Faslodex

Package leaflet: Information for the user

Faslodex 250 mg solution for injection

fulvestrant
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to other people, even if their symptoms 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 this leaflet:

1. What Faslodex is and what it is used for
2. What you need to know before you use 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 a group of medicines called oestrogen receptor blockers. Oestrogens, a type of female sex hormone, may in some cases be involved in the growth of breast cancer.
Faslodex is used:

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

When Faslodex is administered in combination with palbociclib, it is important to also read the palbociclib package leaflet. If you have any doubts about the use of palbociclib, please 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 disease

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Faslodex if you are in any of the
following conditions:

• 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.
Other medicines and Faslodex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
In particular, you must inform your doctor if you are taking anticoagulants (medicines that prevent blood clots).
Pregnancy and breastfeeding
You must not use Faslodex if you are pregnant. If there is a possibility you could become pregnant, you must use effective contraception during treatment with Faslodex and for 2 years
after the last dose.
You must not breastfeed during 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 operate machinery.
Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection,
equivalent to 10 ml of beer or 4 ml of wine.
This is harmful for individuals suffering from alcoholism.
Exercise caution in high-risk groups such as patients with liver disorders or epilepsy.
Faslodex contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Faslodex contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.

3. How to use Faslodex

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections) administered once a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Your doctor or nurse will administer Faslodex by slow intramuscular injection, one injection into each buttock.
If you have any doubts, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediate medical attention may be required if any of the following side effects occur:

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

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

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Musculoskeletal and joint 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, diarrhoea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased levels of bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Reduced platelet levels (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in the leg, particularly 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)
• Bruising and bleeding at the injection site
• Increased levels of gamma-GT, a liver enzyme detected by blood tests
• Inflammation of the liver (hepatitis)
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

*Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease.

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

5. How to store Faslodex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the label of the syringe following the abbreviation "Exp". The expiry date refers to the last day of that month.
Store and transport in a refrigerator (2°C - 8°C).
Temperature excursions outside the range of 2°C - 8°C should be minimized. This includes avoiding storage at temperatures above 30°C, and not exceeding a period of 28 days at an average storage temperature below 25°C (but above 2°C - 8°C). After temperature excursions, the product must be returned immediately to the recommended storage conditions (store and transport in a refrigerator at 2°C - 8°C). Temperature excursions have a cumulative effect on product quality, and the 28-day period must not be exceeded cumulatively during the 4-year shelf life of Faslodex. Exposure to temperatures below 2°C does not harm the product, provided it is not stored at temperatures below -20°C.
Keep the pre-filled syringe in its original packaging to protect the medicine from light.
Healthcare personnel will be responsible for the correct storage, use, and disposal of Faslodex.
This medicine may pose a risk to the environment. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Package contents and other information

What Faslodex contains

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

Description of the appearance of Faslodex and contents of the pack
Faslodex is a clear, colourless to yellow viscous solution in a pre-filled syringe assembled with a tamper-evident seal, containing 5 ml of solution for injection. To receive the recommended monthly dose of 500 mg, two syringes must be administered.
Faslodex is available in two pack sizes: one pack containing one glass pre-filled syringe or one pack containing two glass pre-filled syringes. Safety needles with a connecting device (BD SafetyGlide) are also supplied for attachment to each syringe barrel.
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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft
Tel: +420 222 807 111 Tel: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 2 106871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

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

Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .

The following information is intended for healthcare professionals only:

Faslodex 500 mg (2x250 mg/5 ml solution for injection) must be administered using two pre-filled syringes; see section 3.
Instructions for administration
Warnings – Do not autoclave the needle with the safety device (BD SafetyGlide needle shield) prior to use. Hands must remain behind the needle at all times during use and disposal.
For each of the two syringes:

• Remove the glass syringe body from the tray and check that it is not damaged.
  Figure 1

• Remove the safety needle (SafetyGlide) from its outer packaging.
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe vertically by the flange (C). With the other hand, grasp the cap (A) and carefully rock forward and backward until the cap loosens and can be removed. Do not rotate (see Figure 1).
• Remove the cap (A) by pulling it straight upward. To maintain sterility, do not touch the tip of the syringe (B) (see Figure 2).

• Attach the safety needle to the Luer-Lok and rotate to securely lock it in place (see Figure 3).

Check that the needle is securely attached to the Luer connector before removing it from the vertical plane.

• Remove the needle protector promptly to avoid damaging the needle tip.
• Carry the filled syringe to the administration site.
• Remove the needle sheath.
• Expel excess air from the syringe.
• Administer slowly (1 to 2 minutes/injection) by intramuscular injection into the gluteal region (gluteal area). For user convenience, the “blunt” needle tip is aligned with the lever arm (see Figure 4).

• After injection, immediately apply single-finger pressure to the lever arm with assisted activation to activate the safety mechanism (see Figure 5).

NOTE: Activate away from yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.
Disposal
Pre-filled syringes are for single use only.
This medicinal product may pose a risk to the environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.