Trodelvy - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

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. This will allow quick identification of new safety information. You can help by reporting any side affects you may get. See the end of section 4 for 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Trodelvy is and what it is used for

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

• 3. How you will be given Trodelvy

• 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 a cancer medicine that contains the active substance sacituzumab govitecan. One part of the medicine is a monoclonal antibody that attaches specifically to a protein on the surface of breast cancer cells called Trop-2. The other active part of Trodelvy is SN-38, a substance that can kill cancer cells. Once the medicine has attached to cancer cells, the SN-38 enters the cancer cells and kills them, thereby helping to fight your cancer.

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

The medicine 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 sites in the body (metastasised). 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.

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 are given Trodelvy

You must not be given Trodelvy if you are allergic to sacituzumab govitecan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

Infusion-related reactions

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

• itching
• sudden outbreak of swollen, pale red bumps or plaques (wheals) on the skin
• fever
• sudden severe shivering accompanied by a feeling of coldness
• excessive sweating
• breathing difficulties and wheezing
• chest pain, heart palpitations

Your doctor may give you medicines before Trodelvy to help relieve the symptoms. During each infusion 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.

Neutropenia

This medicine can cause neutropenia, a condition where there are too few neutrophils in your blood, which increases the risk of infections. These infections can be severe and life-threatening. Seek urgent medical attention if you have the following signs and symptoms of neutropenia or 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
• pain or burning when urinating, or urinating more often
• diarrhoea or sores around the anus
• a cough or shortness of breath

Your doctor will take blood samples to monitor the levels of neutrophils in your blood. You will not be given Trodelvy if the neutrophils 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.

Diarrhoea

Seek urgent medical attention if you suffer from severe diarrhoea whilst receiving Trodelvy. 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 will also be given fluids.

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.

Nausea and vomiting

This medicine can cause nausea and vomiting. Seek urgent medical attention if you suffer from severe nausea and vomiting whilst receiving Trodelvy.

Your doctor will give you some medicines before your cancer therapy, and in between infusion sessions 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.

Patients who have 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 the medicine down more slowly. This means you are more likely to develop certain side effects (such as neutropenia with or without fever and low level of red blood cells (anaemia)), than those who do not have the gene. These patients will be closely followed-up by their doctor.

Talk to your doctor, or nurse before you are given Trodelvy if you:

• have liver problems
• have kidney problems
• are a female of child-bearing age (see ‘Pregnancy’, ‘Male and female Contraception’ and ‘Breast-feeding’)
• are taking medicines to treat other conditions (see ‘Other medicines and Trodelvy’)
• have experienced any problems after receiving any infusions in the past.

While you are being given Trodelvy, your doctor will monitor you closely for side effects. If you get any serious side effects, your doctor may give you other medicines to treat these side effects, they may change how much Trodelvy you receive or may stop giving you Trodelvy altogether.

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

Children and adolescents

Trodelvy should not be given to children and adolescents under 18 years old 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 the way Trodelvy works and may raise the level of Trodelvy’s active substance in your blood, increasing the risk of side effects. They are:

• - propofol , given as an anesthetic in surgery.

• - ketoconazole , used to treat fungal infections.

• - tyrosine kinase inhibitors , used to treat cancer (medicines ending in -nib).

Some medicines may lower the level of Trodelvy’s active substance in your blood, decreasing its effects:

• - carbamazepine or phenytoin , used to treat epilepsy.

• - rifampicin , used to treat tuberculosis.

• - ritonavir or tipranavir , used to treat HIV.

Pregnancy

Trodelvy should not be used during pregnancy because it may harm the baby. Tell your doctor immediately if you are pregnant, think you may be pregnant, or are planning to have a baby.

Male and female contraception

Women who might get pregnant must use effective contraception during treatment with Trodelvy, and for 6 months after the last dose of Trodelvy.

Men with 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 e.g. feeling dizzy, fatigue. 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 your doctor or nurse 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 stop infusion-related reactions and any nausea and vomiting. Your doctor will decide what medicines you may need and how much to take.

How much Trodelvy you will be given

Treatment for your cancer is repeated in 21-day (3-week) cycles. The recommended dose of Trodelvy is 10 mg for each kg of your body weight at the start of each cycle (Day 1 of each cycle) and again one week later (Day 8 of each cycle).

How you will be given your medicine

A doctor or nurse will give the medicine via an intravenous infusion (a drip into your vein).

First infusion : you will be given your first infusion of medicine over 3 hours.

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 for 30 minutes after each infusion for signs and symptoms of infusion-related reactions.

Infusion-related reactions

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

Dose of medicine when experiencing some side-effects

Your doctor may change or stop your dose 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 treatment as required.

If a dose of Trodelvy is missed

If you forget or miss your appointment, call your doctor or your treatment centre to make another appointment as soon as possible. Do not wait until your next planned visit. For the treatment to be fully effective, it is very important not to miss a dose.

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 infusions that you receive will depend on how you are responding to treatment. Therefore, you should continue receiving Trodelvy even if you see your symptoms improve and until your doctor decides that Trodelvy should be stopped. If the treatment is stopped too early, your symptoms may return.

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 very common serious side effects (may affect more than 1 in 10 people):

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

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

• – 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

• Diarrhoea (even without other signs)
• Hypersensitivity reactions (including infusion-related reactions) which may cause the following signs and symptoms:

• – swollen lips, tongue, eyes, throat or face

• – swelling or a raised, itchy, red skin rash

• – 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

• – wheezing, chest or throat tightness, shortness of breath, dizziness, feeling of fainting, breathlessness

• – chest pain, heart palpitations

• Feeling sick (nausea), being sick (vomiting)

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
• cough, sore throat, runny nose, headache, and sneezing
• anaemia
• low level of white blood cells (lymphocytes or leukocytes)
• loss of appetite
• low blood level of potassium or magnesium
• high blood level of glucose
• trouble sleeping
• feeling dizzy
• constipation, stomach pain
• hair loss, rash, general itching
• back pain, joint pain
• tiredness
• weight loss

Common (may affect up to 1 in 10 people)

• blocked nose
• pain in your face, wheezing
• flu like symptoms, herpes infection in the mouth
• low blood level of phosphate or calcium
• anxiety
• change in your sense of taste
• nose bleeding, shortness of breath when exercising, cough with phlegm
• inflamed and sore mouth, pain in upper stomach area, reflux, bloated stomach
• dry skin
• muscle pain in the chest, muscle spasms
• blood in urine
• chills
• increase in an enzyme called alkaline phosphatase and abnormal blood tests related to coagulation.

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. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trodelvy

Trodelvy will be stored by healthcare professionals at the hospital or clinic 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 vial after EXP. The expiry date refers to the last day of that month.
• Store in a refrigerator (2°C – 8°C). Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• After reconstitution and dilution, if not used immediately, the infusion bag containing diluted

solution can be stored in a refrigerator (2°C – 8°C) for up to 4 hours.

• Do not use this medicine if you notice the reconstituted solution is cloudy or discoloured.

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

6. Contents of the pack and other information

What Trodelvy contains:

• - The active substance is sacituzumab govitecan. One vial of powder contains 200 mg sacituzumab govitecan. After reconstitution, one mL of solution contains 10 mg of 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 for concentrate for solution for infusion supplied in a glass vial. Each pack contains 1 vial.

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

The following information is intended for healthcare professionals only:

Trodelvy is a cytotoxic medicine. Applicable special handling and disposal procedures have to be followed.

This medicinal product must 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 beginning of each treatment cycle (or more frequently if the patient’s body weight changed by more than 10% since the previous administration).
• Allow the required number of vials to warm to room temperature (20°C to 25°C).
• Using a sterile syringe, slowly inject 20 mL of sodium chloride 9 mg/mL (0.9%) solution for

injection into each vial. The resulting concentration will be 10 mg/mL.

• 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 solution for infusion.

Dilution

• Calculate the required volume of the reconstituted solution needed to obtain the appropriate dose according to the patient’s body weight.
• Determine the final volume of the infusion solution to deliver the appropriate dose at a sacituzumab govitecan concentration range of 1.1 mg/mL to 3.4 mg/mL.
• Withdraw and discard a volume of sodium chloride 9 mg/mL (0.9%) solution for injection from the final infusion bag that is equivalent to the required volume of the reconstituted solution.
• Withdraw the calculated amount of the 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 as needed with sodium chloride 9 mg/mL (0.9%) solution for injection, to obtain 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%) solution for injection should be used since the stability of the reconstituted product has not been determined with other infusion-based solutions.
• For patients whose body weight exceeds 170 kg, divide the total dose of Trodelvy equally 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 diluted solution can be stored refrigerated 2°C to 8°C for up to 4 hours protected from light. Do not freeze. After refrigeration, administer the diluted solution within 4 hours (including infusion time).

Administration

• The infusion bag should be covered during administration to the subject until dosing is complete. It is not necessary to cover the infusion tubing or to use light-protective tubing during the 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 as an infusion, with other medicinal products.
• Upon completion of the infusion, flush the intravenous line with 20 mL sodium chloride