Fulvestrant Ever Pharma

Package leaflet: Information for the user

Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe

fulvestrant
Generic medicine
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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Fulvestrant EVER Pharma is and what it is used for
2. What you need to know before using 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 the group of
estrogen blockers. Estrogens, a type of female sex hormones, may in some cases be involved in the growth of breast cancer.
Fulvestrant EVER Pharma is used either:

• alone, for the treatment of postmenopausal women with a type of breast cancer called estrogen receptor-positive locally advanced or cancer that has spread to other parts of the body (metastatic), or
• in combination with palbociclib for the treatment of women with a type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative, which is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet reached menopause will be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

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

2. What you need to know before using Fulvestrant EVER Pharma

Do not use Fulvestrant EVER Pharma:

• if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding.
• if you have severe liver disease.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Fulvestrant EVER Pharma if you are in any of the following situations:

• kidney or liver problems.
• low platelet count (platelets help blood to clot) or bleeding disorders.
• history of blood clots.
• osteoporosis (loss of bone density).
• alcoholism.

Children and adolescents
Fulvestrant EVER Pharma is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Fulvestrant EVER Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are taking anticoagulants (medicines that prevent blood clots).
Pregnancy and breastfeeding
You must not use Fulvestrant EVER Pharma during pregnancy. If there is a possibility you could become pregnant, you must use an effective contraceptive method during treatment with Fulvestrant EVER Pharma and for two years after the last dose.
You must not breastfeed during treatment with Fulvestrant EVER Pharma.
Driving and using machines
Fulvestrant EVER Pharma is not expected to affect your ability to drive or use machinery. However, if you feel tired after treatment, do not drive or operate machinery.
Fulvestrant EVER Pharma contains ethanol
Fulvestrant EVER Pharma contains 500 mg of alcohol (ethanol) per syringe, equivalent to 10 vol.%.
The amount in each 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 have significant effects.
However, this should be taken into consideration in high-risk groups such as people with liver disease or epilepsy.
Fulvestrant EVER Pharma contains benzyl alcohol
Fulvestrant EVER Pharma contains 500 mg of benzyl alcohol per syringe, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
Fulvestrant EVER Pharma contains benzyl benzoate
Fulvestrant EVER Pharma contains 750 mg of benzyl benzoate per syringe, equivalent to 150 mg/ml.

3. How to use Fulvestrant EVER Pharma

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once
a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Your doctor or nurse will administer Fulvestrant EVER Pharma by slow intramuscular injection,
one in each buttock.
If you have any questions about how to use this medicine, speak to your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediate medical attention may be required if any of the following side effects occur:

• 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)*
• Inflammation of the liver (hepatitis)
• Liver failure

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

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Musculoskeletal and joint 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, diarrhoea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased levels of bilirubin (a pigment of bile produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Reduced platelet levels (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in the leg, particularly 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)
• Bruising and bleeding at the injection site
• Increased levels of gamma-GT, a liver enzyme detected by blood tests
• Inflammation of the liver (hepatitis)
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

*Includes adverse drug reactions for which the exact contribution of Fulvestrant EVER Pharma cannot be assessed due to the underlying disease.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant EVER Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the label of the
syringe after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
This medicine may pose a risk to the aquatic environment.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fulvestrant EVER Pharma 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 components (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate and refined castor oil.
• Each pre-filled syringe contains 10 vol.% ethanol (alcohol), i.e. up to 500 mg.
• 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.

Description of the appearance of Fulvestrant EVER Pharma and contents of the pack
Fulvestrant EVER Pharma is a clear, colourless to yellow, viscous solution, practically free from
particles, in a clear type 1 glass pre-filled syringe with a bromobutyl rubber stopper, plunger rod and plunger support, assembled with a tamper-evident closure, containing 5 ml of injectable solution. To receive the recommended monthly dose of 500 mg, two syringes must be administered.
Fulvestrant EVER Pharma is available in two pack sizes: one pack containing one glass pre-filled syringe or a pack containing two glass pre-filled syringes. Safety needles 21G x 1½ inch (BD SafetyGlide) are also supplied for attachment to each syringe barrel.
Multiple packs containing 4 (2 packs of 2) or 6 (3 packs of 2) pre-filled syringes (5 ml each) are also available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ever Pharma Italia S.r.l.
Via Riccardo Gigante 4
00143 Rome
Italy

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

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Fulvestrant EVER Pharma 250 mg Injektionslösung in einer Fertigspritze
Belgium Fulvestrant EVER Pharma 250 mg oplossing voor injectie in een voorgevulde spuit /
solution injectable en seringue pré-remplie / Injektionslösung in einer Fertigspritze
Bulgaria Фулвестрант EVER Pharma 250 mg инжекционен разтвор в предварително
напълнена спринцовка
Czech Republic Fulvestrant EVER Pharma
Germany Fulvestrant EVER Pharma 250 mg Injektionslösung in einer Fertigspritze
Denmark Fulvestrant EVER Pharma
Greece Fulvestrant/DEMO 250 mg ενέσιµο διάλυµα σε προγεµισµένη σύριγγα
Spain Fulvestrant EVER Pharma 250 mg solución inyectable en jeringa precargada EFG
Finland Fulvestrant EVER Pharma 250 mg injektioneste, liuos, esitäytetty ruisku
France Fulvestrant EVER Pharma 250 mg solution injectable en seringue préremplie
Croatia Fulvestrant EVER Pharma 250 mg otopina za injekciju u napunjenoj štrcaljki
Hungary Fulvestrant EVER Pharma 250 mg oldatos injekció előretöltött fecskendőben
Ireland Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe
Italy Fulvestrant EVER Pharma 250 mg soluzione iniettabile in siringa preriempita
Netherlands Fulvestrant EVER Pharma 250 mg oplossing voor injectie in een voorgevulde spuit
Norway Fulvestrant EVER Pharma
Poland Fulvestrant EVER Pharma
Portugal Ambiful 250 solução injetável em seringa pré-cheia
Romania Fulvestrant EVER Pharma 250 mg soluţie injectabilă în seringă preumplută
Slovenia Fulvestrant EVER Pharma 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Sweden Fulvestrant EVER Pharma 250 mg injektionsvätska, lösning i förfylld spruta
Slovakia Fulvestrant EVER Pharma 250 mg injekčný roztok naplnený v injekčnej striekačke
United Kingdom (Northern Ireland) Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe

The following information is intended exclusively for physicians or healthcare professionals:
Fulvestrant EVER Pharma 500 mg (2x250 mg/5 ml solution for injection in pre-filled syringe) must be administered using two pre-filled syringes; see section 3.
BD SafetyGlide is a registered trademark of Becton Dickinson & Co. and is CE marked: CE 0050.

Instructions for administration
Inject according to local guidelines for administering large-volume intramuscular injections.
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be exercised when administering Fulvestrant EVER Pharma at the dorsogluteal injection site.

Warnings – Do not autoclave the needle with the safety device (BD SafetyGlide safety needle) before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Carefully remove the needle and syringe from the packaging and check that it is undamaged.
• Remove the safety needle (BD SafetyGlide) from its outer packaging.
• Before administration, parenteral solutions should be inspected visually for particulate matter and discoloration.
• Remove the protective cap from the tip of the syringe barrel. To maintain sterility, do not touch the tip of the syringe.
• Attach the safety needle to the Luer-Lock.
• Rotate to secure the needle to the Luer connector. Rotate until firmly locked.

• Quickly remove the needle protector to avoid damaging the needle tip.
• Remove the needle sheath.
• Holding the syringe with the needle pointing upward, gently press the plunger until the medicine reaches the upper part of the syringe. The syringe barrel must not contain air.

• Administer slowly (1 to 2 minutes per injection) into the gluteal muscle (gluteal area). For user convenience, the "blunt" needle tip is aligned with the lever arm.

• After injection, immediately apply single-finger pressure on the lever arm with assisted activation to engage the safety mechanism.
• NOTE: Activate away from yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

Disposal
Pre-filled syringes are for single use only.
This medicinal product may pose a risk to the aquatic environment. Unused medicine and waste material arising from this medicinal product must be disposed of in accordance with local regulations.