Fulvestrant zentiva

Package leaflet: Information for the patient

Fulvestrant Zentiva 250 mg/5 ml,
solution for injection in prefilled syringe
Fulvestrantum
Please read this leaflet carefully before using 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Fulvestrant Zentiva is and what it is used for
2. What you need to know 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 Fulvestrant Zentiva is and what it is used for

Fulvestrant Zentiva contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens are female sex hormones that can sometimes influence the development of breast cancer.
Fulvestrant Zentiva 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 breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer 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 gonadotropin-releasing hormone (GnRH) agonist.

When Fulvestrant Zentiva is given in combination with palbociclib, it is important to also read the patient information leaflet for palbociclib. If you have any questions about palbociclib, please consult your treating doctor.

2. Important information before using Fulvestrant Zentiva

When NOT to use Fulvestrant Zentiva:

• if the patient has hypersensitivity to fulvestrant or to 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
Please inform your doctor, pharmacist or nurse before using Fulvestrant Zentiva if any of the following health problems have ever occurred:

• if kidney or liver disease has ever been diagnosed.
• if the patient has thrombocytopenia (reduced platelet count, which affects blood clotting) or coagulation disorders.
• if the patient has ever had a thromboembolic disorder.
• if the patient has ever had bone mineralization disorders (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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding
Fulvestrant Zentiva must not be used during pregnancy. If the patient may become pregnant, she should use an effective method of contraception during treatment with Fulvestrant Zentiva and for 2 years after the last dose.
Do not use Fulvestrant Zentiva during breastfeeding.

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before taking this medicine.

Driving and using machines
Fulvestrant Zentiva is not expected to affect the ability to drive or operate machinery. However, if fatigue occurs after taking this medicine, the patient should not drive or operate machinery.

Fulvestrant Zentiva contains ethanol (alcohol)
Fulvestrant Zentiva contains 500 mg of ethanol per injection, equivalent to 100 mg/ml (10% m/v). This amount in each injection corresponds to 13 ml of beer or 5 ml of wine.
It is unlikely that the amount of alcohol contained in this medicine will affect adults or adolescents.
The alcohol contained in this medicine may affect the action of other medicines. If the patient is taking other medicines, discuss this with the doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should inform the doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, she should inform the doctor or pharmacist before using this medicine.

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

Fulvestrant Zentiva contains benzyl benzoate
Fulvestrant Zentiva contains 750 mg of benzyl benzoate per pre-filled syringe, equivalent to 150 mg/ml.

3. How to use Fulvestrant Zentiva

Fulvestrant Zentiva will be administered by a doctor or nurse. The medicine will be slowly injected intramuscularly as two separate 5 ml injections, each into a different buttock.
The usual dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), given once a month, with an additional 500 mg dose administered 2 weeks after the first dose.
If you have any further questions about how to use 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, seek immediate medical help:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and (or) throat, which may be symptoms of an anaphylactic reaction,
• 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 affect 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, including swelling of the face, lips, tongue and (or) throat.

All other adverse reactions:
Common adverse reactions (may affect 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 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 gamma-glutamyl transferase, 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 Zentiva product cannot be assessed due to the presence of underlying disease.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fulvestrant Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and the pre-filled syringe label after "EXP". The expiry date refers to the last day of the stated month.
Store and transport in a refrigerated state (2°C - 8°C).
Storage at temperatures other than 2°C to 8°C should be minimized. Avoid storage at temperatures above 30°C and do not exceed a period of 28 days with an average storage temperature below 25°C (but outside the range of 2°C - 8°C). If the temperature range is exceeded, the recommended storage conditions must be immediately reinstated (store and transport refrigerated at 2°C to 8°C). Exceeding the recommended storage temperature may have a cumulative effect on the product's quality, and the 28-day period must not be exceeded during the 2-year shelf life of Fulvestrant Zentiva. Exposure to temperatures below 2°C does not damage the product, provided it is not stored below -20°C.
Store the pre-filled syringe in the original packaging to protect from light.
Healthcare personnel are responsible for the proper storage, handling, and disposal of the packaging after use of Fulvestrant Zentiva.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, colourless to yellow, viscous solution in a pre-filled syringe made of colourless Type I glass, with a plunger made of polystyrene, ending in an elastomeric stopper, and a protective cap, contained in a cardboard box. Each syringe contains 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, the contents of two pre-filled syringes should be injected.
Fulvestrant Zentiva is available in five pack sizes: a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, a pack containing 2 x 2 glass pre-filled syringes, a pack containing 4 glass pre-filled syringes, and a pack containing 6 glass pre-filled syringes. Each pack also includes one, two, four, or six safety needles (BD SafetyGlide), respectively, to be attached to each pre-filled syringe.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries 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

Information intended solely for healthcare professionals

Fulvestrant Zentiva 500 mg (2 x 250 mg/5 ml injection solution) should be administered using two prefilled syringes, see section 3.
Administration instructions
Warning – Do not autoclave the safety needle (BD SafetyGlide Safety Hypodermic Needle) before use.
Avoid hand contact with the needle during administration and disposal of waste.
Applies to both syringes:

• Remove the glass cartridge from its container and check for damage.
• Open the outer packaging of the safety needle (SafetyGlide).
• Prior to administration, visually inspect parenteral solutions for particulate matter and discoloration.
• Hold the syringe vertically by the fluted section (C). With the other hand, grasp the cap (A) and gently turn it counterclockwise (see Figure 1).

Figure 1.

• Remove the cap (A) in an upright position. 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 securely (see Figure 3).

• Check that the needle is properly connected to the Luer tip before proceeding to the upright position.
• When attaching the needle, take care not to damage the sharp tip.
• Bring the filled syringe close to the administration site.
• Remove the needle cover.
• Expel any excess air from the syringe.

Figure 3.

• Administer the medication intramuscularly, slowly (1–2 minutes per injection), into the gluteal muscle (site on the buttock). For the convenience of the person administering, the needle bevel is located on the same side of the needle as the safety needle shield lever (see Figure 4).

Figure 4.
Immediately after drug administration, activate the needle safety shield with a single finger movement by pushing the lever (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
Prefilled syringes are intended for single use only.
This medicinal product may pose a risk to the aquatic environment. Any unused medication or waste material should be disposed of in accordance with local regulations.