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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

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

Fulvestrant Teva 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 Teva 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 Teva

DO NOT use Fulvestrant Teva:

• 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 (see section “Pregnancy and breastfeeding”)
• if you have severe liver problems

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Fulvestrant Teva 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 (see section “Fulvestrant Teva contains 96% ethanol (alcohol)”).

The efficacy and safety of fulvestrant (as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.

Children and adolescents

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

Using Fulvestrant Teva with other medicines

Tell 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 taking anticoagulants (medicines used to prevent blood clots).

Pregnancy and breastfeeding

DO NOT use Fulvestrant Teva if you are pregnant. If you could become pregnant, you must use an effective method of contraception during treatment with Fulvestrant Teva and for 2 years after your last dose.

DO NOT breastfeed while being treated with Fulvestrant Teva.

Driving and using machines

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

Fulvestrant Teva contains 96% ethanol (alcohol)

This medicine contains 474 mg of alcohol (ethanol) in each 5 ml pre-filled syringe, corresponding to 94.8 mg/ml. The amount in a 10 ml dose of this medicine is equivalent to less than 24 ml of beer or 10 ml of wine.

The small amount of alcohol in this medicine will not have any significant effect.

Fulvestrant Teva contains benzyl alcohol

This medicine contains 500 mg of benzyl alcohol in each 5 ml pre-filled syringe, equivalent to 100 mg per ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you have liver or kidney disease. This is because high levels of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Fulvestrant Teva contains benzyl benzoate

This medicine contains 750 mg of benzyl benzoate in each 5 ml pre-filled syringe, equivalent to 150 mg per ml.

3. How to use Fulvestrant Teva

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Your doctor or nurse will administer Fulvestrant Teva to you as a slow intramuscular injection into each buttock.

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 signs of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Inflammation of the liver (hepatitis)
• Liver failure

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

Adverse effects reported in patients treated with fulvestrant monotherapy:

Very common: may affect more than 1 in 10 people

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

All remaining adverse effects:

Common: may affect up to 1 in 10 people

• Headache
• Vomiting, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a pigment in bile produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Low 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: 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 Teva cannot be assessed due to the underlying disease.

Adverse effects reported in patients treated with fulvestrant in combination with palbociclib:

Very common: may affect more than 1 in 10 people

• Decreased neutrophil count (neutropenia)
• Decreased white blood cell count (leucopenia)
• Infections
• Fatigue
• Nausea
• Reduction in red blood cells (anemia)
• Inflammation or ulceration of the mouth
• Diarrhea
• Decreased platelet count (thrombocytopenia)
• Vomiting
• Hair loss
• Rash
• Loss of appetite
• Fever

Common: may affect up to 1 in 10 people

• Feeling of weakness
• Increased liver enzyme levels
• Loss of taste
• Nosebleeds
• Excessive tearing of the eye
• Dry skin
• Blurred vision
• Dry eye

Uncommon: may affect up to 1 in 100 people

• Fever with other signs of infection (febrile neutropenia)

Reporting of adverse effects

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

5. Storage of Fulvestrant Teva

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

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

Do not use this medicine if you notice particles or discoloration before administration.

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

Temperature excursions outside the range of 2°C to 8°C must be controlled. This includes avoiding storage at temperatures above 25°C for longer than a total period of 4 months, during which the average storage temperature of the medicine must remain below 25°C (but above 2°C to 8°C). After temperature excursions, the medicine must be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature excursions have an accumulative effect on the quality of the medicine, and the total duration of such excursions must not exceed the 4-month period or extend beyond the 2-year shelf-life of Fulvestrant Teva. Exposure to temperatures below 2°C will not damage the medicine, provided it is not stored below -20°C.

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

Your healthcare professional is responsible for the proper storage, use, and disposal of Fulvestrant Teva.

This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are in doubt, please consult your pharmacist on how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Teva

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

Appearance of the product and contents of the pack

Fulvestrant Teva is a clear, viscous, colourless to yellow solution in a pre-filled syringe equipped with a Luer-Lock connector containing 5 ml of injectable solution. Two syringes must be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Teva is available in two pack sizes:

• 1 pack containing 1 pre-filled glass syringe and 1 safety needle for attachment to the syringe barrel.

• 1 pack containing 2 pre-filled glass syringes and 2 safety needles provided for attachment to the syringe barrels.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

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

Austria: Fulvestrant ratiopharm 250 mg Injektionslösung in einer Fertigspritze

Belgium: Fulvestrant Teva 250 mg oplossing voor injectie/solution injectable/Injektionslösung

Bulgaria: ??????????? ???? 250 mg ?????????? ??????? ? π???????????? ??π?????? ?π????????

Croatia: Fulvestrant Pliva 250 mg otopina za injekciju u napunjenoj štrcaljki

Czech Republic: Fulvestrant Teva

Denmark: Fulvestrant Teva

Finland: Fulvestrant ratiopharm 250 mg injektioneste, liuos, esitäytetty ruisku

France: Fulvestrant Teva 250mg solution injectable en seringue préremplie

Germany: Fulvestrant Teva 250 mg Injektionslösung in einer Fertigspritze

Hungary: Fulvestrant Teva 250 mg/5 ml oldatos injekció elõretöltött fecskendõben

Iceland: Fulvestrant Teva 250 mg stungulyf, lausn í áfylltri sprautu

Ireland: Fulvestrant Teva 250 mg Solution for Injection in Pre-filled Syringe

Italy: Fulvestrant Teva

Latvia: Fulvestrant Teva 250 mg škidums injekcijām pilnšļircē

Lithuania: Fulvestrant Teva 250mg injekcinis tirpalas užpildytame švirkšte

Luxembourg: Fulvestrant Teva 250 mg oplossing voor injectie/solution injectable/Injektionslösung

Netherlands: Fulvestrant Teva 250 mg, oplossing voor injectie voorgevulde spuit

Poland: Fulvestrant Teva

Portugal: Fulvestrant Teva

Romania: Fulvestrant Teva 250 mg solutie injectabila în seringa preumpluta

Slovakia: Fulvestrant Teva 250 mg

Slovenia: Fulvestrant Teva 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi

Spain: Fulvestrant Teva 250 mg solución inyectable en jeringa precargada EFG

Sweden: Fulvestrant Teva 250 mg injektionsvätska, lösning, förfylld spruta

United Kingdom: Fulvestrant Teva 250mg solution for injection in pre-filled syringe

(Northern Ireland)

Date of the most recent review of this summary: July 2025

Other sources of information

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/80910/P_80910.html

QR Code + URL

This information is intended for healthcare professionals only:

Fulvestrant Teva 500 mg (2 x 250 mg/5 ml solution for injection) must be administered using two pre-filled syringes (see section 3).

Administration instructions

Administer the injection according to local guidelines for intramuscular injection of large volumes.

NOTE: Due to the proximity of the sciatic nerve, caution should be exercised when injecting Fulvestrant Teva into the dorsogluteal region (see section 4.4).

Warning – DO NOT autoclave the safety needle before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

Disposal

The pre-filled syringes are for single use only.

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