Patient Leaflet Updated 13-Jun-2023 | AstraZeneca UK Limited
Faslodex 250 mg solution for injection
Faslodex® 250 mg solution for injection
fulvestrant
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
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:
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.
Talk to your doctor or pharmacist or nurse before using Faslodex if any of these apply to you:
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.
Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Harmful for those suffering from alcoholism.
To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
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.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
* 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 the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 (2°C – 8°C).
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.
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.
This leaflet was last revised in December 2022.
ONC 22 0129
© AstraZeneca 2022
FASLODEX is a trademark of the AstraZeneca group of companies.
SAFETYGLIDE is a trademark of Becton Dickinson and Company.
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Faslodex 250 mg solution for injection 17901/0323
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