Fulvestrant Medical Vallei

Package Leaflet: Information for the User

Fulvestrant Medical Valley, 250 mg, Solution for Injection in Pre-filled Syringe

Fulvestrant
Read all of this leaflet carefully before using this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.

• 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 get 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 and other information:

• 1. What is Fulvestrant Medical Valley and what is it used for
• 2. Before you use Fulvestrant Medical Valley
• 3. How to use Fulvestrant Medical Valley
• 4. Possible side effects
• 5. How to store Fulvestrant Medical Valley
• 6. Contents of the pack and other information

1. What is Fulvestrant Medical Valley and what is it used for

Fulvestrant Medical Valley contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes cause the growth of breast cancer.
Fulvestrant Medical Valley is used:

• Alone to treat postmenopausal women with a specific type of breast cancer that has spread to other parts of the body or has come back; this type of cancer is called hormone receptor-positive breast cancer.

or

• In combination with palbociclib to treat hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women, or in women who have experienced menopause and are also taking a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Medical Valley is used in combination with palbociclib, it is also important to read the package leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. Before you use Fulvestrant Medical Valley

Do not use Fulvestrant Medical Valley

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breast-feeding;
• if you have severe liver problems.

Warnings and precautions

Before starting treatment with Fulvestrant Medical Valley, tell your doctor, pharmacist, or nurse if you:

• have liver or kidney disease;
• have a low platelet count (which helps the blood to clot) or bleeding disorders;
• have had bleeding disorders in the past;
• have osteoporosis (reduced bone density);
• are addicted to alcohol.

Children and adolescents

Fulvestrant Medical Valley is not recommended for use in children and adolescents under 18 years.

Fulvestrant Medical Valley and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.
In particular, inform your doctor if you are taking anticoagulant medicines (to prevent blood clots).

Pregnancy and breast-feeding

Fulvestrant Medical Valley must not be used during pregnancy. If you can become pregnant, you should use effective contraceptive methods during treatment with Fulvestrant Medical Valley and for 2 years after the last dose.
Do not breast-feed during treatment with Fulvestrant Medical Valley.

Driving and using machines

Fulvestrant Medical Valley is unlikely to affect your ability to drive or use machines. However, if you feel tired after receiving Fulvestrant Medical Valley, do not drive or use machines.

Fulvestrant Medical Valley contains 500 mg of ethanol (alcohol) in each injection,

which is equivalent to 100 mg/mL (10% v/v). The amount of alcohol in each injection of this medicine is equivalent to 13 mL of beer or 5 mL of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents.
The alcohol in this medicine may affect the way other medicines work.
Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breast-feeding, talk to your doctor before using this medicine.
If you are addicted to alcohol, talk to your doctor before using this medicine.

Fulvestrant Medical Valley contains 500 mg of benzyl alcohol in each injection,

which is equivalent to 100 mg/mL. Benzyl alcohol may cause allergic reactions.
Fulvestrant Medical Valley contains 750 mg of benzyl benzoate in each injection,
which is equivalent to 150 mg/mL.

3. How to use Fulvestrant Medical Valley

Fulvestrant Medical Valley will be given to you by a doctor or nurse as a slow intramuscular injection, with each injection given into a different buttock.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 mL injections), given once a month, with an additional dose of 500 mg given 2 weeks after the first dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

If you experience any of the following side effects, you may need urgent medical attention.

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be signs of anaphylactic reactions
• Blood clots (increased risk of blood clots in the veins)*
• Hepatitis
• Liver failure.

If you experience any of the following side effects, tell your doctor, pharmacist, or nurse:

Very common side effects(may affect more than 1 in 10 people)

• Injection site reactions, such as pain and/or inflammation;
• Changes in liver enzyme activity (in blood tests)*;
• Nausea;
• Feeling weak, tired*;
• Joint and muscle pain;
• Hot flashes;
• 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 people)

• Headache;
• Vomiting, diarrhea, or loss of appetite*;
• Urinary tract infection;
• Back pain*;
• Increased bilirubin levels (a pigment produced by the liver);
• Blood clots (increased risk of blood clots in the veins)*;
• Low platelet count (thrombocytopenia);
• Vaginal bleeding;
• Lower back pain radiating to one leg (sciatica);
• Sudden weakness, numbness, tingling, or loss of movement in a leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy).

Uncommon side effects(may affect up to 1 in 100 people)

• Thick, white vaginal discharge and vaginal candidiasis (infection);
• Bruising and bleeding at the injection site;
• Increased activity of the liver enzyme gamma-glutamyltransferase in blood tests;
• Hepatitis;
• Liver failure;
• Numbness, tingling, and pain;
• Anaphylactic reactions.

* Includes side effects for which the contribution of Fulvestrant Medical Valley cannot be assessed due to the underlying disease.

Reporting of side effects

If you get 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 via the national reporting system listed in the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Medical Valley

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 syringe after “EXP”. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Store the pre-filled syringe in the original package to protect from light.
Medical personnel will be responsible for the proper storage, use, and disposal of Fulvestrant Medical Valley.
This medicine may pose a risk to aquatic environments.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Medical Valley contains

• The active substance is fulvestrant. Each pre-filled syringe (5 mL) contains 250 mg of fulvestrant.
• The other ingredients (excipients) are: ethanol (96%), benzyl alcohol, benzyl benzoate, and castor oil, purified.

What Fulvestrant Medical Valley looks like and contents of the pack

Fulvestrant Medical Valley is a clear, colorless to yellowish, viscous solution for injection in a pre-filled syringe, containing 5 mL of solution for injection. Two pre-filled syringes are required to administer the recommended monthly dose of 500 mg.
Fulvestrant Medical Valley is available in a carton containing 2 glass pre-filled syringes. Two needles with a safety system (BD SafetyGlide) are provided with the carton, for use with each syringe.

Marketing Authorisation Holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer

Laboratorios Farmalán, S.A.
Calle La Vallina, s/n, Edificio 2
Polígono Industrial Navatejera
24193 Villaquilambre, León
Spain

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

Denmark
Fulvestrant Medical Valley 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte
Spain
Kileza 250 mg solución inyectable en jeringa precargada
Netherlands
Fulvestrant Xiromed 250 mg oplossing voor injectie in een voorgevulde spuit
Iceland
Fulvestrant Medical Valley 250 mg stungulyf, lausn. áfyllt sprauta
Germany
Fulvestrant AXiromed 250 mg Injektionslösung in einer Fertigspritze
Norway
Fulvestrant Medical Valley
Poland
Fulvestrant Medical Valley
Sweden
Fulvestrant Medical Valley 250 mg injektionsvätska, lösning i förfylld spruta
United Kingdom
Fulvestrant 250 mg, solution for injection in pre-filled syringe

Date of last revision of the package leaflet: 10/2024

Other sources of information
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
https://www.gov.pl/web/urpl
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Information intended for healthcare professionals only:

Fulvestrant Medical Valley, 500 mg (2 x 250 mg/5 mL solution for injection) should be administered using two pre-filled syringes, see section 3.
Administration instructions
Caution – do not autoclave the needle with the safety system (BD SafetyGlide Shielding Hypodermic Needle) before use. When handling the medicinal product and disposing of waste, avoid hand contact with the needle.
For both syringes:

• Remove the glass syringe from the container and check it for damage.
• Open the outer packaging of the needle with the safety system (SafetyGlide).
• Visually inspect the solution for injection for particulate matter and discoloration prior to administration.
• Hold the syringe upright in the striped section (C). With your other hand, grasp the needle shield (A) and twist it counterclockwise (patrz Rysunek nr 1).
• (A) and carefully twist the plastic, rigid needle shield counterclockwise (see Figure 1).

Figure 1.

• Remove the needle shield (A) in a vertical direction upwards. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2.

• Attach the needle with the safety system to the Luer-Lock tip and tighten it firmly (see Figure 3).
• Check that the needle is securely attached to the Luer-Lock tip before proceeding to the upright position.
• Pull the needle shield straight off to avoid damaging the needle point.
• Bring the filled needle close to the injection site.
• Remove the needle shield.
• Remove any air from the syringe.

Figure 3.

• Administer the medicinal product slowly intramuscularly (injection lasting 1-2 minutes) into the buttock muscle. For the convenience of the person administering the medicinal product, the needle bevel is on the same surface as the needle shield lever (see Figure 4).

Figure 4.

• Immediately after administering the medicinal product, activate the needle shield by pushing the lever forward with your finger (see Figure 5).

CAUTION: Proceed in such a way as to ensure your safety and the safety of others. Listen for the click and visually confirm that the needle tip is fully covered.

Figure 5.
Disposal of waste
The pre-filled syringes are for single use only.
This medicinal product may pose a risk to aquatic environments. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.