FULVESTRANT MYLAN 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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How to use FULVESTRANT MYLAN 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Introduction
Package Leaflet: Information for the User
Fulvestrant Mylan 250 mg solution for injection in pre-filled syringe EFG
fulvestrant
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 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.
Contents of the pack
- What is Fulvestrant Mylan and what is it used for
- What you need to know before you use Fulvestrant Mylan
- How to use Fulvestrant Mylan
- Possible side effects
- How to store Fulvestrant Mylan
- Contents of the pack and other information
1. What is Fulvestrant Mylan and what is it used for
Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.
Fulvestrant Mylan is used:
- alone, to treat postmenopausal women with a type of breast cancer called hormone receptor-positive breast cancer, which 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 (HER2) 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 medicine called luteinizing hormone-releasing hormone (LHRH) agonist.
Fulvestrant may be administered in combination with palbociclib. It is important that you also read the package leaflet of palbociclib. If you have any questions about palbociclib, ask your doctor.
2. What you need to know before you use Fulvestrant Mylan
Do not use Fulvestrant Mylan
- if you are allergic to fulvestrant or 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
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Fulvestrant Mylan if any of the following apply to you:
- kidney or liver problems
- low platelet count (which helps blood to clot) or bleeding disorders
- previous blood clot problems
- osteoporosis (loss of bone density)
- alcoholism
Children and adolescents
Fulvestrant Mylan is not indicated in children and adolescents under 18 years.
Other medicines and Fulvestrant Mylan
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).
Pregnancy and breast-feeding
You should not use Fulvestrant Mylan if you are pregnant. If you can become pregnant, you should use effective contraception while being treated with Fulvestrant Mylan and for 2 years after the last dose.
You should not breast-feed while being treated with Fulvestrant Mylan.
Driving and using machines
Fulvestrant Mylan 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.
Fulvestrant Mylan contains 10% v/v ethanol (alcohol),i.e., 500 mg per dose, which is equivalent to less than 25 ml of beer or 10 ml of wine per treatment dose (i.e., two syringes). The small amount of alcohol in this medicine does not have any noticeable effect.
Fulvestrant Mylan contains benzyl alcohol
This medicine contains 500 mg of benzyl alcohol in each 5 ml, which is equivalent to 100 mg/ml (10% v/v). Benzyl alcohol may cause allergic reactions.
Fulvestrant Mylan contains benzyl benzoate
This medicine contains 750 mg of benzyl benzoate in each 5 ml, which is equivalent to 150 mg/ml (15% v/v).
3. How to use Fulvestrant Mylan
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.
Your doctor or nurse will administer Fulvestrant Mylan by slow intramuscular injection into each buttock.
If you have any further questions on the use of this medicine, 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 urgent medical attention if you experience any of the following side effects:
- Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be symptoms of anaphylactic reactions
- Thromboembolism (increased risk of blood clots)*
- Hepatitis (inflammation of the liver)
- Liver failure
Tell your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:
Very common side effects(may affect more than 1 in 10 people)
- Injection site reactions, such as pain and/or inflammation
- Abnormal liver enzyme levels (in blood tests)*
- Nausea (feeling sick)
- Weakness, fatigue*
- Joint and musculoskeletal pain
- Hot flashes
- 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, diarrhea, or loss of appetite*
- Urinary tract infections
- Back pain*
- Increased bilirubin (a bile pigment produced by the liver)
- Thromboembolism (increased risk of blood clots)*
- Decreased platelet count (thrombocytopenia)
- Vaginal bleeding
- Lumbar pain radiating to one leg (sciatica)
- Sudden weakness, numbness, tingling, or loss of movement in your leg, especially 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)
- Hematoma and bleeding at the injection site
- Increased gamma-GT, a liver enzyme identified in a blood test
- Hepatitis (inflammation of the liver)
- Liver failure
- Numbness, tingling, and pain
- Numbness, tingling, and pain
- Anaphylactic reactions
*Including side effects for which the exact role of Fulvestrant Mylan cannot be evaluated due to the underlying disease.
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Fulvestrant Mylan
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 on the labels of the syringes after the abbreviation EXP. The expiry date refers to the last day of the month stated.
Store and transport in a refrigerator (between 2°C and 8°C).
Temperature excursions outside the range of 2°C to 8°C are permitted, provided that the mean kinetic temperature does not exceed 25°C (but above 2°C to 8°C). After temperature excursions, the medicine should be immediately returned to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature excursions have a cumulative effect on the quality of the medicine, and the 28-day period should not be exceeded beyond the shelf life of Fulvestrant Mylan. Exposure to temperatures below 2°C will not harm the medicine, provided it is not stored below -20°C.
The pre-filled syringe should be kept in the original packaging to protect it from light.
Your healthcare professional will be responsible for the proper storage, use, and disposal of Fulvestrant Mylan.
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. This will help protect the environment.
6. Contents of the pack and other information
What Fulvestrant Mylan contains
- The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
- The other ingredients (excipients) are: benzyl benzoate (see section 2, ‘Fulvestrant Mylan contains benzyl benzoate’), benzyl alcohol (see section 2, ‘Fulvestrant Mylan contains benzyl alcohol’), anhydrous ethanol (see section 2, ‘Fulvestrant Mylan contains 10% v/v ethanol’), and refined castor oil.
Appearance and pack of Fulvestrant Mylan
Fulvestrant Mylan is a viscous, clear, colorless to yellow solution in a pre-filled syringe equipped with a tamper-evident closure, which contains 5 ml of injectable solution.
Fulvestrant Mylan is available in 4 formats: a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes or a pack containing 4 glass pre-filled syringes or a pack containing 6 glass pre-filled syringes. Safety needles (BD SafetyGlide) are also provided for connection to the syringe body.
Not all pack sizes may be marketed.
Marketing authorisation holder
MYLAN PHARMACEUTICALS LIMITED
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
IRELAND
Manufacturer
MYLAN TEORANTA
Inverin
Co. Galway
IRELAND
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
GERMANY
You can request more information about this medicine from the local representative of the marketing authorisation holder:
België/Belgique/Belgien Mylan bvba/sprl /Tel/Tél: + 32 (0)2 658 61 00 | Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288 |
| Luxembourg/Luxemburg Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) |
Ceská republika Viatris CZ.s.r.o. Tel: +420 222 004 400 | Magyarország Mylan EPD Kft. Tel.: + 36 1 465 2100 |
Danmark Viatris ApS Tlf: + 45 28 11 69 32 | Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 |
Deutschland Viatris Healthcare GmbH Tel: + 49800 0700 800 | Nederland Mylan BV Tel: +31 (0)20 426 3300 |
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: +372 6363 052 | Norge Viatris Norge AS Tlf: + 47 66 75 33 00 |
Ελλáδα Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 993 6410 | Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418 |
España Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 712 | Polska Mylan Healthcare Sp. z.o.o. Tel.: + 48 22 546 64 00 |
France Viatris Santé Tél: +33 4 37 25 75 00 | Portugal Mylan, Lda. Tel: + 351 21 412 72 00 |
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599 | România BGP Products SRL Tel: + 40372 579 000 |
Ireland Mylan Ireland Limited Tel: +353 1 8711600 | Slovenija Viatris d.o.o. Tel: + 386 1 23 63 180 |
Ísland Icepharma hf. Sími: + 354 540 8000 | Slovenská republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 100 |
Italia Mylan Italia S.r.l. Tel: + 39 02 612 46921 | Suomi/Finland Viatris Oy Puh/Tel: + 358 20 720 9555 |
Κúπρος Varnavas Hadjipanavis Ltd. Τηλ: + 357 2220 7700 | Sverige Viatris AB Tel: + 46 (0)8 630 19 00 |
Latvija Mylan Healthcare SIA Tel: +371 676 055 80 | United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600 |
Date of last revision of this leaflet:{MM/AAAA}.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
This information is intended only for healthcare professionals:
Fulvestrant Mylan 500 mg (2 × 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Administration instructions
Warning: Do not autoclave the safety needle (hypodermic needle) before use. Hands should remain behind the needle at all times during use and disposal.
For each of the two syringes:
| Figure 1
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| Figure 2
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| Figure 3
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| Figure 4
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NOTE: Activate the mechanism away from your body and others. Listen for the click and visually confirm that the needle tip is fully protected. | Figure 5
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Disposal
The pre-filled syringes are for single use only.
This medicine may pose a risk to the aquatic environment. Disposal of unused medicine and all materials that have been in contact with it should be done in accordance with local regulations.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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