Fulvestrant medical valley

Package leaflet: Information for the user

Fulvestrant Medical Valley, 250 mg, solution for injection in pre-filled syringe
Fulvestrantum
Please read carefully the entire leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Fulvestrant Medical Valley is and what it is used for
2. Important information before using 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 Fulvestrant Medical Valley is and what it is used for

Fulvestrant Medical Valley contains the active substance fulvestrant, which belongs to a class of medicines known as estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes influence the development of breast cancer.
Fulvestrant Medical Valley is used:

• As a single agent in the treatment of postmenopausal women with a certain type of breast cancer called estrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic)

or

• In combination with palbociclib in the treatment of women with a certain type of hormone receptor-positive breast cancer, human epidermal growth factor receptor 2 (HER2)-negative, that is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Medical Valley is administered in combination with palbociclib, it is important to also read the package leaflet for palbociclib. If you have any questions regarding palbociclib, please consult your treating physician.

2. Important information before using Fulvestrant Medical Valley

When not to use Fulvestrant Medical Valley

• if the patient is allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding;
• if the patient has severe impairment of liver function.

Warnings and precautions
Before starting treatment with Fulvestrant Medical Valley, discuss with your doctor,
pharmacist or nurse if the patient:

• has kidney or liver disease;
• has low platelet count (platelets enable blood clotting) or coagulation disorders;
• has had coagulation disorders in the past;
• has osteoporosis (reduced bone mineral density);
• is alcohol-dependent.

Children and adolescents
Fulvestrant Medical Valley is not recommended for use in children and adolescents under
18 years of age.
Fulvestrant Medical Valley and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking anticoagulant medicines
(medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant Medical Valley must not be used during pregnancy. If the patient may become pregnant, effective contraception is recommended during treatment with Fulvestrant Medical
Valley and for 2 years after the last dose.
Breastfeeding must not be performed during treatment with Fulvestrant Medical Valley.
Driving and operating machinery
Fulvestrant Medical Valley is not expected to affect the ability to drive or operate machinery. However, if fatigue occurs after administration of Fulvestrant Medical Valley, driving and operating machinery should be avoided.
Fulvestrant Medical Valley contains 500 mg of alcohol (ethanol) per injection,
equivalent to 100 mg/mL (10% w/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 affect adults and adolescents.
The alcohol contained in this medicine may alter the effect of other medicines.
Talk to your doctor or pharmacist if the patient is taking other medicines.
If the patient is pregnant or breastfeeding, she should consult a doctor before using this
medicine.
If the patient is alcohol-dependent, she should consult a doctor before using this
medicine.
Fulvestrant Medical Valley contains 500 mg of benzyl alcohol per injection,
equivalent to 100 mg/mL. Benzyl alcohol may cause allergic reactions.
Fulvestrant Medical Valley contains 750 mg of benzyl benzoate per injection,
equivalent to 150 mg/mL.

3. How to use Fulvestrant Medical Valley

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following adverse reactions occur, urgent medical attention may be required.

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and (or) throat, which may be symptoms of anaphylactic reactions
• Thromboembolic disease (increased risk of venous thrombosis)*
• Hepatitis
• Liver failure

If any of the adverse reactions listed below occur, inform your doctor, pharmacist, or nurse:
Very common adverse reactions (may occur in more than 1 in 10 people)

• Reactions at the injection site, such as pain and (or) inflammation;
• Changes in liver enzyme activity (in blood tests)*;
• Nausea;
• Feeling of weakness, fatigue*;
• Joint pain and musculoskeletal pain;
• Hot flushes;
• Skin rash;
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and (or) throat.

All other adverse reactions:
Common adverse reactions (may occur in up to 1 in 10 people)

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

Uncommon adverse reactions (may occur in up to 1 in 100 people)

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

* Includes adverse reactions for which the influence of Fulvestrant Medical Valley cannot be assessed due to the presence of underlying disease.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fulvestrant Medical Valley

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the label of the syringe after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature of the medicine.
Store the pre-filled syringe in its original packaging to protect from light.
Medical personnel will be responsible for the proper storage, handling, and disposal of any unused or waste material from Fulvestrant Medical Valley.
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 medicines no longer required. This 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 purified castor oil.

What Fulvestrant Medical Valley looks like and contents of the pack
Fulvestrant Medical Valley is a clear, colourless to yellow, viscous solution in a pre-filled syringe containing 5 mL of solution for injection. Two pre-filled syinges are required to administer the recommended monthly dose of 500 mg.
Fulvestrant Medical Valley is available in a cardboard package containing 2 glass pre-filled syringes. Two safety needles (BD SafetyGlide) are included in the package, intended for attachment to 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 for marketing in the European Economic Area under the following names:
Denmark Fulvestrant Medical Valley 250 mg injection liquid, solution in prefilled injection syringe
Spain Kileza 250 mg injectable solution in a pre-filled syringe
Netherlands Fulvestrant Xiromed 250 mg solution for injection in a pre-filled syringe
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

Other sources of information
Detailed information about 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

Information intended exclusively for healthcare professionals:

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
Warning – do not place the safety needle (BD SafetyGlide Shielding Hypodermic Needle) in an autoclave before use. During administration of the medicinal product and disposal of waste, avoid hand contact with the needle.
Applies to both syringes:

• Remove the glass vial from its container and inspect it for damage.
• Open the outer packaging of the safety needle (SafetyGlide).
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe vertically by the fluted section (C). With the other hand, grasp the cap (A) and carefully turn the plastic, rigid tip of the cap counterclockwise (see Figure 1).

Figure 1.

• Remove the cap (A) vertically upward. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2.

• Attach the safety needle to the Luer-Lock tip and tighten firmly until resistance is felt (see Figure 3).
• Check that the needle is securely attached to the Luer-Lock tip before proceeding to the upright position.
• Pull off the needle shield with a firm motion to avoid damaging the sharp tip.
• Bring the filled syringe close to the administration site.
• Remove the needle shield.
• Expel any excess air from the syringe.

Figure 3.

• Administer the medicinal product slowly by deep intramuscular injection (over 1–2 minutes) into the gluteal muscle. For the convenience of the person administering the product, the bevel of the needle is located on the same side of the needle as the safety needle mechanism (see Figure 4).

Figure 4.

• Immediately after administration of the medicinal product, activate the needle safety mechanism with the finger by pushing its lever forward (see Figure 5).

WARNING: Act to ensure safety for yourself and others. Listen for the click
and visually confirm that the needle tip is completely covered.

Figure 5.
Waste disposal
Pre-filled syringes are intended exclusively for single use.
This medicinal product may pose a risk to the aquatic environment. Any unused residue of the medicinal product or its waste must be disposed of in accordance with local regulations.