Fulvestrant Mylan

Package leaflet: Information for the user

Fulvestrant Mylan 250 mg solution for injection in pre-filled syringe

fulvestrant
Please 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Fulvestrant Mylan 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 Mylan is used:

• alone, for the treatment of postmenopausal women with a type of breast cancer called estrogen receptor-positive locally advanced or spread to other parts of the body (metastatic) breast cancer, 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 spread to other parts of the body (metastatic). Women who have not yet undergone menopause will be treated with a medicine called a luteinising hormone-releasing hormone (LHRH) agonist.

When fulvestrant 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 consult your doctor.

2. What you should know before using Fulvestrant Mylan

Do not use Fulvestrant Mylan

• 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 Mylan if you are in any of the
following conditions:

• 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 Mylan is not indicated for use in children and adolescents under 18 years of age.
Other medicines and Fulvestrant Mylan
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 Mylan if you are pregnant. If there is any possibility that you could become
pregnant, you must use effective contraception during treatment with Fulvestrant Mylan and for 2 years after the last dose.
You must not breastfeed during treatment with Fulvestrant Mylan.
Driving and using machines
Fulvestrant Mylan is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or operate machinery.
Fulvestrant Mylan contains 10% w/v alcohol (ethanol), i.e. 500 mg in 5 mL,
equivalent to less than 25 mL of beer or 10 mL of wine per treatment dose (i.e. two syringes).
The small amount of alcohol contained in this medicine has no significant effect.
Fulvestrant Mylan contains benzyl alcohol.
This medicine contains 500 mg of benzyl alcohol in 5 mL, equivalent to 100 mg/mL (10% w/v). Benzyl alcohol may cause allergic reactions.
Fulvestrant Mylan contains benzyl benzoate.
This medicine contains 750 mg of benzyl benzoate in 5 mL, equivalent to 150 mg/mL (15% w/v).

3. How to use Fulvestrant Mylan

Use this medicine exactly as instructed 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
monthly, with an additional 500 mg dose given 2 weeks after the initial dose.
Your doctor or nurse will administer Fulvestrant Mylan 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 everybody gets them.
Medical attention should be sought immediately 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 levels of liver enzymes (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 bile pigment 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 Mylan cannot be assessed due to the underlying disease.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fulvestrant Mylan

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 or on the label of the
syringe after the abbreviation "Exp". The expiry date refers to the last day of that month.
Store and transport refrigerated (2 °C–8 °C).
Temperature excursions outside the range of 2 °C–8 °C should be limited, and storage periods exceeding 28 days at a temperature below 25 °C (but above 2 °C–8 °C) must be avoided. After temperature excursions, the product must be returned immediately to the recommended storage conditions (store and transport refrigerated at 2 °C–8 °C). Temperature excursions have a cumulative effect on product quality, and the 28-day period must not be exceeded during the shelf life of Fulvestrant Mylan.
Exposure to temperatures below 2 °C does not damage the product provided it is not stored below -20 °C.
Keep the pre-filled syringe in the original packaging to protect the medicine from light.
Healthcare personnel are responsible for the proper storage, use, and disposal of Fulvestrant Mylan.
This medicine may pose a risk to the environment. Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Package contents and other information

What Fulvestrant Mylan contains

• The active substance is fulvestrant. Each pre-filled syringe (5 mL) contains 250 mg of fulvestrant.
• The other ingredients are benzyl benzoate (see section 2 “Fulvestrant Mylan contains benzyl benzoate”), benzyl alcohol (see section 2 “Fulvestrant Mylan contains benzyl alcohol”), anhydrous ethanol (see section 2 “Fulvestrant Mylan contains 10% weight/volume alcohol (ethanol)”), and purified castor oil.

Description of the appearance of Fulvestrant Mylan and package contents
Fulvestrant Mylan is a clear, colourless to yellow viscous solution in a pre-filled syringe assembled with a tamper-evident seal, containing 5 mL of injection solution.
Fulvestrant Mylan is available in four pack sizes: either a pack containing one pre-filled glass syringe, or a pack containing two pre-filled glass syringes, or a pack containing four pre-filled glass syringes, or a pack containing six pre-filled glass syringes. Safety needles with a connection device (BD SafetyGlide) are also supplied for each syringe barrel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
MYLAN PHARMACEUTICALS LIMITED
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer
MYLAN TEORANTA
Inverin
Co. Galway
IRELAND
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
GERMANY

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Mylan bvba/sprl Mylan Healthcare UAB
Tel/Tél: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Mylan bvba/sprl
Тел: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Mylan EPD Kft.
Tel: +420 222 004 400 Tel: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti Norge
BGP Products Switzerland GmbH Eesti filiaal Viatris AS
Tel: +372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Generics Pharma Hellas ΕΠΕ Arcana Arzneimittel GmbH
Τηλ: +30 210 993 6410 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L.U. Mylan Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: + 351 21 412 72 00

Hrvatska România
Mylan Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: + 354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Mylan Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
Varnavas Hadjipanayis Ltd Viatris AB
Τηλ: + 357 2220 7700 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Mylan Healthcare SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

Fulvestrant Mylan 500 mg (2×250 mg/5 mL solution for injection) must be administered
using two pre-filled syringes; see section 3.
Instructions for administration
Warnings – Do not autoclave the needle with the safety device (BD SafetyGlide needle shield) prior to use. Hands must remain behind the needle at all times during use and disposal.
For each of the two syringes:

• Remove the glass syringe barrel from the tray and Figure 1 check that it is not damaged.

• Remove the safety needle (SafetyGlide) from its outer packaging.
• Prior to administration, parenteral solutions should be inspected visually for particulate matter and discoloration.
• Hold the syringe vertically on the knurled part (C). With the other hand, grasp the cap (A) and carefully rock forward and backward until the cap loosens and can be removed; do not rotate (see Figure 1).
• Remove the cap (A) by pulling it straight upward. For Figure 2 sterility assurance, do not touch the tip of the syringe (B)

(see Figure 2).

• Attach the safety needle to the Luer-Lok and rotate to Figure 3 securely lock it in place (see Figure 3).

• Check that the needle is securely attached to the Luer connector before removing it from the vertical plane.
• Remove the needle protector promptly to avoid damaging the needle tip.
• Carry the filled syringe to the administration site.
• Remove the needle sheath.
• Expel excess air from the syringe.
• Administer slowly (1 to 2 minutes/injection) by Figure 4

intramuscular injection into the gluteal region (gluteal area). For user convenience, the blunt needle tip is aligned with the lever arm (see Figure 4).

• After injection, immediately apply pressure with a single Figure 5

finger on the lever arm with assisted activation to engage the safety mechanism (see Figure 5).
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 environment. Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.