FULVESTRANT PHARMASCIENCE

Patient Information Leaflet

Fulvestrant Pharmascience, 250 mg/5 ml, solution for injection in prefilled syringe
Fulvestrantum

Please read carefully all information in this leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

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

Fulvestrant Pharmascience contains the active substance fulvestrant, which belongs to a group of medicines known as estrogen receptor antagonists. Estrogens are female sex hormones that can sometimes influence the development of breast cancer.
Fulvestrant Pharmascience 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 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 Pharmascience is administered together with palbociclib, it is important to also read the patient information leaflet provided with palbociclib. If you have any questions about palbociclib, please consult your treating physician.

2. Important information before using Fulvestrant Pharmascience

When NOT to use Fulvestrant Pharmascience

• if the patient has hypersensitivity to fulvestrant or to any of the other
  components 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
Pharmascience if the patient has had any of the following health problems:

• has kidney or liver disease
• has low platelet count (which enables blood clotting), or a bleeding disorder
• has had blood clotting disorders in the past
• has osteoporosis (reduced bone mineral density)
• is alcohol-dependent.

Children and adolescents
Fulvestrant Pharmascience must not be used in children and adolescents under 18 years of age.
Fulvestrant Pharmascience and other medicines
Tell your doctor, pharmacist or nurse 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, breastfeeding and effects on fertility
Fulvestrant Pharmascience must not be used during pregnancy. If the patient may become pregnant,
effective contraceptive methods are recommended during treatment with Fulvestrant
Pharmascience and for 2 years after the last dose of this medicine.
Breastfeeding must not be undertaken during treatment with Fulvestrant Pharmascience.
Driving and operating machinery
Fulvestrant Pharmascience is not expected to affect the ability to drive
or operate machinery. However, if fatigue occurs after using Fulvestrant Pharmascience,
driving or operating machinery must not be undertaken.
Fulvestrant Pharmascience contains ethanol (alcohol)
Fulvestrant Pharmascience contains 500 mg of ethanol per injection, equivalent to 100 mg/mL (10% m/v). This amount per injection of this medicine corresponds to 13 mL of beer or 5 mL of wine.
It is unlikely that the amount of alcohol contained in this medicine will have an effect on adults and
adolescents.
The alcohol contained in this medicine may affect the action of other medicines. If the patient is taking other
medicines, discuss this with the doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should inform the doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, she should inform the doctor or pharmacist before using this medicine.
Fulvestrant Pharmascience contains benzyl alcohol
Fulvestrant Pharmascience contains 500 mg of benzyl alcohol per pre-filled syringe,
equivalent to 100 mg/mL. Benzyl alcohol may cause allergic reactions.
Fulvestrant Pharmascience contains benzyl benzoate
Fulvestrant Pharmascience contains 750 mg of benzyl benzoate per pre-filled syringe,
equivalent to 150 mg/mL.

3. How to use Fulvestrant Pharmascience

Fulvestrant Pharmascience will be administered by a doctor or nurse. The medicine will be slowly injected intramuscularly, with each injection given in a different buttock.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), given once a month and an additional 500 mg dose administered 2 weeks after the first dose.
If you have any further questions about how to use this medicine, consult 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, seek immediate medical help:

• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and (or) throat, which may be symptoms of an anaphylactic reaction
• Thromboembolic disease (increased risk of venous thrombosis)*
• Hepatitis (liver inflammation)
• Liver failure

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

• Reactions at the injection site, i.e. pain and (or) inflammation
• Changes in liver enzyme activity (seen 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 affect up to 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 venous thrombosis)*
• 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, especially on one side of the body; sudden difficulty walking or maintaining balance (peripheral neuropathy)

Uncommon adverse reactions (may affect up to 1 in 100 people)

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

* Refers to adverse reactions in which the influence of Fulvestrant Pharmascience cannot be assessed due to the presence of underlying disease.
Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, 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 Pharmascience

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the prefilled syringe label after "EXP". The expiry date refers to the last day of the stated month.
Store and transport under refrigerated conditions (2°C - 8°C).
Storage at temperatures other than 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 outside the 2°C - 8°C range). If the temperature limits are exceeded, immediately return to the recommended storage conditions (store and transport refrigerated at 2°C - 8°C). Exposure to inappropriate storage temperatures may have a cumulative effect on the quality of the medicine, and the 28-day period must not be exceeded during the 2-year shelf life of Fulvestrant Pharmascience. Exposure to temperatures below 2°C does not damage the product, provided it is not stored below -20°C.
Store the prefilled syringe in its original packaging to protect from light.
Healthcare personnel will be responsible for the proper storage, handling, and disposal of the packaging and used Fulvestrant Pharmascience medicine.
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 pack and other information

What Fulvestrant Pharmascience contains
The active substance is fulvestrant. Each ampoule-syringe (5 ml) contains 250 mg of fulvestrant.
The other components are: ethanol (96%), benzyl alcohol, benzyl benzoate, and purified castor oil.

What Fulvestrant Pharmascience looks like and contents of the pack
Fulvestrant Pharmascience is a clear, colourless to yellow, viscous solution in an ampoule-syringe containing 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, the contents of two ampoule-syringes should be injected.
Fulvestrant Pharmascience is available in three pack sizes: a pack containing 1 glass ampoule-syringe, a pack containing 2 glass ampoule-syringes, and a pack containing 6 glass ampoule-syringes. The ampoule-syringes are made of colourless type I glass with plungers made of polystyrene, sealed with elastomeric stoppers and protective caps, all contained in a cardboard box. Correspondingly, one, two, or six safety-engineered needles (BD SafetyGlide) are included, intended to be attached to each ampoule-syringe.
Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmascience International Limited
Lampousas 1
1095 Nicosia
Cyprus

Manufacturer
Laboratorios Farmalan S.A.
Calle La Vallina, s/n, Edificio 2
Polígono Industrial Navatejera
24193-Villaquilambre, León,
Spain

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

Information intended exclusively for healthcare professionals:

Fulvestrant Pharmascience, 500 mg (2 x 250 mg/5 ml, solution for injection) should be
administered using two pre-filled syringes (see section 3).
Instructions for administration
Warning – Do not place the safety needle device (BD SafetyGlide, Safety Hypodermic Needle) in an autoclave before use. Avoid hand contact with the needle during administration and disposal of the product.
Applies to both syringes:

• Remove the glass cartridge from its container and check for any damage.
• Open the outer packaging of the safety needle (BD SafetyGlide).
• Prior to administration of parenteral solutions, visually inspect them for particulate matter and discoloration.
• Hold the syringe vertically by the ribbed section (C). With the other hand, grasp the cap (A) and carefully turn the rigid plastic cap counterclockwise (see Figure 1).

Figure 1

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

Figure 2

• Attach the safety needle to the Luer-Lock tip and screw firmly to secure (see Figure 3).
• Confirm that the needle is securely connected to the Luer tip before proceeding to the upright position.
• Bring the filled needle close to the administration site.
• Remove the needle cap.
• Expel any excess air from the syringe.

Figure 3

• Administer the medication intramuscularly, slowly (1–2 minutes per injection), into the gluteal muscle (site on the buttock). For the convenience of the person administering, the needle bevel is located on the same side of the needle as the safety needle mechanism lever (see Figure 4).

Figure 4

• Immediately after injection, activate the safety needle mechanism in one motion by pushing the lever forward with one finger (see Figure 5).

Warning: Handle in a manner that ensures safety for yourself and others. Listen for the audible click and visually confirm that the needle tip is fully enclosed.

Figure 5
Disposal of waste
The pre-filled syringe is for single use only.
This medicinal product may pose a risk to the aquatic environment. Any unused residues or waste must be disposed of in accordance with local regulations.