Trodelvy 200 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Trodelvy 200 mg powder for concentrate for solution for infusion

sacituzumab govitecan

This medicinal product is subject to additional monitoring, which will enable rapid identification of new information on its safety. You can help by reporting any side effects you may experience. Section 4 at the end includes information on how to report these side effects.

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

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

Leaflet contents

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

1. What Trodelvy is and what it is used for

Trodelvy is an anticancer medicine that contains the active substance sacituzumab govitecan. 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 component of Trodelvy is SN-38, a substance that can destroy cancer cells. Once the medicine has bound to the cancer cells, 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 it has spread 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 treatment for locally advanced or metastatic cancer.

Talk to your doctor or nurse if you have any questions about how Trodelvy works or why it has been prescribed for you.

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

Do not use Trodelvy if you are allergic to sacituzumab govitecan or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

Warnings and precautions

Infusion-related reactions

Trodelvy is administered by intravenous infusion. Some people experience infusion-related reactions, which may be severe or potentially life-threatening. Seek urgent medical attention if you experience any of the following signs and symptoms of infusion-related reactions:

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

Your doctor may give you medications before Trodelvy to help reduce these symptoms. During each infusion and for 30 minutes afterward, you will be closely monitored for signs and symptoms of infusion-related reactions. Your doctor may slow down or stop the infusion if you have a severe infusion-related reaction.

Neutropenia

This medicine may cause neutropenia, a condition in which there are very few neutrophils in the blood, increasing the risk of infections. These infections may be serious and potentially life-threatening. Seek urgent medical attention if you experience any of the following signs and symptoms of neutropenia or infection:

• fever (temperature of 38.5°C or higher)
• chills or sweating
• sore throat, mouth sores, or toothache
• stomach pain
• pain near the anus
• pain or burning when urinating, or more frequent urination
• 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 count is below a certain level on day 1 or day 8 of any treatment cycle.

Your doctor may adjust the dose of medicine you receive if you have severe neutropenia.

Diarrhea

Seek urgent medical attention if you develop severe diarrhea while receiving Trodelvy.

Your treatment with Trodelvy will be postponed until the diarrhea has improved. You will be given loperamide to treat the diarrhea, provided there is no infection. If needed, you will also receive fluids.

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

Nausea and vomiting

This medicine may cause nausea and vomiting. Seek urgent medical attention if you experience severe nausea and vomiting while receiving Trodelvy.

Your doctor will give you certain medications before cancer treatment and between infusion sessions to help reduce nausea and vomiting. Trodelvy will not be administered if you have severe nausea and vomiting, and treatment will only resume once symptoms are under control.

Patients with the UGT1A1*28 gene

Some patients are more likely to experience certain adverse effects 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 experience certain side effects (such as neutropenia, with or without fever, and low red blood cell levels (anemia)) compared to those who do not have this gene. Your doctor will monitor you closely.

Talk to your doctor or nurse before receiving Trodelvy if:

• you have liver problems
• you have kidney problems
• you are a woman of childbearing potential (see “Pregnancy”, “Contraception in men and women”, and “Breast-feeding”)
• you are taking medicines for other conditions (see “Other medicines and Trodelvy”)
• you have had any problems receiving infusions in the past.

While you are receiving Trodelvy, your doctor will monitor you closely for adverse effects. If you experience any serious side effects, your doctor may prescribe other medicines to treat them, adjust your Trodelvy dose, or stop Trodelvy treatment completely.

See section 4 for a list of all possible adverse effects associated with Trodelvy.

Children and adolescents

Trodelvy should not be given to children and adolescents under 18 years of age, as there is no information on its use in this age group.

Other medicines and Trodelvy

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

• propofol, used as an anesthetic during surgery
• ketoconazole, used to treat fungal infections
• tyrosine kinase inhibitors, used to treat cancer (medicines ending in -nib)

Some medicines may decrease the concentration of the active ingredient of Trodelvy in the blood, reducing its effectiveness:

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

Pregnancy

Trodelvy must not be used during pregnancy because it may harm the unborn 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 could become pregnant must use effective contraception during treatment with Trodelvy and for 6 months after the last dose of Trodelvy.

Men who have female partners who could 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 and could affect the baby.

Driving and using machines

Trodelvy may affect your ability to drive and use machines, for example due to dizziness or fatigue. Therefore, you should be cautious when driving, operating tools, or using machinery after receiving Trodelvy.

3. How Trodelvy will be administered to you

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

It is important that your doctor or the healthcare professional managing your care has confirmed you can receive this medicine by performing a blood test before treatment.

Medicines given before Trodelvy treatment

You will be given certain medicines before receiving Trodelvy to help prevent infusion-related reactions and nausea and vomiting. Your doctor will decide which medicines you may need and the doses to be given.

Dose of Trodelvy you will receive

Your cancer treatment is repeated in 21-day (3-week) cycles. The recommended dose of Trodelvy is 10 mg per kg of body weight at the beginning of each cycle (day 1 of each cycle) and again one week later (day 8 of each cycle).

How the medicine will be given

A doctor or nurse will administer the medicine as an intravenous infusion (a drip into the vein).

First infusion: The first infusion will be given over 3 hours.
Second and subsequent infusions: The following infusions will be given over 1 to 2 hours if the first infusion was completed without problems.

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

Infusion-related reactions

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

Dose adjustments due to certain side effects

Your doctor may adjust 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 qualified healthcare professional, an overdose is unlikely. If you accidentally receive too much medicine, your doctor will monitor you and provide additional treatment as needed.

If you miss a dose of Trodelvy

If you miss or forget your appointment, contact your doctor or treatment center as soon as possible to reschedule. Do not wait until your next scheduled visit. It is very important not to miss any doses for the treatment to be fully effective.

If you stop treatment with Trodelvy

Do not stop treatment earlier than planned without first consulting your doctor.

Breast cancer treatment with Trodelvy generally requires multiple treatments. The number of infusions you receive will depend on how you respond to treatment. Therefore, you should continue receiving Trodelvy even if you notice your symptoms improving, until your doctor decides it should be stopped. If treatment is stopped too early, your symptoms may return.

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

4. Possible adverse effects

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

Serious adverse effects

Seek urgent medical attention if you experience any of the following very common serious adverse effects (may affect more than 1 in 10 people):

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

• fever, defined as a body temperature of 38.5°C or higher: this is called febrile neutropenia

• chills or sweating

• sore throat, mouth sores, or toothache

• stomach pain

• pain near the anus or sores around the anus

• pain or burning when urinating, or frequent urination

• diarrhea

• cough or shortness of breath

• Diarrhea (even without other signs)

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

• swelling of the lips, tongue, eyes, throat, or face

• raised, red, itchy skin rash or swelling

• sudden appearance of swollen, pale red wheals (hives) on the skin

• fever

• sudden intense shivering accompanied by a feeling of cold

• excessive sweating

• wheezing, chest tightness or throat tightness, shortness of breath, dizziness, feeling faint, difficulty breathing

• chest pain, palpitations

• Feeling unwell (nausea), vomiting

Other possible adverse effects

The following adverse effects are listed below. If any of these become severe or intense, inform your doctor immediately.

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

• burning sensation when urinating and frequent, urgent need to urinate
• cough, sore throat, runny nose, headache, and sneezing
• anemia
• low white blood cell count (lymphocytes or leukocytes)
• loss of appetite
• low blood potassium or magnesium levels
• high blood glucose 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, oral herpes infection
• low blood phosphate or calcium levels
• anxiety
• altered sense of taste
• nosebleeds, shortness of breath during exercise, cough with phlegm
• painful and inflamed mouth, upper stomach pain, reflux, bloated stomach
• dry skin
• chest muscle pain, muscle spasms
• blood in the urine
• chills
• increased levels of an enzyme called alkaline phosphatase and abnormal blood tests related to coagulation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Trodelvy

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

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer packaging and vial after EXP. The expiry date refers to the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• Keep the vial in its outer packaging to protect it from light.
• After reconstitution and dilution, if not used immediately, the infusion bag containing the diluted solution may 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 the reconstituted solution appears cloudy or shows any changes in colour.

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

6. Contents of the pack and other information

Composition of Trodelvy

• The active substance is sacituzumab govitecan. One 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 contents of the pack

This medicine is a white to yellowish powder for concentrate for solution for infusion supplied in a glass vial. Each pack 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 more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this package 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. Appropriate special handling and disposal procedures must be followed.

This medicinal product must not be mixed with others except as specified below.

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 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 the powder to dissolve for up to 15 minutes. Do not shake. The product should be inspected visually for particles and discoloration prior to administration. The solution should be free of visible particles and should be clear and yellow. Do not use the reconstituted solution if it is cloudy or shows signs of discoloration.
• Use immediately to prepare a diluted infusion solution.

Dilution

• Calculate the volume of reconstituted solution required to achieve 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 sacituzumab govitecan concentration range of 1.1 mg/ml to 3.4 mg/ml.
• Withdraw and discard from the final infusion bag an amount of sodium chloride 9 mg/ml (0.9%) injection solution equal to the volume of reconstituted solution to be added.
• Withdraw the calculated amount of reconstituted solution from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).
• To minimize foaming, 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 with sodium chloride 9 mg/ml (0.9%) injection solution to achieve a concentration of 1.1 mg/ml to 3.4 mg/ml (total volume must 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 established.
• For patients whose body weight exceeds 170 kg, divide the total dose of Trodelvy equally into 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 at 2 °C to 8 °C for up to 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 must be protected from light during administration to the patient until administration is complete. It is not necessary to cover the infusion tubing or use light-protective tubing during infusion.
• Administer Trodelvy as an intravenous infusion. Protect the infusion bag from light.
• An infusion pump may be used.
• Do not mix Trodelvy or administer it as a concurrent 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

Any unused medicinal product and all materials that have come into contact with it must be disposed of in accordance with local regulations.