Faslodex 250 mg solution for injection

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

Faslodex is used to treat advanced or metastatic breast cancer in postmenopausal women.

Do not use Faslodex

• if you are allergic (hypersensitive) to fulvestrant or to any of the other ingredients of Faslodex (listed in section 6 ?What Faslodex contains?)
• if you are pregnant or breast-feeding
• if you have severe liver problems

Take special care with Faslodex
Tell your doctor if any of these apply to you:

• kidney or liver problems
• low numbers of platelets (which help blood clotting) or bleeding disorders
• previous problems with blood clots
• osteoporosis (loss of bone density)
• Alcoholism

Children

Faslodex is not indicated in children and adolescents under 18 years.

Using other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 should use effective contraception while being treated with Faslodex.

You must not breast-feed while on treatment 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 .

Important information about some of the ingredients of Faslodex

This medicinal product contains 10% w/v ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

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

Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.

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

These side effects may occur with certain frequencies, which are defined as follows:

• very common: affects more than 1 user in 10
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000
• not known: frequency cannot be estimated from the available data.

Very common side effects

• Injection site reactions, such as pain and/or inflammation
• Abnormal levels of liver enzymes (in blood tests)*
• Nausea (feeling sick)
• Weakness, tiredness*

Common side effects

• Headache
• Hot flushes
• Vomiting, diarrhoea, or loss of appetite*
• Rash
• Urinary tract infections
• Back pain*
• Thromboembolism (Increased risk of blood clots)*
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat

Uncommon side effects

• Vaginal bleeding, thick, whitish discharge and candidiasis (infection)
• Bruising and bleeding at the site of injection

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Store in a refrigerator (2°C - 8°C)
Keep the pre-filled syringe in the original package, in order to protect from light.

Keep out of the reach and sight of children.

Do not use Faslodex after the expiry date which is stated on the carton or syringe labels after the abbreviation EXP. The expiry date refers to the last day of that month.

Your health care professional will be responsible for the correct storage, use and disposal of Faslodex.

What Faslodex contains

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

What Faslodex looks like and contents of the pack

Faslodex is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose.

Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes. Safety needles (BD SafetyGlide?) for connection to each barrel are also provided.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AstraZeneca UK Limited
Alderley Park
Macclesfield
Cheshire
SK10 4TG
United Kingdom

Manufacturer

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder (see contacts list):

BelgiëBelgiqueBelgien NV AstraZeneca SA Tel 32 2 370 48 11 LuxembourgLuxemburg NV AstraZeneca SA TélTel 32 2 370 48 11

AstraZeneca UK Limited . 359 2 971 25 33 Magyarország AstraZeneca Kft Tel 36 1 883 6500

eská republika AstraZeneca Czech Republic s.r.o. Tel 420 222 807 111 Malta Associated Drug Co. Ltd Tel 356 2277 8000

Danmark AstraZeneca AS Tlf 45 43 66 64 62 Nederland AstraZeneca BV Tel 31 79 363 2222

Norge

AstraZeneca AS
Tlf: +47 21 00 64 00

Deutschland

AstraZeneca GmbH
Tel: +49 41 03 7080

Eesti AstraZeneca Tel 372 6549 600 Österreich AstraZeneca Österreich GmbH Tel 43 1 711 31 0

AstraZeneca A.E. 30 2 106871500 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel. 48 22 874 35 00

España AstraZeneca Farmacéutica Spain, S.A. Tel 34 91 301 91 00 Portugal AstraZeneca Produtos Farmacêuticos, Lda. Tel 351 21 434 61 00

France AstraZeneca Tél 33 1 41 29 40 00 România AstraZeneca Pharma SRL Tel 40 21 317 60 41

Ireland AstraZeneca Pharmaceuticals Ireland Ltd Tel 353 1609 7100 Slovenija AstraZeneca UK Limited Tel 386 1 51 35 600

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika AstraZeneca AB o.z. Tel. 421 2 5737 7777

Italia AstraZeneca S.p.A. Tel 39 02 9801 1 SuomiFinland AstraZeneca Oy PuhTel 358 10 23 010

357 22490305 Sverige AstraZeneca AB Tel 46 8 553 26 000

Latvija AstraZeneca AB prstvniecba Latvij Tel 371 67377100 United Kingdom AstraZeneca UK Ltd Tel 44 1582 836 836

Lietuva

UAB AstraZeneca Lietuva
Tel: +370 5 2660550

This leaflet was last approved in

The following information is intended for healthcare professionals only:

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

BD SafetyGlide is a trademark of Becton Dickinson and Company and is CE-marked: CE 0050.

Instructions for administration
Warning - Do not autoclave safety needle (BD SafetyGlide? Shielding Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

Remove glass syringe barrel from tray and check that it is Figure 1 not damaged. Break the seal of the white plastic cover on the syringe Luer connector Luer-Lok to remove the cover with the attached rubber tip cap see Figure 1.

Peel open the safety needle BD SafetyGlide outer Figure 2 packaging. Attach the safety needle to the Luer-Lok see Figure 2 Twist until firmly seated. Twist to lock the needle to the Luer connector. Pull shield straight off needle to avoid damaging needle point. Transport filled syringe to point of administration. Remove needle sheath. Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration. Expel excess gas from the syringe.

• Administer intramuscularly slowly (1-2 minutes/injection) Figure 3 into the buttock. For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 3).
• After injection, immediately apply a single-finger stroke to Figure 4 the activation assisted lever arm to activate the shielding mechanism (see Figure 4). NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.

Disposal
Pre-filled syringes are for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.