Fulvestrant glenmark

Package leaflet: Information for the user

Fulvestrant Glenmark, 250 mg/5 ml, solution for injection in pre-filled syringe
Fulvestrantum
Read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.

• 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 a specific individual. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

1. What Fulvestrant Glenmark is and what it is used for
2. What you need to know before using 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 Fulvestrant Glenmark is and what it is 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 influence the development of breast cancer.

Fulvestrant Glenmark is used either:

• as a single agent, for the treatment of postmenopausal women with a certain type of breast cancer called estrogen receptor-positive breast cancer, which 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 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 gonadotropin-releasing hormone (GnRH) agonist.

When Fulvestrant Glenmark 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 Glenmark

When not to use Fulvestrant Glenmark:

• 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
Before starting treatment with Fulvestrant Glenmark, discuss with your doctor,
pharmacist, or nurse if any of the following situations apply to you:

• kidney or liver disease
• low platelet count (which enables blood clotting) or bleeding disorders
• history of blood clotting disorders
• reduced bone mineral density (osteoporosis)
• alcohol dependence

Children and adolescents
Fulvestrant Glenmark must not be used in children and adolescents under 18 years of age.
Fulvestrant Glenmark and other medicines
You must 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 you are taking anticoagulant medicines (medicines that prevent blood clots).
Pregnancy and breastfeeding
Fulvestrant Glenmark must not be used during pregnancy. If you are of childbearing potential, you should use effective contraception during treatment with Fulvestrant Glenmark and for 2 years after receiving the last dose.
Breastfeeding must not be undertaken during treatment with Fulvestrant Glenmark.
Driving and using machines
Fulvestrant Glenmark is not expected to affect the ability to drive or operate machinery. However, if you experience fatigue after receiving Fulvestrant Glenmark, you must not drive or operate machinery.
Fulvestrant Glenmark contains 500 mg of alcohol (ethanol) per injection, 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 alter the effects of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before using this medicine.
If you are alcohol-dependent, you should consult your doctor or pharmacist before using this medicine.
Fulvestrant Glenmark contains benzyl alcohol
This medicine contains 500 mg of benzyl alcohol in each pre-filled syringe, equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before using this medicine.
Pregnant or breastfeeding women, and patients with liver or kidney disease, should consult their doctor before using this medicine, as high amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Fulvestrant Glenmark contains benzyl benzoate
Fulvestrant Glenmark contains 750 mg of benzyl benzoate in each pre-filled syringe, equivalent to 150 mg/ml.

3. How to use Fulvestrant Glenmark

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
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.
Fulvestrant Glenmark will be slowly injected intramuscularly by a doctor or nurse,
each injection into a different buttock.
If you have any further questions about 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.
If the patient experiences any of the following adverse reactions,
contact a doctor immediately:

• Hypersensitivity reactions (allergic reactions), 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 the patient experiences any of the following adverse reactions,
inform a doctor, pharmacist or nurse:
Very common adverse reactions (may occur in more than 1 in 10 people)

• Reactions at the injection site such as pain and (or) inflammation
• Changes in liver enzyme activity (in blood tests)*
• Nausea
• Weakness, fatigue*
• Joint pain and musculoskeletal pain
• Hot flushes
• Skin rash
• Hypersensitivity reactions (allergic reactions), including swelling of the face, lips, tongue and (or) throat

All other adverse reactions:
Common adverse reactions (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 mobility in the leg, particularly on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy)

Uncommon adverse reactions (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-glutamyltransferase activity, a liver enzyme measured in blood tests
• Hepatitis (hepatitis)
• Liver failure
• Numbness, tingling and pain
• Anaphylactic reactions

* Includes adverse reactions for which the influence of Fulvestrant Glenmark product cannot be
assessed due to the presence of underlying disease.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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.: + 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 this medicine.

5. How to store Fulvestrant Glenmark

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after:
Expiry (EXP) or on the label after the abbreviation: EXP. The expiry date refers to the last day of the stated month.
Store and transport in a refrigerated condition (2°C - 8°C).
Storage of the product at temperatures other than 2°C - 8°C should be minimized. Avoid storage at temperatures above 30°C and do not exceed a period of 28 days with an average storage temperature below 25°C (but outside the range of 2°C - 8°C). 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 proper storage temperature range may have a cumulative effect on the product's quality, and the 28-day period must not be exceeded during the 2-year shelf life of Fulvestrant Glenmark.
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.
Medical personnel are responsible for the proper storage, handling, and disposal of the Fulvestrant Glenmark packaging after use.
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 in use. Following this advice will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Glenmark contains

• The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
• The other components 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, colourless to yellow, viscous solution in a pre-filled syringe 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 Glenmark is available in two pack sizes: a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
The packs also contain administration needles with a safety system (BD Safety Glide).

Marketing Authorisation Holder
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 more detailed information, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Osmańska Street 14
02-823 Warsaw
Poland

This medicinal product is authorised in the Member States under the following names:

Information intended exclusively for healthcare professionals:

Fulvestrant Glenmark 500 mg (2 x 250 mg/5 ml solution for injection) should be
administered using two pre-filled syringes, see section 3.
Administration instructions
Warning – do not place the safety needle (BD SafetyGlide Safety 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 check for damage.
• Open the outer packaging of the safety needle (SafetyGlide).
• Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
• Hold the syringe vertically by the ridged part (C). With the other hand, grasp the cap (A) and carefully twist the plastic, rigid end of the cap counterclockwise (see Figure 1).

Figure 1

• Remove the rigid end of the cap (A) vertically upward. To maintain sterility, do not touch the syringe tip (B) (see Figure 2).

Figure 2
Attach the safety needle to the Luer-Lock tip and screw tightly until resistance is felt
(see Figure 3).

• Check that the needle is securely connected to the Luer tip before proceeding to the upright position.
• Pull off the needle shield with a firm motion to avoid damaging the sharp tip.
• Bring the filled syringe close to the injection site.
• Remove the needle shield.
• Expel any excess air from the syringe.

Figure 3

• Administer the medicinal product intramuscularly, slowly (1–2 minutes per injection), into the gluteal muscle (site on the buttock). For the convenience of the administrator, the needle bevel is located on the same side of the needle as the safety mechanism lever (see Figure 4).

Figure 4
Immediately after drug administration, activate the needle safety mechanism with a finger by
pushing its lever forward (see Figure 5).
WARNING: Activate the safety mechanism away from yourself and others. The needle tip is fully enclosed upon hearing a click; visually confirm this.

Figure 5
Disposal of waste
Pre-filled syringes are intended only for single use.
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.