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FULVESTRANT 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): FULVESTRANT

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Fulvestrant 250mg/5ml solution for
injection in pre-filled syringe
fulvestrant

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• 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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.
What is in this leaflet:
1. What fulvestrant is and what it is used for
2. What you need to know before you use
fulvestrant
3. How to use fulvestrant
4. Possible side effects
5. How to store fulvestrant
6. Contents of the pack and other information

1. WHAT FULVESTRANT IS AND WHAT IT IS USED FOR
Fulvestrant 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 is used to treat advanced or metastatic breast cancer in postmenopausal
women.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FULVESTRANT
Do not use fulvestrant:
• if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed
in section 6 ‘What fulvestrant contains’)
• if you are pregnant or breast-feeding
• if you have severe liver problems
Warnings and precautions
Tell your doctor 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 is not indicated in children and adolescents under 18 years.
Other medicines and fulvestrant
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken 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 if you are pregnant. If you can become pregnant, you should
use effective contraception while being treated with fulvestrant.
You must not breast-feed while on treatment with fulvestrant.
Driving and using machines
Fulvestrant 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 contains 10% w/v ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent
to 20 ml beer or 8 ml wine per dose.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk
groups such as patients with liver or kidney impairment, or epilepsy.
Fulvestrant contains 100mg benzyl alcohol per ml. Must not be given to premature
babies or neonates. May cause toxic reactions and allergic reactions in infants and children
up to 3 years old.
Fulvestrant contains 150mg benzyl benzoate per ml. May increase the risk of jaundice in
newborn babies.

3. HOW TO USE FULVESTRANT
The dosage is individually decided for you by your doctor.
The recommended dose is 500 mg fulvestrant (two 250 mg 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 as a slow intramuscular injection, one into
each of your buttocks.

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
• 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*
Common side effects (may affect up to 1 in 10 people)
• Headache
• Hot flushes
• Vomiting, diarrhoea, or loss of appetite*
• Rash
• Urinary tract infections
• Back pain*
• Increase of bilirubin (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)
• Decreased level of platelets (thrombocytopenia)
• Vaginal bleeding, thick, whitish 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
* Includes side effects for which the exact role of fulvestrant 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.
Reporting of side effects
If you get any side effects, talk to your doctor. 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. By reporting side effects you can help provide more
information on the safety of this medicine.

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5. HOW TO STORE FULVESTRANT
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C – 8°C)
Store the pre-filled syringe in the original package in order to protect from light
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.
Do not use this medicine if you notice that the device or content has deteriorated in any
way, such as damage to the syringe, cloudy solution, floating particles, or change in the
colour of the solution.
Do not throw away 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 contains
• The active substance is fulvestrant.
Each pre-filled syringe contains 250 mg fulvestrant in 5 ml solution (50 mg/ml).
• The other excipients are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and
castor oil.



What fulvestrant looks like and contents of the pack
Fulvestrant is a clear, colourless to yellow, viscous solution for injection in a pre-filled
syringe.
Fulvestrant is provided in one or two single-use pre-filled syringes. Additionally a sterile
needle is provided.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Manufacture
Oncotec Pharma Production GmbH
Am Pharmapark
06861 Dessau-Roßlau
Germany
Phone: +49 (0)34901 885-0
This leaflet was last revised in 08/2015

The following information is intended for healthcare professionals only:
Instructions for administration:
Warning - Do not autoclave safety needle before use. Hands must remain behind the
needle at all times during use and disposal.
®
®
Syringes are supplied with safety needle BD SafetyGlide or Terumo SurGuard .
Instructions for safety needle BD SafetyGlide

®

For each of the two syringes:






Carefully remove the needle and syringe from the packaging.
Remove the protective cap from the tip of the syringe barrel
Peel open the safety needle (BD SafetyGlide) outer packaging. Attach the safety needle
to the Luer-Lock
Twist to lock the needle to the Luer connector. Twist until firmly seated.

• Pull shield straight off needle to avoid
damaging needle point.

 

• Remove needle sheath.
• While holding the syringe with the needle pointing upward, gently push in the plunger
until the medicine is up to the top of the syringe. There should be no air within the barrel





Administer intramuscularly slowly
(1-2 minutes/injection) into the buttock.
For user convenience, the needle bevel- up
position is oriented to the lever arm.






After injection, immediately apply a
single-finger stroke to the activation
assisted lever arm to activate the
shielding mechanism

 

NOTE: Activate away from self and others. Listen for click and visually confirm
needle tip is fully covered.
Instructions for safety needle Terumo SurGuard

®

For each of the two syringes:
• Carefully remove the needle and syringe from the packaging.
• Remove the protective cap from the tip of the syringe barrel.

• Tighten the syringe to the needle using
aseptic technique. Grip the base of the
needle, not the sheath, and turn the
syringe clockwise.













Move the safety shield away from the
needle and toward the syringe barrel
to the angle shown. Then remove the
needle cap.

 

While holding the syringe with the needle pointing upward, gently push in the plunger
until the medicine is up to the top of the syringe. There should be no air within the barrel
Administer intramuscularly slowly (1-2 minutes/injection) into the buttock.
After completing the injection, remove the needle from the skin and use a one-handed
technique to activate the safety mechanism using any of the three methods:
- Finger activation


- Thumb activation

- Surface activation


Activation is verified by an audible and/or tactile “click”, and can be visually
confirmed.
If uncertain that the safety shield is fully engaged, repeat this step.
Disposal
Pre-filled syringes are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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