Fulvestrant vipharm

Package leaflet: Information for the user

Fulvestrant Vipharm, 250 mg/5 mL, solution for injection in prefilled syringe
Fulvestrantum
Please read all of this leaflet carefully before 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 personally. 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.

Contents of the leaflet

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

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

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

Fulvestrant Vipharm is used:

• as a single agent, for the treatment of postmenopausal women with a certain type of breast cancer called oestrogen receptor-positive advanced breast cancer that has spread locally or 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 has spread locally or 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 Vipharm is given in combination with palbociclib, it is important to also read the package leaflet for palbociclib. If you have any questions about palbociclib, please consult your doctor.

2. Important information before using Fulvestrant Vipharm

When not to use Fulvestrant Vipharm

• 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 liver function impairment

Warnings and precautions
Inform your doctor, pharmacist, or nurse before using Fulvestrant Vipharm if any of the following health problems have ever occurred:

• if kidney or liver diseases have ever been diagnosed
• if thrombocytopenia (reduced platelet count, which enables blood clotting) or coagulation disorders have been diagnosed
• if thrombotic disorders have ever occurred
• if problems related to reduced bone mineralization (osteoporosis) have ever occurred
• alcohol dependence

Children and adolescents
Fulvestrant Vipharm is not recommended for use in children and adolescents under 18 years of age.
Fulvestrant Vipharm 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 the patient is taking anticoagulant medicines (medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant Vipharm must not be used during pregnancy. If the patient may become pregnant, she should use effective contraception during treatment with Fulvestrant Vipharm and for 2 years after the last dose.
Breastfeeding must not be performed during treatment with Fulvestrant Vipharm.
Driving and operating machinery
Fulvestrant has not been shown to affect the ability to drive motor vehicles or operate machinery. However, if fatigue occurs after administration of Fulvestrant Vipharm, driving and operating machinery must not be undertaken.
This medicine contains 500 mg of alcohol (ethanol) per injection , equivalent to a concentration of 100 mg/ml (10% w/v). The amount of alcohol in this medicine is equivalent to 13 ml of beer or 5 ml of wine.
The alcohol content in this medicine is unlikely to affect adults and adolescents.
The alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, medical advice should be sought from a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, he should consult a doctor or pharmacist before using this medicine.
Fulvestrant Vipharm contains 500 mg of benzyl alcohol per injection , equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Fulvestrant Vipharm contains 750 mg of benzyl benzoate per injection , equivalent to 150 mg/ml.

3. How to use Fulvestrant Vipharm

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure,
ask your doctor or pharmacist.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections), administered once a month,
plus an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant Vipharm is administered by a doctor or nurse. The medicine will be slowly injected
intramuscularly in two separate 5 ml injections, each into a different buttock.
If you have any further questions about 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 everyone will experience them.
If any of the following side effects occur, you must
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 side effects occur, inform your
doctor, pharmacist, or nurse:
Very common side effects (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
• 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 side effects:
Common side effects (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 side effects (may occur in up to 1 in 100 people)

• thick, whitish 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 (hepatitis)
• liver failure
• numbness, tingling and pain
• anaphylactic reactions * Includes side effects for which the influence of fulvestrant cannot be assessed due to the presence of underlying disease.

Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Side effects
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.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Fulvestrant Vipharm

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 the abbreviation: EXP. The expiry date refers to the last day of the stated month.
There are no special temperature requirements for storage of this medicine.
Store the pre-filled syringe in the original packaging to protect from light.
Medical personnel are responsible for the proper storage, handling, and disposal of used Fulvestrant Vipharm 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 package and other information

What Fulvestrant Vipharm 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 Vipharm looks like and contents of the pack
Fulvestrant Vipharm is a clear, colourless to yellow, viscous solution in a pre-filled syringe made of colourless type I glass, with a plunger made of polystyrene ending in an elastomeric stopper, and a protective tip cap, contained in a cardboard box. Each syringe contains 5 ml of fulvestrant solution for injection. To administer the recommended monthly dose of 500 mg, the contents of two pre-filled syringes should be injected.
Three pack sizes of the medicinal product Fulvestrant Vipharm are available, containing 1, 2 or 6 pre-filled syringes. The packs also contain 1, 2 or 6 administration needles respectively, with a safety system (BD Safety Glide).
Not all pack types are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Manufacturer:
Laboratorios Farmalán, S.A.
Calle La Vallina s/n, Edificio 2
Polígono Industrial Navatejera
24193, Villaquilambre, León
Spain

This medicinal product has been authorised in the European Economic Area Member States under the following names:
Netherlands Fulvefar 250 mg solution for injection in a pre-filled syringe
Austria Fulvestrant +pharma 250 mg injection solution in a pre-filled syringe
Czech Republic Fulvestrant Vipharm
Hungary Fulvestrant Vipharm 250 mg oldatos injekció előretöltött fecskendőben
Poland Fulvestrant Vipharm
Slovakia Fulvestrant Vipharm 250 mg

Information intended exclusively for healthcare professionals:

Fulvestrant Vipharm 250 mg/5 mL, solution for injection in pre-filled syringes should be
administered using two pre-filled syringes (see section 3).
Instructions for administration
Warning – do not place the needle with safety shield (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 its container and inspect it for damage.
• Open the outer packaging of the safety-shielded 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 rock forward and backward until the cap disconnects and can be removed—do not twist (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-shielded needle to the Luer-Lock tip and screw it on securely (see Figure 3).
• Confirm 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 per injection), into the gluteal muscle (site on the buttock). For the convenience of the person administering, the needle bevel is located on the same side of the needle as the safety shield lever (see Figure 4).

Figure 4

• Immediately after drug administration, activate the needle safety shield by pushing its lever forward (see Figure 5).

WARNING: Act 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.