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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Read the entire leaflet carefully before you are given 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 side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See Section 4.

Leaflet contents

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

2. What you need to know before receiving Fulvestrant Stadafarma

3. How Fulvestrant Stadafarma is administered

4. Possible side effects

5. Storage of Fulvestrant Stadafarma

6. Contents of the pack and other information

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

Fulvestrant Stadafarma 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 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 receiving Fulvestrant Stadafarma

Do not use Fulvestrant Stadafarma:

• 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

• Consult your doctor, pharmacist, or nurse before receiving fulvestrant if you have any of the following conditions:
• 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 Stadafarma

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 used 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 result in a positive doping test.

This medicine contains 1000 mg of alcohol (ethanol) in each 2 x 5 ml dose of injectable solution. The amount present in 2 x 5 ml of this medicine is equivalent to less than 20 ml of beer or 8 ml of wine.

The small amount of alcohol present in this medicine has no significant effect.

This medicine may be harmful for individuals suffering from alcoholism.

The alcohol content should be taken into account in high-risk groups, such as patients with liver disease or epilepsy.

This medicine contains 500 mg of benzyl alcohol in each 5 ml injection, equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have any liver or kidney problems, as large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (known as "metabolic acidosis").

This medicine contains 750 mg of benzyl benzoate in each 5 ml injection, equivalent to 150 mg/ml.

3. How to use Fulvestrant Stadafarma

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 as a slow intramuscular injection into each of your buttocks.

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

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

4. Possible adverse effects

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

Immediately inform your doctor if you experience any of the following adverse effects, as you may require immediate medical treatment:

• 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

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

• Very common (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

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 bile pigment produced by the liver)

• 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

• 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system, including the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fulvestrant Stadafarma

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 abbreviation CAD. The expiry date refers to the last day of the month indicated.

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

Temperature deviations from the range of 2 °C to 8 °C should be limited. This includes avoiding storage at temperatures above 25 °C, and not exceeding a total period of 28 days during which the average storage temperature of the medicine is below 25 °C (but above the 2 °C to 8 °C range). If any temperature deviation occurs, the medicine must be returned immediately to the recommended storage conditions (refrigerated storage and transport between 2 °C and 8 °C). Temperature deviations have an accumulative effect on the quality of the medicine, and the 28-day period must not be exceeded during the 36-month shelf life of injectable fulvestrant. Exposure to temperatures below 2 °C will not damage the medicine as long as 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 Stadafarma 250 mg solution for injection in pre-filled syringe EFG.

This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. Return unused packaging and medicines to the SIGRE collection point at your pharmacy. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Stadafarma

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) 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 Fulvestrant Stadafarma and contents of the pack

Fulvestrant Stadafarma is a viscous, transparent, colourless to yellow solution in a pre-filled syringe with a bromobutyl rubber stopper, a polystyrene plunger and a polypropylene cap, containing 5 ml of injectable solution. To complete the recommended monthly dose of 500 mg, two syringes must be administered.

Fulvestrant Stadafarma is available in three pack sizes: one pack containing 1 glass pre-filled syringe, one pack containing 2 glass pre-filled syringes, or one pack containing 6 glass pre-filled syringes. Safety-engineered needles (“BD SafetyGlide”) are also provided for attachment to the barrel of each syringe.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

KeVaRo GROUP Ltd.

9 Tzaritza Elenora Str., office 23

Sofia 1618

Bulgaria

or

Laboratori Fundació Dau

Calle Lletra C de la Zona Franca 12-14,

Polígono Industrial de la Zona Franca de Barcelona,

08040, Barcelona,

Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany Fulvestrant AL 250 mg Injektionslösung in einer Fertigspritze

Italy Fulvestrant EG STADA

Hungary Fulmerak 250 mg oldatos injekció eloretöltött fecskendoben

Portugal Fulvestrant ELC

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

Date of most recent review of this leaflet: December 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 500 mg (2 x 250 mg/5 ml solution for injection) must 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”).
• Before 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, hold the screw cap (A) and carefully turn it counterclockwise until it loosens and can be removed (see Figure 1).

Figure 1

• Remove the screw cap (A) by pulling it straight upward. To maintain sterility, do not touch 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).
• Ensure the needle is securely attached to the Luer connector before ceasing to hold the syringe vertically.

Figure 3

• Remove the needle protective cap in a straight line to avoid damaging the needle tip.
• Take the loaded syringe to the administration site.
• Remove the needle protective cap.
• Expel excess air from the syringe.
• Administer the solution slowly (1 to 2 minutes per injection) by intramuscular injection into the gluteal region (gluteal area). For user comfort, the needle bevel facing upward has the same orientation as the lever arm (see Figure 4).

Figure 4

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

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

Figure 5

Disposal

The pre-filled syringes are for single use only.

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