Active ingredients: Fulvestrant
Faslodex 250 mg solution for injection.
Why is Faslodex used? What is it for?
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogen, a type of female sex hormone, 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.
Contraindications When Faslodex should not be used
Do not use Faslodex
- if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or breastfeeding
- if you have severe liver disease
Precautions for use What you need to know before taking Faslodex
Talk to your doctor or pharmacist or nurse before using Faslodex if you have any of the following conditions:
- kidney or liver problems
- low number of platelets (which help blood clot) or bleeding problems - previous problems with blood clots
- osteoporosis (loss of bone density)
- alcoholism
Children and adolescents
Faslodex is not indicated for children and adolescents less than 18 years of age.
Interactions Which drugs or foods may change the effect of Faslodex
Tell your doctor or pharmacist if you are taking or have recently taken or might take.
In particular, you should tell your doctor if you are using anticoagulants (medicines that prevent blood clots).
Warnings It is important to know that:
Pregnancy and breastfeeding
You should not use Faslodex if you are pregnant. If there is a possibility that you may become pregnant, you must use effective contraception during treatment with Faslodex.
You should 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 use machines.
Faslodex contains 10% by weight / volume of ethanol (alcohol), i.e. up to 1000 mg per serving, equivalent to 20 ml of beer or 8 ml of wine per serving.
It is harmful for those suffering from alcoholism.
Caution should be exercised in pregnant or lactating women, children and high-risk groups such as patients with liver disorders or epilepsy.
Dose, Method and Time of Administration How to use Faslodex: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg / 5 ml injections) administered once monthly with an additional 500 mg dose administered 2 weeks after the initial dose.
Your doctor or nurse will administer Faslodex as a slow intramuscular injection, one in each buttock.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Side Effects What are the side effects of Faslodex
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediate medical attention may be needed if any of the following side effects occur:
- Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and / or throat
- Thromboembolism (increased risk of blood clots) *
- Inflammation of the liver (hepatitis)
- Hepatic insufficiency
If any of the following side effects occur, tell 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 levels of liver enzymes (in blood tests) *
- Nausea (feeling sick)
- Weakness, tiredness *
All other side effects:
Common side effects (may affect up to 1 in 10 people)
- Headache
- Hot flashes
- Vomiting, diarrhea or loss of appetite *
- Rash
- Urinary tract infections
- Back pain*
- Increased levels of bilirubin (a bile pigment produced by the liver)
- Thromboembolism (increased risk of blood clots) *
- Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and / or throat
Uncommon side effects (may affect up to 1 in 100 people)
- Reduced levels of platelets (thrombocytopenia)
- Vaginal bleeding, thickening, whitish discharge and candidiasis (infection)
- Bruising and bleeding at the injection site
- Increased levels of gamma-GT, a liver enzyme detected in a blood test
- Inflammation of the liver (hepatitis)
- Hepatic insufficiency
* Includes adverse drug reactions for which the exact contribution of Faslodex cannot be estimated due to the underlying disease.
Reporting of side effects
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 national reporting system listed in Appendix V. side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 label after the abbreviation EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated (2 ° C - 8 ° C).
Temperature excursions outside 2 ° C - 8 ° C must be limited. This includes avoiding storage at temperatures above 30 ° C, and not exceeding a period of 28 days at an average product storage temperature below 25 ° C (but above 2 - 8 ° C). temperature excursions, the product must be returned immediately to the recommended storage conditions (store and transport refrigerated 2 ° C - 8 ° C). The temperature excursions have a cumulative effect on the quality of the product and the time period of 28 be exceeded within the 4-year shelf life of Faslodex. Exposure to temperatures below 2 ° C will not harm the product as long as it is not stored at temperatures below -20 ° C.
Keep the pre-filled syringe in the original package in order to protect the medicine from light.
Healthcare professionals will be responsible for the proper storage, use and disposal of Faslodex.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What Faslodex contains
- The active ingredient is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
- The other ingredients are ethanol (96 percent), benzyl alcohol, benzyl benzoate and castor oil.
What Faslodex looks like and contents of the pack
Faslodex is a clear, colorless to viscous yellow solution in a pre-filled syringe assembled with a tamper-evident closure, containing 5 ml of solution for injection. Two syringes should be administered to receive the recommended monthly dose of 500 mg.
Faslodex is available in two packs, either a pack containing a pre-filled glass syringe or a pack containing two pre-filled glass syringes. Also provided are safety needles equipped with a device (BD SafetyGlideTM) for connection to each syringe barrel.
Not all pack sizes may be marketed.
Deadline "> Information for healthcare professionals
Faslodex 500 mg (2x250 mg / 5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
BD SafetyGlide is a trademark of Bacton Dickinson and Company and is CE marked: CE0050.
Instructions for administration
Warnings - Do not autoclave the needle with the protective device (Hypodermic Needle with BD SafetyGlide protection) before use. Hands must remain behind the needle for the entire time of use and disposal.
For each of the two syringes:
- Remove the glass syringe body from the tray and check for damage.
- Break the seal of the white plastic cap on the Luer-Lok fitting of the Luer syringe to remove the cap with the included rubber cap
- Remove the safety needle (BD SafetyGlide) from the outer packaging. Attach the safety needle to the Luer-Lok
- Rotate to lock securely.
- Rotate to lock the needle to the Luer fitting.
- Remove the needle guard quickly to avoid damage to the needle tip.
- Bring the filled syringe to the administration site.
- Remove the needle sheath.
- Parenteral solutions should be visually inspected for particle contamination and discoloration prior to administration.
- Expel excess gas from the syringe.
- Administer slowly (1 to 2 minutes / injection) intramuscularly into the buttock. For the convenience of the user, the "blunt" needle tip is aligned with the lever arm.
- After injection, immediately apply single finger force to the arm of the assisted activation lever to activate the guard mechanism (see Figure 4). NOTE: Activate away from yourself and others. Hear the click and visually confirm that the tip needle is completely covered.
Disposal
The pre-filled syringes are for single use only.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
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