Fulvestrant reddy

Patient Information Leaflet

Fulvestrant Reddy, 250 mg, solution for injection in pre-filled syringe
Fulvestrantum
Please read all of this leaflet carefully before 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, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Fulvestrant Reddy is and what it is used for
2. What you need to know 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 Fulvestrant Reddy is and what it is used for

Fulvestrant Reddy contains the active substance fulvestrant, which belongs to a group of medicines called oestrogen receptor antagonists. Oestrogens are female sex hormones that can sometimes influence the growth of breast cancer.
Fulvestrant is used:

• as a single agent, for the treatment of postmenopausal women with a certain type of breast cancer called oestrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
• in combination with palbociclib, for the treatment of women with a certain 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 yet reached menopause will also receive a medicine called a gonadotropin-releasing hormone (GnRH) agonist.

When fulvestrant is given in combination with palbociclib, it is important to also read the patient information leaflet included with the palbociclib medicine. If you have any questions about palbociclib, please consult your doctor.

2. Important information before using Fulvestrant Reddy

When not to use Fulvestrant Reddy

• if the patient is allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if the patient is pregnant or breastfeeding
• if the patient has severe impairment of liver function

Warnings and precautions
Please inform your doctor, pharmacist, or nurse before using Fulvestrant Reddy if any of the following health problems have ever occurred:

• if the patient has ever had kidney or liver disease
• if the patient has had low platelet count (which enables blood clotting) or a bleeding disorder
• if the patient has ever had a blood clotting disorder
• if the patient has ever had problems with reduced bone mineralization (osteoporosis)
• alcohol dependence.

Children and adolescents
Fulvestrant is not recommended for use in children and adolescents under 18 years of age.
Fulvestrant Reddy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform your doctor if the patient is taking anticoagulant medicines (medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant must not be used during pregnancy. If the patient could become pregnant, she should use effective contraception during treatment with fulvestrant and for 2 years after receiving the last dose.
Breastfeeding is not allowed during treatment with fulvestrant.
Driving and operating machinery
It has not been established that fulvestrant affects the ability to drive or operate machinery. However, if fatigue occurs after taking this medicine, the patient must not drive or operate machinery.
Fulvestrant Reddy contains ethanol, benzyl alcohol, and benzyl benzoate.
Ethanol
This medicine contains 500 mg of alcohol (ethanol) in each pre-filled syringe. The amount in one dose (two pre-filled syringes) corresponds to 25 ml of beer or 10 ml of wine. The amount of alcohol in this medicine is unlikely to affect adults. However, alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, they should consult their doctor or pharmacist. If the patient is alcohol-dependent, they should consult their 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 consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called 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 a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), administered once a month,
and an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant is administered by a doctor or nurse. The medicine will be slowly injected
intramuscularly in two separate 5 ml injections, each into a different buttock.
If you have any further questions about the use of this medicine,
consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, it is essential to contact your doctor immediately and without delay:

• Hypersensitivity reactions, including swelling of the face, lips, tongue and (or) throat, which may be symptoms of anaphylactic reactions
• Thromboembolic disease (increased risk of venous thrombosis)*
• Hepatitis
• Liver failure

If any of the following adverse reactions occur, inform your doctor, pharmacist or nurse:
Very common adverse reactions (may occur in more than 1 in 10 people)

• Injection site reactions, i.e. pain and (or) inflammation
• Changes in liver enzyme activity (in blood tests)*
• Nausea
• Feeling of weakness, fatigue*
• Joint pain and musculoskeletal pain
• Hot flushes
• Skin rash
• Hypersensitivity reactions, including swelling of the face, lips, tongue and (or) throat

All other adverse reactions:
Common adverse reactions (may occur in up to 1 in 10 people)

• Headache
• Vomiting, diarrhoea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin levels (a pigment produced by the liver)
• Thromboembolic disease (increased risk of venous thrombosis)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (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 adverse reactions (may occur in up to 1 in 100 people)

• Thick, white vaginal discharge and vaginal candidiasis (infection)
• Bruising and bleeding at the injection site
• Increased gamma-glutamyl transferase (GGT) activity, a liver enzyme measured in blood tests
• Hepatitis
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions * Includes adverse reactions for which the influence of fulvestrant cannot be assessed due to the presence of underlying disease.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Fulvestrant Reddy

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label on the syringe following "EXP": Expiry date (EXP) / EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of this medicine.
Store the pre-filled syringe in its original packaging to protect it from light.
Medical personnel are responsible for the proper storage, handling, and disposal of used fulvestrant packaging.
This medicine may pose a risk to the aquatic environment. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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, colourless to yellow, viscous solution in a pre-filled syringe with a tamper-proof closure, containing 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, the contents of 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 connecting the cylinder and a finger grip, or a pack containing 2 glass pre-filled syringes + 2 needles with safety systems for connecting to each cylinder and finger grips.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany

Manufacturer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany

This medicinal product is authorised in the European Economic Area countries 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

Information intended exclusively for healthcare professionals:

Fulvestrant Reddy 500 mg (2 x 250 mg injections) should be administered using two
vial-syringes (see section 3).
Administration instructions
Warning – do not autoclave the needle with the safety system in place. Avoid hand contact with the needle during administration and disposal of waste.
Applies to both syringes:

• Remove the glass vial from the container and Figure 1

check whether it is damaged.

• Open the outer packaging of the safety needle.
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Holding the syringe vertically, tear off the seal of the white plastic cover at the Luer-Lock connection to remove the cover with the attached rubber cap (see Figure 1).
• Remove the cap in an upright position. To maintain sterility, do not touch the syringe tip.

Figure 2

• Attach the safety needle to the Luer-Lock connector and twist until firmly seated (see Figure 2).
• Check that the needle is securely locked into the Luer connector before changing from the upright position.
• Slide the needle safety shield away from the Figure 3

syringe barrel in the direction and at the angle shown in Figure 3.

• Slide the needle shield straight off to avoid damaging the needle tip.
• Bring the filled syringe close to the administration site.
• Remove the needle cap. Expel any excess air from the syringe.
• Administer slowly intramuscularly (1–2 minutes/injection) into the gluteal muscle. For the convenience of the administrator, the needle bevel is located on the same surface of the needle as the shield activation lever (see Figure 3).
• If necessary, use the finger grip.
• After injection, use one hand to activate the Figure 4

safety mechanism using one of the three methods illustrated here (activation is confirmed by an audible and/or tactile "click" and can be visually verified) (see Figure 4).
WARNING: Act to ensure safety for yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.
Disposal of waste
Vial-syringes are intended exclusively for single use.
This medicinal product may pose a risk to the aquatic environment. Any unused product or waste material should be disposed of in accordance with local regulations.