Trodelvy 180 mg powder for concentrate for solution for infusion

• 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.

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

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 to death. 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. 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.

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

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.

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.

• 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.

Trodelvy must not be given to children under 18 years of age because there is no information about its use in this age group.

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.

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.

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.

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.

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.

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 you forget or miss your appointment, contact your doctor or your treatment centre to make another appointment as soon as possible.

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 to take Trodelvy even if you see your symptoms improve until your doctor recommends that Trodelvy should be stopped.

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:
  • black or bloody stools
  • symptoms of dehydration such as lightheadedness, dizziness, or faintness
  • inability to take fluids by mouth due to nausea or vomiting
  • inability to get diarrhoea under control within 24 hours.
• 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.

Common

(may affect up to 1 in 10 people)

• Low neutrophil count with fever, which may cause the following signs and symptoms:
  • a fever, which is a 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 or burning when urinating, or urinating often
  • diarrhoea
  • a cough or shortness of breath.
• Pneumonia (Lung infection) which may cause the following signs and symptoms:
  • cough, which may produce greenish, yellow or even bloody mucus
  • fever, sweating and shaking chills
  • shortness of breath
  • rapid, shallow breathing
  • sharp or stabbing chest pain that gets worse when you breathe deeply or cough
  • loss of appetite, low energy, and fatigue

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)

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.

• The active substance is sacituzumab govitecan
• The other ingredients are 2-(N-morpholino)ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrate.

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.