Fulvestrant Stada

Package Leaflet: Information for the User

Fulvestrant Stada, 250 mg/ 5 ml, Solution for Injection in a Prefilled Syringe

Fulvestrant

Read the Package Leaflet Carefully Before Using the Medication, 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, 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Fulvestrant Stada and what is it used for
• 2. Important information 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 is Fulvestrant Stada and what is it used for

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

• alone to treat breast cancer in postmenopausal women with a specific 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 to treat women with a specific type of breast cancer called hormone receptor-positive breast cancer, without excessive expression of human epidermal growth factor receptor 2, 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 luteinizing hormone-releasing hormone agonist.

When fulvestrant 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 Stada

When not to use Fulvestrant Stada:

• 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 or pharmacist or nurse before using Fulvestrant Stada 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 blood to clot) or bleeding disorders;
• if you have had a blood clotting disorder;
• if you have osteoporosis (loss of bone density);
• if you have a history of alcohol abuse.

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 taking, or have recently taken, and any medicines you plan to take.
In particular, tell your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding

Pregnancy
Do not use Fulvestrant Stada during pregnancy. If you may become pregnant, you should use effective contraceptive methods during treatment with Fulvestrant Stada and for 2 years after the last dose.
Breastfeeding
Do not breastfeed while using Fulvestrant Stada.

Driving and using machines

Fulvestrant Stada has not been shown to affect the ability to drive or use machines. If you feel tired after using Fulvestrant Stada, do not drive or use machines.

Fulvestrant Stada contains ethanol

This medicine contains 1000 mg of ethanol (alcohol) in each dose containing 500 mg of fulvestrant. The amount of alcohol in a 500 mg dose of this medicine is equivalent to 25 ml of beer or 10 ml of wine.
The amount of alcohol in this medicine is unlikely to have an effect on adults.
The alcohol in this medicine may affect the way other medicines work. Tell your doctor or pharmacist about all medicines you are taking.
If you are addicted to alcohol, ask your doctor or pharmacist for advice 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.
Patient with liver or kidney disease should consult their doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (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 your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended 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.
Fulvestrant Stada is given by a doctor or nurse. The medicine will be slowly injected into a muscle in two consecutive injections, each into a different buttock.
If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Fulvestrant Stada can cause side effects, although not everybody gets them.

In case of the following side effects, immediate 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
• blood clotting disorders (increased risk of blood clots)*
• liver inflammation
• liver failure

If you notice 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
• 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 liver pigment)
• blood clotting disorders (increased risk of blood clots)*
• low platelet count (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 candidiasis (infection)
• bruising or bleeding at the injection site
• increased activity of the liver enzyme gamma-glutamyltransferase, observed in blood tests
• liver inflammation
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions

* includes side effects for which the impact of fulvestrant 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Stada

Keep this medicine out of the sight and reach of children.
Store and transport in a cool place (2°C - 8°C).
Store the prefilled syringe in its original packaging to protect it from light.
Limit storage of the medicine to a temperature other than the range 2°C - 8°C. Avoid storing 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 in a refrigerator at 2°C - 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 48 months of the product's validity. Exposure to a temperature 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 labels of the syringe after the expiry date (EXP). The expiry date refers to the last day of the month stated.
Medical personnel are responsible for the proper storage, use, and disposal of the packaging of the used Fulvestrant Stada 250 mg/5 ml solution for injection in a prefilled syringe.
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. This will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Stada contains

• The active substance is fulvestrant. One prefilled syringe (5 ml) contains 250 mg of fulvestrant. One ml of the 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, colorless to yellow, nearly particle-free, oily, and viscous solution in a glass prefilled syringe. Each syringe contains 5 ml of the solution for injection.
Fulvestrant Stada is available in three pack sizes:

• A cardboard box with one blister pack containing one prefilled syringe, one sterile hypodermic needle with a safety system (BD SafetyGlide), and one package leaflet. Or
• A cardboard box with two blister packs, each containing one prefilled syringe, two sterile hypodermic needles with a safety system (BD SafetyGlide), and one package leaflet. Or
• A cardboard box with six blister packs, each containing one prefilled syringe, six sterile hypodermic needles with a safety system (BD SafetyGlide), and one package leaflet.

Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 07/2022

Information intended for healthcare professionals only:

Fulvestrant Stada should be administered using two prefilled syringes, see section 3.
Administration instructions
Administer the injection according to local guidelines for performing large-volume intramuscular injections.
CAUTION: Be careful when administering Fulvestrant Stada into the upper outer quadrant of the buttock due to the proximity of the sciatic nerve.
Warnings: Do not put the needle with the safety system (BD SafetyGlide Shielding Hypodermic Needle) in an autoclave before use.
When handling the medicine and disposing of the leftovers, avoid hand contact with the needle.
For both syringes:

• Remove the glass syringe from the blister pack and check if it is damaged.
• Open the outer packaging of the needle with the safety system (SafetyGlide).
• Before administering parenteral solutions, visually inspect them for particulate matter and changes in color.
• Hold the syringe vertically.
• With the other hand, grasp the protective cap, gently unscrew, and remove the tip cap. To maintain sterility, do not touch the tip of the syringe (see Figure 1).

Figure 1

• Attach the needle with the safety system to the Luer-Lock tip and screw on to secure (see Figure 2).

Figure 2

• Check if the needle is attached to the Luer-Lock tip before moving from the vertical position.
• When screwing on the needle, be careful not to damage its sharp end.
• Bring the filled syringe close to the injection site.
• Remove the needle shield.
• Remove any excess air from the syringe.
• Administer the medicine intramuscularly, slowly (1-2 minutes/injection), into the buttock (gluteal muscle area). For the convenience of the person administering, the needle bevel is on the same surface as the safety system's trigger (see Figure 3).

Figure 3

• Immediately after administering the medicine, activate the needle safety system by pushing its trigger forward (see Figure 4). CAUTION: 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 medicine:
The prefilled syringes are intended for single use only.
This medicine may pose a risk to aquatic environments. Any unused medicine or waste material should be disposed of in accordance with local requirements.