Fulvestrant teva

Package leaflet: Information for the user

Fulvestrant Teva, 250 mg/5 ml, solution for injection in pre-filled syringe
fulvestrant
Please read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Fulvestrant Teva is and what it is used for
2. What you need to know before you use 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 Fulvestrant Teva is and what it is used for

Fulvestrant Teva contains the active substance fulvestrant, which belongs to a group of medicines called
estrogen receptor antagonists. Estrogens are female sex hormones that can sometimes affect the growth of breast cancer.
Fulvestrant Teva 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 Teva is given in combination with palbociclib, it is important to also read the leaflet provided with palbociclib. If you have any questions about palbociclib, please speak to your doctor.

2. Important information before using Fulvestrant Teva

When NOT to use Fulvestrant Teva

• if the patient has hypersensitivity to fulvestrant or to any of the other components of this medicine (listed in section 6)
• if the patient is pregnant or breastfeeding (see section "Pregnancy and breastfeeding")
• if the patient has severe hepatic impairment.

Warnings and precautions
Please inform your doctor, pharmacist or nurse before using Fulvestrant Teva if the patient has any of the following health conditions:

• if kidney or liver disease has ever been diagnosed
• if thrombocytopenia (low platelet count, which affects blood clotting) or a bleeding disorder has been diagnosed
• if thromboembolic disease has ever occurred
• if bone mineralization disorders (e.g. osteoporosis) have ever occurred
• alcohol dependence (see section "Fulvestrant Teva contains 96% ethanol (alcohol)").

The efficacy and safety of fulvestrant (as monotherapy or in combination with palbociclib) have not been studied in patients with extensive 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 medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking anticoagulant medicines (medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant Teva must not be used during pregnancy. If the patient may become pregnant, effective contraception is recommended during treatment with Fulvestrant Teva and for 2 years after the last dose.
Breastfeeding must not be undertaken during treatment with Fulvestrant Teva.
Driving and operating machinery
Fulvestrant Teva has not been shown to affect the ability to drive or operate machinery. However, if fatigue occurs after administration of Fulvestrant Teva, the patient must not drive or operate machinery.
Fulvestrant Teva contains 96% ethanol (alcohol)
This medicine contains 474 mg of alcohol (ethanol) in each 5 ml pre-filled syringe, equivalent to 94.8 mg/ml. The amount of alcohol in one dose of this medicine (10 ml, 2 pre-filled syringes) corresponds to less than 24 ml of beer or 10 ml of wine.
The small amount of alcohol in this medicine is unlikely to cause noticeable effects.
Fulvestrant Teva contains benzyl alcohol
This medicine contains 500 mg of benzyl alcohol in each 5 ml pre-filled syringe, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult their doctor or pharmacist before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Fulvestrant Teva contains benzyl benzoate
This medicine contains 750 mg of benzyl benzoate in each 5 ml pre-filled syringe, equivalent to 150 mg/ml.

3. How to use Fulvestrant Teva

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The usual dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml each), administered
once a month, with an additional 500 mg dose given 2 weeks after the first dose.
Fulvestrant Teva is administered by a doctor or nurse. The medicine will be slowly injected
intramuscularly in two separate injections, each into a different buttock.
If there are further doubts about how to use this medicine, consult a doctor, pharmacist, or
nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, seek immediate medical help:

• allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and (or) throat, which may be symptoms of an anaphylactic reaction
• thromboembolic disease (increased risk of venous thrombosis) *
• hepatitis (liver inflammation)
• liver failure

If any of the following adverse reactions occur, inform your doctor, pharmacist, or nurse:
Adverse reactions reported in patients treated with Fulvestrant Teva monotherapy:
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 sick)
• weakness, fatigue*
• joint pain and musculoskeletal pain
• hot flushes, skin rash
• allergic (hypersensitivity) reactions, 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 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 affect up to 1 in 100 people)

• thick, white vaginal discharge and vaginal fungal infection (candidiasis)
• bruising and bleeding at the injection site
• increased gamma-glutamyl transferase (GGT) activity, a liver enzyme measured in blood tests
• hepatitis (liver inflammation)
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions

* Adverse reactions for which the influence of Fulvestrant Teva cannot be assessed due to the presence of underlying disease.
Adverse reactions reported in patients treated with Fulvestrant Teva in combination with palbociclib:
Very common adverse reactions (may affect more than 1 in 10 people)

• decreased neutrophil count (neutropenia)
• decreased white blood cell count (leukopenia)
• infections
• fatigue
• nausea
• decreased red blood cell count (anaemia)
• mouth inflammation or ulceration
• diarrhoea
• decreased platelet count (thrombocytopenia)
• vomiting
• hair loss
• rash
• loss of appetite
• fever

Common adverse reactions (may affect up to 1 in 10 people)

• feeling weak
• increased liver enzyme levels
• loss of taste
• nosebleeds
• excessive tearing
• dry skin
• blurred vision
• dry eyes

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

• fever with other signs of infection (febrile neutropenia)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

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 stated on the carton or on the syringe label
after "EXP". The expiry date refers to the last day of the stated month.
Do not use the medicine if particles or discoloration are observed before administration.
Store and transport in a refrigerator (2°C - 8°C).
Storage of the medicine at temperatures other than 2°C - 8°C should be minimized. 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 2°C - 8°C range). If the temperature range is
exceeded, the recommended storage conditions should be immediately reinstated (store and
transport refrigerated at 2°C - 8°C). Exceeding the recommended storage temperature may have
a cumulative effect on the product quality, 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, provided it is not stored below -20°C.
Store the pre-filled syringe in its original packaging to protect from light.
Healthcare professionals are responsible for the proper storage, handling, and disposal of
used Fulvestrant Teva 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. This will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Teva contains
The active substance is fulvestrant. Each pre-filled syringe contains 250 mg of fulvestrant.
One millilitre of 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, colourless to yellow, viscous solution in a pre-filled syringe with a Luer-Lock connector, 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 Teva is available in two pack sizes:

• A pack containing 1 glass pre-filled syringe with one administration needle, with a safety system.
• A pack containing 2 glass pre-filled syringes with two administration needles, with a safety system.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00

Manufacturer
PLIVA Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz baruna Filipovića 25
10000 Zagreb, Croatia

Information intended exclusively for healthcare professionals:

Fulvestrant Teva 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using
two pre-filled syringes (see section 3).
Administration instructions
The injection should be given in accordance with local guidelines for administering large-volume
intramuscular injections.
WARNING: Caution should be exercised if Fulvestrant Teva is administered into the upper outer
gluteal region due to the proximity of the sciatic nerve (see section 4.4).
Note – DO NOT place the needle with the safety shield system into an autoclave prior to use.
When handling the product and disposing of waste, AVOID HAND CONTACT with the needle.
Applies to both syringes:

Remove the glass ampoule from the container and check whether it is damaged. Open the outer needle packaging with safety shield system. Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration. Hold the syringe vertically at the ribbed part (C). With the other hand, grasp the cap (A) and carefully turn it counterclockwise until the cap disconnects and can be removed (see Figure 1).	Figure 1
Remove the cap (A) in an upright vertical position. To maintain sterility, DO NOT TOUCH THE LUER-LOCK NOZZLE (B) (see Figure 2).	Figure 2
Attach the needle with safety shield system to the Luer-Lock nozzle and screw on securely (see Figure 3). Check that the needle is properly connected to the Luer nozzle before proceeding to the upright position. Bring the filled needle close to the administration site. Remove the needle protective cover without damaging	Figure 3
its sharp tip.
Expel any excess air from the syringe. The medicinal product should be administered intramuscularly, slowly (1-2 minutes/injection), into the gluteal muscle (site on buttock). For user convenience, the needle bevel is located on the same surface of the needle as the safety shield lever (see Figure 4).	Figure 4
Immediately after administering the medicine, activate the needle safety shield system by pushing its lever forward (see Figure 5). Caution: Act to ensure safety of yourself and others. Listen for a click and visually confirm that the needle tip is completely covered.	Figure 5

Disposal of residues
The vial-syringe is for single use only.
This medicinal product may pose a risk to the aquatic environment. Any unused residues or
waste must be disposed of in accordance with local regulations.