Fulvestrant Mylan - patient leaflet, side effects, dosage

- 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.

What is in this leaflet

• 1. What Fulvestrant Mylan is and what it is 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 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, can in some cases be involved in the growth of breast cancer.

Fulvestrant Mylan is used either:

• alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that 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-negative breast cancer, that 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 a luteinizing hormone releasing hormone (LHRH) agonist.

When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, please 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 to 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 or pharmacist or nurse before using Fulvestrant Mylan if any of these apply to you:

• – kidney or liver problems

• – low numbers of platelets (which help blood clotting) or bleeding disorders

• – previous problems with blood clots

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

You must not breast-feed while on 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 use machines.

Fulvestrant Mylan contains 10% w/v ethanol (alcohol) i.e. 500 mg in each 5 ml, equivalent to 25 ml beer or 10 ml wine per one treatment dose (i.e. two syringes). The small amount of alcohol in this medicine will not have any noticeable effects.

Fulvestrant Mylan contains benzyl alcohol

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

Fulvestrant Mylan contains benzyl benzoate

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

3. How to use Fulvestrant Mylan

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Your doctor or nurse will give you Fulvestrant Mylan as a slow intramuscular injection, one into each of your buttocks.

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 immediate medical treatment if you experience any of the following side effects:

• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
• Thromboembolism (increased risk of blood clots)
• Inflammation of the liver (hepatitis)
• Liver failure

Tell your doctor, pharmacist, or nurse 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 levels of liver enzymes (in blood tests)
• Nausea (feeling sick)
• Weakness, tiredness*
• Joint and musculoskeletal pain
• Hot flushes
• Skin rash
• Allergic (hypersensitivity) reactions, 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*
• Increase of bilirubin (bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)
• Decreased levels of platelets (thrombocytopenia)
• Vaginal bleeding
• Lower back pain irradiating to leg on one side (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy)

Uncommon side effects (may affect up to 1 in 100 people)

• Thick, whitish vaginal discharge and candidiasis (infection)
• Bruising and bleeding at the site of injection
• Increase of gamma-GT, a liver enzyme seen in a blood test
• Inflammation of the liver (hepatitis)
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

• Includes side effects for which the exact role of Fulvestrant Mylan cannot be assessed due to the underlying disease.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy 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 syringe labels after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2°C – 8°C).

Temperature excursions outside 2°C – 8°C should be limited and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C – 8°C). After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C – 8°C). Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the shelf life of Fulvestrant Mylan. Exposure to temperatures below 2°C will not damage the product providing it is not stored below – 20°C.

Keep the pre-filled syringe in the original package in order to protect from light.

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

This medicine may pose a risk to the aquatic environment. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 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’), ethanol anhydrous (see section 2 ‘Fulvestrant Mylan contains 10% w/v ethanol (alcohol)’), castor oil, refined.

What Fulvestrant Mylan looks like and contents of the pack

Fulvestrant Mylan is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.

Fulvestrant Mylan has 4 pack presentations, either 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) for connection to each barrel are also provided.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

MYLAN S.A.S.

117 Allée des Parcs

69800 SAINT-PRIEST

FRANCE

Manufacturer

MYLAN TEORANTA

Inverin

Co. Galway

IRELAND

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Etnrapua Maw.iaH EOO4 Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400	Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Mylan Denmark ApS Tel: +45 28 11 69 32	Malta V.J.Salomone Pharma Ltd Tel: + 356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800	Nederland Mylan BV Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052	Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00
EZZáSa Generics Pharma Hellas EnE Tql: +30 210 993 6410	Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418
España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00
France Mylan S.A.S Tel: +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BPG Products SRL Tel: + 40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 (0) 87 1694982	Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

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

Instructions for administration

Warning – Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Remove glass syringe barrel from tray and check that it is not damaged.
• Peel open the safety needle (SafetyGlide) outer packaging.
• Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.