FULVESTRANT SUN 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE - patient leaflet, side effects, dosage

Fulvestrant 250 mg solution for injection in pre-filled syringe

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.

What is in this leaflet

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

• 2. What you need to know before you are given Fulvestrant

• 3. How Fulvestrant will be given

• 4. Possible side effects

• 5. How to store Fulvestrant

• 6. Contents of the pack and other information

1. what fulvestrant is and what it is used for

Fulvestrant 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 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 are given fulvestrant

You should NOT be given Fulvestrant

• – 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 being treated with Fulvestrant 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 is not for use in children and adolescents under 18 years.

Other medicines and Fulvestrant

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 taking:

• – anticoagulants (medicines to prevent blood clots).

Pregnancy and breast-feeding

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

You must not breast-feed while on treatment with Fulvestrant.

Driving and using machines

Fulvestrant 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 contains 10% w/v ethanol (alcohol), i.e. up to 1 g per dose, equivalent to 20 ml beer or 8 ml wine per dose. Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.

Fulvestrant contains castor oil, which may cause severe allergic reactions.

Fulvestrant contains benzyl alcohol

This medicine contains 1 g benzyl alcohol in each dose which is equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions.

Askyour doctor or pharmacist for advice if you are pregnant or breast-feeding or if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called „metabolic acidosis“).

• 3. How Fulvestrant will be given

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

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.

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

4. possible side effects

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

Serious side effects

Tell your doctor immediately if you experience any of the following side effects

– allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat (very common side effect), that may be signs of anaphylactic reactions

• – thromboembolism (increased risk of blood clots)* (common side effect). Symptoms may include pain, deep ache and swelling in the affected area (particularly in one leg), breathlessness and chest pain (if a clot moves into the lung)

• – inflammation of the liver (hepatitis) (uncommon side effect). Symptoms may include nausea (feeling sick), diarrhea jaundice, (yellow discoloration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills

• – liver failure (uncommon side effect). Symptoms may include nausea (feeling sick), diarrhoeajaundice (your skin or the whites of your eyes look yellow).

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following

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.

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)

• – decreased levels of platelets (thrombocytopenia)

• – vaginal bleeding

• – lower back pain irradiating to the leg on one side (sciatica)

• – sudden weakness, numbness, tingling, or loss of movement in your leg, especially if only on 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

• – numbness, tingling and pain

• – anaphylactic reactions.

• * Includes side effects for which the exact role of Fulvestrant 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 Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store fulvestrant

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 and 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 to 8°C should be limited. This includes avoiding storage at temperatures exceeding 30°C, and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C to 8°C). After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C to 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. Exposure to temperatures below 2°C will not damage the product providing it is not stored below –20°C.

Store 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.

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 contains

• - The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.

• – The other ingredients are ethanol (96%), benzyl alcohol (E1519), benzyl benzoate and castor oil, refined.

What Fulvestrant looks like and contents of the pack

Fulvestrant 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. Two syringes must be administered to receive the 500 mg recommended monthly dose.

Fulvestrant has 4 pack presentations, consisting of packs containing 1, 2, 4 or 6 glass pre-filled syringe(s). 1, 2, 4 or 6 safety needle(s) (BD SafetyGlide) for connection to each barrel are also provided.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

This leaflet was last revised in September 2020

044BP3142B