FULVESTRANT STADAFARMA 250 mg INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet:information for the patient

Fulvestrant STADAFARMA 250 mg injectable solutionin a pre-filled EFG syringe

Read all of this leaflet carefully before you receive 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, pharmacist, or nurse.
• 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 experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See Section 4.

Contents of the pack

1. What is Fulvestrant Stadafarma and what is it used for
2. What you need to know before you receive Fulvestrant Stadafarma
3. How Fulvestrant Stadafarma is administered
4. Possible side effects

5 Conservation of Fulvestrant Stadafarma

1. Contents of the pack and additional information

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

Fulvestrant Stadafarma contains 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 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, 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 of palbociclib. If you have any questions about palbociclib, ask your doctor.

2. What you need to know before you receive Fulvestrant Stadafarma

You must not receiveFulvestrant Stadafarma:

• 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

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

Other medicines andFulvestrant Stadafarma

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

You must not use fulvestrant if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while being treated with fulvestrant and for 2 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 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 contains 1000mg of alcohol (ethanol)in each dose of 2 x 5 ml 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 noticeable effect.

This medicine is harmful to people with alcoholism.

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

This medicinecontains 500mg of benzyl alcoholin each 5 ml injection, which is equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have any liver or kidney problems. You should do this because if you receive large amounts of benzyl alcohol, they may accumulate in your body and cause side effects (known as "metabolic acidosis").

This medicine contains 750mg of benzyl benzoatein each 5 ml injection, which is equivalent to 150 mg/ml.

3. How to use Fulvestrant Stadafarma

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 at 2 weeks after the initial dose.

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

If you have any further questions on 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 Toxicological Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

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

Tell your doctor immediately if you experience any of the following side effects, as you may need urgent medical treatment:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which can 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(may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling sick)
• Weakness, fatigue*
• Joint and musculoskeletal pain
• Hot flashes
• Rash

All other side 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 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(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
• Numbness, tingling, and pain
• Anaphylactic reactions

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system, including the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Fulvestrant Stadafarma

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 label of the syringes after the abbreviation EXP. The expiry date is the last day of the month stated.

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

Temperature deviations between 2°C and 8°C should be limited. This includes avoiding storage at temperatures above 25°C, and not exceeding a period of 28 days in which the average storage temperature of the medicine is below 25°C (but above 2°C and 8°C). After any temperature deviation, the medicine should be immediately returned to the recommended storage conditions (refrigerated storage between 2°C and 8°C). Temperature deviations have a cumulative effect on the quality of the medicine, and the 28-day period should not be exceeded during the 36-month validity period of fulvestrant injectable solution. Exposure to temperatures below 2°C will not damage the medicine as long as it is not stored below -20°C.

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

Your healthcare professional will be responsible for the correct storage, use, and disposal of Fulvestrant Stadafarma 250 mg injectable solution in a pre-filled EFG syringe.

This medicine may pose a risk to the aquatic environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. This will help protect the environment.

6. Contents of the pack and additional information

Composition ofFulvestrantStadafarma

• 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 ingredients (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate, and refined castor oil.

Appearance ofFulvestrantStadafarmaandcontents of the pack

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

Fulvestrant Stadafarma is available in 3 formats: a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, or a pack containing 6 glass pre-filled syringes. Safety needles ("BD SafetyGlide") are also provided for connection to the syringe body.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area 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 solución inyectable en jeringa precargada EFG

Date of last revision of this leaflet:December 2023

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

This information is intended only for healthcare professionals:

Fulvestrant 500 mg (2 x 250 mg/5 ml injectable solution) should be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning – Do not autoclave the safety needle (Protected Hypodermic Needle "BD SafetyGlide") before use. Hands should remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Remove the glass body of the syringe from the tray and check that it is not damaged.
• Open the outer package of the safety needle ("SafetyGlide").
• Before administration, parenteral solutions should be inspected visually for particulate matter and discoloration.
• Hold the syringe in a vertical position by the striated part (C). With the other hand, hold the screw cap (A) and carefully turn it counterclockwise until it comes off and can be removed (see Figure 1).

Figure 1

• Remove the screw cap (A) by pulling it straight up. To maintain sterility, do not touch the tip of the syringe (B) (see Figure 2).

Figure 2

• Attach the safety needle to the "Luer-Lok" and screw it on until it is firmly attached (see Figure 3).
• Check that the needle is attached to the Luer connector before releasing it from the vertical position.

Figure 3

• Pull the protective cap of the needle straight off to avoid damaging the tip.
• Take the loaded syringe to the injection site.
• Remove the protective cap of the needle.
• Eliminate excess gas from the syringe.
• Proceed with the administration by slow intramuscular injection (1 to 2 minutes per injection) in the buttock (gluteal area). For greater user comfort, the position of the needle with the bevel up has the same orientation as the lever arm (see Figure 4).

Figure 4

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

NOTE: Activate the protective mechanism 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 single use only.

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.