Fulvestrant Zentiva

Package Leaflet: Information for the Patient

Fulvestrant Zentiva 250 mg/5 ml,

injection solution in a pre-filled syringe
Fulvestrantum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Fulvestrant Zentiva and what is it used for
• 2. Important information before using Fulvestrant Zentiva
• 3. How to use Fulvestrant Zentiva
• 4. Possible side effects
• 5. How to store Fulvestrant Zentiva
• 6. Contents of the pack and other information

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

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

• as a single medicine, in the treatment of postmenopausal women with a certain type of breast cancer called hormone receptor-positive breast cancer, which 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 breast cancer called hormone receptor-positive, 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 yet reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Zentiva is given 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. Important information before using Fulvestrant Zentiva

When NOT to use Fulvestrant Zentiva:

• 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

Tell your doctor, pharmacist, or nurse before using Fulvestrant Zentiva if you have ever had any of the following health problems:

• if you have had kidney or liver disease.
• if you have had a reduced number of platelets (which help the blood to clot) or bleeding disorders;
• if you have had a blood clotting disorder.
• if you have had problems with decreased bone mineral density (osteoporosis).
• alcohol dependence.

Children and adolescents

Fulvestrant Zentiva is not recommended for use in children and adolescents under 18 years of age.

Fulvestrant Zentiva and other medicines

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

Pregnancy and breastfeeding

Fulvestrant Zentiva must not be used during pregnancy. If you can become pregnant, you should use effective contraception during treatment with Fulvestrant Zentiva and for 2 years after the last dose.
Do not use Fulvestrant Zentiva if you are breastfeeding.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Fulvestrant Zentiva is unlikely to affect your ability to drive or use machines. However, if you feel tired after taking this medicine, do not drive or use machines.

Fulvestrant Zentiva contains ethanol (alcohol)

Fulvestrant Zentiva contains 500 mg of ethanol in each injection, which is equivalent to 100 mg/ml (10% m/v). This amount in each injection of this medicine is equivalent to 13 ml of beer or 5 ml of wine.
It is unlikely that the amount of alcohol in this medicine will have an effect on adults and adolescents.
The alcohol in this medicine may affect the way other medicines work. If you are taking other medicines, talk to your doctor or pharmacist.
If you are pregnant or breastfeeding, tell your doctor or pharmacist before using this medicine.
If you are addicted to alcohol, tell your doctor or pharmacist before using this medicine.

Fulvestrant Zentiva contains benzyl alcohol

Fulvestrant Zentiva contains 500 mg of benzyl alcohol in each pre-filled syringe, which is equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions.

Fulvestrant Zentiva contains benzyl benzoate

Fulvestrant Zentiva contains 750 mg of benzyl benzoate in each pre-filled syringe, which is equivalent to 150 mg/ml.

3. How to use Fulvestrant Zentiva

Fulvestrant Zentiva will be given to you by a doctor or nurse. The medicine will be injected slowly into a muscle in two consecutive injections of 5 ml, each into a different buttock.
The usual dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), given once a month, and 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, Fulvestrant Zentiva can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following side effects, seek medical attention immediately:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be signs of an anaphylactic reaction,
• blood clotting disorders (increased risk of forming blood clots)*,
• liver inflammation,
• 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 sick),
• feeling weak, tired*,
• joint and muscle pain
• hot flushes,
• 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 people)

• headache,
• vomiting, diarrhea, or loss of appetite*,
• urinary tract infection,
• back pain*,
• increased bilirubin levels (a pigment produced by the liver),
• blood clotting disorders (increased risk of forming blood clots)*,
• decreased number of platelets (thrombocytopenia),
• vaginal bleeding,
• lower back pain radiating to one leg (sciatica),
• sudden weakness, numbness, tingling, or loss of movement in one 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 thrush (infection),
• bruising and bleeding at the injection site,
• increased activity of gamma-glutamyltransferase, a liver enzyme measured in blood tests,
• liver inflammation,
• liver failure,
• numbness, tingling, and pain,
• anaphylactic reactions.

* Includes side effects for which the impact of Fulvestrant Zentiva cannot be assessed due to the underlying disease.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Zentiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.
Store and transport refrigerated (2°C - 8°C).
Limit storage of the medicine at temperatures other than 2°C to 8°C. Avoid storage above 30°C and do not exceed 28 days with an average storage temperature below 25°C (but above the range 2°C - 8°C). If the temperature range is exceeded, apply the recommended storage conditions immediately (store and transport refrigerated at 2°C to 8°C). Exceeding the recommended storage temperature may have a cumulative effect on the quality of the product, and the 28-day period must not be exceeded within the 2-year shelf life of Fulvestrant Zentiva. Exposure to temperatures below 2°C does not damage the product if it is not stored below -20°C.
Keep the pre-filled syringe in the original package to protect from light.
Medical personnel are responsible for proper storage, use, and disposal of the packaging after the medicine has been used.
Medicines should 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 Zentiva contains

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

What Fulvestrant Zentiva looks like and contents of the pack

Fulvestrant Zentiva is a clear, colorless to yellowish, viscous solution in a pre-filled syringe made of colorless glass type I, with a piston made of polystyrene and a rubber stopper, in a cardboard box, containing 5 ml of injection solution. To administer the recommended monthly dose of 500 mg, two pre-filled syringes are required.
Fulvestrant Zentiva has 5 types of packaging: a package containing 1 glass pre-filled syringe, a package containing 2 glass pre-filled syringes, a package containing 2 x 2 glass pre-filled syringes, a package containing 4 glass pre-filled syringes, a package containing 6 glass pre-filled syringes. The package also includes one, two, four, or six needles with a safety system (BD SafetyGlide) to be attached to each pre-filled syringe.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer

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

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

Estonia, Poland, Italy
Fulvestrant Zentiva
France
Fulvestrant Zentiva 250 mg,
solution injectable en seringue pré-remplie
Netherlands
Fulvestrant Zentiva 250 mg
oplossing voor injectie in een voorgevulde spuit
Lithuania
Fulvestrant Zentiva 250 mg injekcinis tirpalas užpildytame švirkšte
Germany
Fulvestrant Zentiva 250 mg Injektionslösung in einer fertigspritze
United Kingdom
Fulvestrant Zentiva 250 mg solution for injection in pre-filled syringe
Date of last revision of the leaflet:January 2021

Information intended for healthcare professionals only

Fulvestrant Zentiva 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 a safety system (BD Safetyglide Safety Hypodermic Needle) before use.
When handling the medicine and disposing of waste, avoid hand contact with the needle.
For both syringes:

• Remove the glass syringe from the container and check if it is damaged.
• Open the outer packaging of the needle with a safety system (SafetyGlide).
• Before administering parenteral solutions, visually inspect them for particulate matter and changes in color.
• Hold the syringe vertically in the striped part (C). With your other hand, grasp the cap (A) and carefully twist it counterclockwise (see Figure 1).

Figure 1.

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

Figure 2.
Attach the needle with a safety system to the Luer-Lock tip and tighten to secure (see Figure 3).

• Check if the needle is attached to the Luer-Lock tip before moving to a vertical position.
• When tightening the needle, avoid damaging its sharp end.
• Bring the filled needle close to the injection site.
• Remove the needle shield.
• Remove any excess air from the syringe.

Figure 3.

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

Figure 4.
Immediately after administering the medicine, activate the needle safety system by pushing the lever (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 medicine may pose a risk to the aquatic environment. Any unused medicine or waste material should be disposed of in accordance with local requirements.