Faslodex
fulvestrant
fulvestrant
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.
What Faslodex is and what it is used for
What you need to know before you use Faslodex
How to use Faslodex
Possible side effects
How to store Faslodex
Contents of the pack and other information
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 either:
alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that 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 breast cancer, that 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 a luteinizing hormone releasing hormone (LHRH) agonist.
When Faslodex is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, please ask your doctor.
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 breast-feeding
if you have severe liver problems
Talk to your doctor or pharmacist or nurse before using Faslodex 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
Faslodex is not indicated in children and adolescents under 18 years.
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).
You must not use Faslodex if you are pregnant. If you can become pregnant, you should use effective contraception while you are being treated with Faslodex and for 2 years after your last dose.
You must not breast-feed while on treatment with Faslodex.
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.
Harmful for those suffering from alcoholism.
To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended 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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Thromboembolism (increased risk of blood clots)*
Inflammation of the liver (hepatitis)
Liver failure
Injection site reactions, such as pain and/or inflammation
Abnormal levels of liver enzymes (in blood tests)*
Nausea (feeling sick)
Weakness, tiredness*
Joint and musculoskeletal pain
Hot flushes
Skin rash
Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat
Headache
Vomiting, diarrhoea, or loss of appetite*
Urinary tract infections
Back pain*
Increase of bilirubin (bile pigment produced by the liver)
Thromboembolism (increased risk of blood clots)*
Decreased levels of platelets (thrombocytopenia)
Vaginal bleeding
Lower back pain irradiating to leg on one side (sciatica)
Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy)
Thick, whitish vaginal discharge and candidiasis (infection)
Bruising and bleeding at the site of injection
Increase of gamma-GT, a liver enzyme seen in a blood test
Inflammation of the liver (hepatitis)
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.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 syringe labels after EXP. The expiry date refers to the last day of that month.
Store and transport in a refrigerator (2C - 8C).
Temperature excursions outside 2°C - 8°C should be limited. This includes avoiding storage at temperatures exceeding 30°C, and not exceeding a 28-day period where the average storage temperature for the product is below 25°C (but above 2°C - 8°C). After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C). Temperature excursions have a cumulative effect on the product quality and the 28-day time period must not be exceeded over the duration of the 4-year shelf life of Faslodex. Exposure to temperatures below 2°C will not damage the product providing it is not stored below
-20°C.
Keep the pre-filled syringe in the original package, in order to protect from light.
Your healthcare professional will be responsible for the correct storage, use and disposal of Faslodex. This medicine may pose a risk to the aquatic environment. Do not throw away any medicines via
wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
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.
AstraZeneca AB
SE-151 85 Södertälje Sweden
AstraZeneca AB
Global External Sourcing (GES) Astraallén
Gärtunaporten
SE-151 85 Södertälje Sweden
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:
UAB AstraZeneca Lietuva Tel: +370 5 2660550
АстраЗенека България ЕООД
Тел.: +359 24455000
AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111
Associated Drug Co. Ltd
Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: +47 21 00 64 00
AstraZeneca A.E.
Τηλ: + 30 210 6871500
AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00
AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
AstraZeneca
Tél: +33 1 41 29 40 00
AstraZeneca Produtos Farmacêuticos, Lda. Tel: +351 21 434 61 00
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7100
AstraZeneca UK Limited Tel: +386 1 51 35 600
Vistor hf.
Sími: +354 535 7000
AstraZeneca AB, o.z. Tel: +421 2 5737 7777
AstraZeneca S.p.A. Tel: +39 02 9801 1
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA AstraZeneca Latvija Tel: +371 67377100
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Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Instructionsforadministration
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 not damaged.
Peel open the safety needle (SafetyGlide) outer packaging.
Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Hold the syringe upright on the ribbed part (C). With the
other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure 1).
Figure 1
Remove the cap (A) in a straight upward direction. To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
Check that the needle is locked to the Luer connector
before moving out of the vertical plane.
Pull shield straight off needle to avoid damaging needle point.
Transport filled syringe to point of administration.
Remove needle sheath.
Expel excess gas from the syringe.
Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area). For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.
Figure 2
Figure 3
Figure 4
Figure 5
Disposal
Pre-filled syringes are for single use only.
This medicine may pose a risk to the aquatic environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.