Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fulvestrant Eugia is and what it is used for
2. What you need to know before using Fulvestrant Eugia
3. How to use Fulvestrant Eugia
4. Possible side effects
5. How to store Fulvestrant Eugia
6. Contents of the pack and other information

1. What Fulvestrant Eugia is and what it is used for

Fulvestrant Eugia contains the active substance fulvestrant, which belongs to the group of estrogen blockers.

Estrogens, a type of female sex hormones, may in some cases be involved in the development of breast cancer.

Fulvestrant is used:

• alone, to treat postmenopausal women with a type of breast cancer called estrogen 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-negative (HER2-negative) breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet 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 palbociclib package leaflet. If you have any questions about palbociclib, consult your doctor.

2. What you need to know before using Fulvestrant Eugia

Do not use Fulvestrant Eugia

• if you are allergic to fulvestrant or to 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

Talk to your doctor, pharmacist, or nurse before using fulvestrant if any of the following apply to you:

• kidney or liver problems
• low platelet count (platelets help blood to clot) or bleeding disorders
• history of blood clots
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents

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

Other medicines and Fulvestrant Eugia

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

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

Pregnancy and breastfeeding

You must not use fulvestrant if you are pregnant. If you could become pregnant, you must use an effective method of contraception during treatment with fulvestrant and for two years after your last dose.

You must not breastfeed while being treated with fulvestrant.

Driving and using machines

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

Use in athletes

This medicine contains fulvestrant, which may lead to a positive result in doping control tests.

Excipients:

Ethanol:

This medicine contains 10% p/v ethanol (alcohol), i.e. up to 500 mg per injection.

The amount in a treatment dose (i.e. two syringes) of this medicine is equivalent to 25 ml of beer or 10 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. However, the amount of alcohol contained in this medicine may alter the effect of other medicines. Consult your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.

If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

Benzyl alcohol:

This medicine contains 500 mg of benzyl alcohol in each injection, equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions.

Benzyl benzoate:

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

3. How to use Fulvestrant Eugia

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor or nurse will administer fulvestrant to you by slow intramuscular injection into each of your buttocks.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You may need urgent medical treatment if you experience any of the following adverse 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)*.
• Inflammation of the liver (hepatitis).
• Liver failure.

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

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

• Reactions at the injection site, such as pain and/or swelling.
• Abnormal levels of liver enzymes (in blood tests)*.
• Nausea (feeling unwell).
• Weakness, fatigue*.
• Joint and musculoskeletal pain.
• Hot flushes.
• Skin rash.
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat.

All remaining adverse effects:

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

• Headache.
• Vomiting, diarrhoea 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 levels (thrombocytopenia).
• Vaginal bleeding.
• Lower back 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 adverse effects (may affect up to 1 in 100 people)

• Thick, whitish vaginal discharge and candidiasis (infection).

• Bruising and bleeding at the injection site.

• Increased gamma-GT, a liver enzyme detected in blood tests.

• Inflammation of the liver (hepatitis).

• Liver failure.

• Numbness, tingling, and pain.

• Anaphylactic reactions.

• Includes adverse effects for which the exact role of fulvestrant cannot be evaluated due to the underlying disease.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fulvestrant Eugia

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2°C and 8°C).

Do not use this medicine after the expiry date stated on the packaging or on the labels of the syringes, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.

Your healthcare professional is responsible for the proper storage, use, and disposal of fulvestrant. This medicine may pose a risk to the aquatic environment.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Eugia

• The active substance is fulvestrant. Each 5 ml pre-filled syringe (50 mg/ml) contains 250 mg of fulvestrant.
• The other components (excipients) are ethanol (96%), benzyl alcohol (E1519), benzyl benzoate and refined castor oil.

Nature of the medicinal product and contents of the container

Injectable solution in a pre-filled syringe.

Viscous, transparent, colourless to yellowish solution, practically free from visible particles.

Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe EFG is supplied in a clear type I glass syringe of 5 ml with a tip cap, equipped with a tamper-evident seal and closed with a grey plunger stopper made of bromobutyl rubber, together with a plunger.

A safety-engineered hypodermic needle ("BD SafetyGlide") is also provided for attachment to the syringe barrel, for administration of the fulvestrant injection solution. The glass syringe barrel together with the needle will be placed in a plastic protective container with a transparent lid.

Fulvestrant Eugia 250 mg solution for injection in pre-filled syringe EFG is available in 6 pack sizes: a pack containing 1 pre-filled glass syringe, a pack containing 2 pre-filled glass syringes, a pack containing 4 pre-filled glass syringes, a pack containing 5 pre-filled glass syringes, a pack containing 6 pre-filled glass syringes, and a pack containing 10 pre-filled glass syringes. Safety-engineered needles ("BD SafetyGlide") are also provided for attachment to each syringe.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

OR

Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora
Portugal

OR

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Belgium: Fulvestrant Eugia 250 mg oplossing voor injectie in voorgevulde spuit / solution injectable en seringue préremplie / Injektionslösung in einer Fertigspritze
France: Fulvestrant Arrow 250 mg, solution injectable en seringue préremplie
Germany: Fulvestrant PUREN 250 mg Injektionslösung in einer Fertigspritze
Italy: Fulvestrant Aurobindo
Netherlands: Fulvestrant Eugia 250 mg, oplossing voor injectie in een voorgevulde spuit
Poland: Fulvestrant Eugia
Portugal: Fulvestrant Generis
Romania: Fulvestrant Eugia 250 mg soluție injectabila în seringa preumpluta
Spain: Fulvestrant Eugia 250 mg solución inyectable en jeringa precargada EFG

Date of the most recent review of this leaflet: February 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Fulvestrant Eugia 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-engineered needle (Protected Hypodermic Needle “BD SafetyGlide”) before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Remove the glass syringe barrel from the tray and check that it is undamaged.
• Open the outer packaging of the safety-engineered needle (“SafetyGlide”).
• Prior to administration, parenteral solutions should be visually inspected for particulate matter and discoloration.
• Hold the syringe vertically by the fluted part (C). With the other hand, grasp the cap (A) and carefully tilt it back and forth until the cap loosens and can be removed; do not twist (see Figure 1).

Figure 1

• Remove the cap (A) by pulling upwards. To maintain sterility, avoid touching the syringe tip (B) (see Figure 2).

Figure 2

• Attach the safety-engineered needle to the Luer-Lok and screw it on until firmly secured (see Figure 3).
• Confirm that the needle is securely attached to the Luer connector before ceasing to hold the syringe vertically.
• Remove the needle protective cap in a straight line to avoid damaging the needle tip.
• Carry the loaded syringe to the administration site.
• Remove the needle protective cap.
• Expel excess air from the syringe.

Figure 3

• Administer slowly by intramuscular injection into the gluteal region (gluteal area) (1-2 minutes per injection). For greater comfort, positioning the needle with the bevel facing upward aligns with the orientation of the raised lever arm (see Figure 4).

Figure 4

• Immediately after injection, press once with a finger on the lever arm to activate the safety mechanism (see Figure 5).

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

Figure 5

Disposal

Pre-filled syringes are for single use only.

This medicinal product may pose a risk to the aquatic environment. The disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations (see section 5).