Fulvestrant fresenius kabi

Patient Information Leaflet

Fulvestrant Fresenius Kabi, 250 mg/5 ml, solution for injection in ampoule-syringe
Fulvestrantum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

Table of contents

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

1. What Fulvestrant Fresenius Kabi is and what it is used for

Fulvestrant Fresenius Kabi contains the active substance fulvestrant, which belongs to a group of medicines known as estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes influence the development of breast cancer.
Fulvestrant Fresenius Kabi is used:

• as a single agent, for the treatment of postmenopausal women with a certain 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 for the treatment of women with a certain type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced 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 Fresenius Kabi 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 treating doctor.

2. Important information before using Fulvestrant Fresenius Kabi

When not to use Fulvestrant Fresenius Kabi

• 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 using Fulvestrant Fresenius Kabi if any of the following health problems have ever occurred:

• kidney or liver disease;
• low platelet count (which enables blood clotting) or coagulation disorders;
• thrombotic disease;
• osteoporosis (problems related to decreased bone mineral density);
• alcohol dependence.

Children and adolescents
Fulvestrant Fresenius Kabi is not recommended for use in children and adolescents under 18 years of age.

Fulvestrant Fresenius Kabi and other medicines
You must tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
In particular, you should inform your doctor if the patient is using anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding
Fulvestrant Fresenius Kabi must not be used during pregnancy. If the patient could become pregnant, she should use effective contraception during treatment with Fulvestrant Fresenius Kabi and for 2 years after the last dose.
Breastfeeding must not be performed during treatment with Fulvestrant Fresenius Kabi.

Driving and operating machinery
It has not been established that fulvestrant affects the ability to drive or operate machinery.
However, if fatigue occurs after administration of this medicine, driving and operating machinery should be avoided.

Fulvestrant Fresenius Kabi contains 500 mg of alcohol (ethanol) per injection, which corresponds to 100 mg/ml (10% w/v). The amount of alcohol in each injection of this medicinal product is equivalent to 13 ml of beer or 5 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents.
However, 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 Fresenius Kabi contains 500 mg of benzyl alcohol per injection, corresponding to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.

Fulvestrant Fresenius Kabi contains 750 mg of benzyl benzoate per injection, corresponding to 150 mg/ml.

3. How to use Fulvestrant Fresenius Kabi

Fulvestrant Fresenius Kabi is administered by a doctor or nurse. The medicine will be slowly injected intramuscularly in two separate injections of 5 ml each, given into separate 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 regarding the use of this medicine, 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, it is essential to
contact your doctor immediately and without delay:

• allergic reactions (hypersensitivity), 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 affect more than 1 in 10 people):

• injection site reactions, i.e. pain and (or) inflammation;
• changes in liver enzyme activity (in blood tests)*;
• nausea;
• feeling of weakness, fatigue*;
• joint pain and musculoskeletal pain;
• hot flushes;
• skin rash;
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and (or) throat.

All other adverse reactions:
Common adverse reactions (may affect 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 the leg on one side of the body (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 affect 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 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 cannot be assessed due to the underlying disease.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Fulvestrant Fresenius Kabi

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Store and transport under refrigerated conditions (2°C - 8°C).
Storage of the medicine at temperatures outside the range of 2°C - 8°C should be minimized. Avoid storage above 30°C and do not exceed a period of 28 days with an average storage temperature below 25°C (but outside the 2°C - 8°C range). If the temperature limits are exceeded, the recommended storage conditions should be immediately reinstated (store and transport refrigerated at 2°C - 8°C). Exposure to inappropriate storage temperatures may have a cumulative effect on the quality of the medicine, and the 28-day period must not be exceeded during the shelf life of Fulvestrant Fresenius Kabi (see section 6.3). Exposure to temperatures below 2°C does not damage the medicine, provided it is not stored below -20°C.
Store the pre-filled syringe in its original packaging to protect from light.
Healthcare personnel are responsible for the proper storage, handling, and disposal of unused or waste material from Fulvestrant Fresenius Kabi.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Fresenius Kabi contains

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

What Fulvestrant Fresenius Kabi looks like and contents of the pack
Fulvestrant Fresenius Kabi is a clear, colourless to yellow, viscous solution in a pre-filled
syringe made of colourless type I glass, with a polystyrene plunger terminating in an elastomeric
stopper, and a protective cap, contained in a cardboard box, containing 5 ml of fulvestrant solution.
Two pre-filled syringes should be used to administer the recommended monthly dose of 500 mg.
Fulvestrant Fresenius Kabi is available in three pack sizes containing 1, 2 or 6 pre-filled syringes.
The packs also contain 1, 2 or 6 administration needles with a safety device (BD SafetyGlide), respectively.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
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:

Information intended exclusively for healthcare professionals:

Fulvestrant Fresenius Kabi 500 mg (2 x 250 mg/5 ml solution for injection) must be administered using two pre-filled syringes, see section 3.
Administration instructions
Warning – do not place the safety-engineered needle (BD SafetyGlide Shielding Hypodermic Needle) in an autoclave before use. Avoid hand contact with the needle during administration and disposal.
Applies to both syringes:

• Remove the glass cartridge from the container and inspect for damage.
• Open the outer packaging of the safety-engineered needle (SafetyGlide).
• Prior to administration of parenteral solutions, visually inspect the solution for particulate matter and discoloration.
• Hold the syringe vertically by the fluted section (C). With the other hand, grasp the cap (A) and gently tilt forward and carefully turn the plastic cap counterclockwise (see Figure 1).

Figure 1

• Remove the cap (A) in an upright vertical position. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2

• Attach the safety-engineered needle to the Luer-Lock tip and screw on securely (see Figure 3).
• Check that the needle is properly connected to the Luer tip before proceeding to the 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 any excess air from the syringe.

Figure 3

• Administer the medication 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 side of the needle as the needle shield activation lever (see Figure 4).

Figure 4

• Immediately after injection, activate the needle safety mechanism by pushing forward the shield activation lever (see Figure 5).

WARNING: Handle in a manner that ensures safety for yourself and others. Listen for the click and visually confirm that the needle tip is completely covered.

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