Package leaflet: Information for the patient

Fulvestrant Sandoz, 250 mg/5 ml, solution for injection in prefilled syringe
Fulvestrantum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Fulvestrant Sandoz is and what it is used for
Important information before using Fulvestrant Sandoz
How to use Fulvestrant Sandoz
Possible side effects
How to store Fulvestrant Sandoz
Contents of the pack and other information

1. What Fulvestrant Sandoz is and what it is used for
Fulvestrant Sandoz contains the active substance fulvestrant, which belongs to a group of medicines known as oestrogen receptor blockers.
Oestrogens, female sex hormones, may in some cases contribute to the development of breast cancer.
Fulvestrant Sandoz is used:

as monotherapy in the treatment of postmenopausal women with a certain type of breast cancer, so-called oestrogen receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastatic),
in combination with palbociclib in the treatment of women with a certain type of breast cancer, so-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). Premenopausal women will also receive a medicine called a gonadotropin-releasing hormone (GnRH) agonist.

When Fulvestrant Sandoz is used together with palbociclib, it is important to also read the leaflet included in the palbociclib medicine pack. If you have any questions about palbociclib, please consult your doctor.

2. Important information before using Fulvestrant Sandoz

When not to use Fulvestrant Sandoz
Do not use this medicine 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 impairment of liver function.

Warnings and precautions
Before using Fulvestrant Sandoz, discuss with your doctor, pharmacist, or nurse if any of the following health conditions apply to you:
kidney or liver function disorders;
low platelet count (involved in blood clotting) or bleeding disorders;
history of thromboembolic disease;
osteoporosis (reduced bone density);
alcohol-related liver disease.

Children and adolescents
Fulvestrant Sandoz is not intended for use in children and adolescents under 18 years of age.

Fulvestrant Sandoz and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Fulvestrant Sandoz must not be used during pregnancy. Women of childbearing potential should use effective contraception during treatment and for 2 years after the last dose.
Breastfeeding must not be undertaken while receiving Fulvestrant Sandoz.

Driving and operating machinery
The effect of Fulvestrant Sandoz on the ability to drive or operate machinery is not expected. However, if treatment causes fatigue, you should avoid such activities.

Fulvestrant Sandoz contains ethanol, benzyl alcohol, and benzyl benzoate
This medicine contains 1000 mg of alcohol (96% ethanol) per dose, equivalent to 100 mg/ml (10% w/v). The amount of alcohol in a dose of this medicine is equivalent to less than 24 ml of beer or 10 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
This medicine contains 1000 mg of benzyl alcohol per dose, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to neonates and small children is associated with a risk of serious adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Do not administer to neonates (up to 4 weeks of age) without medical advice.
Do not administer to small children (under 3 years of age) for longer than one week without medical advice or consultation with a pharmacist.
Patients with liver or kidney disease should consult their doctor before using this medicine, as high amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
This medicine contains 1500 mg of benzyl benzoate per dose, equivalent to 150 mg/ml.
Benzyl benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in neonates (up to 4 weeks of age).

3. How to use Fulvestrant Sandoz

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose of fulvestrant is 500 mg (two injections of 250 mg each), administered once a
month, and an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant Sandoz is administered by a doctor or nurse as a slow intramuscular injection, one into each buttock.
If you have any further questions regarding the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediate medical attention may be required if any of the following adverse reactions occur:
hypersensitivity reactions, including swelling of the face, lips, tongue and (or) throat, which may
be symptoms of anaphylactic reactions
thromboembolism (increased risk of blood clots)*
hepatitis
liver failure
Inform your doctor, pharmacist or nurse if you experience any of the following adverse reactions:
Very common adverse reactions (may affect more than 1 in 10 people)
injection site reactions, e.g. pain and (or) inflammation;
abnormal liver enzyme activity (detected in blood tests)*
nausea
weakness, fatigue*
joint pain and bone or musculoskeletal pain
hot flushes
skin rash
allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and (or) throat
All other adverse reactions
Common adverse reactions (may affect less than 1 in 10 people)
headache
vomiting, diarrhoea or loss of appetite*
urinary tract infections
back pain*
increased bilirubin levels (a bile pigment produced in the liver)
thromboembolism (increased risk of blood clots)*
decreased platelet count (thrombocytopenia)
vaginal bleeding
lower back pain radiating to one leg (sciatica)
sudden weakness, numbness, tingling or loss of movement in the leg (especially on one side
of the body), sudden difficulty walking or maintaining balance (peripheral neuropathy)
Uncommon adverse reactions (may affect less than 1 in 100 people):
thick, whitish vaginal discharge and candidiasis (infection)
bruising and bleeding at the injection site
increased activity of the liver enzyme gamma-GT (detected in blood tests)
hepatitis
liver failure
numbness, tingling and pain
anaphylactic reactions
* adverse reactions in which the exact role of Fulvestrant Sandoz is not established due to the
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 181 C, 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 provide more information on the safety of the medicine.

5. How to store Fulvestrant Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton or on the pre-filled syringe label after: EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Healthcare professionals are responsible for the proper storage, handling, and disposal of the packaging of used Fulvestrant Sandoz medicine.
Do not use the medicine if you notice any signs of damage to the pre-filled syringe or deterioration of its contents, such as cloudiness of the solution, floating particles, or change in colour.
Medicines must not be disposed of via the sewage system 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 Sandoz contains
The active substance is fulvestrant.
One pre-filled syringe contains 250 mg of fulvestrant in 5 ml of solution (50 mg/ml).
The other ingredients are: ethanol (96%), benzyl alcohol, benzyl benzoate and castor oil.

What Fulvestrant Sandoz looks like and contents of the pack
Fulvestrant Sandoz is a clear, colourless to yellow, viscous injection solution in a pre-filled syringe.
The pack contains one or two single pre-filled syringes. A sterile needle is also included in the pack.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestrasse 11
4866 Unterach, Austria
Fareva Unterach GmbH
Mondseestraße 11
4866 Unterach, Austria

For further information about the medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Information intended exclusively for healthcare professionals:

The dose of Fulvestrant Sandoz 500 mg (2 x 250 mg/5 ml solution for injection) should be administered
using two pre-filled syringes (see section 3).
Administration instructions
Warning – Do not sterilize the safety needle device in an autoclave prior to use.
Avoid hand contact with the needle during administration and disposal of waste.
The syringes are supplied with a BD SafetyGlide or Terumo SurGuard safety needle device.
Instructions for BD SafetyGlide safety needle
Apply to each syringe:

Carefully remove the needle and syringe from the packaging.
Remove the protective cap from the syringe tip.
Open the outer needle packaging (BD SafetyGlide®). Attach the needle to the Luer-Lock tip.
Screw securely to firmly attach to the Luer connector.
Remove the needle cover by pulling it straight off, taking care not to damage the sharp tip.
Remove the cap from the needle.
Holding the syringe with the needle pointing upward, gently press the plunger to move the medication to the top of the syringe. Ensure there is no air in the syringe.
Administer the medication slowly intramuscularly (over 1–2 minutes) into the gluteal muscle. For the convenience of the person administering the medication, the needle bevel is located on the same surface as the safety needle shield activation lever.
Immediately after administering the medication, activate the needle safety shield by pushing its lever forward with your finger.
WARNING: Handle carefully to ensure safety for yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

Instructions for Terumo SurGuard safety needle
Applies to each syringe:

Carefully remove the needle and syringe from the packaging.
Remove the protective cap from the syringe tip.
Attach the needle to the syringe aseptically. Holding the base of the needle (not the shield), turn the syringe clockwise.
Partially remove the protective needle shield in the direction of the syringe (at the angle indicated in the figure). Then remove the cap from the needle.
Holding the syringe with the needle pointing upward, gently press the plunger to move the medication to the top of the syringe. There should be no air in the syringe.
Administer the medication slowly intramuscularly (injection lasting 1–2 minutes) into the gluteal muscle.
After completing the injection, withdraw the needle from the skin and activate the needle shielding system using one of the three methods:
• activation with the index finger
• activation with the thumb
• activation against a surface
Activation is confirmed by an audible and/or palpable click, and can also be visually verified. If in doubt whether the shield has fully covered the needle, repeat the final step.

Disposal
Vial-syringes are intended exclusively for single use.
Any unused remnants of the product or waste materials must be disposed of in accordance with local regulations.