Fulvestrant Dr. Reddy's 250 mg solution for injection in pre-filled syringe EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fulvestrant Dr. Reddys 250 mg solution for injection in pre-filled syringe EFG

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 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.

Contents of this leaflet

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

1. What Fulvestrant Dr. Reddy's is and what it is used for

Fulvestrant Dr. Reddy's 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:

• As monotherapy, to treat postmenopausal women with a type of breast cancer called estrogen receptor-positive breast cancer, which 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 (HER2-negative) breast cancer, which 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 (LHRH) agonist.

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

2. What you need to know before using Fulvestrant Dr. Reddy's

Do not use Fulvestrant Dr. Reddy's:

• 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

Consult your doctor, pharmacist, or nurse before starting treatment with Fulvestrant Dr. Reddy's 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.

Use of Fulvestrant Dr. Reddy's with other medicines

Inform 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

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 2 years after your last dose.

You must not breastfeed while being treated 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 operate machinery.

Ethanol

This medicine contains 500 of alcohol (ethanol) in 5 ml of solution. The amount in one dose (two 5 ml syringes) of this medicine is equivalent to less than 25 ml of beer or 10 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents. However, the alcohol 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.

Benzyl alcohol

This medicine contains 500 mg of benzyl alcohol in each 5 ml vial. 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 your body and cause side effects (known as "metabolic acidosis").

Benzyl benzoate

This medicine contains 750 mg of benzyl benzoate in each 5 ml vial.

Castor oil

May cause severe allergic reactions.

3. How to use Fulvestrant Dr. Reddy's

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

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

Your doctor or nurse will administer fulvestrant by 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, this medicine can cause adverse effects, although not everyone will experience 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 signs of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Inflammation of the liver (hepatitis)
• Liver failure

Contact your doctor, pharmacist, or nurse immediately 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, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Low 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 problems with walking or 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fulvestrant Dr. Reddys

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

Do not use this medicine after the expiry date stated on the packaging or on the label of the pre-filled syringe after EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require special storage temperature conditions.

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

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

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 containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Fulvestrant Dr. Reddy's

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.

Each ml contains 50 mg of fulvestrant.

• The other components (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and refined castor oil.

Appearance of the product and contents of the container

Fulvestrant Dr. Reddy's is a viscous, clear, colourless to yellow solution in a pre-filled syringe equipped with a tamper-proof seal, containing 5 ml of injectable solution. Two syringes must be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Dr. Reddy's is available in 4 pack sizes: either a pack containing 1 pre-filled glass syringe, or a pack containing 2 pre-filled glass syringes, or a pack containing 4 pre-filled glass syringes, or a pack containing 6 pre-filled glass syringes. Safety-engineered needles (Terumo® SurGuard® 3) for attachment to the syringe body and a syringe holder are also provided with each syringe.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Reddy Pharma Iberia, S.A.U.

Avenida Josep Tarradellas, nº 38

08029 Barcelona (Spain)

Tel: +34 93 355 49 16

Fax: +34 93 355 49 61

Manufacturer:

Betapharm Arzneimittel GmbH

Kobelweg 95-Augsburg

86156

Germany

Fax No.: +004982174881-420

Tel No: +004982174881-0

O

S.C. Rual Laboratories S.R.L.,

313, Splaiul Unirii, Building H, 1st floor,

sector 3, Bucharest,

030138, Romania

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

Date of the most recent review of this leaflet: August 2023

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This information is intended for healthcare professionals only:

Fulvestrant Dr. Reddy's 500 mg (2 injections of 250 mg) must be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning – Do not autoclave the safety needle system (Terumo® SurGuard® 3) prior to use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

Figure 1

• Remove the glass syringe body from the tray and check that it is not damaged.
• Break the seal of the transparent plastic protector on the Luer-Lock connector of the syringe to remove this protector together with the rubber cap from the tip (see Figure 1).

Figure 2

• Open and remove the outer packaging of the safety needle system. Attach the safety needle system to the Luer-Lock connector (see Figure 2).
• Rotate until it securely locks into place on the Luer connector.
• Carry the loaded syringe to the administration site.

Figure 3

• Before removing the needle cap, remove the safety sheath by pulling it toward the syringe barrel at the angle shown.

• Prior to administration, parenteral solutions should be visually inspected for particulate matter and discoloration.

• Remove excess air from the syringe.

• Administer slowly via intramuscular injection into the gluteal region (1–2 minutes per injection). For greater comfort, positioning the needle with the bevel facing upward corresponds to the same orientation as the raised lever arm (see Figure 3).

• Use the grip if necessary.

Figure 4

• After injection, to activate the safety mechanism, perform the single-handed technique using any of the three methods illustrated above (activation is confirmed by an audible or tactile "click" and can be visually verified) (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.

Disposal

The 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 come into contact with it must be carried out in accordance with local regulations.