Fulvestrant Stada 250 mg solution for injection in pre-filled syringe EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fulvestrant Stada 250 mg solution for injection in pre-filled syringe EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Fulvestrant Stada 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 development of breast cancer.

Fulvestrant is used:

• 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 yet reached menopause will also be treated with a medicine called a luteinizing hormone-releasing hormone agonist (LHRH agonist).

Fulvestrant may be given in combination with palbociclib. It is important that you also read the palbociclib package leaflet. If you have any questions about palbociclib, please consult your doctor.

2. What you need to know before using Fulvestrant Stada

Do not use Fulvestrant Stada

• 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 problems.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using fulvestrant if any of the following apply to you:

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

Children and adolescents

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

Using Fulvestrant Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, you must tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breastfeeding

Pregnancy

You must not use fulvestrant if you are pregnant. If you could become pregnant, you must use an effective method of contraception during treatment with fulvestrant and for two years after your last dose.

Breastfeeding

You must not breastfeed while being treated with fulvestrant.

Driving and using machines

Fulvestrant Stada 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.

Use in athletes

Patients should be advised that this medicine contains fulvestrant, which may result in a positive doping test.

Fulvestrant Stada contains ethanol

This medicine contains 1,000 mg of alcohol (ethanol) in each 500 mg dose of fulvestrant. The amount of alcohol in each 500 mg dose of this medicine is equivalent to 25 ml of beer or 10 ml of wine.

The amount of alcohol in this medicine is unlikely to have an effect in adults.

The alcohol present in this medicine may alter the effects of other medicines. Speak with your doctor or pharmacist if you are taking other medicines.

If you are alcohol-dependent, consult your doctor or pharmacist before taking this medicine.

Fulvestrant Stada contains benzyl alcohol

This medicine contains 1,000 mg of benzyl alcohol in each 500 mg dose of fulvestrant. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Fulvestrant Stada contains benzyl benzoate

This medicine contains 1,500 mg of benzyl benzoate in each 500 mg dose of fulvestrant.

3. How to use Fulvestrant Stada

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once a month, with an additional 500 mg dose given 2 weeks after the initial dose.

Your doctor or nurse will administer fulvestrant to you as a slow intramuscular injection into each of your buttocks.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, fulvestrant may cause adverse effects, although not everyone experiences them.

You may need urgent medical treatment if you experience any of the following adverse effects:

? 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)*

? Inflammation of the liver (hepatitis)

? Liver failure

Immediately inform your doctor, pharmacist or nurse if you notice any of the following adverse effects:

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

• reactions at the injection site, such as pain and/or swelling

• abnormal liver enzyme levels (in blood tests)*

• nausea (feeling unwell)

• weakness, fatigue*

• joint and musculoskeletal pain

• hot flushes

• skin rash

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat

All remaining adverse effects:

Common adverse effects (may affect up to 1 in 10 people)

• headache
• vomiting, diarrhoea or loss of appetite*
• urinary tract infections
• back pain*
• increased bilirubin (a bile pigment produced by the liver)
• thromboembolism (increased risk of blood clots)*
• decreased platelet levels (thrombocytopenia)
• vaginal bleeding
• lower back pain radiating to one leg (sciatica)
• sudden weakness, numbness, tingling or loss of movement in your leg, especially on one side of the body, sudden difficulty walking or with balance (peripheral neuropathy)

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

• thick, whitish vaginal discharge and candidiasis (infection)

• bruising and bleeding at the injection site

• increased gamma-GT, a liver enzyme detected in blood tests

• inflammation of the liver (hepatitis)

• liver failure

• numbness, tingling and pain

• anaphylactic reactions

• Includes adverse effects for which the exact role of fulvestrant cannot be assessed due to the underlying disease.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fulvestrant Stada

Keep this medicine out of the sight and reach of children.

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

Keep the pre-filled syringe in the original packaging to protect it from light.

Temperature excursions outside the range of 2°C to 8°C must be controlled. This includes avoiding storage at temperatures above 30°C for more than a total of 28 days, during which the average storage temperature of the medicine must be below 25°C (but above the 2°C to 8°C range). After temperature excursions, the medicine must be returned immediately to the recommended storage conditions (store and transport refrigerated between 2°C and 8°C). Temperature excursions have an accumulative effect on the quality of the medicine, and the 28-day period must not extend beyond the expiry date of fulvestrant. Exposure to temperatures below 2°C will not damage the medicine, provided it is not stored below -20°C.

Do not use this medicine after the expiry date stated on the packaging or on the labels of the syringes after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Your healthcare professional is responsible for the proper storage, use, and disposal of Fulvestrant Stada.

This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Stada

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant. Each ml of solution contains 50 mg of fulvestrant.
• The other components (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate and refined castor oil.

Appearance of the product and contents of the pack

Fulvestrant Stada is a clear, colourless to yellow solution, practically free from visible particles, oily and viscous, contained in a glass pre-filled syringe. Each syringe contains 5 ml of injectable solution.

Fulvestrant Stada is available in three pack sizes:

• Carton box containing one blister with one pre-filled syringe, one sterile hypodermic needle (BD SafetyGlide) and a package leaflet.

or

• Carton box containing two blisters, each containing one pre-filled syringe, two sterile hypodermic needles (BD SafetyGlide) and a package leaflet.

or

• Carton box containing six blisters, each containing one pre-filled syringe, six sterile hypodermic needles (BD SafetyGlide) and a package leaflet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

S.C. Rompharm Company S.R.L.

Strada Eroilor nr. 1A,

Otopeni 075100

Romania

or

STADA Arzneimittel AG

Stadastr. 2-18, Dortelweil

D-61118 Bad Vilbel

Hessen

Germany

or

STADApharm GmbH

Feodor-Lynen-Str. 35

D-30625 Hannover

Germany

or

STADA Arzneimittel GmbH

Registered office -

Muthgasse 36/2 Doebling

A-1190 Vienna

Austria

Date of the most recent revision of this leaflet: December 2020

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Fulvestrant Stada should be administered using two pre-filled syringes, see section 3.

Administration instructions

Administer the injection according to local guidelines for intramuscular injection of large volumes.

NOTE: Due to the proximity of the sciatic nerve, caution should be exercised when injecting fulvestrant into the dorsogluteal area (see section 4.4).

Warnings: Do not autoclave the safety needle (Protected Hypodermic Needle “BD SafetyGlide”) before use.

Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Remove the glass syringe body from the tray (blister) and check that it is not damaged.
• Open the outer packaging of the safety needle (“SafetyGlide”).
• Prior to administration, parenteral solutions should be visually inspected for particulate matter and discoloration.
• Hold the syringe in an upright position.
• With the other hand, grasp the cap and carefully twist and remove it. To maintain sterility, do not touch the tip of the syringe (see Figure 1).

Figure 1

?? Attach the safety needle to the “Luer-Lok” connector and screw it on until firmly secured (see Figure 2).

Figure 2

• Check that the needle is securely attached to the Luer-Lock connector before ceasing to hold it upright.
• Pull the protective needle cap straight off to avoid damaging the needle tip.
• Carry the loaded syringe to the administration site.
• Remove the protective needle cap.
• Expel excess air from the syringe.
• Administer slowly by intramuscular injection into the gluteal region (gluteal area) (1-2 minutes/injection). For greater comfort, positioning the needle with the bevel facing upward aligns with the raised lever arm (see Figure 3).

Figure 3

?? Immediately after injection, press the lever arm once with your finger to activate the safety mechanism (see Figure 4).

NOTE: Activate away from your body and others. Listen for the click and visually confirm that the needle tip is fully covered.

Figure 4

Disposal

Pre-filled syringes are for single use only.

This medicinal product may pose a risk to the aquatic environment. Disposal of unused medicine and all materials that have been in contact with it must be carried out in accordance with local regulations.