Skip to Content

FULVESTRANT TEVA 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): FULVESTRANT

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
FULVESTRANT 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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.

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 Solution for Injection in Pre-filled Syringe 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 any of the other ingredients of this medicine (listed in section 6)

are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”)

have severe liver problems.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fulvestrant 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 (see section “Fulvestrant contains ethanol 96% (alcohol)”).
Children and adolescents
Fulvestrant is not indicated in children and adolescents under 18 years.
Other medicines and Fulvestrant

Tell your doctor, pharmacist or nurse 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, breast-feeding and fertility
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 ethanol 96% (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 disease or epilepsy.
Fulvestrant contains benzyl alcohol, the amount of benzyl alcohol per dose is 500 mg per 5 ml (100 mg per
1 ml), which may cause allergic reactions.
Fulvestrant contains castor oil, refined, which may cause severe allergic reactions.
3.

How to use Fulvestrant

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 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.
Tell your doctor, pharmacist or nurse IMMEDIATELY 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.

These are serious side effects. You may need immediate medical treatment.

Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Very common: 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: may affect up to 1 in 10 people
 headache
 hot flushes
 vomiting (being sick), diarrhoea or loss of appetite*
 rash
 urinary tract infections
 back pain*
 increase of bilirubin (bile pigment produced by the liver).
Uncommon: may affect up to 1 in 100 people
 decreased levels 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.
* Includes side effects for which the exact role of Fulvestrant 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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Fulvestrant

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.
Do not use this medicine if you notice any particles or discolouration prior to administration.
Keep the pre-filled syringe in the original package, in order to protect from light.
Store and transport refrigerated (2°C - 8°C).
Temperature excursions outside 2°C - 8°C should be limited. This includes avoiding storage at temperatures
exceeding 25°C 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 refrigerated 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 2-year shelf life of Fulvestrant. Exposure to temperatures below 2°C
will not damage the product providing it is not stored below –20°C.
Your health care professional will be responsible for the correct storage, use and disposal of Fulvestrant.
6.

Contents of the pack and other information

What Fulvestrant contains

-

The active substance is fulvestrant. Each pre-filled syringe contains 250 mg fulvestrant. Each ml of
solution contains 50 mg of fulvestrant.
The other ingredients (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate and castor oil,
refined.

What Fulvestrant looks like and contents of the pack
Fulvestrant is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamperevident closure, containing 5 ml solution for injection. Two syringes must be administered to receive the 500
mg recommended monthly dose.
Fulvestrant has 2 pack presentations:
1 pack containing 1 glass pre-filled syringe and 1 safety needle for connection to the barrel.
1 pack containing 2 glass pre-filled syringes and 2 safety needles for connection to each barrel are also
provided.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia
*OR
TEVA Gyógyszergyár Zrt. (Teva Pharmaceutical Works Private Limited Company),
Gödöllő, Táncsics Mihály út 82.,
H-2100,
Hungary
*OR
Teva Operations Poland Sp. z o.o,
ul. Mogilska 80., Krakow,
31-546,
Poland
This leaflet was last revised in 02/2016.
PL 00289/1930
* Only the actual site of batch release will appear on the printed version of the leaflet

-----------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Fulvestrant 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled
syringes.
Instructions for administration

Warning - Do not autoclave safety 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
break the seal of the clear plastic cover on the syringe
Luer-Lock connector to remove the cover with the
attached rubber tip cap (see Figure 1).

Figure 1

peel open the safety needle outer packaging. Attach
the safety needle to the Luer-Lock (see Figure 2)
twist until firmly seated.

Figure 2




twist to lock the needle to the Luer connector
pull shield straight off needle to avoid damaging
needle point (see Figure 3).

Figure 3




transport filled syringe to point of administration
parenteral solutions must be inspected visually for
particulate matter and discolouration prior to
administration
expel excess gas from the syringe
administer intramuscularly slowly (1-2
minutes/injection) into the buttock. For user
convenience, the needle bevel-up position is oriented
to the lever arm (see Figure 4).

Figure 4

after injection, immediately apply a single-finger
stroke to the activation assisted lever arm to activate
the needle shielding mechanism (see Figure 5).
NOTE: Activate away from self and others. Listen
for click and visually confirm needle tip is fully
covered.

Figure 5











Disposal
Pre-filled syringes are for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.

Expand view ⇕

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.

Hide