Fulvestrant Reddi

Package Leaflet: Information for the User

Fulvestrant Reddy, 250 mg, Solution for Injection in a Pre-filled Syringe

Fulvestrant

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

• Keep this package 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 effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

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

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

Fulvestrant Reddy contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes affect the growth of breast cancer. Fulvestrant is used:

• alone to treat postmenopausal women with a specific type of breast cancer called hormone 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 specific type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer that is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When fulvestrant is given in combination with palbociclib, it is also important to read the package leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. Important information before using Fulvestrant Reddy

When not to use Fulvestrant Reddy

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breast-feeding
• if you have severe liver problems

Warnings and precautions

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

• if you have ever had kidney or liver disease
• if you have ever had a low platelet count (which helps the blood to clot) or bleeding disorder
• if you have ever had a blood clotting disorder
• if you have ever had problems with bone mineral density (osteoporosis)
• alcohol dependence

Children and adolescents

Fulvestrant is not recommended for use in children and adolescents under 18 years.

Fulvestrant Reddy and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. In particular, tell your doctor if you are taking anticoagulant medicines (medicines that prevent blood clotting).

Pregnancy and breast-feeding

Fulvestrant must not be used during pregnancy. If you can become pregnant, you must use effective contraception during treatment with fulvestrant and for 2 years after the last dose. You must not breast-feed during treatment with fulvestrant.

Driving and using machines

Fulvestrant has not been shown to affect the ability to drive or use machines. However, if you feel tired after receiving this medicine, do not drive or use machines.

Fulvestrant Reddy contains ethanol, benzyl alcohol, and benzyl benzoate

Ethanol
This medicine contains 500 mg of ethanol (alcohol) in each pre-filled syringe. The amount in one dose (two pre-filled syringes) 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 in this medicine may affect the way other medicines work. If you are taking other medicines, ask your doctor or pharmacist. If you are addicted to alcohol, ask your doctor or pharmacist before using this medicine.
Benzyl alcohol
This medicine contains 500 mg of benzyl alcohol in each pre-filled syringe. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should contact their doctor before using this medicine, as large amounts of benzyl alcohol may build up in their body and cause side effects (such as metabolic acidosis).
Benzyl benzoate
This medicine contains 750 mg of benzyl benzoate in each pre-filled syringe.

3. How to use Fulvestrant Reddy

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), given once a month, and an additional dose of 500 mg given 2 weeks after the first dose.
Fulvestrant is given by a doctor or nurse. The medicine will be slowly injected into a muscle in two consecutive injections of 5 ml each, one in each buttock.
If you have any further 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.

If you experience any of the following side effects, contact your doctor immediately:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be signs of anaphylactic reactions
• blood clotting disorders (increased risk of venous thromboembolism)*
• hepatitis
• liver failure

If you experience any of the following side effects, tell your doctor, pharmacist, or nurse:

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

• injection site reactions, such as pain and/or inflammation
• changes in liver enzyme activity (in blood tests)*
• nausea
• feeling weak, tired*
• 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 (a pigment produced by the liver)
• blood clotting disorders (increased risk of venous thromboembolism)*
• low platelet count (thrombocytopenia)
• vaginal bleeding
• lower back pain radiating to one leg (sciatica)
• sudden weakness, numbness, tingling, or loss of movement in one 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)
• bruising and bleeding at the injection site
• increased gamma-glutamyltransferase activity, a liver enzyme measured in blood tests
• hepatitis
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions * Includes side effects for which the contribution of fulvestrant cannot be assessed due to the underlying disease.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Reddy

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 and on the label of the pre-filled syringe after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Store the pre-filled syringe in the original package to protect from light.
Medical personnel are responsible for the proper storage, use, and disposal of the packaging after the used fulvestrant.
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 pack and other information

What Fulvestrant Reddy contains

• 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 are ethanol (96%), benzyl alcohol, benzyl benzoate, and purified castor oil.

What Fulvestrant Reddy looks like and contents of the pack

Fulvestrant Reddy is a clear, colorless to yellow, viscous solution in a pre-filled syringe with a protective cap, containing 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, two pre-filled syringes should be injected.
Fulvestrant Reddy is available in 2 pack sizes: a pack containing 1 glass pre-filled syringe + 1 needle with a safety system for attachment to the syringe and a finger grip or a pack containing 2 glass pre-filled syringes + 2 needles with safety systems for attachment to each syringe and finger grips.
Not all pack sizes may be marketed.

Marketing authorization holder

Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany

Manufacturer

betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

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

Austria:
Fulvestrant Reddy 250 mg Injektionslösung in einer Fertigspritze
Belgium:
Fulvestrant Reddy 250 mg oplossing voor injectie in een voorgevulde spuit
Denmark:
Fulvestrant Reddy
Finland:
Fulvestrant Reddy 250 mg injektioneste, liuos, esitäytetty ruisku
Netherlands:
Fulvestrant Reddy 250 mg oplossing voor injectie in een voorgevulde spuit
Ireland:
Fulvestrant 250 mg solution for injection in pre-filled syringe
Germany:
Fulvestrant beta 250 mg Injektionslösung in einer Fertigspritze
Norway:
Fulvestrant Reddy
Poland:
Fulvestrant Reddy
Portugal:
Fulvestrante Reddy 250 mg solução injetável em seringa pré-cheia
Czech Republic:
Fulvestrant Reddy
Slovakia:
Fulvestrant Reddy 250 mg injekčný roztok v naplnenej injekčnej striekačke
Sweden:
Fulvestrant Reddy 250 mg injektionsvätska, lösning i förfylld spruta
Hungary:
Fulvestrant Reddy 250 mg oldatos injekció előretöltött fecskendőben

Date of last revision of the package leaflet: 12/2023

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Information intended for healthcare professionals only:

Fulvestrant Reddy 500 mg (2 x 250 mg injections) should be administered using two pre-filled syringes (see section 3).
Administration instructions
Caution – do not autoclave the needle with the safety system before use. When handling the medicine and disposing of waste, avoid hand contact with the needle. Applies to both syringes:

• Remove the glass syringe from the container and check for damage.
• Open the outer packaging of the needle with the safety system.
• Before administering parenteral solutions, visually inspect for particulate matter and discoloration.
• Holding the syringe vertically, break the seal of the white plastic cap on the Luer-Lock connector of the syringe to remove the cap with the attached rubber tip (see Figure 1).
• Remove the tip in an upright position. To maintain sterility, do not touch the syringe tip. Figure 1

• Attach the needle with the safety system to the Luer-Lock connector and twist until it is securely locked (see Figure 2).
• Check that the needle is locked in the Luer-Lock connector before changing from the upright position. Figure 2

• Slide the needle shield back towards the syringe barrel at the angle shown in Figure 3.
• Slide the needle shield straight back to avoid damaging the needle point.
• Hold the filled syringe near the injection site.
• Remove the needle shield. Remove any air from the syringe. Figure 3

• Administer slowly (1-2 minutes/injection) into the buttock. For the convenience of the administrator, the needle bevel is on the same surface as the safety mechanism (see Figure 3).
• If necessary, use the finger grip.
• After injection, use one hand to activate the safety mechanism using one of the three methods shown here (activation is confirmed by an audible and/or palpable "click" and can be visually confirmed). (see Figure 4). CAUTION: Proceed to ensure your safety and the safety of others. Listen for the click and visually confirm that the needle tip is fully covered. Disposal of waste The pre-filled syringes are 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.