortness of breath

• Diarrea(even without other symptoms)

• swollen lips, tongue, eyes, throat, or face
• swelling or red, raised, and itchy skin rash
• sudden appearance of raised or flat, pale red patches on the skin
• fever
• sudden, intense chills accompanied by a feeling of cold
• excessive sweating
• whistling, feeling of oppression in the chest or throat, shortness of breath, dizziness, feeling of fainting, difficulty breathing
• chest pain, palpitations

Other possible side effects

The following are other possible side effects. If any of these become severe or serious, inform your doctor immediately

Very common(may affect more than 1 in 10 people)

• burning sensation when urinating and frequent and urgent need to urinate
• cough, sore throat, runny nose, headache, and sneezing
• anemia
• low white blood cell count (lymphocytes or leucocytes)
• loss of appetite
• low potassium or magnesium levels in the blood
• high blood sugar levels
• difficulty sleeping
• dizziness
• constipation, stomach pain
• hair loss, rash, generalized itching
• back pain, joint pain
• fatigue
• weight loss

Common(may affect up to 1 in 10 people)

• lung infection
• nasal congestion
• facial pain, wheezing
• flu-like symptoms, mouth herpes infection
• low phosphate or calcium levels in the blood
• anxiety
• change in sense of taste
• nosebleed, shortness of breath during exercise, cough with mucus
• sore mouth, inflamed upper stomach, acid reflux, bloated stomach
• dry skin
• chest muscle pain, muscle spasms
• blood in the urine
• chills
• increase in an enzyme called alkaline phosphatase and abnormal blood test results related to coagulation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Trodelvy will be stored by healthcare professionals in the hospital or treatment center where you receive treatment. The storage details are as follows:

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the outer packaging and the vial after CAD. The expiration date is the last day of the month indicated.
• Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.
• Store the vial in the outer packaging to protect it from light.
• After reconstitution and dilution, if not used immediately, the infusion bag containing the diluted solution can be stored in the refrigerator (between 2 °C and 8 °C) for up to 24 hours protected from light.
• Do not use this medication if you observe that the reconstituted solution is cloudy or has changed color.

Trodelvy is a cytotoxic medication. Special handling and disposal procedures must be followed.

Composition of Trodelvy

• The active ingredient is sacituzumab govitecan. A vial of powder contains 200 mg of sacituzumab govitecan. After reconstitution, 1 ml of solution contains 10 mg of sacituzumab govitecan.
• The other components are 2-(N-morfolino) ethane sulfonic acid (MES), polisorbate 80, and dihydrate trehalose.

Appearance of Trodelvy and contents of the container

This medicine is a white to yellowish powder for concentrate for solution for infusion supplied in a glass vial. Each container contains 1 vial.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Responsible Person

Gilead Sciences Ireland UC

IDA Business and Technology Park

Carrigtohill

County Cork, T45 DP77

Ireland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Trodelvy is a cytotoxic medicine. Follow the special handling and disposal procedures.

This medicine should not be mixed with others, except as mentioned below.

Reconstitution

• Calculate the required dose (mg) of Trodelvy based on the patient's body weight at the start of each treatment cycle (or more frequently if the patient's body weight has changed by more than 10% since the previous administration).
• Allow the required number of vials to reach room temperature (between 20°C and 25°C).
• Using a sterile syringe, slowly inject 20 ml of 9 mg/ml sodium chloride injection (0.9%) into each vial. The resulting concentration will be 10 mg/ml.
• Gently shake the vials and allow them to dissolve for a period of up to 15 minutes. Do not shake. Visually inspect the product to detect particles and color changes before administration. The solution should not have visible particles and should be transparent and yellow. Do not use the reconstituted solution if it is turbid or has color changes.
• Use it immediately to prepare a diluted infusion solution.

Dilution

• Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose based on the patient's body weight.
• Determine the final volume of the infusion solution to administer the appropriate dose within a concentration range of sacituzumab govitecan from 1.1 mg/ml to 3.4 mg/ml.
• Withdraw and discard the volume of 9 mg/ml sodium chloride injection (0.9%) from the final infusion bag equivalent to the required volume of the reconstituted solution.
• Withdraw the calculated volume of the reconstituted solution from the vial(s) using a syringe. Discard any unused portion that remains in the vial(s).
• To minimize foam formation, slowly inject the required volume of the reconstituted solution into a polyvinyl chloride, polypropylene, or ethylene/propylene copolymer infusion bag. Do not agitate the contents.
• If necessary, adjust the volume in the infusion bag as needed with 9 mg/ml sodium chloride injection (0.9%) to obtain a concentration of 1.1 mg/ml to 3.4 mg/ml (the total volume should not exceed 500 ml). Only 9 mg/ml sodium chloride injection (0.9%) should be used since the stability of the reconstituted product with other infusion solutions has not been determined.
• For patients whose body weight exceeds 170 kg, divide the total dose of Trodelvy into equal parts between two 500 ml infusion bags and infuse sequentially over 3 hours in the first infusion and 1-2 hours in subsequent infusions.
• If not used immediately, the infusion bag containing the diluted solution can be stored refrigerated between 2°C and 8°C for a maximum period of 24 hours protected from light. Do not freeze. After refrigeration, administer the diluted solution at room temperature up to 25°C within 8 hours (including infusion time).

Administration

• The infusion bag should be covered during administration until the administration is complete. It is not necessary to cover the infusion tube or use a light-protective tube during infusion.
• Administer Trodelvy as an intravenous infusion. Protect the infusion bag from light.
• A infusion pump can be used.
• Do not mix Trodelvy or administer it as an infusion with other medications.
• Once the infusion is complete, flush the intravenous line with 20 ml of 9 mg/ml sodium chloride injection (0.9%).

Disposal

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.