FULVESTRANT VISO FARMACEUTICA 250 mg INJECTABLE SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the Patient

Fulvestrant Viso Pharmaceutical 250 mg injectable solution in pre-filled syringe EFG

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fulvestrant Viso Pharmaceutical and what is it used for
2. What you need to know before starting to use Fulvestrant Viso Pharmaceutical
3. How to use Fulvestrant Viso Pharmaceutical
4. Possible side effects
5. Storage of Fulvestrant Viso Pharmaceutical
6. Package Contents and Additional Information

1. What is Fulvestrant Viso Pharmaceutical and what is it used for

This medication contains the active ingredient 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:

• as monotherapy, for the treatment of 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 breast cancer and human epidermal growth factor receptor 2 (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 medication called luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant is administered in combination with palbociclib, it is essential that you also read the package leaflet of palbociclib. If you have any questions about palbociclib, consult your doctor.

2. What you need to know before starting to use Fulvestrant Viso Pharmaceutical

Do not useFulvestrant Viso Pharmaceuticalif:

• you are allergic to fulvestrant or any of the other components of this medication (listed in section 6),
• you are pregnant or breastfeeding,
• you have severe liver problems.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Fulvestrant Viso Pharmaceutical if any of the following applies to you:

• kidney or liver problems,
• low platelet count (which helps blood 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 Medications and Fulvestrant Viso Pharmaceutical

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

You should not use this medication if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while being treated with this medication and for two years after the last dose.

You should not breastfeed while being treated with Fulvestrant Viso Pharmaceutical.

Driving and Using Machines

This medication 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 medication contains fulvestrant, which may produce a positive result in doping tests.

Fulvestrant Viso Pharmaceutical contains ethanol

This medication contains 500 mg of alcohol (ethanol) in each pre-filled syringe, equivalent to 100 mg/ml (10% m/v). The amount in each pre-filled syringe of this medication is equivalent to less than 13 ml of beer or 5 ml of wine.

It is unlikely that the amount of alcohol in this medication will have any noticeable effect on adults or adolescents. It may have some effects on young children, such as drowsiness.

The amount of alcohol in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

If you have a history of alcoholism, consult your doctor or pharmacist before using this medication.

Fulvestrant Viso Pharmaceutical contains benzyl alcohol

This medication contains 500 mg of benzyl alcohol in each pre-filled syringe, equivalent to 100 mg/ml (10% m/v). Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Fulvestrant Viso Pharmaceutical contains benzyl benzoate

This medication contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.

3. How to use Fulvestrant Viso Pharmaceutical

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You may need urgent medical attention if you experience any of the following side effects:

• 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.

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

Very Common Side Effects(may affect more than 1 in 10 patients)

• injection site reactions, such as pain and/or inflammation,
• abnormal liver enzyme levels (in blood tests),
• nausea (feeling of discomfort),
• weakness, fatigue,
• joint and musculoskeletal pain,
• hot flashes,
• skin rash,
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat.

All Other Side Effects:

Common Side Effects(may affect up to 1 in 10 patients)

• headache,
• vomiting, diarrhea, 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 count (thrombocytopenia),
• vaginal bleeding,
• lumbar pain that radiates 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 Side Effects(may affect up to 1 in 100 patients)

• 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,
• hepatitis (inflammation of the liver),
• liver failure,
• numbness, tingling, and pain,
• anaphylactic reactions.

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

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Fulvestrant Viso Pharmaceutical

This medication does not require special storage conditions.

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

Your healthcare professional will be responsible for the proper storage, use, and disposal of Fulvestrant Viso Pharmaceutical.

This medication may pose a risk to the aquatic environment. Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fulvestrant Viso Pharmaceutical

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

Appearance of the Product and Package Contents

Fulvestrant Viso Pharmaceutical is a viscous, transparent, colorless to yellow solution in a pre-filled syringe containing 5 ml of injectable solution. Two pre-filled syringes should be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Viso Pharmaceutical is available in three package sizes: a package containing 1 pre-filled glass syringe, a package containing 2 pre-filled glass syringes, and a package containing 6 pre-filled glass syringes. One, two, or six safety needles (BD SafetyGlide) are also provided for attachment to the syringe body.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Laboratorios Farmalán, S.A.

C/ La Vallina s/n, Edificio 2

Polígono Industrial Navatejera

24193, Villaquilambre, León

Spain

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7ª planta

28045 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Fulvestrant Glenmark 250 mg oplossing voor injectie in een voorgevulde spuit

Germany: Fulvestrant Glenmark 250 mg Injektionslösung in einer Fertigspritze

Denmark: Fulvestrant Glenmark

Spain: Fulvestrant Viso Farmacéutica 250 mg solución inyectable en jeringa precargada EFG

Norway: Fulvestrant Glenmark

Sweden: Fulvestrant Glenmark

Date of the last revision of this package leaflet: April 2025

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

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This information is intended only for healthcare professionals:

Fulvestrant Viso Pharmaceutical 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 sterilize the safety needle (BD SafetyGlide hypodermic safety needle) in an autoclave before use. Hands should remain behind the needle at all times during use and disposal.

For each of the two pre-filled syringes:

-Remove the glass syringe from the tray and check that it is not damaged.

-Remove the outer packaging of the safety needle (SafetyGlide).

-Parenteral solutions should be inspected visually for particles and discoloration before administration.

-Hold the syringe in a vertical position over the grooved part (C). With the other hand, grasp the cap (A) and carefully twist the rigid plastic tip cap counterclockwise. (see Figure 1):

Figure 1

-Remove the rigid plastic tip cap (A) in a straight upward direction. To maintain sterility, do not touch the syringe tip (B) (see Figure 2)

Figure 2

Connect the safety needle to the Luer-Lok and twist until it is firmly seated (see Figure 3).

• Check that the needle is locked into the Luer connector before leaving the vertical plane.
• Remove the needle protector to avoid damaging the needle tip.
• Bring the filled syringe to the injection site.
• Remove the needle shield.
• Expel excess air from the syringe.

Figure 3

• Administer slowly (1-2 minutes/injection) by intramuscular injection into the buttock (gluteal area). For user comfort, the bevel of the needle is oriented towards the lever arm (see Figure 4).

Figure 4

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

NOTE: Activate it 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.

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