Fulvestrant eugia

Patient Information Leaflet

Fulvestrant Eugia, 250 mg, solution for injection in a prefilled syringe
Fulvestrantum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Leaflet Contents:

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

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

Fulvestrant Eugia contains the active substance fulvestrant, which belongs to a group of medicines called estrogen blockers.
Estrogens, a type of female sex hormones, may in some cases contribute to the growth of breast cancer.
Fulvestrant Eugia is used:

• as a single agent in the treatment of postmenopausal women with a type of breast cancer known as 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 known as 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 luteinizing hormone-releasing hormone (LHRH) agonist.

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

2. Important information before taking Fulvestrant Eugia

When not to take Fulvestrant Eugia:

• 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 liver function impairment

Warnings and precautions
Before starting treatment with Fulvestrant Eugia, discuss with a doctor, pharmacist, or nurse if any of the following apply to the patient:

• if the patient has ever had kidney or liver function disorders
• if the patient has thrombocytopenia (low platelet count, which helps blood clotting) or coagulation disorders
• if the patient has ever had blood clots
• if the patient has osteoporosis (loss of bone density)
• alcohol dependence

Children and adolescents
Fulvestrant Eugia is not recommended for use in children and adolescents under 18 years of age.
Fulvestrant Eugia 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 Eugia must not be used if the patient is pregnant. If the patient may become pregnant, she should use effective contraception during treatment with Fulvestrant Eugia and for 2 years after the last dose.
Breastfeeding must not be performed during treatment with Fulvestrant Eugia.
Driving and operating machinery
It has not been established that Fulvestrant Eugia affects the ability to drive or operate machinery. However, if fatigue occurs after administration, the patient must not drive or operate machinery.
Excipients:
Ethanol:
This medicine contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection. The amount of alcohol in each injection (i.e. in two syringes) of this medicine corresponds to 25 mL of beer or 10 mL of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents. However, alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, she should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, she should consult a doctor or pharmacist before using this medicine.
Benzyl alcohol:
This medicine contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/mL. Benzyl alcohol may cause allergic reactions.
Benzyl benzoate:
This medicine contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/mL.

3. How to use Fulvestrant Eugia

This medicine should always be used exactly as your doctor or pharmacist has told you.
If you are unsure, check with your doctor or pharmacist.
The usual dose is 500 mg of fulvestrant (two 250 mg/5 mL injections), administered once
monthly, with an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant Eugia will be administered by a doctor or nurse as a slow intramuscular
injection, one injection into each buttock.
If you have any further questions about the use of this medicine, speak with your doctor,
pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, it is essential to contact a doctor immediately:

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

Inform your doctor, pharmacist or nurse if you notice any of the following adverse reactions:
Very common adverse reactions (may occur in 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
• Weakness, fatigue*
• Joint pain and musculoskeletal pain
• Hot flushes
• Skin rash
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and (or) throat

All other adverse reactions:
Common adverse reactions (may occur in 1 in 10 people)

• Headache
• Vomiting, diarrhoea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin levels (a pigment produced by the liver)
• Thromboembolic disease (increased risk of blood clots)*
• 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 occur in 1 in 100 people)

• Thick, white vaginal discharge and vaginal candidiasis (infection)
• Bruising and bleeding at the injection site
• Increased gamma-GT enzyme activity, a liver enzyme measured in blood tests
• Hepatitis
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

* Includes adverse reactions for which the exact role of Fulvestrant Eugia cannot be assessed due to the underlying disease.
Reporting 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 Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to collect more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Fulvestrant Eugia

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not use this medicine after the expiry date stated on the carton or syringe label after EXP. The expiry date refers to the last day of the stated month.
Healthcare professionals are responsible for the correct storage, handling, and disposal of this medicine. This medicine may pose a risk to the aquatic environment.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Eugia contains

• The active substance is fulvestrant. Each 5 mL pre-filled syringe (50 mg/mL) contains 250 mg of fulvestrant.
• The other ingredients (excipients) are: ethanol (96%), benzyl alcohol (E 1519), benzyl benzoate and purified castor oil.

What Fulvestrant Eugia looks like and contents of the pack
Injection solution in a pre-filled syringe.
A clear, colourless to yellow viscous solution, essentially free from visible particles.
Fulvestrant Eugia 250 mg solution for injection is supplied in a 5 mL cylinder made of colourless type I glass, with a plunger stopper closed with a grey bromobutyl rubber closure and an OVS cap. A safety needle for subcutaneous injection is also included, designed to connect to the cylinder for administration of the fulvestrant injection solution. The glass syringe cylinder with the needle will be placed in a protective plastic tray with a transparent lid.
Fulvestrant Eugia is available in 6 pack sizes: packaging containing 1 glass pre-filled syringe, 2 glass pre-filled syringes, 4 glass pre-filled syringes, 5 glass pre-filled syringes, 6 glass pre-filled syringes, and 10 glass pre-filled syringes. The packages also contain administration needles with a safety system (BD Safety Glide).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eugia Pharma (Malta) Ltd.
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Generis Farmacêutica S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Fulvestrant Eugia 250 mg oplossing voor injectie in voorgevulde spuit / solution injectable en seringue préremplie / Injektionslösung in einer Fertigspritze
France: Fulvestrant Arrow 250 mg, solution injectable en seringue pré-remplie
Germany: Fulvestrant Eugia 250 mg Injektionslösung in einer Fertigspritze
Italy: Fulvestrant Eugia
Netherlands: Fulvestrant Eugia 250 mg, oplossing voor injectie in een voorgevulde spuit
Poland: Fulvestrant Eugia
Portugal: Fulvestrant Eugia
Romania: Fulvestrant Eugia 250 mg soluție injectabilă în seringă preumplută
Spain: Fulvestrant Eugia 250 mg solución inyectable en jeringa precargada EFG

Information intended exclusively for healthcare professionals:

Fulvestrant Eugia 500 mg (2 x 250 mg/5 mL, solution for injection) must be administered using two pre-filled syringes, see section 3.

Administration instructions
Warning – Do NOT autoclave the needle with safety shield (BD SafetyGlide Shielding Hypodermic Needle) before use.
During administration and disposal, avoid hand contact with the needle.

For each of the two syringes:

• Remove the glass syringe barrel from its container and inspect for damage.
• Remove the outer packaging of the safety needle (SafetyGlide).
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe vertically by the fluted section (C). With the other hand, grasp the cap (A) and gently rock it forward and backward until it disconnects, then remove it. Do not twist (see Figure 1).

Figure 1

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

Figure 2

• Attach the safety-shielded needle to the Luer-Lok tip and screw on securely (see Figure 3).
• Ensure the needle is locked into the Luer connector before proceeding to the upright position.
• Remove the needle cover carefully to avoid damaging the needle tip.
• Transport the filled syringe to the administration site.
• Remove the needle cap.
• Expel any excess air from the syringe.

Figure 3

• Administer the medicinal product intramuscularly, slowly (1–2 minutes per injection), into the gluteal muscle (site on buttock). For the convenience of the administrator, the needle bevel is located on the same surface of the needle as the arm of the needle safety shield mechanism (see Figure 4).

Figure 4

• Immediately after drug administration, activate the needle safety shield by pushing forward its activation lever (see Figure 5).
• WARNING: Activate away from yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

Figure 5

Disposal of waste
Pre-filled syringes are for single use only.
This medicinal product may be hazardous to the aquatic environment. Any unused product or waste material should be disposed of in accordance with local regulations (see section 5.3 of the SmPC).