FASLODEX 250 mg/5 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Faslodex250mg solution for injection

fulvestrant

Read all of this leaflet carefully before you start 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 Faslodex and what is it used for
2. What you need to know before you use Faslodex
3. How to use Faslodex
4. Possible side effects
5. Storage of Faslodex
6. Contents of the pack and other information

1. What is Faslodex and what is it used for

Faslodex contains the active substance fulvestrant, which belongs to a group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Faslodex is used:

• alone, to treat postmenopausal women with a type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastatic), or
• in combination with palbociclib to treat women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called luteinizing hormone-releasing hormone (LHRH) agonist.

Faslodex may be administered in combination with palbociclib. It is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. What you need to know before you use Faslodex

Do not use Faslodex:

• 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 starting treatment with Faslodex if any of the following apply to you:

• kidney or liver problems
• low platelet count (which helps blood to clot) or bleeding disorders
• previous blood clot problems
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents

Faslodex is not intended for use in children and adolescents under 18 years.

Using Faslodex with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breast-feeding

You must not use Faslodex if you are pregnant. If you can become pregnant, you must use effective contraception while being treated with Faslodex and for 2 years after your last dose.

You must not breast-feed while being treated with Faslodex.

Driving and using machines

Faslodex is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or use machines.

Faslodex contains10%v/v ethanol (alcohol),that is up to 500 mg per injection, equivalent to 12 ml of beer or 5 ml of wine.

This medicine is harmful to people with alcoholism.

The alcohol content should be taken into account in high-risk groups, such as patients with liver disease, or epilepsy.

Faslodex contains 500 mg of benzyl alcohol in each injection, equivalent to 100 mg/ml.

Benzyl alcohol may cause allergic reactions.

Faslodex contains 750 mg of benzyl benzoate in each injection, equivalent to 150 mg/ml.

3. How to use Faslodex

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections) administered once a month, with an additional dose of 500 mg administered 2 weeks after the initial dose.

Your doctor or nurse will administer Faslodex by slow intramuscular injection into each of your buttocks.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

You may need urgent medical attention if you experience any of the following side effects:

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

Tell your doctor, pharmacist or nurse immediately if you notice any of the following side effects:

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

• Injection site reactions, such as pain and/or inflammation
• Abnormal liver enzymes (in blood tests)*
• Nausea (feeling sick)
• Weakness, tiredness*
• Joint and musculoskeletal 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, diarrhea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lumbar pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling or loss of movement in your leg, especially 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)
• Hematoma and bleeding at the injection site
• Increased gamma-GT, a liver enzyme identified in a blood test
• Hepatitis (inflammation of the liver)
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

• Includes side effects for which the exact role of Faslodex cannot be assessed due to the underlying disease.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Faslodex

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 labels of the syringes after the abbreviation EXP. The expiry date refers to the last day of the month shown.

Store and transport in a refrigerator (between 2°C and 8°C).

Temperature excursions outside the range of 2°C to 8°C should be controlled. This includes avoiding storage at temperatures above 30°C, and not exceeding a period of 28 days, during which the average storage temperature of the medicine is below 25°C (but above 2°C to 8°C). After temperature excursions, the medicine should be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature excursions have a cumulative effect on the quality of the medicine, and the 28-day period should not exceed the shelf-life of 4 years of Faslodex. Exposure to temperatures below 2°C will not harm the medicine, provided it is not stored below -20°C.

Store the pre-filled syringe in the original packaging to protect it from light.

Your healthcare professional will be responsible for the proper storage, use and disposal of Faslodex.

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 is in Faslodex

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

Appearance and packaging

Faslodex is a viscous, clear, colorless to yellow solution in a pre-filled syringe equipped with a tamper-evident closure, which contains 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Faslodex is available in 2 formats, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes. Safety needles (“BD SafetyGlide”) are also provided for connection to the syringe body.

Not all pack sizes may be marketed.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Karlebyhusentrén

Astraallén

SE-152 57 Södertälje

Sweden

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

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

Administration instructions

Warning – Do not autoclave the safety needle (Protected Hypodermic Needle “BD SafetyGlide”) before use. Hands should remain behind the needle at all times during use and disposal.

For each of the two syringes:

Disposal

The pre-filled syringes are for singleuse only.

This medicine may pose a risk to the aquatic environment. Disposal of unused medicine and all materials that have been in contact with it should be done in accordance with local regulations.