Fulvestrant Pharmascience

Package Leaflet: Information for the User

Fulvestrant Pharmascience, 250 mg/5 ml, solution for injection in a pre-filled syringe
Fulvestrantum
Read all of 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

• alone to treat women with a certain type of breast cancer that has spread or cannot be removed by surgery, in post-menopausal women with hormone receptor-positive breast cancer, or
• in combination with palbociclib for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in women who have received prior endocrine therapy. Women who have not reached menopause will also receive a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Pharmascience 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 Pharmascience

When NOT to use Fulvestrant Pharmascience

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)

if you are pregnant or breast-feeding

• if you have severe liver problems.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before using Fulvestrant Pharmascience if you have or have had any of the following:

• kidney or liver problems
• a low platelet count (which can make you bruise or bleed more easily) or a bleeding disorder
• had a blood clotting disorder in the past
• osteoporosis (a condition that affects the bones and can make them weaker)
• are addicted to alcohol.

Children and adolescents

Fulvestrant Pharmascience is not intended for use in children and adolescents under 18 years of age.

Fulvestrant Pharmascience with other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking or have recently taken, and about any medicines you plan to take. In particular, tell your doctor if you are taking anticoagulant medicines (to prevent blood clots).

Pregnancy, breast-feeding, and fertility

Fulvestrant Pharmascience must not be used during pregnancy. If you can become pregnant, you should use effective contraception during treatment with Fulvestrant Pharmascience and for 2 years after the last dose of this medicine.
Do not breast-feed during treatment with Fulvestrant Pharmascience.

Driving and using machines

Fulvestrant Pharmascience is unlikely to affect your ability to drive or use machines. However, if you feel tired after receiving Fulvestrant Pharmascience, do not drive or use machines.

Fulvestrant Pharmascience contains ethanol (alcohol)

Fulvestrant Pharmascience contains 500 mg of ethanol in each injection, which is equivalent to 100 mg/ml (10% m/v). This amount of ethanol in each injection of this medicine is equivalent to 13 ml of beer or 5 ml of wine.
It is unlikely that the amount of alcohol in this medicine will have any effect on adults and adolescents.
The alcohol in this medicine may affect the way other medicines work. If you are taking other medicines, talk to your doctor or pharmacist.
If you are pregnant or breast-feeding, tell your doctor or pharmacist before using this medicine.
If you are addicted to alcohol, tell your doctor or pharmacist before using this medicine.

Fulvestrant Pharmascience contains benzyl alcohol

Fulvestrant Pharmascience contains 500 mg of benzyl alcohol in each pre-filled syringe, which is equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions.

Fulvestrant Pharmascience contains benzyl benzoate

Fulvestrant Pharmascience contains 750 mg of benzyl benzoate in each pre-filled syringe, which is equivalent to 150 mg/ml.

3. How to use Fulvestrant Pharmascience

Fulvestrant Pharmascience will be given to you by a doctor or nurse. The medicine will be injected slowly into a muscle, with each injection given into a different buttock.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections), given once a month, with an additional 500 mg dose given 2 weeks after the first dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, contact a doctor immediately:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be signs of anaphylactic reaction
• blood clots (increased risk of venous thromboembolism)*
• liver inflammation (hepatitis)
• liver failure.

If you experience 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 sick)
• feeling weak, tired*
• joint and muscle pain
• hot flushes
• 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 infections
• back pain*
• increased bilirubin levels (a pigment produced by the liver).
• blood clots (increased risk of venous thromboembolism)*
• low platelet count (thrombocytopenia)
• vaginal bleeding
• sciatica (pain in the lower back radiating to one leg)
• sudden weakness, numbness, tingling, or loss of movement in a 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 and bleeding at the injection site
• increased gamma-glutamyltransferase activity, a liver enzyme measured in blood tests
• liver inflammation (hepatitis)
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions.

* refers to side effects where the impact of Fulvestrant Pharmascience cannot be assessed due to the underlying disease.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the national reporting system listed below.
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 Pharmascience

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 label after EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated (2°C - 8°C).
Limit storage at temperatures other than 2°C - 8°C. Avoid storage above 30°C and do not exceed 28 days with an average storage temperature below 25°C (but above the 2°C - 8°C range). If the temperature range is exceeded, apply the recommended storage conditions (store and transport refrigerated at 2°C - 8°C) immediately. 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 the 2-year shelf-life of Fulvestrant Pharmascience. Exposure to temperatures below 2°C does not affect the product if it is not stored below -20°C.
Store the pre-filled syringe in the original package to protect from light.
Medical personnel will be responsible for the proper storage, use, and disposal of the packaging after the medicine has been used.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Pharmascience contains

The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
The other ingredients 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, colorless to yellow, viscous solution for injection in a pre-filled syringe, containing 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, two pre-filled syringes should be injected.
Fulvestrant Pharmascience is available in three pack sizes: a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, and a pack containing 6 glass pre-filled syringes, which are made of colorless type I glass with plungers made of polystyrene and stoppers made of elastomer with protective caps in a cardboard box. One, two, or six needles with a safety system (BD SafetyGlide) are provided for use with each syringe.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

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

Administration instructions

Caution– Do not autoclave the needle with the safety system (BD SafetyGlide, Safety Hypodermic Needle) before use. When handling the medicine and disposing of its remains, avoid hand contact with the needle.
Apply to both syringes:

• Remove the glass pre-filled syringe from the container and check for damage.
• Open the outer packaging of the needle with the safety system (BD SafetyGlide).
• Before administering parenteral solutions, visually inspect for particulate matter and discoloration.
• Hold the syringe upright by the ribbed part (C). With the other hand, grasp the plunger rod (A) and twist the rigid plastic plunger rod counterclockwise (see Figure 1).

Figure 1

• Remove the rigid plastic plunger rod (A) in an upright position. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2

• Attach the needle with the safety system to the Luer-Lock tip and tighten to secure (see Figure 3).
• Check that the needle is attached to the Luer-Lock tip before moving to the upright position.
• Bring the filled needle close to the injection site.
• Remove the needle cap.
• Remove any excess air from the syringe.

Figure 3

• Administer the medicine intramuscularly, slowly (1-2 minutes/injection), into the buttock muscle (on the buttock). For the convenience of the person administering, the needle bevel is on the same surface as the safety system lock (see Figure 4).

Figure 4

• Immediately after injection, activate the needle safety system by a single finger motion forward (see Figure 5).

Caution: proceed in a way that ensures your safety and the safety of others. Listen for the click and visually confirm that the needle tip is fully covered.

Figure 5
Disposal of remains
The pre-filled syringe is for single use only.
This medicine may pose a risk to aquatic environments. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.