Fulvestrant Teva

Package Leaflet: Information for the User

Fulvestrant Teva, 250 mg/5 ml, Solution for Injection in a Prefilled Syringe

fulvestrant

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet:

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

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

Fulvestrant Teva contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes influence the growth of breast cancer.

Fulvestrant Teva is used:

• alone to treat breast cancer in postmenopausal women with a specific type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastatic) or
• in combination with palbociclib to treat a specific type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, which 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 luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Teva is given in combination with palbociclib, it is also important to read the package leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. Important information before using Fulvestrant Teva

When NOT to use Fulvestrant Teva

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding")
• if you have severe liver problems.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before using Fulvestrant Teva if you have had any of the following health problems:

• if you have ever had kidney or liver disease
• if you have had a low platelet count (which helps the blood to clot) or have had bleeding problems
• if you have ever had a blood clotting disorder
• if you have ever had problems with bone thinning (osteoporosis)
• if you are addicted to alcohol (see section "Fulvestrant Teva contains ethanol (alcohol) 96%").

The effectiveness and safety of fulvestrant (alone or in combination with palbociclib) have not been studied in patients with massive visceral metastases.

Children and adolescents

Fulvestrant Teva is NOT recommended for use in children and adolescents under 18 years of age.

Fulvestrant Teva and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

Fulvestrant Teva MUST NOT be used during pregnancy. If you may become pregnant, you are advised to use effective contraceptive methods during treatment with Fulvestrant Teva and for 2 years after the last dose.

Driving and using machines

Fulvestrant Teva has not been shown to affect the ability to drive and use machines. However, if you experience fatigue after using Fulvestrant Teva, DO NOT drive or use machines.

Fulvestrant Teva contains ethanol (alcohol) 96%

This medicine contains 474 mg of ethanol (alcohol) in each 5 ml prefilled syringe, which is equivalent to 94.8 mg/ml. The amount of alcohol in one dose of this medicine (10 ml, 2 prefilled syringes) is equivalent to less than 24 ml of beer or 10 ml of wine.

Fulvestrant Teva contains benzyl alcohol

This medicine contains 500 mg of benzyl alcohol in each 5 ml prefilled syringe, which is equivalent to 100 mg/ml.

Fulvestrant Teva contains benzyl benzoate

This medicine contains 750 mg of benzyl benzoate in each 5 ml prefilled syringe, which is equivalent to 150 mg/ml.

3. How to use Fulvestrant Teva

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 usual dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml), given once a month, and an additional dose of 500 mg given 2 weeks after the first dose.

Fulvestrant Teva is given by a doctor or nurse. The medicine will be slowly injected into a muscle in two consecutive injections, each into a different buttock.

4. Possible side effects

Like all medicines, Fulvestrant Teva can cause side effects, although not everybody gets them.

If you experience any of the following side effects, seek medical attention immediately:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be signs of anaphylactic reaction
• blood clotting disorders (increased risk of venous thromboembolism) *
• hepatitis
• liver failure.

If you experience any of the following side effects, tell your doctor, pharmacist, or nurse:

Side effects reported in patients treated with Fulvestrant Teva alone:

• injection site reactions, such as pain and/or inflammation
• changes in liver enzyme activity (in blood tests)*
• nausea (feeling sick)
• fatigue*
• joint and muscle pain
• hot flashes, skin rash
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat

All other side effects:

Common side effects(may affect up to 1 in 10 people)

• headache
• vomiting, diarrhea, or loss of appetite*
• urinary tract infections
• back pain*
• increased bilirubin levels (a pigment produced by the liver).
• blood clotting disorders (increased risk of venous thromboembolism)*
• low platelet count (thrombocytopenia)
• vaginal bleeding
• lower back pain radiating to one leg (sciatica)
• sudden weakness, numbness, tingling, or loss of movement in one leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy).

Uncommon side effects(may affect up to 1 in 100 people)

• thick, white vaginal discharge and vaginal yeast infection
• bruising and bleeding at the injection site
• increased activity of the liver enzyme gamma-glutamyltransferase
• hepatitis
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions

Reporting of side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below.

5. How to store Fulvestrant Teva

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or label after EXP. The expiry date refers to the last day of that month.

Do not use the medicine if you notice any particles or discoloration before administration.

Store and transport in a refrigerator (2°C - 8°C).

Limit storage of the medicine at temperatures other than 2°C - 8°C. Avoid storage at temperatures above 25°C and do not exceed a period of 28 days with an average storage temperature below 25°C (but above the range 2°C - 8°C). If the storage temperature range is exceeded, the recommended storage conditions should be applied immediately (store and transport in a refrigerated state at 2°C - 8°C). Exceeding the recommended storage temperature may have a cumulative effect on the quality of the product, and the 28-day period must not be exceeded within the 2-year shelf life of Fulvestrant Teva. Exposure to temperatures below 2°C does not damage the product if it is not stored at temperatures below -20°C.

Store the prefilled syringe in its original packaging to protect it from light.

Medical personnel are responsible for the proper storage, use, and disposal of the packaging after the medicine has been used.

This medicine may pose a risk to aquatic environments. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Teva contains

The active substance is fulvestrant. Each prefilled syringe contains 250 mg of fulvestrant.

One milliliter of the solution contains 50 mg of fulvestrant.

The other ingredients are ethanol (96%), benzyl alcohol, benzyl benzoate, and purified castor oil.

What Fulvestrant Teva looks like and contents of the pack

Fulvestrant Teva is a clear, colorless to yellowish, viscous solution in a prefilled syringe with a Luer-Lock connector, containing 5 ml of solution for injection.

To administer the recommended monthly dose of 500 mg, two prefilled syringes should be injected.

Fulvestrant Teva has two types of packaging:

• Packaging containing 1 glass prefilled syringe with a needle for administration, with a safety system.
• Packaging containing 2 glass prefilled syringes with 2 needles for administration, with a safety system. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

tel. (22) 345 93 00

Manufacturer

PLIVA Hrvatska d.o.o. (Pliva Croatia Ltd.)

Prilaz baruna Filipovića 25

10000 Zagreb, Croatia

Date of last revision of the package leaflet:February 2021

Information intended for healthcare professionals only:

Fulvestrant Teva 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two prefilled syringes (see section 3).

Administration instructions

Administer the injection according to local guidelines for performing large-volume intramuscular injections.

CAUTION: Be careful when administering Fulvestrant Teva into the upper outer quadrant of the buttock due to the proximity of the sciatic nerve (see section 4.4).

NOTE - DO NOT put the needle with the safety system in an autoclave before use. When handling the medicine and disposing of waste, AVOID hand contact with the needle.

Remove the glass syringe from the container and check for damage. Open the outer packaging of the needle with the safety system. Before administering parenteral solutions, visually inspect for particulate matter and change in color. Hold the syringe vertically in the striped part (C). With the other hand, grasp the cap (A) and carefully twist it counterclockwise until the cap separates and can be removed (see Figure 1).	Rysunek 1
Remove the cap (A) in a vertical position upwards. To maintain sterility, DO NOT TOUCH THE Luer-Lock CONNECTOR (B) (see Figure 2).	Rysunek 2
Attach the needle with the safety system to the Luer-Lock connector and tighten securely (see Figure 3). Check that the needle is attached to the Luer-Lock connector before proceeding to the vertical position. Bring the filled needle close to the injection site. Remove the needle shield without damaging the sharp point of the needle.	Rysunek 3

Remove the needle shield without damaging the sharp point of the needle.
Remove any air from the syringe. Administer the medicine intramuscularly, slowly (1-2 minutes/injection), into the buttock muscle (injection site on the buttock). For the convenience of the person administering the injection, the needle cut is on the same surface as the safety system activation lever (see Figure 4).	Rysunek 4
Immediately after administering the medicine, activate the needle safety system by pushing the lever forward (see Figure 5). CAUTION: Proceed in such a way as to ensure your safety and the safety of others. Listen for the click and visually confirm that the needle tip is completely covered.	Rysunek 5

Disposal of waste

The prefilled syringe is for single use only.

This medicine may pose a risk to aquatic environments. Any unused medicine or waste material should be disposed of in accordance with local requirements.