Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - trodelvy

Document Subject

Generated Narrative: MedicinalProductDefinition mp27ec6b1f73b141fda5344cc71ceec655

identifier: http://ema.europa.eu/identifier/EU/1/21/1592/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Trodelvy 200 mg powder for concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-27ec6b1f73b141fda5344cc71ceec655

identifier: http://ema.europa.eu/identifier/EU/1/21/1592/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - trodelvy

Attesters

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

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 (TNBC). 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.

Trodelvy is used to treat a type of breast cancer in adults called hormone receptor -positive (HR+), human epidermal growth factor receptor 2 -negative (HER2-) breast cancer. Trodelvy should only be used after patients have tried a treatment including a hormonal anticancer treatment and at least two additional other treatments for a locally advanced cancer or metastasised 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).

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

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, life-threatening and may lead to death. 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.
Your diarrhoea can lead to dehydration and sudden kidney damage. Talk to your doctor if you experience dark-coloured urine or decreased urine volume.

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 make- up. 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.

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.

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
• lack of enough red blood cells (anaemia)
• low level of white blood cells (lymphocytes or leukocytes)
• 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 discoloured skin, shortness of breath due to overwhelmed bloodstream by bacteria (sepsis)
• infection of the lungs (pneumonia)
• blocked nose, pain in your face, wheezing
• hacking cough which may bring up clear, yellow-grey or greenish phlegm
• flu like symptoms; herpes infection in the mouth
• low number of platelets, which may lead to bleeding and bruising (thrombocytopenia)
• high blood level of glucose
• decreased water in the body
• low blood level of phosphate, calcium or sodium
• anxiety
• change in your sense of taste
• low blood pressure
• nose bleeding; a cough reflex triggered by the drip down of mucus in the back of your throat
• inflammation of the small and large bowel (colitis)
• inflamed and sore mouth; pain in upper stomach area; reflux; bloated stomach
• darkening of the skin; acne-like skin problem; dry skin
• muscle pain in the chest; muscle spasms
• blood in urine; excess protein in urine
• chills
• 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)

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. 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.

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 vial label and carton 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 24 hours protected from light.
• 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.

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 DPIreland

Manufacturer Gilead Sciences Ireland UC IDA Business and Technology Park Carrigtohill County Cork, T45 DPIreland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 Lietuva Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1
Gilead Sciences Ireland UC .: + 353 (0) 1 686 1Luxembourg/Luxemburg Gilead Sciences Belgium SRL-BV T l/Tel: + 32 (0) 24 01 35 esk republika Gilead Sciences s.r.o. Tel: + 420 910 871 Magyarorsz g Gilead Sciences Ireland UC Tel.: + 353 (0) 1 686 1Danmark Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1Malta Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0

Nederland Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 Eesti Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Norge Gilead Sciences Sweden AB Tlf: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 210 8930 sterreich Gilead Sciences GesmbH Tel: + 43 1 260 Espa a Gilead Sciences, S.L. Tel: + 34 91 378 98 Polska Gilead Sciences Poland Sp. z o.o. Tel.: + 48 22 262 8France Gilead Sciences T l: + 33 (0) 1 46 09 41 Portugal Gilead Sciences, Lda. Tel: + 351 21 7928Hrvatska Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1Rom nia Gilead Sciences (GSR) S.R.L. Tel: + 40 31 631 18 Ireland Gilead Sciences Ireland UC Tel: + 353 (0) 214 825 Slovenija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1 sland Gilead Sciences Sweden AB S mi: + 46 (0) 8 5057 1Slovensk republika Gilead Sciences Slovakia s.r.o. Tel: + 421 232 121 Italia Gilead Sciences S.r.l. Tel: + 39 02 439Suomi/Finland Gilead Sciences Sweden AB Puh/Tel: + 46 (0) 8 5057 1
Gilead Sciences . . : + 30 210 8930 Sverige Gilead Sciences Sweden AB Tel: + 46 (0) 8 5057 1Latvija Gilead Sciences Ireland UC Tel: + 353 (0) 1 686 1United Kingdom (Northern Ireland) Gilead Sciences Ireland UC Tel: + 44 (0) 8000 113 This leaflet was last revised in

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