250 mg injection, solution
fulvestrant
1. What Faslodex is and what it is used for
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogen er, a type of female sex hormone may 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 for the treatment of women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 ‑ negative breast cancer, which 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 drug called 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. Ask your doctor if you have any questions about palbociclib.
2. What you need to know before using Faslodex
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 problems
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Faslodex if any of the following apply to you:
- kidney or liver problems
- low platelet count, (contributes to blood clotting), bleeding disorder
- previous problems with blood clots
- problems with bone mineral loss ( osteoporosis )
- alcohol problem
Children and young people
Faslodex is not intended for 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. You must tell 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 you can get pregnant, you should use an effective contraceptive when you are treated with Faslodex and for 2 years after your last dose.
You must not breast-feed while being treated with Faslodex.
Driving and using machines
Faslodex is unlikely to affect your ability to drive or use machines, but if you feel tired after the treatment, avoid driving or using machines.
Faslodex contains 10% w / v ethanol (alcohol),
corresponding to about 500 mg per injection, to be equated with 10 ml of beer or 4 ml of wine.
Harmful to those who suffer from alcoholism.
To be considered for high-risk groups such as patients with liver disease, or epilepsy.
Faslodex contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/ml.
Benzyl alcohol can cause allergic reactions.
Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
3. How to use Faslodex
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
The recommended dose is 500 mg fulvestrant (two 250 mg / 5 ml injections ) once a month, with an additional dose of 500 mg two weeks after the initial dose.
Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one in each buttock.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may need immediate medical attention if you get any of the following side effects:
- 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
Tell your doctor, pharmacist, or nurse if you get any of the following side effects:
A very common side effect is (may affect more than one in 10)
- Injection site reactions, such as pain and/or inflammation
- Changes in liver enzyme values (shown by blood tests) *
- Nausea
- Weakness, fatigue *
- Joint and musculoskeletal pain
- Hemorrhoids
- Rash
- Allergic (hypersensitivity) reaction, including swelling of the face, lips, tongue, and/or throat
Other side effects:
Common side effects are (may affect up to 1 in 10)
- Headache
- Vomiting, diarrhea, or decreased appetite *
- Urinary tract infection
- Back pain *
- Elevation of bilirubin (a bile pigment produced by the liver)
- Thromboembolism (increased risk of blood clots) *
- Decreased platelet count ( thrombocytopenia )
- Vaginal bleeding
- Pain in the lower back that radiates to the leg on one side (sciatica)
- Sudden weakness, numbness, tingling, or loss of mobility in the leg, especially on one side of the body, sudden difficulty walking or maintaining balance ( peripheral neuropathy )
Less common side effects are (may affect up to 1 in 100)
- Thick, whitish vaginal discharge and fungal infection
- Bruising and bleeding at the injection site
- Increase in 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 effect of Faslodex can not be assessed due to the underlying disease.
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 which is stated on the carton or syringe label after “EXP”. The expiration date is the last day of the specified month.
Store and transport in a refrigerator (2 -C-8ºC).
Deviations outside the temperature range 2 ° C-8 ° C must be limited. This includes avoiding storage at temperatures exceeding 30 ° C and not exceeding a period of 28 days where the average storage temperature of the product is below 25 ° C (but above 2 ° C ‑ 8 ° C). After temperature deviations, the product must be returned immediately to the recommended storage conditions (stored and transported in a refrigerator, 2 ° C-8 ° C). Temperature deviations have a cumulative effect on product quality and the time period of 28 days must not be exceeded during the entire shelf life of 4 years for Faslodex. Exposure to temperatures below 2 ° C does not damage the product, provided it is not stored below -20 ° C.
Store the prefilled syringe in the original package. Sensitive to light
The healthcare staff is responsible for the correct storage, use, and disposal of Faslodex.
This medicine may pose a risk to the aquatic environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
- The other ingredients (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and castor oil (refined).
What the medicine looks like and the contents of the pack
Faslodex is a clear, colorless to yellow, viscous solution in a pre-filled syringe fitted with a safety closure containing 5 ml solution for injection. Two syringes must be administered to reach the recommended monthly dose of 500 mg.
Faslodex is available in two pack sizes, either a pack containing 1 pre-filled syringe or a pack containing 2 pre-filled syringes. Protected needles (BD SafetyGlide) to attach to each syringe are also included.
Not all pack sizes may be marketed.
Manufacturer
AstraZeneca AB
Global External Sourcing (GES)
Astraallén
AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire
SK10 2NA
UK
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaTel .: +370 5 266055 |
| BulgariaAstrology Bulgaria BODYTel: +359 24455000 | Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11 |
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| DenmarkAstraZeneca A / STel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000 |
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| GreeceAstraZeneca AE:Ηλ: + 30 210 6871500 | AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: + 48 22 245 73 00 |
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