FULVESTRANT MYLAN 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

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

fulvestrant

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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 pack

1. What is Fulvestrant Mylan and what is it used for
2. What you need to know before you use 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 is Fulvestrant Mylan and what is it used for

Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Fulvestrant Mylan is used:

• alone, to treat postmenopausal women with a type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastatic) or,
• in combination with palbociclib to treat women with a type of breast cancer 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). Women who have not reached menopause will also be treated with a medicine called luteinizing hormone-releasing hormone (LHRH) agonist.

Fulvestrant may be administered in combination with palbociclib. It is important that you also read the package leaflet of palbociclib. If you have any questions about palbociclib, ask your doctor.

2. What you need to know before you use Fulvestrant Mylan

Do not use Fulvestrant Mylan

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breast-feeding
• if you have severe liver problems

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Fulvestrant Mylan if any of the following apply to you:

• kidney or liver problems
• low platelet count (which helps blood to clot) or bleeding disorders
• previous blood clot problems
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents

Fulvestrant Mylan is not indicated in children and adolescents under 18 years.

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 should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breast-feeding

You should not use Fulvestrant Mylan if you are pregnant. If you can become pregnant, you should use effective contraception while being treated with Fulvestrant Mylan and for 2 years after the last dose.

You should not breast-feed while being treated 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 use machines.

Fulvestrant Mylan contains 10% v/v ethanol (alcohol),i.e., 500 mg per dose, which is 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 in this medicine does not have any noticeable effect.

Fulvestrant Mylan contains benzyl alcohol

This medicine contains 500 mg of benzyl alcohol in each 5 ml, which is equivalent to 100 mg/ml (10% v/v). Benzyl alcohol may cause allergic reactions.

Fulvestrant Mylan contains benzyl benzoate

This medicine contains 750 mg of benzyl benzoate in each 5 ml, which is equivalent to 150 mg/ml (15% v/v).

3. How to use Fulvestrant Mylan

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.

Your doctor or nurse will administer Fulvestrant Mylan by slow intramuscular injection into each buttock.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may need urgent medical attention if you experience any of the following side effects:

• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be symptoms of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)*
• Hepatitis (inflammation of the liver)
• Liver failure

Tell your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:

Very common side effects(may affect more than 1 in 10 people)

• Injection site reactions, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling sick)
• Weakness, fatigue*
• Joint and musculoskeletal pain
• Hot flashes
• 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, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lumbar pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially 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)
• Hematoma and bleeding at the injection site
• Increased gamma-GT, a liver enzyme identified in a blood test
• Hepatitis (inflammation of the liver)
• Liver failure
• Numbness, tingling, and pain
• Numbness, tingling, and pain
• Anaphylactic reactions

*Including side effects for which the exact role of Fulvestrant Mylan cannot be evaluated due to the underlying disease.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix 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 labels of the syringes after the abbreviation EXP. The expiry date refers to the last day of the month stated.

Store and transport in a refrigerator (between 2°C and 8°C).

Temperature excursions outside the range of 2°C to 8°C are permitted, provided that the mean kinetic temperature does not exceed 25°C (but above 2°C to 8°C). After temperature excursions, the medicine should be immediately returned to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature excursions have a cumulative effect on the quality of the medicine, and the 28-day period should not be exceeded beyond the shelf life of Fulvestrant Mylan. Exposure to temperatures below 2°C will not harm the medicine, provided it is not stored below -20°C.

The pre-filled syringe should be kept in the original packaging to protect it from light.

Your healthcare professional will be responsible for the proper storage, use, and disposal of Fulvestrant Mylan.

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. This will help protect the environment.

6. Contents of the pack 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 (excipients) 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% v/v ethanol’), and refined castor oil.

Appearance and pack of Fulvestrant Mylan

Fulvestrant Mylan is a viscous, clear, colorless to yellow solution in a pre-filled syringe equipped with a tamper-evident closure, which contains 5 ml of injectable solution.

Fulvestrant Mylan is available in 4 formats: a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes or a pack containing 4 glass pre-filled syringes or a pack containing 6 glass pre-filled syringes. Safety needles (BD SafetyGlide) are also provided for connection to the syringe body.

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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{MM/AAAA}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Fulvestrant Mylan 500 mg (2 × 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning: Do not autoclave the safety needle (hypodermic needle) before use. Hands should remain behind the needle at all times during use and disposal.

Disposal

The pre-filled syringes are for single use only.

This medicine may pose a risk to the aquatic environment. Disposal of unused medicine and all materials that have been in contact with it should be done in accordance with local regulations.