Fulvestrant Accord

Leaflet attached to the packaging: Patient Information

Fulvestrant Accord, 250 mg/ 5 ml, solution for injection in a pre-filled syringe

Fulvestrant

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fulvestrant Accord and what is it used for
• 2. Important information before using Fulvestrant Accord
• 3. How to use Fulvestrant Accord
• 4. Possible side effects
• 5. How to store Fulvestrant Accord
• 6. Contents of the packaging and other information

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

Fulvestrant Accord contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes influence the development of breast cancer.

Fulvestrant Accord is used:

• as a single medicine, in the treatment of postmenopausal women with a certain type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastases) or
• in combination with palbociclib in the treatment of women with a certain type of breast cancer called hormone receptor-positive breast cancer, without excessive expression of human epidermal growth factor receptor 2, which is locally advanced or has spread to other parts of the body (metastases). Women who have not yet reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Accord is given in combination with palbociclib, it is also important to read the leaflet attached to the packaging of palbociclib. If you have any questions about palbociclib, ask your doctor.

2. Important information before using Fulvestrant Accord

When not to use Fulvestrant Accord:

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding
• if you have severe liver function disorders

Warnings and precautions

Tell your doctor or pharmacist or nurse before using Fulvestrant Accord if you have ever had any of the following health problems:

• kidney or liver function disorders;
• low platelet count (involved in the blood clotting process) or bleeding disorders;
• a history of thromboembolic disease;
• osteoporosis (decreased bone density);
• alcoholic disease.

Children and adolescents

Fulvestrant Accord is not intended for use in children and adolescents under 18 years of age.

Fulvestrant Accord and other medicines:

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Fulvestrant Accord should not be used during pregnancy. If you may become pregnant, you should use effective contraception during treatment with Fulvestrant Accord and for 2 years after the last dose.

Driving and using machines

The effect of Fulvestrant Accord on the ability to drive and use machines is not expected. However, if treatment causes fatigue, you should not perform these activities.

Fulvestrant Accord contains 10% v/v ethanol (alcohol),i.e. up to 500 mg per dose, which is equivalent to 10 ml of beer or 4 ml of wine per dose. This is harmful to patients with alcoholic disease.

Fulvestrant Accord contains 500 mg of benzyl alcoholper injection, which is equivalent to 100 mg/ml.

Benzyl alcohol may cause allergic reactions. If you have liver or kidney function disorders, consult your doctor, as large amounts of benzyl alcohol may accumulate in the body and cause side effects (called metabolic acidosis).

Fulvestrant Accord contains 750 mg of benzyl benzoateper injection, which is equivalent to 150 mg/ml.

3. How to use Fulvestrant Accord

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of fulvestrant is 500 mg (two injections of 250 mg), given once a month, and an additional dose of 500 mg given 2 weeks after the first dose.

Fulvestrant Accord is given by a doctor or nurse as a slow intramuscular injection, one injection into each buttock.

4. Possible side effects

Like all medicines, Fulvestrant Accord can cause side effects, although not everybody gets them.

If you experience any of the following side effects, immediate medical attention may be required:

• 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
• liver failure

Tell your doctor, pharmacist, or nurse if you experience any of the following side effects:

Very common side effects(may affect more than 1 in 10 people)

• injection site reaction, e.g. pain and/or inflammation;
• abnormal liver enzyme activity (detected in blood tests)*
• nausea
• weakness, fatigue*
• joint and muscle pain
• hot flashes
• 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, diarrhea, or loss of appetite*
• urinary tract infections
• back pain*
• increased bilirubin levels (bile pigment produced in the liver)
• thromboembolism (increased risk of blood clots)*
• decreased platelet count (thrombocytopenia)
• vaginal bleeding
• lower back pain radiating to the leg on one side of the body (sciatica)
• sudden weakness, numbness, tingling, or loss of mobility in the leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy)

Uncommon side effects(may affect up to 1 in 100 people):

• thick, white vaginal discharge and vaginal candidiasis (infection)
• anaphylactic reactions
• bruising and bleeding at the injection site
• increased gamma-GT enzyme activity (detected in blood tests)
• hepatitis
• liver failure
• numbness, tingling, and pain

* side effects whose exact role of fulvestrant is not established due to the underlying disease

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

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 pre-filled syringe after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2°C - 8°C).

Limit storage of the medicine at a temperature other than 2°C - 8°C. Avoid storage at temperatures above 30°C and do not exceed 28 days with an average storage temperature below 25°C (but above the range 2°C - 8°C). If the temperature range is exceeded, apply the recommended storage conditions immediately [store and transport refrigerated (2°C - 8°C)]. Exceeding the recommended storage temperature may have a cumulative effect on the quality of the medicine, and the 28-day period must not be exceeded within the 2-year shelf life of Fulvestrant Accord (see section 6.3).

Exposure to temperatures below 2°C does not damage the medicine if it is not stored at temperatures below -20°C.

Store the pre-filled syringes in the original packaging to protect from light.

Medical personnel are responsible for the proper storage, use, and disposal of the packaging after the medicine Fulvestrant Accord has been used.

This medicine may pose a risk to aquatic environments. 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 packaging and other information

What Fulvestrant Accord contains

The active substance is fulvestrant.

One pre-filled syringe contains 250 mg of fulvestrant in 5 ml of solution (50 mg/ml).

The other ingredients are: ethanol 96%, benzyl alcohol, benzyl benzoate, and purified castor oil.

What Fulvestrant Accord looks like and contents of the pack

Fulvestrant Accord is a clear, colorless to yellow, viscous solution.

The pre-filled syringe is made of colorless glass type I, closed with a stopper and a stopper cap, with a safety device to prevent tampering, containing 250 mg of fulvestrant in 5 ml of solution.

The packaging also includes a needle with a safety system (BD SafetyGlide), intended for attachment to the syringe cylinder.

The packaging of Fulvestrant Accord contains two pre-filled syringes, for single use.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.

Manufacturer/Importer

Accord Healthcare Polska Sp.z o.o.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: March 2024

Information intended for healthcare professionals only:

Fulvestrant Accord 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes (see section 3).

Administration instructions

Warning – do not put the needle with the safety system in an autoclave before use.

Avoid hand contact with the needle during use and disposal.

The syringes are provided with a needle with a safety system BD SafetyGlide.

For both syringes:

Remove the glass syringe from the container and check if it is not damaged.

Twist the plastic safety device of the Luer syringe until it comes off and can be removed (see Figure 1)

Open the packaging of the needle (BD Safety Glide) with the safety system.

Attach the needle with the safety system to the Luer end (see Figure 2)

Tighten the needle to the Luer end to secure it.

Remove the needle sheath without damaging its sharp end.

Bring the filled needle close to the injection site.

Before administering parenteral solutions, visually inspect them for particulate matter and color changes.

Remove any excess air from the syringe.

Administer the medicine intramuscularly, slowly (1-2 minutes/injection), into the buttock muscle (on the buttock). For the convenience of the person administering, the needle cut is on the same surface of the needle as the safety system lever (see Figure 3)

Immediately after administering the medicine, activate the needle safety system by pushing its lever forward (see Figure 4)

Caution: Proceed in such a way as to ensure your safety and that of others. Listen for the click and visually confirm that the needle tip is completely hidden.

Disposal

The pre-filled syringe is for single use only.

This medicine may pose a risk to aquatic environments. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.