Fulvestrant cipla

Patient Information Leaflet

Fulvestrant Cipla, 250 mg, solution for injection in prefilled syringe
fulvestrant
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

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

Fulvestrant Cipla contains the active substance fulvestrant, which belongs to a group of medicines called oestrogen receptor antagonists. Oestrogens, female sex hormones, can sometimes influence the development of breast cancer.
Fulvestrant Cipla is used:

• as a single agent in the treatment of postmenopausal women with a certain type of breast cancer called oestrogen receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
• in combination with palbociclib in the treatment of women with a certain type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet reached menopause will also receive a medicine called a gonadotropin-releasing hormone (GnRH) agonist.

When Fulvestrant Cipla is given in combination with palbociclib, it is important to also read the patient information leaflet provided with palbociclib. If you have any questions about palbociclib, please consult your doctor.

2. Important information before administering Fulvestrant Cipla

When NOT to administer Fulvestrant Cipla

• 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
You should inform your doctor, pharmacist or nurse before treatment with Fulvestrant Cipla
if any of the following health problems have ever occurred:

• if kidney or liver disease has ever been diagnosed
• if thrombocytopenia (reduced number of platelets, which enable blood clotting) or a bleeding disorder has been diagnosed
• if thrombotic disease has ever occurred
• if problems with reduced bone mineralization (osteoporosis) have ever occurred
• alcohol dependence

Children and adolescents
Fulvestrant Cipla is not recommended for use in children and adolescents under 18 years of age.
Fulvestrant Cipla and other medicines
You must tell your doctor or pharmacist about all medicines you are currently taking,
have recently taken, or plan to take.
In particular, you should inform your doctor if the patient is taking anticoagulant medicines (medicines
that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant Cipla must not be given to women who are pregnant. Women who could become pregnant
should use effective contraception during treatment with Fulvestrant Cipla and for 2 years
after the last dose.
Breastfeeding must not be undertaken during treatment with Fulvestrant Cipla.
Driving and operating machinery
It has not been established that Fulvestrant Cipla affects the ability to drive
motor vehicles or operate mechanical equipment. However, if fatigue occurs after administration of Fulvestrant Cipla,
driving motor vehicles and operating machinery must be avoided.
Fulvestrant Cipla contains 500 mg of alcohol (ethanol) per injection, equivalent to 100 mg/ml
(10% w/v). This amount in each injection of this medicine corresponds to 13 ml of beer or
5 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents. It may
cause some effects in younger children, such as drowsiness.
The alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines,
they should consult their doctor or pharmacist.
If the patient is pregnant or breastfeeding, they should consult their doctor or pharmacist before
using this medicine.
If the patient is alcohol-dependent, they should consult their doctor or pharmacist before
using this medicine.
Fulvestrant Cipla contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Fulvestrant Cipla contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.

3. How to administer Fulvestrant Cipla

Your doctor or nurse will slowly inject Fulvestrant Cipla intramuscularly, alternating each injection between the two buttocks.
The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), administered once a month, with an additional 500 mg dose 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 they do not occur in everyone.
Serious adverse reactions
If any of the following adverse reactions occur, you must contact your doctor immediately and without delay:

• Hypersensitivity reactions, including swelling of the face, lips, tongue and (or) throat, which may be symptoms of anaphylactic reactions
• Thromboembolic disease (increased risk of venous thrombosis)*
• Hepatitis
• Liver failure

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

• Reactions at the injection site, i.e. pain and (or) inflammation
• Changes in liver enzyme activity (in blood tests)*
• Nausea
• Weakness, fatigue*
• Joint pain and musculoskeletal pain
• Hot flushes
• Skin rash
• Hypersensitivity reactions, including swelling of the face, lips, tongue and (or) throat

All other adverse reactions:
Common adverse reactions (may occur in up to 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)
• Thromboembolic disease (increased risk of venous thrombosis)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lower back pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling or loss of movement in the leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy)

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Thick, white vaginal discharge and vaginal candidiasis (infection)
• Bruising and bleeding at the injection site
• Increased gamma-glutamyl transferase (GGT) activity, a liver enzyme measured in blood tests
• Hepatitis
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

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

5. How to store Fulvestrant Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or on the label of the syringe following: EXP. The expiry date refers to the last day of the stated month.
Store and transport in a refrigerated state (2°C – 8°C).
Storage of the product at temperatures other than 2°C – 8°C should be minimized. Avoid storage at temperatures above 30°C and do not exceed a period of 28 days with an average storage temperature below 25°C (but outside the range of 2°C – 8°C). If the temperature range is exceeded, the recommended storage conditions should be applied immediately (store and transport in a refrigerator at 2°C – 8°C). Exposure to improper storage temperatures may have a cumulative effect on the quality of the product, and the 28-day period must not extend beyond the product's expiry date. 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 its original packaging to protect it from light.
Healthcare personnel are responsible for the proper storage, handling, and disposal of used Fulvestrant Cipla packaging.
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 Cipla contains

• The active substance is fulvestrant. One pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
• Other ingredients are: ethanol (96 percent), benzyl alcohol (E1519), benzyl benzoate, and purified castor oil.

What Fulvestrant Cipla looks like and contents of the pack
Fulvestrant Cipla is a clear, colourless to yellow, viscous solution in a pre-filled syringe containing 5 ml of solution for injection.
To administer the recommended monthly dose of 500 mg, the contents of two pre-filled syringes should be injected.
Fulvestrant Cipla is available in four pack sizes: packs containing 1 pre-filled syringe, packs containing 2 pre-filled syringes, packs containing 4 pre-filled syringes, and packs containing 6 pre-filled syringes. Each pack also contains one, two, four, or six safety needles (BD Safety Glide) for administration of the medicine.
Not all pack sizes are marketed.

Marketing Authorisation Holder
Cipla Europe NV
De Keyserlei 58-60, Box-19
2018 Antwerp
Belgium

Manufacturer
Laboratorios Farmalán, S.A.
Calle La Vallina s/n, Edificio 2
Polígono Industrial Navatejera
24193, Villaquilambre, León
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Netherlands | Fulvestrant Leon Farma 250 mg solution for injection in a pre-filled syringe | | France | Fulvestrant Farmalan 250 mg solution injectable en seringue pré-remplie | | Austria | Fulvestrant AptaPharma 250 mg Injektionslösung in einer Fertigspritze | | Slovenia | Fulvestrant AptaPharma 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi | | Croatia | Fulvestrant AptaPharma 250 mg otopina za injekciju u napunjenoj štrcaljki | | Hungary | Fulvestrant AptaPharma 250 mg oldatos injekció előretöltött fecskendőben | | Germany | Fulvestrant Cipla 250 mg Injektionslösung in einer Fertigspritze | | Czech Republic | Fulvestrant Cipla | | Poland | Fulvestrant Cipla | | Romania | Fulvestrant Cipla 250 mg soluție injectabilă în seringă preumplută |

Information intended exclusively for healthcare professionals:

Fulvestrant Cipla 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 shielded needle system (BD SafetyGlide™ Safety Hypodermic Needle) prior to use. Avoid hand contact with the needle during administration and disposal.

For both syringes:

• Remove the glass cartridge from its container and inspect for damage.
• Open the outer packaging of the shielded needle (SafetyGlide).
• Prior to administration of parenteral solutions, visually inspect the solution for particulate matter and discoloration.
• Hold the syringe vertically by the ridged section (C). With the other hand, grasp the cap (A) and carefully twist the rigid plastic cap counterclockwise (see Figure 1).

Figure 1

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

Figure 2

• Attach the shielded needle to the Luer-Lock tip and tighten securely (see Figure 3).
• Check that the needle is properly connected to the Luer tip before proceeding to upright position.
• When attaching the needle, take care not to damage the sharp tip.
• Bring the needle with cap close to the administration site.
• Remove the needle cap.
• Expel excess air from the syringe.

Figure 3

• Administer the medicinal product intramuscularly, slowly (1–2 minutes/injection), into the gluteal muscle (site on buttock). For the convenience of the person administering, the needle bevel is located on the same surface of the needle as the needle shield activation lever (see Figure 4).

Figure 4
Immediately after administration, activate the needle shield by pushing forward the shield activation lever (see Figure 5).
WARNING: Handle carefully 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 for single use only.
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.