FULVESTRANT STADA

Package leaflet: Information for the user

Fulvestrant Stada, 250 mg/5 ml, solution for injection in ampoule-syringe
Fulvestrantum
Please 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

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

Fulvestrant Stada contains the active substance fulvestrant, which belongs to a group of medicines called
estrogen receptor antagonists.
Estrogens are female sex hormones that may sometimes influence the development of breast cancer.
Fulvestrant Stada 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 for the treatment of women with a certain type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced 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 is given in combination with palbociclib, it is important to also read the patient information leaflet
included with the palbociclib medicine. If you have any questions about palbociclib, please consult your doctor.

2. Important information before using Fulvestrant Stada

When not to use Fulvestrant Stada:

• 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
Inform your doctor, pharmacist, or nurse before using Fulvestrant Stada if any of the following health problems have ever occurred:

• if kidney or liver disease has ever been diagnosed;
• if thrombocytopenia (low platelet count, which affects blood clotting) or bleeding disorders have been diagnosed;
• if thrombotic disease has ever occurred;
• in case of osteoporosis (loss of bone mineral density);
• in case of alcohol dependence.

Children and adolescents
Fulvestrant Stada is not intended for use in children and adolescents under 18 years of age.
Fulvestrant Stada and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).
Pregnancy and breastfeeding
Pregnancy
Fulvestrant Stada must not be used during pregnancy. If the patient could become pregnant, she should use effective contraception during treatment with Fulvestrant Stada and for 2 years after the last dose.
Breastfeeding
Breastfeeding is not allowed while taking Fulvestrant Stada.
Driving and operating machinery
Fulvestrant Stada has not been shown to affect the ability to drive or operate machinery. However, if fatigue occurs after administration of Fulvestrant Stada, the patient should not drive or operate machinery.
Fulvestrant Stada contains ethanol
This medicine contains 1000 mg of alcohol (ethanol) in each dose containing 500 mg of fulvestrant. The amount of alcohol in a 500 mg dose is equivalent to 25 ml of beer or 10 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults.
The alcohol contained in this medicine may alter the effect of other medicines. Inform your doctor or pharmacist about all medicines you are taking.
If the patient is alcohol-dependent, medical advice should be sought from a doctor or pharmacist before using this medicine.
Fulvestrant Stada contains benzyl alcohol
Fulvestrant Stada contains 1000 mg of benzyl alcohol in each dose containing 500 mg of fulvestrant.
Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult a doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Fulvestrant Stada contains benzyl benzoate
Fulvestrant Stada contains 1500 mg of benzyl benzoate in each dose containing 500 mg of fulvestrant.

3. How to use Fulvestrant Stada

This medicine should always be used as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections), administered once a month,
with an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant Stada is administered by a physician or nurse. The medicine will be slowly injected
intramuscularly in two consecutive injections, each into a different buttock.
If you have any further questions regarding the use of this medicine, consult your physician,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
In case of the following adverse reactions, immediate contact with a doctor may be necessary:

• 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 blood clots)*
• hepatitis
• liver failure

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

• injection site reactions, i.e. 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 no more than 1 in 10 people)

• headache
• vomiting, diarrhoea or loss of appetite*
• urinary tract infection
• back pain*
• increased bilirubin concentration (a bile pigment produced by the liver)
• thromboembolic disease (increased risk of blood clots)*
• reduced 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 no more than 1 in 100 people)

• thick, whitish vaginal discharge and vaginal candidiasis (infection)
• bruising or bleeding at the injection site
• increased gamma-glutamyl transferase activity, a liver enzyme, observed in blood tests
• hepatitis
• liver failure
• numbness, tingling and pain
• anaphylactic reactions

* includes adverse reactions for which the influence of fulvestrant cannot be assessed due to the presence of underlying disease.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 to provide more information on the safety of the medicine.

5. How to store Fulvestrant Stada

Keep this medicine out of sight and reach of children.
Store and transport in a refrigerated condition (2°C - 8°C).
Keep the pre-filled syringe in its original packaging to protect from light.
Storage outside the temperature range of 2°C - 8°C should be minimized. Avoid storage above 30°C, and do not exceed a period of 28 days with an average storage temperature below 25°C (but above the 2°C - 8°C range). If the temperature range is exceeded, immediately return to the recommended storage conditions (store and transport refrigerated at 2°C - 8°C). Exposure to improper storage temperatures may have a cumulative effect on product quality, and the 28-day period must not be exceeded during the 48-month shelf life of Fulvestrant Stada. Exposure to temperatures below 2°C does not damage the product, provided it is not stored below -20°C.
Do not use this medicine after the expiry date stated on the carton and syringe label following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Medical personnel are responsible for the proper storage, handling, and disposal of packaging after use of Fulvestrant Stada 250 mg/5 ml, solution for injection in pre-filled syringe.
This medicine may pose a risk to the aquatic environment. 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 package and other information

What Fulvestrant Stada contains

• The active substance is fulvestrant. One pre-filled syringe (5 ml) contains 250 mg of fulvestrant. One ml of solution contains 50 mg of fulvestrant.
• The other ingredients are: ethanol 96%, benzyl alcohol, benzyl benzoate, and purified castor oil.

What Fulvestrant Stada looks like and contents of the pack
Fulvestrant Stada is a clear, colourless to yellow, almost free from visible particles, oily and sticky solution in a glass pre-filled syringe. Each syringe contains 5 ml of solution for injection.
Fulvestrant Stada is available in three pack sizes:

• A cardboard box containing one blister with one pre-filled syringe, one sterile hypodermic needle with safety system (BD SafetyGlide), and one leaflet. Or
• A cardboard box containing two blisters, each containing one pre-filled syringe, two sterile hypodermic needles with safety system (BD SafetyGlide), and one leaflet. Or
• A cardboard box containing six blisters, each containing one pre-filled syringe, six sterile hypodermic needles with safety system (BD SafetyGlide), and one leaflet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

Manufacturer
S.C. Rompharm Company S.R.L.
Strada Eroilor nr. 1A
075100 Otopeni, Romania
STADA Arzneimittel AG
Stadastrasse 2-18, Dortelweil
61118 Bad Vilbel, Germany
STADApharm GmbH
Feodor-Lynen-Strasse 35
30625 Hannover, Germany
STADA Arzneimittel GmbH
Muthgasse 36/2, Doebling
1190 Vienna, Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Fulvestrant STADA 250 mg Injektionslösung
Czech Republic Fulvestrant STADA
Denmark Fulvestrant STADA 250 mg
Estonia Fulvestrant STADA 250 mg solución inyectable en jeringa precargada EFG
Finland Fulvestrant STADA 250 mg injektioneste, liuos
France FULVESTRANT EG 250 mg, solution injectable en seringue pré-remplie
Netherlands Fulvestrant Stada 250 mg oplossing voor injectie
Iceland Fulvestrant STADA 250 mg
Germany Fulvestrant STADA 250 mg Injektionslösung in einer Fertigspritze
Slovakia Fulvestrant STADA 250 mg
Sweden Fulvestrant STADA 250 mg injektionsvätska, lösning
Hungary Fulvestrant STADA 250 mg oldatos injekció
United Kingdom Fulvestrant 250 mg solution for injection in prefilled syringe
Italy FULVESTRANT EG 250 mg soluzione iniettabile in siringa preriempita

Information intended exclusively for healthcare professionals:

Fulvestrant Stada must be administered using two pre-filled syringes, see section 3.
Administration instructions
Administer the injection according to local guidelines for performing large-volume intramuscular injections.
WARNING: Exercise caution when administering Fulvestrant Stada into the upper outer quadrant of the buttock due to the proximity of the sciatic nerve.
Warnings: Do not place the safety-shielded needle (BD SafetyGlide Shielding Hypodermic Needle) in an autoclave before use.
Avoid hand contact with the needle during administration and disposal.
Applies to both syringes:

• Remove the glass cartridge from the blister and check for any damage.
• Open the outer packaging of the safety-shielded needle (SafetyGlide).
• Prior to administration of parenteral solutions, visually inspect the solution for particulate matter and discoloration.
• Hold the syringe vertically.
• With the other hand, grasp the protective cap and gently unscrew and remove the tip cap. To maintain sterility, do not touch the syringe tip (see Figure 1).

Figure 1

• Attach the safety-shielded needle to the Luer-Lock tip and screw it on securely (see Figure 2).

Figure 2

• Check that the needle is securely attached to the Luer-Lock tip before moving from 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 cap.
• Expel any excess air from the syringe.
• Administer the drug intramuscularly, slowly (1–2 minutes/injection), into the buttock (gluteal muscle area). For the convenience of the person administering, the bevel of the needle is on the same surface as the safety shield lever (see Figure 3).

Figure 3

• Immediately after drug administration, activate the needle safety shield by pushing the shield lever forward in one motion (see Figure 4). WARNING: Activate the system at a safe distance from yourself and others. After hearing the click, visually confirm that the needle tip is fully covered.

Figure 4
Disposal of the medicinal product:
The pre-filled syringes are intended for single use only.
This medicinal product may pose a risk to the aquatic environment. Any unused medicinal product or waste material must be disposed of in accordance with local regulations.