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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

fulvestrant

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, consult 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Sibudel is and what it is used for

Sibudel 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.

Sibudel 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 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 package leaflet for palbociclib. If you have any questions about palbociclib, consult your doctor.

2. What you need to know before using Sibudel

DO NOT use Sibudel:

• 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

Consult your doctor, pharmacist, or nurse before starting to use Sibudel if any of the following apply to you:

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

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

Use of Sibudel with other medicines

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 taking anticoagulants (medicines used to prevent blood clots).

Pregnancy and breastfeeding

You must NOT use Sibudel if you are pregnant. If you are able to become pregnant, you must use an effective method of contraception during treatment with Sibudel and for 2 years after the last dose.

You must NOT breastfeed while being treated with Sibudel.

Driving and using machines

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

Sibudel contains 96% ethanol (alcohol)

This medicine contains 474 mg of alcohol (ethanol) in each 5 ml pre-filled syringe, equivalent to 94.8 mg/ml. The amount in a 10 ml dose of this medicine corresponds 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.

Sibudel 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 large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Sibudel 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 Sibudel

Follow exactly the instructions for administration of 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/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 Sibudel 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 may cause adverse effects, although not everyone will experience 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 as monotherapy:

Very common: may affect more than 1 in 10 people

• injection site reactions, such as pain and/or swelling
• abnormal liver enzyme levels (in blood tests)*
• nausea (feeling unwell)
• weakness, tiredness*
• 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: may affect up to 1 in 10 people

• headache
• vomiting, diarrhoea 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 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: 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 Sibudel 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
• tiredness
• nausea
• reduction in red blood cells (anaemia)
• mouth inflammation or ulceration
• diarrhoea
• decreased platelet levels (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
• excessively watery eyes
• dry skin
• blurred vision
• dry eyes

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 they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sibudel

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 the word "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 more than a total 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 a cumulative effect on the quality of the medicine and must not exceed a total duration of 4 months beyond the 2-year shelf life of Sibudel. 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 Sibudel.

This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Sibudel

• 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 medicinal product and contents of the pack

Sibudel is a clear, colourless to yellow, viscous 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.

Sibudel is available in two pack sizes:

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

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

Only certain pack sizes may be marketed.

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 European Economic Area member states under the following names:

Germany: Fulvestrant AbZ 250 mg Injektionslösung in einer Fertigspritze

Spain: Sibudel 250 mg solution for injection in pre-filled syringe EFG

Date of the most recent revision of this leaflet: 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 on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/80999/P_80999.html

QR Code + URL

This information is intended for healthcare professionals only:

Sibudel 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 Sibudel 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 medicine may pose a risk to the aquatic environment. Disposal of unused medicine and of all materials that have been in contact with it should be carried out in accordance with local regulations.