Fulvestrant EG

Package leaflet: Information for the user

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

Generic medicine
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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• 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 is and what it is used for
2. What you need to know before using Fulvestrant EG
3. How to use Fulvestrant EG
4. Possible side effects
5. How to store Fulvestrant EG
6. Contents of the pack and other information

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

Fulvestrant EG 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 is used either:

• alone, for the treatment of postmenopausal women with a type of breast cancer called estrogen receptor-positive locally advanced or cancer that 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 reached menopause will be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When fulvestrant is administered in combination with palbociclib, it is important to also read the palbociclib package leaflet. If you have any questions about the use of palbociclib, ask your doctor.

2. What you need to know before using Fulvestrant EG

Do not use Fulvestrant EG

• 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 problems.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fulvestrant EG if you are in any of the following
conditions:

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

Children and adolescents
Fulvestrant EG is not indicated in children and adolescents under 18 years of age.
Other medicines and Fulvestrant EG
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 using anticoagulants (medicines that prevent blood
clots).
Pregnancy, breast-feeding and fertility
Pregnancy
You must not use Fulvestrant EG during pregnancy. If there is any possibility you could become pregnant, you must use an effective contraceptive method during treatment with Fulvestrant EG.
Breast-feeding
You must not breastfeed during treatment with Fulvestrant EG.
Driving and using machines
Fulvestrant EG is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or operate machinery.
Fulvestrant EG contains 12.4% ethanol (alcohol), e.g. up to 1000 mg per dose, equivalent to 25 ml of
beer or 10 ml of wine per dose. This may be harmful for alcoholics. This should be taken into consideration in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.
Fulvestrant EG contains 500 mg of benzyl alcohol per 5 ml.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large
amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic
acidosis).
Fulvestrant EG contains 750 mg of benzyl benzoate per 5 ml.

3. How to use Fulvestrant EG

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediate medical attention may be required if any of the following side effects occur:

• 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 side effects (may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation.
• Abnormal liver enzyme levels (in blood tests)*.
• Nausea (feeling unwell).
• Weakness, fatigue*.
• Musculoskeletal and joint pain.
• Hot flushes.
• 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, diarrhoea or loss of appetite*.
• Urinary tract infections.
• Back pain*.
• Increased levels of bilirubin (a bile pigment produced by the liver).
• Thromboembolism (increased risk of blood clots)*.
• Low platelet levels (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.
• Inflammation of the liver (hepatitis).
• Liver failure.
• Numbness, tingling and pain.
• Anaphylactic reactions.

*Includes adverse drug reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the following website:
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

Keep this medicine out of the sight and reach of children.
Store and transport in a refrigerator (2°C - 8°C).
Keep the pre-filled syringe in its original packaging to protect the medicine from light.
Temperature excursions outside the range of 2°C - 8°C must be limited. This includes avoiding storage at temperatures above 30°C, and not exceeding a period of 28 days at a mean storage temperature below 25°C (but above 2°C - 8°C). After temperature excursions, the product must be returned immediately to the recommended storage conditions (store and transport in a refrigerator at 2°C - 8°C). Temperature excursions have a cumulative effect on product quality, and the 28-day period must not be exceeded cumulatively during the 48-month shelf life of Fulvestrant EG. Exposure to temperatures below 2°C does not damage the product provided it is not stored at temperatures below -20°C.
Do not use this medicine after the expiry date stated on the packaging and labels after the word EXP. The expiry date refers to the last day of that month.
Healthcare personnel will be responsible for the correct storage, use, and disposal of Fulvestrant EG 250 mg solution for injection in pre-filled syringe.
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 no longer required. This will help protect the environment.

6. Package contents and other information

What Fulvestrant EG 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 ingredients are ethanol (96 percent), benzyl alcohol, benzyl benzoate and refined castor oil.

Description of the appearance of Fulvestrant EG and contents of the pack
Fulvestrant EG is a clear, colourless to yellow, oily and viscous solution, practically free from visible particles, contained in a glass pre-filled syringe. Each syringe contains 5 ml of solution for injection.
Fulvestrant EG is available in two pack sizes:

• Carton box containing one blister with one pre-filled syringe, one sterile hypodermic needle (BD SafetyGlide), and a package leaflet. Or
• Carton box containing two blisters, each containing one pre-filled syringe, two sterile hypodermic needles (BD SafetyGlide), and a package leaflet.

Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy
Responsible manufacturer for batch release
S.C. Rompharm Company S.r.l., Strada Eroilor nr. 1A, 075100 Otopeni (Romania)
Stada Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel (Germany)
STADApharm GmbH, Feodor-Lynen-Straße 35, 30625 Hannover (Germany)
Stada Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna (Austria)
This medicinal product is authorized in the European Economic Area Member States under the following
names:
AT: Fulvestrant STADA 250 mg Injektionslösung
CZ: Fulvestrant STADA
DK: Fulvestrant STADA 250 mg
DE: Fulvestrant STADA 250 mg Injektionslösung in einer Fertigspritze
ES: Fulvestrant STADA 250 mg solución inyectable en jeringa precargada EFG
FI: Fulvestrant STADA 250 mg injektioneste, liuos
FR: FULVESTRANT EG 250 mg, solution injectable en seringue pré-remplie
HU: Fulvestrant STADA 250 mg oldatos injekció
IS: Fulvestrant STADA 250 mg
IT: FULVESTRANT EG 250 mg soluzione iniettabile in siringa preriempita
NL: Fulvestrant Stada 250 mg oplossing voor injectie
PL: Fulvestrant Stada
SE: Fulvestrant STADA 250 mg injektionsvätska, lösning
SK: Fulvestrant STADA 250 mg
UK: Fulvestrant 250 mg solution for injection in prefilled syringe

The following information is intended exclusively for physicians or healthcare professionals:
Fulvestrant EG must be administered using two pre-filled syringes; see section 3.
Instructions for administration
Inject according to local guidelines for administering large-volume intramuscular injections.
NOTE: Due to the proximity of the underlying sciatic nerve, caution must be exercised when administering Fulvestrant EG at the dorsogluteal injection site.
Warnings: Do not autoclave the needle with the safety device (BD SafetyGlide 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 body from the blister and check that it is undamaged.
• 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 in an upright position.
• With the other hand, grasp the protective cap and carefully twist and remove the cap. To ensure sterility, do not touch the tip of the syringe (see Figure 1).

Figure 1

• Attach the safety needle to the Luer-Lok connector and rotate to securely lock it in place (see Figure 2).

Figure 2

• Check that the needle is securely attached to the Luer-Lok connector before removing it from the vertical plane.
• Remove the needle cover quickly to avoid damaging the needle tip.
• Bring the filled syringe to the administration site.
• Remove the needle sheath.
• Expel excess air from the syringe.
• Administer slowly (1 to 2 minutes per injection) by intramuscular injection into the gluteal region (gluteal area). For user convenience, the blunt needle tip is aligned with the lever arm (see Figure 3).

Figure 3

• After injection, immediately apply single-finger pressure on the lever arm with assisted activation to engage the safety mechanism (see Figure 4).
  NOTE: Activate away from yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

Figure 4
Disposal:
Pre-filled syringes are for single use only.
This medicinal product may pose a risk to the environment. Unused medicine and waste derived from this medicinal product must be disposed of in accordance with local regulations.