TRODELVY 180 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

3.

• ■ 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.

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.

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

• ■ 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.

Children and adolescents

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

Other medicines and Trodelvy

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.

Pregnancy

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.

Male and female contraception

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.

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.

Driving and using machines

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.

3.

Trodelvy will only be given to you by your doctor or a nurse experienced in using anti-cancer therapies.

It is important that the doctor 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 with side effects, such as nausea and vomiting and influsion-related reactions.

How much you will be given

The dose you are given will depend on your height, weight, and general health. Your doctor will calculate your body surface area in square meters (m2) and will determine the dose you should receive.

Frequency of administration

You should usually receive Trodelvy twice every 3 weeks on Days 1 and 8 of a 21– day treatment cycle.

How you will be given your medicine

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

First infusion : you will be given your first infusion of Trodelvy over 3 hours. Your doctor or nurse will monitor you for signs and symptoms of infusion-related reactions both during the infusion and 30 minutes after.

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 30 minutes after your infusion.

Infusion-related reactions

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

The following information is intended for healthcare professionals only:

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

Reconstitution

• ■ The product should be prepared in a hospital aseptic unit.

• ■ 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.

• ■ Using a sterile syringe, slowly inject 20 mL of sodium chloride 0.9% solution for injection, into each 180 mg Trodelvy vial. The resulting concentration will be 10 mg/mL.

• ■ The product should only be reconstituted with 0.9% sodium chloride.

• ■ 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 Trodelvy solution for infusion.

Dilution

• ■ Calculate the required volume of the reconstituted Trodelvy solution needed to obtain the appropriate dose according to patient’s body weight. Withdraw this amount from the vial(s) using a syringe. Discard any unused portion remaining in the vial(s).

• ■ Adjust the volume in the infusion bag as needed with sodium chloride 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). For patients whose body weight exceeds 170 kg, divide the total dosage of Trodelvy equally between two 500 mL infusion bags and infuse sequentially via slow infusion.

• ■ Slowly inject the required volume of reconstituted Trodelvy solution into a polyvinyl chloride, polypropylene, or polypropylene copolymer infusion bag to minimise foaming. Do not shake the contents.

• ■ Only sodium chloride 0.9% solution for injection should be used since the stability of the reconstituted product has not been determined with other infusion-based solutions. Use the diluted solution in the infusion bag immediately. If not used immediately, the infusion bag containing Trodelvy solution can be stored refrigerated 2°C to 8°C for up to 4 hours. After refrigeration, administer diluted solution within 4 hours (including infusion time).

Do not freeze or shake. Protect from light.

Administration

• ■ Administer Trodelvy as an intravenous infusion. Protect 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 0.9% solution for injection.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number ofthe administered product should be clearly recorded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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GS TRO 180 mg Great Britain PIL 90405802.indd 2

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