Fulvestrant EG STADA

Package leaflet: Information for the user

Fulvestrant EG STADA 250 mg injection solution in pre-filled syringe

fulvestrant

Read this entire leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Fulvestrant EG STADA is and what it is used for
2. What you need to know before you are given Fulvestrant EG STADA
3. How Fulvestrant EG STADA is administered
4. Possible side effects
5. How to store Fulvestrant EG STADA
6. Contents of the pack and other information

1. What Fulvestrant EG STADA is and what it is used for

Fulvestrant EG STADA contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, may in some cases be involved in the growth of breast cancer.
Fulvestrant EG STADA is used either:

• alone, for the treatment of postmenopausal women with a 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 type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet gone through menopause will be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist. When Fulvestrant EG STADA is administered in combination with palbociclib, it is important to also read the package leaflet for palbociclib. If you have any doubts about the use of palbociclib, ask your doctor.

2. What you need to know before you are given Fulvestrant EG STADA

Fulvestrant EG STADA must not be administered

• if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if you have severe liver disease.

Warnings and precautions
Inform your doctor, pharmacist, or nurse before receiving Fulvestrant EG STADA if any of the following apply to you:

• kidney or liver problems;
• low platelet count (which help blood to clot) or bleeding disorders;
• history of blood clots;
• osteoporosis (loss of bone density);
• alcoholism.

Children and adolescents
Fulvestrant EG STADA is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Fulvestrant EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are taking anticoagulants (medicines that prevent blood clots).
Pregnancy and breastfeeding
You must not use Fulvestrant EG STADA if you are pregnant. If there is any possibility you could become pregnant, you must use effective contraception during treatment with Fulvestrant EG STADA and for 2 years after the last dose.
You must not breastfeed during treatment with Fulvestrant EG STADA.
Driving and using machines
Fulvestrant EG STADA is not expected to affect your ability to drive or operate machinery. However, if you feel tired after treatment, do not drive or operate machinery.
This medicine contains 1,000 mg of alcohol (ethanol) in each 2 x 5 ml dose of injectable solution.
The amount contained in 2 x 5 ml of this medicine is equivalent to less than 20 ml of beer or 8 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.
It may be harmful for individuals suffering from alcoholism.
Exercise caution in high-risk groups such as patients with liver disorders or epilepsy.
This medicine contains 500 mg of benzyl alcohol in each 5 ml injection, equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and may cause unwanted effects (called "metabolic acidosis").
This medicine contains 750 mg of benzyl benzoate in each 5 ml injection, equivalent to 150 mg/ml.

3. How to use Fulvestrant EG STADA

The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once a month, with an additional dose of 500 mg given 2 weeks after the initial dose.
Your doctor or nurse will administer Fulvestrant EG STADA by slow intramuscular injection, one injection into each buttock.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately inform your doctor if you experience any of the following side effects, as you may require immediate medical treatment:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat, which may be signs of anaphylactic reactions.
• Thromboembolism (increased risk of blood clots)*.
• Inflammation of the liver (hepatitis).
• Liver failure.

If any of the following side effects occur, inform your doctor, pharmacist or nurse:
Very common (may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation.
• Abnormal levels of liver enzymes (in blood tests)*.
• Nausea (feeling unwell).
• Weakness, fatigue*.
• Musculoskeletal and joint pain.
• Hot flushes.
• Rash.

All other side effects:
Common (may affect up to 1 in 10 people)

• Headache.
• Vomiting (feeling unwell), diarrhoea or loss of appetite*.
• Urinary tract infections.
• Back pain*.
• Increased levels of bilirubin (a bile pigment produced by the liver).
• Low platelet count (thrombocytopenia).
• Vaginal bleeding.
• Lower back pain radiating to one leg (sciatica).
• Sudden weakness, numbness, tingling, or loss of movement in the leg, particularly on one side of the body, sudden problems with walking or balance (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

• Thick, white vaginal discharge and candidiasis (infection).
• Bruising and bleeding at the injection site.
• Increased levels of gamma-GT, a liver enzyme detected by blood tests.
• Numbness, tingling, and pain.
• Anaphylactic reactions.

*Includes adverse drug reactions for which the exact contribution of Fulvestrant EG STADA cannot be assessed due to the underlying disease.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or on the label of the syringe
after the abbreviation "Exp". The expiry date refers to the last day of that month.
Store and transport in a refrigerator (2°C - 8°C).
Temperature excursions outside the range 2°C - 8°C must be limited. This includes avoiding storage at
temperatures above 25°C, and not exceeding a total period of 28 days during which the average storage
temperature of the medicine is below 25°C (but above 2°C - 8°C). After any temperature excursion, the
medicine must immediately be returned to the recommended storage conditions (store and transport in a
refrigerator, 2°C - 8°C). Temperature excursions have a cumulative effect on the quality of the medicine, and the 28-day period must not be exceeded over the 24-month shelf life of fulvestrant injection. Exposure to temperatures below 2°C will not damage the medicine provided it is not stored at temperatures below -20°C.
Keep the pre-filled syringe in the original packaging to protect from light.
Healthcare professionals are responsible for the correct storage, use, and disposal of Fulvestrant EG STADA.
This medicine may pose a risk to the environment. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fulvestrant EG STADA contains

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant. Each ml of solution contains 50 mg of fulvestrant.
• The other components (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate and refined castor oil.

Description of the appearance of Fulvestrant EG STADA and contents of the pack
Fulvestrant EG STADA is a viscous, clear, colourless to yellow solution in a pre-filled syringe with
a bromobutyl stopper, polystyrene plunger and polypropylene backstop, containing 5 ml of injectable solution.
Two syringes must be administered to receive the recommended monthly dose of 500 mg.
Fulvestrant EG STADA is available in two pack sizes: one pack containing one glass pre-filled syringe or one pack containing two glass pre-filled syringes. Safety needles equipped with a device (BD SafetyGlide) are also supplied for attachment to each syringe barrel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Pharma Pack Hungary Kft., Vasút u. 13, Budaörs, Postcode: H-2040, Hungary

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

The following information is intended exclusively for physicians or healthcare professionals:
Fulvestrant EG STADA 500 mg (2 x 250 mg/5 ml solution for injection) must be administered
using two pre-filled syringes, see section 3.
Instructions for administration
Warnings – Do not autoclave the safety needle (BD SafetyGlide protective hypodermic needle) before use. Hands must remain behind the needle at all times during use and disposal.
For each of the two syringes:

• Remove the glass syringe barrel from the tray and check that it is not damaged.
• Remove the safety needle (SafetyGlide) from its outer packaging.
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe vertically in the notched area (C). With the other hand, take the screw cap (A) and carefully turn it counterclockwise until it disengages and can be removed (see Figure 1).

Figure 1

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

Figure 2

• Attach the safety needle to the Luer-Lok and rotate to securely lock it in place (see Figure 3).
• Check that the needle is securely attached to the Luer connector before removing it from the vertical plane.

Figure 3

• Remove the needle protector quickly to avoid damaging the needle tip.
• Carry the filled syringe to the administration site.
• Remove the needle sheath.
• Expel excess air from the syringe.
• Administer slowly by intramuscular injection (1 to 2 minutes per injection) into the buttock (gluteal area). For user convenience, the orientation of the needle bevel is directed toward the lever arm (see Figure 4).

Figure 4

• After injection, immediately apply single-finger force to the lever arm with assisted activation to engage the safety mechanism (see Figure 5).

NOTE: Activate away from yourself and others. Listen for the click and visually confirm that the needle tip is
completely covered.
Figure 5

Disposal
Pre-filled syringes are for single use only.
This medicinal product may be hazardous to the aquatic environment. Unused medicine and waste material derived from this medicinal product must be disposed of in accordance with local regulations.