Fulvestrant Accord

Package leaflet: Information for the user

Fulvestrant Accord 250 mg solution for injection in pre-filled syringe

Generic medicine
Please 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 symptoms are the same as yours.
• If you experience any side effect, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Fulvestrant Accord is and what it is used for
2. What you need to know before you use Fulvestrant Accord
3. How to use Fulvestrant Accord
4. Possible side effects
5. How to store Fulvestrant Accord
6. Contents of the pack and other information

1. What Fulvestrant Accord is and what it is used for

Fulvestrant Accord contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, may in some cases be involved in the growth of breast cancer.
Fulvestrant Accord is used:

• alone, for the treatment of postmenopausal women with a type of breast cancer called estrogen receptor-positive locally advanced or metastatic breast cancer, 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 (HER2)-negative, which is locally advanced or metastatic. Women who are not yet postmenopausal will be treated with a medicine called a luteinising hormone-releasing hormone (LHRH) agonist. When Fulvestrant Accord is administered in combination with palbociclib, it is important to also read the palbociclib package leaflet. If you have any questions about the use of palbociclib, please ask your doctor.

2. What you need to know before using Fulvestrant Accord

Do not use Fulvestrant Accord:

• 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 breastfeeding
• if you have severe liver disease

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Fulvestrant Accord if you are in any of the following situations:

• kidney or liver problems
• low platelet count (platelets help blood to clot) or bleeding disorders
• history of blood clots
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents
Fulvestrant Accord is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Fulvestrant Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are using anticoagulants (medicines that prevent blood clots).
Pregnancy and breastfeeding
You must not use Fulvestrant Accord if you are pregnant. If you could become pregnant, you must use an effective contraceptive during treatment with Fulvestrant Accord.
You must not breastfeed during treatment with Fulvestrant Accord.
Driving and using machines
Fulvestrant Accord is not expected to affect your ability to drive or use machinery.
However, if you feel tired after treatment, do not drive or operate machinery.
Fulvestrant Accord contains 10% w/v ethanol (alcohol), up to 500 mg per dose,
equivalent to 10 ml of beer or 4 ml of wine per dose.
It is harmful for individuals suffering from alcoholism.
This should be taken into consideration in high-risk groups such as patients with liver disease or epilepsy.
Fulvestrant Accord contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and may cause side effects (such as metabolic acidosis).
Fulvestrant Accord contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.

3. How to use Fulvestrant Accord

Use this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
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 given 2 weeks after the initial dose.
Your doctor or nurse will administer Fulvestrant Accord by slow intramuscular injection, one injection into each of your buttocks.
If you have further questions about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediate medical attention may be required if any of the following side effects occur:

• 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 notice any of the following side effects:
Very common side effects (may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Musculoskeletal and joint pain
• Hot flushes
• Skin 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, diarrhoea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased levels of bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Reduced platelet levels (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in the leg, particularly 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)
• Anaphylactic reactions
• Bruising and bleeding at the injection site
• Increased gamma-GT, a liver enzyme seen in blood tests
• Inflammation of the liver (hepatitis)
• Liver failure
• Numbness, tingling, and pain * Includes adverse reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.

Reporting of side effects
If you experience any side effect, 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 national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Accord

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 label of the
syringe after Exp. The expiry date refers to the last day of that month.
Store and transport in a refrigerator (2 °C – 8 °C).
Temperature excursions outside the range of 2 °C – 8 °C should be limited. This includes avoiding
storage at temperatures above 30°C, and not exceeding a period of 28 days at an average storage
temperature below 25°C (but above 2 °C – 8 °C). After temperature excursions, the product must be
returned immediately to the recommended storage conditions (store and transport in a refrigerator at
2 °C – 8 °C). Temperature excursions have a cumulative effect on product quality, and the 28-day period
must not be exceeded cumulatively during the 2-year shelf life of Fulvestrant Accord. Exposure to
temperatures below 2 °C will not damage the product provided it is not stored at temperatures below
-20 °C.
Keep the pre-filled syringe in its original packaging to protect the medicine from light.
Healthcare personnel are responsible for the correct storage, use and disposal of Fulvestrant Accord.
This medicine may pose a risk to the environment. Do not dispose of any medicine via wastewater or
household waste. Ask your pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Package contents and other information

What Fulvestrant Accord contains

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
• The other components (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and refined castor oil.

Description of the appearance of Fulvestrant Accord and contents of the pack
Fulvestrant Accord is a clear, colourless to yellow viscous solution.
Fulvestrant Accord is contained in a pre-filled syringe with a transparent type I glass barrel, tamper-evident cap (luer tip & tip cap), closed with a plunger stopper and rod, containing 250 mg of fulvestrant in 5 ml of solution.
A safety needle (BD Safety Glide®) is provided for attachment to the syringe barrel.
Fulvestrant Accord is supplied in a pack containing two single-use pre-filled syringes.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House
319 Pinner Road,
Harrow, Middlesex
HA1 4HF
United Kingdom
Or
Accord Healthcare Polska Sp.z o.o.
ul. Lutomierska 50,
95-200 Pabianice
Poland

The following information is intended exclusively for healthcare professionals:

Fulvestrant Accord 500 mg (2x250 mg/5 ml solution for injection) must be administered
using two pre-filled syringes; see section 3.
Instructions for administration
Warnings – Do not autoclave the safety needle before use. Hands must
remain behind the needle at all times during use and disposal.
The syringes are supplied with a BD Safety Glide® safety needle.
For each of the two syringes:

• Carefully remove the glass syringe barrel from the tray and check that it is not damaged (see Figure 1).

• Rotate the plastic cap seal on the Luer-Lock syringe to remove the cap with the attached rubber stopper (see Figure 1).
• Open the outer packaging of the safety needle (BD SafetyGlide) (see Figure 2). Attach the safety needle to the Luer-Lok connector (see

Figure 2).

• Rotate to lock the needle securely onto the Luer connector. Rotate until firmly seated.
• Pull the needle out of its protective wrap to avoid damaging the needle tip.
• Carry the filled syringe to the administration site.
• Remove the needle shield.
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Expel excess air from the syringe.
• Administer slowly by intramuscular injection (1–2 minutes / injection) into the gluteal muscle. For user convenience, the blunt needle tip is aligned with the lever arm (see Figure 3).

• After injection, immediately activate the safety mechanism by pushing the Luer arm forward until the needle tip is completely covered (see Figure 4).

NOTE: Activate away from yourself and others. Listen for the
"click" and visually confirm that the needle tip is
completely covered.
Disposal
Pre-filled syringes are for single use only.
This medicine may pose a risk to the environment. Any unused product or waste material must be disposed of in accordance with local requirements.