TRODELVY 200 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: 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 allow for quick identification of new safety information. You can help by reporting any side effects you may have. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Trodelvy and what is it used for
2. What you need to know before you are given Trodelvy
3. How Trodelvy will be given to you
4. Possible side effects
5. Storage of Trodelvy
6. Contents of the pack and other information

1. What is Trodelvy and what is it used for

Trodelvy is a cancer medicine that contains the active substance sacituzumab govitecan. One part of the medicine 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 medicine has bound to the cancer cells, the SN-38 enters the cancer cells and destroys them, helping to fight the cancer.

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

The medicine is used when the cancer cannot be removed by surgery, because the cancer has spread to areas outside the breast (locally advanced) or has spread to other parts of the body (metastasized). 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 metastasized cancer.

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

2. What you need to know before you are given Trodelvy

You should not be given Trodelvyif you are allergicto sacituzumab govitecanor to any of the other ingredientsof this medicine (listed in section 6). If you think you may be allergic, talk to your doctor.

Warnings and precautions

Infusion-related reactions

Trodelvy is given by infusion into a vein. Some people may have infusion-related reactions that can be severe or life-threatening. Seek urgent medical attentionif you have any of the following signs and symptoms of infusion-related reactions:

• itching
• sudden appearance of hives or raised, pale red patches on the skin
• fever
• sudden severe chills accompanied by a feeling of cold
• excessive sweating
• difficulty breathing and wheezing
• chest pain, palpitations

Your doctor may give you medicines before Trodelvy to help relieve the symptoms. During each infusion and for 30 minutes afterwards, 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 have a severe infusion-related reaction.

Neutropenia

This medicine can cause neutropenia, a condition where there are very few neutrophils in the blood, increasing the risk of infections. These infections can be severe and life-threatening. Seek urgent medical attentionif you have any of the following signs and symptoms of neutropenia or infections:

• fever (temperature of 38.5°C or higher)
• chills or sweating
• sore throat, mouth ulcers or toothache
• stomach pain
• pain near the anus
• pain or burning when urinating or urinating more frequently
• diarrhea
• cough or shortness of breath

Your doctor will take blood samples to check the levels of neutrophils in your blood. You should not be given Trodelvy if your neutrophil levels are below a certain level on day 1 or day 8 of any treatment cycle.

Your doctor will adjust the amount of medicine you are given if you have severe neutropenia.

Diarrhea

Seek urgent medical attentionif you have severe diarrheawhile receiving Trodelvy.

Your treatment with Trodelvy will be delayed until the diarrhea has improved. You will be given loperamide to treat the diarrhea, unless you have an infection. You may also be given fluids if necessary.

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

Nausea and vomiting

This medicine can cause nausea and vomiting. Seek urgent medical attentionif you have severe nausea and vomitingwhile receiving Trodelvy.

Your doctor will give you some medicines before treatment with Trodelvy to help relieve nausea and vomiting. You should not be given Trodelvy if you have severe nausea and vomiting, and you should only be given Trodelvy when your symptoms are under control.

Patients with the UGT1A1*28 gene

Some patients are more likely to have certain side effects from the medicine due to their genetic makeup. If you have the UGT1A1*28 gene, your body breaks down the medicine more slowly. This means you are more likely to have 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. These patients will be closely monitored by their doctor.

Tell your doctor or nurse before you are given Trodelvy if:

• you have liver problems
• you have kidney problems
• you are a woman who could become pregnant (see “Pregnancy”, “Contraception in men and women” and “Breast-feeding”)
• you are taking other medicines to treat other conditions (see “Other medicines and Trodelvy”)
• you have had problems after receiving infusions in the past.

While you are being given Trodelvy, your doctor will closely monitor you for side effects. If you have any serious side effects, your doctor may prescribe you other medicines to treat them, may change the amount of Trodelvy you are given, or may stop giving you Trodelvy altogether.

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

Children and adolescents

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

Other medicines and Trodelvy

Tell your doctor if you are taking, have recently taken, or might take any other medicines. Some medicines may affect how Trodelvy works and may increase the levels of the active substance of Trodelvy in the blood, increasing the risk of side effects. These include:

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

Some medicines may decrease the levels of the active substance of Trodelvy in the blood, reducing its effects:

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

Pregnancy

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

Contraception in men and women

Women who could become pregnant must use effective contraceptive methods during treatment with Trodelvy and for 6 months after the last dose of Trodelvy.

Men with female partners who could become pregnant must use an effective contraceptive method during treatment and for 3 months after the last dose of Trodelvy.

Breast-feeding

Do not breast-feedduring treatment with Trodelvy and for 1 month after the last dose. It is not known if this medicine passes into breast milk and could affect the baby.

Driving and using machines

Trodelvy may affect your ability to drive and use machines, for example, feeling dizzy, tired. Therefore, you should be careful when driving, using tools, or operating machines after receiving Trodelvy.

3. How Trodelvy will be given to you

Trodelvy will only be given to you by your doctor or a nurse with experience in the use of cancer treatments.

It is important that your doctor or nurse has confirmed that you can receive this medicine by doing a blood test before treatment.

Medicines given before treatment with Trodelvy

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

How much Trodelvy will be given to you

Your cancer treatment will be given in cycles of 21 days (3 weeks). The recommended dose of Trodelvy is 10 mg per kilogram of body weightat the start of each cycle (day 1 of each cycle) and again one week later (day 8 of each cycle).

How the medicine will be given to you

A doctor or nurse will give you the medicine by infusion into a vein.

First infusion:the first infusion of the medicine will be given over 3 hours. Second infusion and subsequent infusions:the other infusions will be given over 1 to 2 hours if the first infusion was uneventful.

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

Infusion-related reactions

Your doctor will slow down the infusion rate of the medicine if you have an infusion-related reaction. The medicine will be stopped if the infusion-related reaction is life-threatening. See section 2.

Dose of medicine if you experience certain side effects

Your doctor may change the dose or stop the medicine if you experience certain side effects. See section 4.

If you are given too much Trodelvy

Because the infusion is given by your doctor or another trained person, it is unlikely that you will be given too much medicine. If you are given too much medicine by accident, your doctor will monitor you and give you any additional treatment that is needed.

If you miss a dose of Trodelvy

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

If you stop treatment with Trodelvy

You should not stop treatment early without talking to your doctor first.

Treatment for breast cancer with Trodelvy usually requires a number of treatments. The number of infusions you receive will depend on how you are responding to treatment. Therefore, you should keep receiving Trodelvy even if you notice that your symptoms are improving and until your doctor decides that you should stop treatment with Trodelvy. If treatment is stopped too early, your symptoms may come back.

If you have any other questions about 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 have any of the following serious side effects which are very common(may affect more than 1 in 10 people):

• Low white blood cell count (neutropenia),which can cause the following signs and symptoms:

• fever, which is a body temperature of 38.5°C or higher: this is called febrile neutropenia
• chills or sweating
• sore throat, mouth ulcers or toothache
• stomach pain
• pain near the anus or sores around the anus
• pain or burning when urinating or urinating more frequently
• diarrhea
• cough or shortness of breath

• Diarrhea(even without other signs)

• Hypersensitivity reactions (including infusion-related reactions)which can cause the following signs and symptoms:

• lips, tongue, eyes, throat or face swelling
• redness, itching, and raised patches on the skin
• sudden appearance of hives or raised, pale red patches on the skin
• fever
• sudden severe chills accompanied by a feeling of cold
• excessive sweating
• wheezing, feeling of chest or throat tightness, shortness of breath, dizziness, feeling of fainting, difficulty breathing
• chest pain, palpitations

• Feeling unwell (nausea), vomiting

Other possible side effects

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

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

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

Common(may affect up to 1 in 10 people)

• lung infection
• nasal congestion
• face pain, wheezing
• flu-like symptoms, cold sores
• low levels of phosphate or calcium in the blood
• anxiety
• change in sense of taste
• nosebleeds, shortness of breath when exercising, coughing up mucus
• sore and inflamed mouth, pain in the upper stomach, reflux, bloated stomach
• dry skin
• muscle pain in the chest, muscle spasms
• blood in the urine
• chills
• increased levels of an enzyme called alkaline phosphatase and abnormal blood tests related to blood clotting.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Trodelvy

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

• 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 outer packaging and the vial after EXP. The expiry date is the last day of the month shown.
• Store in a 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 medicine if you notice that the reconstituted solution is cloudy or has changed color.

Trodelvy is a cytotoxic medicine. Special handling and disposal procedures should be followed.

6. Container Content and Additional Information

Trodelvy Composition

• 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-morpholino)ethanesulfonic acid (MES), polysorbate 80, and trehalose dihydrate.

Appearance of Trodelvy and Container Content

This medicinal product 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

Manufacturer

Gilead Sciences Ireland UC

IDA Business and Technology Park

Carrigtohill

County Cork, T45 DP77

Ireland

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Trodelvy is a cytotoxic medicinal product. Special handling and disposal procedures should be followed.

This medicinal product should not be mixed with other medicinal products, except those 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 sodium chloride 9 mg/ml (0.9%) injection solution into each vial. The resulting concentration will be 10 mg/ml.
• Gently swirl the vials and allow them to dissolve for a period of up to 15 minutes. Do not shake. The product should be visually inspected for particles and color changes before administration. The solution should not contain visible particles and should be clear and yellow. Do not use the reconstituted solution if it is cloudy or has changed color.
• Use immediately to prepare a diluted solution for infusion.

Dilution

• Calculate the volume of reconstituted solution required to achieve the desired dose based on the patient's body weight.
• Determine the final volume of the infusion solution to administer the desired dose within a concentration range of sacituzumab govitecan of 1.1 mg/ml to 3.4 mg/ml.
• Withdraw and discard the volume of sodium chloride 9 mg/ml (0.9%) injection solution from the final infusion bag equivalent to the required volume of reconstituted solution.
• Withdraw the calculated volume of reconstituted solution from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).
• To minimize foam formation, slowly inject the required volume of reconstituted solution into a polyvinyl chloride, polypropylene, or ethylene/propylene copolymer infusion bag. Do not shake the contents.
• If necessary, adjust the volume in the infusion bag as needed with sodium chloride 9 mg/ml (0.9%) injection solution to achieve a concentration of 1.1 mg/ml to 3.4 mg/ml (the total volume should not exceed 500 ml). Only sodium chloride 9 mg/ml (0.9%) injection solution should be used, as 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 two equal parts between two 500 ml infusion bags and infuse sequentially over 3 hours for the first infusion and over 1-2 hours for subsequent infusions.
• If not used immediately, the infusion bag containing the diluted solution may 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 the next 8 hours (including infusion time).

Administration

• The infusion bag should be covered during administration to the subject until 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.
• An infusion pump may be used.
• Do not mix Trodelvy with other medicinal products or administer as an infusion with other medicinal products.
• After completion of the infusion, flush the intravenous line with 20 ml of sodium chloride 9 mg/ml (0.9%) injection solution.

Disposal

Disposal of unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local regulations.