KILEZA 250 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Kileza 250mg solution for injection in pre-filled syringe EFG

Fulvestrant

Read all of this leaflet carefully before you start using 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 pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Kilezaand what is it used for

1. What you need to know before you use Kileza
2. How to use Kileza
3. Possible side effects

1. Storage of Kileza
2. Contents of the pack and further information

1. What is Kileza and what is it used for

Kilezacontains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Fulvestrant is used:

• alone, to treat postmenopausal women with a type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastatic), or
• in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

Fulvestrant may be administered in combination with palbociclib. It is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. What you need to know before you use Kileza

Do not use Kileza:

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding
• if you have severe liver problems

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start using this medicine if any of the following apply to you:

• kidney or liver problems
• low platelet count (which helps blood to clot) or bleeding disorders
• previous blood clot problems
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents

Fulvestrant is not indicated in children and adolescents under 18 years of age.

Using Kileza with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are being treated with this medicine and for 2 years after your last dose.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Do not breastfeed while you are being treated with this medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or use machines.

Use in athletes

This medicine contains fulvestrant, which may produce a positive result in doping tests.

This medicine contains500 mg of alcohol (ethanol)per pre-filled syringe, which is equivalent to 100 mg/ml (10% w/v). The amount in each pre-filled syringe of this medicine is equivalent to 13 ml of beer or 5 ml of wine.

The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents.

The alcohol in this medicine may affect the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

This medicine contains 500 mg of benzyl alcohol in each pre-filled syringe, equivalent to 100 mg/ml.

Benzyl alcohol may cause allergic reactions.

Talk to your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

Talk to your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (metabolic acidosis).

This medicine contains 750 mg of benzyl benzoate in each injection, equivalent to 150 mg/ml

This medicine may cause severe allergic reactions because it contains refined castor oil.

3. How to use Kileza

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

Your doctor or nurse will administer Kilezaby slow intramuscular injection into each of your buttocks.

The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

You may need urgent medical treatment if you experience any of the following side effects:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be symptoms of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Hepatitis (inflammation of the liver)
• Liver failure

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:

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

• Injection site reactions, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling sick)
• Weakness, tiredness*
• Joint and musculoskeletal pain
• Hot flushes
• Rash
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat

All other side effects:

Common side effects(may affect up to 1 in 10 people)

• Headache
• Vomiting, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lumbar pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on one side of the body, sudden problems with walking or balance (peripheral neuropathy)

Uncommon side effects(may affect up to 1 in 100 people)

• Thick, white, vaginal discharge and candidiasis (infection)
• Hematoma and bleeding at the injection site
• Increased gamma-GT, a liver enzyme identified in a blood test
• Hepatitis (inflammation of the liver)
• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

• Includes side effects for which the exact role of this medicine cannot be evaluated due to the underlying disease.

Reporting of side effects

If you experience 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 Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kileza

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 carton or on the labels of the syringes after EXP. The expiry date refers to the last day of the month shown.

This product does not require any special storage conditions.

Store the pre-filled syringe in the original packaging to protect it from light.

Your healthcare professional will be responsible for the proper storage, use, and disposal of Kileza.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofKileza

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
• The other ingredients (excipients) are: ethanol (96%), benzyl alcohol (E1519), benzyl benzoate, and refined castor oil.

Appearance and pack contents

Kileza is a viscous, clear, colorless to yellow solution for injection in a pre-filled syringe, which contains 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Kileza is available in 3 formats: a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, and a pack containing 6 glass pre-filled syringes. One, two, or six needles with a safety system (BD SafetyGlide) are also provided for connection to the syringe body.

Not all pack sizes may be marketed.

Marketing authorization holder

Exeltis Healthcare, S.L

Avda. Miralcampo, 7.

Pol. Ind. Miralcampo.

19200 Azuqueca de Henares (Guadalajara)

Spain

Manufacturer

Laboratorios Farmalán, S.A.

Calle La Vallina, s/n, Edificio 2

Polígono Industrial Navatejera

Villaquilambre, León, 24193, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

NL – Fulvestrant Xiromed 250 mg oplossing voor injectie in een voorgevulde spuit

DE – Fulvestrant Axiromed 250 mg Injektionslösung in einer Fertigspritze.

DK – Fulvestrant Medical Valley 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte.

IS – Fulvestrant Medical Valley 250 mg stungulyf, lausn, áfyllt sprauta

NO – Fulvstrant Medical Valley

SE – Fulvestrant Medical Valley 250 mg injektionsvätska, lösning i förfylld spruta

ES – Kileza 250 mg solución inyectable en jeringa precargada.

UK – Fulvestrant 250 mg, solution for injection in pre-filled syringe.

Date of last revision of this leaflet: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

--------------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Kileza 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes. See section 3.

Administration instructions

Warning – Do not autoclave the safety needle (BD SafetyGlide or Terumo SurGuard) before use. Hands should remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Remove the protective cap from the top of the syringe barrel and ensure it is not damaged.
• Open by removing the outer packaging of the safety needle
• Parenteral solutions should be inspected visually for particles and discoloration before administration.
• Hold the syringe in a vertical position over the grooved area (C). With the other hand, grasp the plunger (A) and carefully turn the rigid plastic plunger in a counterclockwise direction. (see Figure 1):

Figure 1

• Remove the rigid plastic plunger (A) in a straight upward direction. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2

Attach the safety needle to the "Luer-Lok" and turn until it is securely attached.

• Check that the needle is attached to the Luer connector before moving it from the vertical position.
• Pull the needle cap straight off to avoid damaging the needle tip.
• Place the syringe at the injection site.
• Remove the needle cap.
• Expel excess air from the syringe.

Figure 3

• Administer slowly via intramuscular injection into the buttock (1 to 2 minutes/injection). For greater comfort, the position of the needle with the bevel up has the same orientation as the lever raised (see Figure 4).

Figure 4

• After injection, immediately touch the lever with your finger to activate the protective mechanism (see Figure 5).

NOTE: Activate it away from your body and others. Listen for the click and visually confirm that the needle tip is fully protected.

Figure 5

Disposal

The pre-filled syringes are for singleuse.

This medicine may pose a risk to the aquatic environment. Any unused medicine or waste material should be disposed of in accordance with local regulations.