FULVESTRANT 250 mg /5 Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Fulvestrant Glenmark, 250 mg/5 ml, Solution for Injection in a Prefilled Syringe
   1. Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.
   2. Contents of the Pack and Other Information
3. What is Fulvestrant Glenmark and What is it Used For
4. Before You Use Fulvestrant Glenmark
   1. Do Not Use Fulvestrant Glenmark:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Fulvestrant Glenmark and Other Medicines
   5. Pregnancy and Breast-Feeding
   6. Driving and Using Machines
   7. Fulvestrant Glenmark Contains Benzyl Alcohol
   8. Fulvestrant Glenmark Contains Benzyl Benzoate
5. How to Use Fulvestrant Glenmark
6. Possible Side Effects
   1. If You Experience Any of the Following, Tell Your Doctor Immediately:
   2. If You Experience Any of the Following, Tell Your Doctor, Pharmacist, or Nurse:
   3. All Other Side Effects:
   4. Reporting of Side Effects
7. How to Store Fulvestrant Glenmark
8. Contents of the Pack and Other Information
   1. What Fulvestrant Glenmark Contains
   2. What Fulvestrant Glenmark Looks Like and Contents of the Pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Manufacturer
   5. For Further Information, Contact Your Local Representative of the Marketing Authorisation Holder:
   6. This Medicinal Product is Authorised in the Member States of the EEA Under the Following Names:
   7. Date of Last Revision of the Leaflet:
   8. Information Intended for Healthcare Professionals Only:

Package Leaflet: Information for the User

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

Fulvestrant

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

• You should 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 signs of illness 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 Pack and Other Information

• 1. What is Fulvestrant Glenmark and What is it Used For
• 2. Before You Use Fulvestrant Glenmark
• 3. How to Use Fulvestrant Glenmark
• 4. Possible Side Effects
• 5. How to Store Fulvestrant Glenmark
• 6. Contents of the Pack and Other Information

1. What is Fulvestrant Glenmark and What is it Used For

Fulvestrant Glenmark contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes affect the growth of breast cancer. Fulvestrant Glenmark is used either:

• alone to treat postmenopausal women with a specific type of breast cancer called hormone receptor-positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic) or
• in combination with palbociclib to treat women with a specific 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 reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Glenmark 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. Before You Use Fulvestrant Glenmark

Do Not Use Fulvestrant Glenmark:

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding.
• if you have severe liver problems.

Warnings and Precautions

Before starting treatment with Fulvestrant Glenmark, tell your doctor or pharmacist if you have any of the following conditions:

• kidney or liver disease
• low platelet count (which can make you bruise or bleed easily) or bleeding disorders
• history of blood clots
• decreased bone density (osteoporosis)
• alcohol dependence

Children and Adolescents

Fulvestrant Glenmark is not intended for use in children and adolescents under 18 years of age.

Fulvestrant Glenmark and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.

Pregnancy and Breast-Feeding

Fulvestrant Glenmark must not be used during pregnancy. If you are able to become pregnant, you should use effective contraception during treatment with Fulvestrant Glenmark and for 2 years after the last dose. You must not breast-feed while you are having treatment with Fulvestrant Glenmark.

Driving and Using Machines

Fulvestrant Glenmark is unlikely to affect your ability to drive or use machines. However, if you feel tired after receiving Fulvestrant Glenmark, do not drive or use machines. Fulvestrant Glenmark contains 500 mg of alcohol (ethanol) in each injection, which is equivalent to 100 mg/ml (10% w/v).The amount of alcohol in each injection of this medicine is equivalent to 13 ml of beer or 5 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect in adults and adolescents. However, the alcohol in this medicine may affect how other medicines work. If you are taking other medicines, ask your doctor or pharmacist for advice. If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. If you are alcohol dependent, ask your doctor or pharmacist for advice before taking this medicine.

Fulvestrant Glenmark Contains Benzyl Alcohol

The medicine contains 500 mg of benzyl alcohol in each prefilled syringe, which is equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions. If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine. Women who are pregnant or breast-feeding, patients with liver or kidney disease should consult their doctor before taking this medicine, as large amounts of benzyl alcohol may build up in their body and cause side effects (such as metabolic acidosis).

Fulvestrant Glenmark Contains Benzyl Benzoate

Fulvestrant Glenmark contains 750 mg of benzyl benzoate in each prefilled syringe, which is equivalent to 150 mg/ml.

3. How to Use Fulvestrant Glenmark

This medicine should always be used under the guidance of a doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections), given once a month, with an additional 500 mg dose given 2 weeks after the first dose. Fulvestrant Glenmark will be slowly injected into a muscle by a doctor or nurse, with each injection given into a different buttock. If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If You Experience Any of the Following, Tell Your Doctor Immediately:

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

If You Experience Any of the Following, Tell Your Doctor, Pharmacist, or Nurse:

Very Common Side Effects(may affect more than 1 in 10 people)

• injection site reactions, such as pain and/or inflammation
• changes in liver enzyme activity (in blood tests)*
• nausea
• feeling weak, tired*
• joint and muscle 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 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 clots (increased risk of venous thromboembolism)*
• low platelet count (thrombocytopenia)
• vaginal bleeding
• sciatica (pain in the lower back radiating to one leg)
• sudden weakness, numbness, tingling, or loss of movement in one leg, especially if it occurs 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 candidiasis (infection)
• bruising and bleeding at the injection site
• increased gamma-glutamyltransferase activity, a liver enzyme measured in blood tests
• liver inflammation (hepatitis)
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions

* Includes side effects for which the contribution of Fulvestrant Glenmark cannot be assessed due to the underlying disease.

Reporting of Side Effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Fulvestrant Glenmark

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C - 8°C). The product should be kept in the original package to protect it from light. Healthcare professionals are responsible for the proper storage, handling, and disposal of Fulvestrant Glenmark after use. Medicines should 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 Glenmark Contains

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

What Fulvestrant Glenmark Looks Like and Contents of the Pack

Fulvestrant Glenmark is a clear, colorless to yellow, viscous solution in a prefilled syringe, containing 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, two prefilled syringes should be injected. Fulvestrant Glenmark is available in two pack sizes: a pack containing 1 glass prefilled syringe or a pack containing 2 glass prefilled syringes. The packs also contain needles for administration, with a safety device (BD SafetyGlide). The medicine should be inspected visually for particulate matter and discoloration prior to administration.

Marketing Authorisation Holder and Manufacturer

Glenmark Pharmaceuticals s.r.o., Hvězdova 1716/2b, 140 78 Prague 4, Czech Republic

Manufacturer

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

For Further Information, Contact Your Local Representative of the Marketing Authorisation Holder:

Glenmark Pharmaceuticals Sp. z o.o., ul. Osmańska 14, 02-823 Warsaw

This Medicinal Product is Authorised in the Member States of the EEA Under the Following Names:

Date of Last Revision of the Leaflet:

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Information Intended for Healthcare Professionals Only:

Fulvestrant Glenmark, 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two prefilled syringes, see section 3. Administration Instructions Note - the needle with a safety device (BD SafetyGlide Safety Hypodermic Needle) should not be placed in an autoclave before use. When handling the medicine and disposing of waste, avoid hand contact with the needle. Applies to both syringes:

• Remove the glass syringe from the container and check it for damage.
• Open the outer packaging of the needle with a safety device (SafetyGlide).
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe upright in the fluted part (C). With the other hand, grasp the needle shield (A) and twist it counterclockwise (see Figure 1).

Figure 1

• Remove the needle shield (A) in a vertical direction away from you. To maintain sterility, do not touch the needle (B) (see Figure 2).

Figure 2
Attach the needle with a safety device to the Luer-Lock and tighten it firmly (see Figure 3).

• Check that the needle is securely attached to the Luer-Lock before proceeding to the upright position.
• Pull the needle shield off with a firm motion to avoid damaging the needle point.
• Bring the filled needle close to the injection site.
• Remove the needle shield.
• Remove any air from the syringe.

Figure 3

• Administer the medicine intramuscularly, slowly (1-2 minutes/injection), into the buttock muscle (on the buttock). For the convenience of the administrator, the needle bevel is on the same surface as the safety device activation lever (see Figure 4).

Figure 4
Immediately after administration, activate the needle safety device by sliding the lever forward with your finger (see Figure 5). CAUTION:The device should be activated away from you and others. The needle tip is completely covered when you hear a click, confirm this visually.

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