Faslodex 250 mg/5 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Faslodex 250 mg solution for injection

fulvestrant

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See Section 4.

Leaflet contents

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

1. What Faslodex is and what it is used for

Faslodex 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 development of breast cancer.

Faslodex is used:

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

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

2. What you need to know before using Faslodex

Do not use Faslodex:

• 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 Faslodex if any of the following apply to you:

• 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

Faslodex is not indicated for use in children and adolescents under 18 years of age.

Using Faslodex with other medicines

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

In particular, you must tell your doctor if you are taking anticoagulants (medicines used to prevent blood clots).

Pregnancy and breastfeeding

You must not use Faslodex if you are pregnant. If you are able to become pregnant, you should use an effective method of contraception during treatment with Faslodex and for two years after your last dose.

You must not breastfeed 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 operate machinery.

Faslodex contains 10% v/v ethanol (alcohol), i.e., up to 500 mg per injection, equivalent to 12 ml of beer or 5 ml of wine.

This medicine may be harmful for individuals suffering from 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 administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor or nurse will administer Faslodex to you as a slow intramuscular injection into each of your buttocks.

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

4. Possible adverse effects

Like all medicines, Faslodex can cause adverse effects, although not everyone experiences them.

You may need urgent medical treatment if you experience any of the following adverse 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)*
• Inflammation of the liver (hepatitis)
• Liver failure

Immediately inform your doctor, pharmacist or nurse if you notice any of the following adverse effects:

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

• Reactions at the injection site, such as pain and/or swelling
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Joint and musculoskeletal pain
• Hot flushes
• Skin rash
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat

All remaining adverse effects:

Common adverse effects (may affect up to 1 in 10 people)

• Headache
• Vomiting, diarrhoea 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 levels (thrombocytopenia)
• Vaginal bleeding
• Lower back 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 adverse effects (may affect up to 1 in 100 people)

• Thick, whitish vaginal discharge and candidiasis (infection)

• Bruising and bleeding at the injection site

• Increased gamma-GT, a liver enzyme detected in blood tests

• Inflammation of the liver (hepatitis)

• Liver failure

• Numbness, tingling and pain

• Anaphylactic reactions

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V*. By reporting adverse 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 stated on the packaging or on the labels of the syringes following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Temperature excursions outside the range of 2°C to 8°C must be controlled. This includes avoiding storage at temperatures above 30°C for more than a total of 28 days, during which the mean storage temperature of the medicine must be below 25°C (but above 2°C to 8°C). After any temperature excursion, the medicine must 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 total duration of such excursions must not exceed 28 days over the shelf life of Faslodex of 4 years. Exposure to temperatures below 2°C will not damage the medicine, provided it is not stored below -20°C.

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

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

This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Faslodex

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

Appearance of the product and contents of the pack

Faslodex is a viscous, clear, colourless to yellow solution in a pre-filled syringe equipped with a tamper-proof seal, containing 5 ml of injectable solution. Two syringes must be administered to receive the recommended monthly dose of 500 mg.

Faslodex is available in two pack sizes: one containing 1 glass pre-filled syringe, and one containing 2 glass pre-filled syringes. Safety needles (“BD SafetyGlide”) are also provided for attachment to each syringe.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer

AstraZeneca AB
Karlebyhusvägen
Astraallén
SE‑152 57 Södertälje
Sweden

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.euopa.eu.

This information is intended for healthcare professionals only:

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

Instructions for administration

Warning – Do not sterilize the safety needle (BD SafetyGlide Protected Hypodermic Needle) in an autoclave before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

Disposal

The pre-filled syringes are for single use only.

This medicine may pose a risk to the aquatic environment. Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.