FULVESTRANT DR. REDDYS 250 mg READY-TO-USE INJECTION SOLUTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Fulvestrant Dr. Reddys 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.

Contents of the pack

1. What is Fulvestrant Dr. Reddys and what is it 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. Storage of Fulvestrant Dr. Reddys
6. Contents of the pack and other information

1. What is Fulvestrant Dr. Reddys and what is it used for

Fulvestrant Dr. Reddys contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

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 (HER2)-negative breast cancer, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called luteinizing hormone-releasing hormone (LHRH) agonist.

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

2. What you need to know before you use Fulvestrant Dr. Reddys

Do not use Fulvestrant Dr. Reddys:

• 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 problems

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Fulvestrant Dr. Reddys if any of the following apply to you:

• kidney or liver problems
• low platelet count (which helps blood to clot) or bleeding disorders
• previous blood clots
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents

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

Using Fulvestrant Dr. Reddys with other medicines

Tell your doctor or pharmacist 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 and breastfeeding

You should not use fulvestrant if you are pregnant. If you can become pregnant, you should use an effective contraceptive method while being treated with fulvestrant and for 2 years after your last dose.

You should 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 use machines.

Ethanol

This medicine contains 500 mg of ethanol (alcohol) in 5 ml of solution. The amount in a dose (two 5 ml syringes) of this medicine is equivalent to less than 25 ml of beer or 10 ml of wine. It is unlikely that the amount of alcohol in this medicine will have an effect on adults and adolescents. The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are addicted to alcohol, talk to 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 (so-called "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. Reddys

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

The recommended dose is 500 mg of fulvestrant (two 250 mg injections) administered once a month with an additional dose of 500 mg administered 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 other questions about 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.

You may need urgent medical attention if you experience any of the following side 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)*
• Hepatitis (inflammation of the liver)
• Liver failure

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

Very common side effects(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*
• Joint and musculoskeletal pain
• Hot flushes
• 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 (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lumbar 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 side effects(may affect up to 1 in 100 people)

• Thick, white, vaginal discharge and candidiasis (infection)
• Hematoma and bleeding at the injection site
• Increased gamma-GT, a liver enzyme identified in a blood test
• Hepatitis (inflammation of the liver)

• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: http://www.notificaram.es. By reporting side 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 which is stated on the carton or on the label of the syringe after EXP.

The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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

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

This medicine may pose a risk to the aquatic environment. Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Fulvestrant Dr. Reddys

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

Appearance and pack contents

Fulvestrant Dr. Reddys is a viscous, clear, colorless to yellow solution in a pre-filled syringe equipped with a tamper-evident closure, which contains 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Fulvestrant Dr. Reddys is available in 4 formats: a pack containing 1 glass pre-filled syringe, a pack containing 2 glass pre-filled syringes, a pack containing 4 glass pre-filled syringes, or a pack containing 6 glass pre-filled syringes. Safety needles (Terumo SurGuard 3) for connection to the body and a handle on each syringe are also provided.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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: +004982174881-420

Phone: +004982174881-0

Or

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

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

sector 3, Bucharest,

030138, Romania

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

Date of last revision

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This information is intended only for healthcare professionals:

Fulvestrant Dr. Reddys 500 mg (2 injections of 250 mg) should be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning – Do not autoclave the safety needle (Terumo SurGuard 3) before use. Hands should remain behind the needle at all times during use and disposal.

For each of the two syringes:

Figure 1

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

Figure 2

• Open by removing the outer packaging of the safety needle. Connect the safety needle to the Luer-Lock (see Figure 2).
• Turn until it is firmly locked onto the connector.
• Take the loaded syringe to the administration point.

Figure 3

• Before removing the needle cap, remove the safety sleeve, towards the syringe cylinder at the angle shown.

• Before administration, parenteral solutions should be inspected visually for particulate matter and discoloration.
• Remove excess gas from the syringe.
• Administer slowly via intramuscular injection into the buttock (1-2 minutes/injection). For greater comfort, the position of the needle with the bevel upwards has the same orientation as the arm of the lever raised (see Figure 3).
• Use the handle if necessary

Figure 4

• After injection, to activate the safety mechanism, perform the technique with one hand using any of the three methods illustrated above (activation is verified by an audible or tactile "click" and can be visually confirmed) (see Figure 4).

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

Disposal

The pre-filled syringes are for singleuse only.

This medicine may pose a risk to the aquatic environment. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.