Patient leaflet - Fulvestrant Mylan 250 mg solution for injection in Pre-filled syringe
1. What Fulvestrant Mylan is and what it is used for
Fulvestrant Mylan 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.
Fulvestrant Mylan 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 fulvestrant 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.
2. What you need to know before you use Fulvestrant Mylan
Do not use Fulvestrant Mylan
- 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
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Fulvestrant Mylan 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
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 must not use Fulvestrant Mylan if you are pregnant. If you can become pregnant, you should use effective contraception while you are being treated with Fulvestrant Mylan and for 2 years after your last dose.
You must not breast-feed while on treatment 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% w/v ethanol (alcohol) i.e. 500 mg in each 5 ml, equivalent to 25 ml beer or 10 ml wine per one treatment dose (i.e. two syringes). The small amount of alcohol in this medicine will not have any noticeable effects.
Fulvestrant Mylan contains benzyl alcohol
This medicine contains 500 mg benzyl alcohol in each 5 ml which is equivalent to 100 mg/ml (10% w/v). Benzyl alcohol may cause allergic reactions.
Fulvestrant Mylan contains benzyl benzoate
This medicine contains 750 mg benzyl benzoate in each 5 ml, which is equivalent to 150 mg/ml (15%w/v).
3. How to use Fulvestrant Mylan
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 Fulvestrant Mylan 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. You may need immediate medical treatment if you experience any of the following side effects:
- 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
Tell your doctor, pharmacist, or nurse 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 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
All other side effects:
Common side effects (may affect up to 1 in 10 people)
- 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)
Uncommon side effects (may affect up to 1 in 100 people)
- 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 Fulvestrant Mylan cannot be assessed 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
United Kingdom
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.
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 syringe labels after 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 should be limited 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 shelf life of Fulvestrant Mylan. 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 Fulvestrant Mylan.
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.
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 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’), ethanol anhydrous (see section 2 ‘Fulvestrant Mylan contains 10% w/v ethanol (alcohol)’), castor oil, refined.
What Fulvestrant Mylan looks like and contents of the pack
Fulvestrant Mylan 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.
Fulvestrant Mylan has 4 pack presentations, either 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) for connection to each barrel are also provided.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Generics [UK] Ltd. t/a Mylan
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
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
This leaflet was last revised in November 2021
Figure 1
Figure 2
Figure 4 Figure 3 ------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:
Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Instructions for administration
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).
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
Figure 5 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.
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.