Fulvestrant sun

V004

Package leaflet: Information for the patient

Fulvestrant SUN, 250 mg/5 mL, solution for injection in pre-filled syringe
Fulvestrantum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

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

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

This medicine contains the active substance fulvestrant, which blocks the action of oestrogen receptors.
Oestrogens, female sex hormones, may influence the development of breast cancer.
Fulvestrant SUN is used:

• as a single agent in the treatment of oestrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic) in postmenopausal women, or
• in combination with palbociclib in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. These medicines are used when the tumour is locally advanced or has spread to other parts of the body (metastatic). Premenopausal women will also receive a medicine called a gonadotropin-releasing hormone (GnRH) agonist.

When Fulvestrant SUN is administered in combination with palbociclib, it is important to read the package leaflets for both medicines. If you have any questions about palbociclib, please consult your doctor.

2. Important information before using Fulvestrant SUN

When NOT to use Fulvestrant SUN

• if the patient is allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant or breastfeeding;
• if the patient has severe impairment of liver function.

Warnings and precautions
Inform your doctor, pharmacist, or nurse before using Fulvestrant SUN if you have ever had:

• kidney or liver disease;
• low platelet count (which enables blood clotting), or bleeding disorders;
• blood clotting disorders;
• osteoporosis (loss of bone mass);
• alcohol dependence.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
Fulvestrant SUN and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant SUN must not be used during pregnancy. If the patient could become pregnant, she should use effective contraception during treatment with Fulvestrant SUN and for 2 years after the last dose.
Breastfeeding must not be performed during treatment.
Driving and operating machinery
Fulvestrant SUN has not been shown to affect the ability to drive or operate machinery. However, if fatigue occurs after taking this medicine, driving or operating machinery should not be undertaken.
Fulvestrant SUN contains 10% w/v ethanol (alcohol), i.e. up to 1 g per dose, equivalent to 20 mL of beer or 8 mL of wine per dose. It is harmful for individuals with alcohol dependence.
This should be taken into account when administering to pregnant or breastfeeding women and patients at high risk, such as those with liver disease or epilepsy.
Fulvestrant SUN contains castor oil, which may cause severe allergic reactions.
Fulvestrant SUN contains benzyl alcohol
This medicine contains 1 g of benzyl alcohol, equivalent to 100 mg/mL.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before using this medicine, as high amounts of benzyl alcohol may accumulate in the body and cause adverse effects (so-called metabolic acidosis).

3. How to use Fulvestrant SUN

Fulvestrant SUN is administered by a doctor or nurse as two slow intramuscular injections, each into a separate buttock.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg each) given once a month, and an additional 500 mg given 2 weeks after the first dose.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following adverse reactions occur, contact your doctor immediately:

• allergic reactions, including swelling of the face, lips, tongue, and (or) throat (common adverse reactions), which may be signs of anaphylactic reactions;
• thromboembolic disease (increased risk of blood clots)* (common adverse reaction). Symptoms may include pain, deep discomfort and swelling in a specific area (especially in one leg), shortness of breath, and chest pain (if the clot travels to the lungs);
• hepatitis (uncommon adverse reaction). Symptoms may include nausea, diarrhoea, jaundice (yellowing of the skin or eyes), dark urine, pale stools, easy bleeding, itching, or chills;
• liver failure (uncommon adverse reaction). Symptoms may include nausea, diarrhoea, jaundice (yellowing of the skin or whites of the eyes).

Other adverse reactions
If any of the following adverse reactions occur, inform your doctor, pharmacist, or nurse.
Very common adverse reactions (occurring in more than 1 in 10 people):

• reactions at the injection site, such as pain and (or) inflammation;
• changes in liver enzyme activity (in blood tests)*;
• nausea;
• feeling of weakness, fatigue*;
• joint pain and musculoskeletal pain;
• hot flushes;
• rash.

Common adverse reactions (occurring in fewer than 1 in 10 people):

• headache;
• vomiting, diarrhoea, or loss of appetite*;
• urinary tract infections;
• back pain*;
• increased bilirubin levels (a pigment produced by the liver);
• decreased platelet count;
• vaginal bleeding;
• lower back pain radiating to the leg (sciatica);
• sudden weakness, numbness, tingling, or loss of movement in the leg, especially if occurring on only one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy).

Uncommon adverse reactions (occurring in fewer than 1 in 100 people):

• thick, white vaginal discharge and vaginal candidiasis (infection);
• bruising and bleeding at the injection site;
• increased gamma-glutamyltransferase activity, a liver enzyme measured in blood tests;
• numbness, tingling, and pain;
• anaphylactic reactions.

*Includes adverse reactions for which the influence of Fulvestrant SUN cannot be assessed due to the presence of underlying disease.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fulvestrant SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and blister.
The expiry date refers to the last day of the stated month.
Store and transport under refrigerated conditions (2°C - 8°C).
Keep the pre-filled syringe in its original packaging to protect from light.
Storage at temperatures other than 2°C - 8°C should be minimized. Avoid storage above 30°C and do not exceed 28 days with an average storage temperature below 25°C (but above 2°C - 8°C).
If the recommended temperature range is exceeded, the recommended storage conditions (storage and transport under refrigerated conditions (2°C - 8°C)) should be immediately reinstated. Exposure to inappropriate storage temperatures may have a cumulative effect on product quality, and the total time outside the recommended temperature range must not exceed 28 days during the product's shelf life. Exposure to temperatures below 2°C is not harmful, provided the medicine is not stored below -20°C.
Keep the pre-filled syringe in its original packaging to protect from light.
Healthcare personnel are responsible for the proper storage, handling, and disposal of packaging after use of Fulvestrant SUN.
This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant SUN contains

• The active substance is fulvestrant. One pre-filled syringe (5 mL) contains 250 mg of fulvestrant.
• Other ingredients: ethanol (96%), benzyl alcohol (E 1519), benzyl benzoate, and purified castor oil.

What Fulvestrant SUN looks like and contents of the pack
A clear, colourless to yellow, viscous solution in a pre-filled syringe equipped with a tamper-evident system, containing 5 mL of solution for injection.
To administer the recommended monthly dose of 500 mg, the contents of two pre-filled syringes must be injected.
Fulvestrant SUN is available in four pack sizes, containing 1, 2, 4 or 6 pre-filled syringes and correspondingly 1, 2, 4 or 6 safety needles.
Not all pack sizes are marketed.

Marketing Authorisation Holder / Manufacturer / Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following name:
Denmark, Germany, France, Italy, the Netherlands, Norway, Romania, Spain, Sweden, United Kingdom:
Fulvestrant SUN

Information intended exclusively for healthcare professionals

Fulvestrant SUN should be administered using two pre-filled syringes (see section 3).
Administration instructions
Warning – do not sterilize the safety-shield hypodermic needle (BD SafetyGlide Shielding Hypodermic Needle) in an autoclave. During use and disposal, hands must always remain behind the needle.
Applies to syringes:

• Remove the glass syringe body from its container and inspect for damage.
• Open the outer needle packages.
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe vertically by the ribbed part (C). With the other hand, grasp the cap (A) and gently turn the hard plastic tip cap counterclockwise (see Figure 1).

Figure 1.

• Remove the cap (A) vertically upward. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2

• Attach the safety-shield needle to the Luer-Lock tip and screw it on firmly until securely attached (see Figure 3).
• Check that the needle is properly connected to the Luer tip before tilting away from vertical.
• Pull the shield along the needle without damaging the sharp tip.
• Bring the needle with shield attached close to the administration site.
• Remove the needle cap.
• Expel any excess air from the syringe.

Figure 3

• The medicinal product should be administered intramuscularly, slowly (1–2 minutes/injection) into the gluteal muscle. For the administrator’s convenience, the needle bevel is in the same plane as the needle safety shield lever (see Figure 4).

Figure 4

• Immediately after administering the medicinal product, activate the needle safety shield by pushing forward the shield lever with one finger (see Figure 5).

WARNING: Activate in such a way as to ensure safety for yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

Figure 5
Disposal of waste
Pre-filled syringes are intended solely for single use.
This medicinal product may pose a risk to the aquatic environment. Any unused product or waste material should be disposed of in accordance with local regulations.