Fulvestrant ever pharma

Package leaflet: Information for the user

Fulvestrant EVER Pharma, 250 mg/5 ml, 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people. 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 the leaflet

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

1. What Fulvestrant EVER Pharma is and what it is used for

Fulvestrant EVER Pharma contains the active substance fulvestrant, which belongs to a group of medicines called oestrogen receptor antagonists. Oestrogens are female sex hormones that can sometimes affect the growth of breast cancer.
Fulvestrant EVER Pharma 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 luteinising hormone-releasing hormone agonist.

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

2. Important information before using Fulvestrant EVER Pharma

When not to use Fulvestrant EVER Pharma

• 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
Before starting treatment with Fulvestrant EVER Pharma, discuss this with the doctor,
pharmacist, or nurse if the patient:

• has kidney or liver disease;
• has reduced platelet count (which enables blood clotting) or a bleeding disorder;
• has had blood clotting disorders in the past;
• has osteoporosis (reduced bone mineral density);
• is alcohol-dependent.

Children and adolescents
Fulvestrant EVER Pharma is not indicated for use in children and adolescents under
18 years of age.
Fulvestrant EVER Pharma and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has
recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking anticoagulant medicines
(medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant EVER Pharma must not be used during pregnancy. If the patient could become pregnant,
she should use effective contraception during treatment with Fulvestrant EVER Pharma
and for 2 years after the last dose.
Breastfeeding must not be performed during treatment with Fulvestrant EVER Pharma.
Driving and operating machinery
Fulvestrant EVER Pharma is not expected to affect the ability to drive or operate machinery. However, if fatigue occurs after administration of Fulvestrant EVER Pharma, the patient must not drive or operate machinery.
Fulvestrant EVER Pharma contains ethanol
This medicine contains 500 mg of alcohol (ethanol) in each pre-filled syringe, equivalent to 10%
by volume. The amount of alcohol in each pre-filled syringe of this medicine is equivalent to less than
10 ml of beer or 4 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
This should be taken into consideration when administering the medicine to patients at high risk, such as
patients with liver disease or epilepsy.
Fulvestrant EVER Pharma contains benzyl alcohol
This medicine contains 500 mg of benzyl alcohol in each pre-filled syringe, equivalent to 100 mg/ml.
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").
Fulvestrant EVER Pharma contains benzyl benzoate
This medicine contains 750 mg of benzyl benzoate in each pre-filled syringe, equivalent to 150 mg/ml.

3. How to use Fulvestrant EVER Pharma

This medicine should always be used exactly as instructed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections), administered once a month,
and an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant EVER Pharma will be administered by a doctor or nurse. The medicine will be slowly
injected intramuscularly, with each injection given in a different buttock.
If you have any further questions about 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 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 adverse reactions listed below occur, inform your
doctor, pharmacist or nurse:
Very common adverse reactions (may occur in more than 1 in 10 people)

• Reactions at the injection site, 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 infection;
• Back pain*;
• Increased bilirubin concentration (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 movement 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 EVER Pharma 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, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +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 EVER Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or syringe label after "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
There are no special storage instructions for this medicine.
Healthcare professionals are responsible for the proper storage, handling, and disposal of used Fulvestrant EVER Pharma packaging.
This medicine may pose a risk to the aquatic environment.
Medicines must 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 pack and other information

What Fulvestrant EVER Pharma contains

• The active substance is fulvestrant. One pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
• The other ingredients are: ethanol 96%, benzyl alcohol, benzyl benzoate and purified castor oil. Each pre-filled syringe contains 10% v/v ethanol (alcohol), i.e. up to 500 mg of ethanol. Each pre-filled syringe contains 500 mg of benzyl alcohol, equivalent to 100 mg/ml. Each pre-filled syringe contains 750 mg of benzyl benzoate, equivalent to 150 mg/ml.

What Fulvestrant EVER Pharma looks like and contents of the pack
Fulvestrant EVER Pharma is a clear, colourless to yellow, viscous solution free from visible particles, in a pre-filled syringe made of colourless Type I glass, with a polystyrene plunger closed with a bromobutyl stopper, with a needle shield and a plunger backstop mechanism, containing 5 ml of solution for injection in a pre-filled syringe. To administer the recommended monthly dose of 500 mg, the contents of two pre-filled syringes should be injected.
Fulvestrant EVER Pharma is available in two pack sizes: a pack containing 1 pre-filled syringe or a pack containing 2 pre-filled syringes. The packs also contain needles of size 21 G x 1.5 inches (BD SafetyGlide) with a safety system, intended to be attached to the syringe barrel.
A multiple pack containing 4 (2 packs of 2) or 6 (3 packs of 2) pre-filled syringes (5 ml each).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Straße 15
07745 Jena
Germany
EVER Pharma Jena GmbH
Brüsseler Straße 18
07747 Jena
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for healthcare professionals:

Fulvestrant EVER Pharma, 500 mg (2 x 250 mg/5 ml solution for injection
in prefilled syringe) should be administered using two prefilled syringes,
see section 3.
BD SafetyGlide is a trademark of Becton Dickinson and Company and bears the CE marking: CE 0050.

Administration instructions
Administer the injection according to local guidelines for performing large-volume intramuscular injections.
WARNING: Exercise caution when administering Fulvestrant EVER Pharma into the upper-outer gluteal region due to the proximity of the sciatic nerve.
Note – do not place the safety-shielded needle (BD SafetyGlide Shielding Hypodermic Needle) in an autoclave before use. Avoid hand contact with the needle during administration and disposal of the product.

For each syringe:

• Carefully remove the needle and syringe from the packaging and inspect for damage.
• Open the outer packaging of the safety-shielded needle (BD SafetyGlide).
• Prior to administration, visually inspect parenteral solutions for particulate matter and discoloration.
• Remove the protective cap from the syringe tip. To maintain sterility, do not touch the syringe tip.
• Attach the needle to the Luer-Lock tip.
• Screw firmly to securely attach it to the Luer connector.
• Pull off the needle cover

so as not to damage the sharp tip.

• Remove the needle cap.
• Holding the syringe with the needle pointing upward, gently press the plunger to expel the medicinal product to the top of the syringe. Ensure there is no air in the syringe.
• Administer the medicinal product slowly

intramuscularly (injection lasting 1–2 minutes) into the gluteal muscle. For the convenience of the person administering the medicinal product, the needle bevel is located on the same surface of the needle as the safety shield lever.

• Immediately after administering the medicinal product, activate the needle safety shield by pushing forward its lever with a finger.
• WARNING: Handle in a manner that ensures safety for yourself and others. Listen for a click and visually confirm that the needle tip is completely covered.

Waste disposal
Prefilled syringes are intended for single use only.
This medicinal product may pose a risk to the aquatic environment. Any unused residue of the medicinal product or waste material must be disposed of in accordance with local regulations.