Prospect: information for the user

Fulvestrant Stada 250 mg injectable solution in pre-filled syringe EFG

Read this prospect carefully before starting to use this medication, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Fulvestrant Stada

3.How to use Fulvestrant Stada

4.Possible adverse effects

5.Storage of Fulvestrant Stada

6.Contents of the package and additional information

Fulvestrant Stada contains the active ingredient fulvestrant, which belongs to the group of estrogen receptor blockers.

Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Fulvestrant is used:

• alone, to treat postmenopausal women with a 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 to treat women with a type of breast cancer called hormone receptor-positive breast cancer, human epidermal growth factor receptor 2-negative breast cancer that is locally advanced or has spread to other parts of the body (metastatic). Women who have not yet reached menopause may also be treated with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist.

Fulvestrant may be administered in combination with palbociclib. It is essential that you read the prospectus of palbociclib as well. If you have any questions about palbociclib, consult your doctor.

No use Fulvestrant Stada

• if you are allergic to fulvestrant or any of the ingredients in this medication (listed in section 6)

-if you are pregnant or breastfeeding

-if you have severe liver problems.

Advertencias y precauciones

Consult your doctor, pharmacist, or nurse before starting to use fulvestrant if any of the following apply:

-kidney or liver problems

-low platelet count (which helps blood clotting) or bleeding disorders

-previous blood clotting problems

-osteoporosis (bone density loss)

-alcoholism.

Niños y adolescentes

Fulvestrant is not indicated for children and adolescents under 18 years.

Uso de Fulvestrant Stada con otros medicamentos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, tell your doctor if you are using anticoagulants (medications to prevent blood clots).

Embarazo y lactancia

Embarazo

You should not use fulvestrant if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are on treatment with fulvestrant and for two years after your last dose.

Lactancia

You should not breastfeed while on treatment with fulvestrant.

Conducción y uso de máquinas

Fulvestrant Stada is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment, do not drive or use machines.

Uso en deportistas

Inform patients that this medication contains fulvestrant, which may produce a positive result in doping control tests.

Fulvestrant Stada contains etanol

This medication contains 1,000 mg of alcohol (ethanol) in each 500 mg dose of fulvestrant. The amount of alcohol in each 500 mg dose of this medication is equivalent to 25 ml of beer or 10 ml of wine.

It is unlikely that the amount of alcohol in this medication will have an effect on adults.

The alcohol in this medication may interact with other medications. Talk to your doctor or pharmacist if you are taking other medications.

If you are an alcoholic, consult your doctor or pharmacist before taking this medication.

Fulvestrant Stada contains benzyl alcohol

This medication contains 1,000 mg of benzyl alcohol in each 500 mg dose of fulvestrant. Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

Fulvestrant Stada contains benzyl benzoate

This medication contains 1,500 mg of benzyl benzoate in each 500 mg dose of fulvestrant.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 500 mg of fulvestrant (two injections of 250 mg/5 ml) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.

Your doctor or nurse will administer fulvestrant via a slow intramuscular injection in each of your buttocks.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, fulvestrant may cause side effects, although not everyone will experience them.

You may need urgent medical treatment if you experience any of the following side effects:

?Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be symptoms of anaphylactic reactions.

?Thromboembolism (increased risk of blood clots)*

?Liver inflammation (hepatitis)

?Liver failure

Inform your doctor, pharmacist, or nurse immediately if you notice any of the following side effects:

Very common side effects(may affect more than 1 in 10 people)

• Reactions at the injection site, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood analysis)*
• Nausea (feeling of discomfort)
• Weakness, fatigue*
• Joint and muscle skeletal pain
• Headaches
• Acne.

• 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)

• Headaches
• Vomiting, diarrhea, or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet levels (thrombocytopenia)
• Vaginal bleeding
• Lower back pain that radiates to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in one leg, especially on one side of the body, sudden problems walking or balance (peripheral neuropathy).

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

• Thick, white vaginal discharge, and candidiasis (infection)
• Hematoma and hemorrhage at the injection site
• Increased gamma-GT, a liver enzyme identified in blood analysis
• Liver inflammation (hepatitis)
• Liver failure
• Numbness, tingling, and pain
• Anaphylactic reactions

* Includes side effects for which the exact role of fulvestrant cannot be evaluated due to underlying disease.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store and transport refrigerated (between 2°C and 8°C).

Store the pre-filled syringe in the original packaging to protect it from light.

Temperature deviations outside the range of 2°C to 8°C must be controlled. This includes avoiding storage at temperatures above 30°C, and not exceeding a period of 28 days, during which the average storage temperature of the medication is below 25°C (but above 2°C and 8°C). After temperature deviations, the medication must be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature deviations have an accumulative effect on the quality of the medication, and should not exceed the period of 28 days beyond the expiration date of fulvestrant. Exposure to temperatures below 2°C does not affect the medication, provided it is not stored below -20°C.

Do not use this medication after the expiration date that appears on the packaging or on the labels of the syringes after the abbreviation CAD. The expiration date is the last day of the month indicated.

Your healthcare professional will be responsible for the correct conservation, use, and disposal of Fulvestrant Stada.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. In this way, you will help protect the environment.

Composition of Fulvestrant Stada

-The active ingredient is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant. Each ml of solution contains 50 mg of fulvestrant.

-The other components (excipients) are ethanol (96%), benzyl alcohol, benzyl benzoate, and refined ricin oil.

Appearance of the product and contents of the pack

Fulvestrant Stada is a transparent, colorless to yellowish, practically particle-free, oily, and viscous solution contained in a pre-filled syringe of glass. Each syringe contains 5 ml of injectable solution.

Fulvestrant Stada is presented in three pack formats:

-Carton box with a blister pack containing a pre-filled syringe, a sterile hypodermic needle (BD SafetyGlide), and a leaflet.

or

-Carton box with two blister packs, each containing a pre-filled syringe, two sterile hypodermic needles (BD SafetyGlide), and a leaflet.

or

-Carton box with six blister packs, each containing a pre-filled syringe, six sterile hypodermic needles (BD SafetyGlide), and a leaflet.

Only some pack sizes may be marketed.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible Person for Manufacturing

S.C. Rompharm Company S.R.L.

Strada Eroilor nr. 1A,

075100 Otopeni

Romania

or

STADA Arzneimittel AG

Stadastr. 2-18, Dortelweil

D-61118 Bad Vilbel

Hessen

Germany

or

STADApharm GmbH

Feodor-Lynen-Str. 35

D-30625 Hannover

Germany

or

STADA Arzneimittel GmbH

Geschäftsanschrift -

Muthgasse 36/2 Doebling

A-1190 Vienna

Austria

Last review date of this leaflet:December 2020

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Fulvestrant Stada should be administered using two pre-filled syringes, see section 3.

Administration Instructions

Administer the injection according to local guidelines for the intramuscular injection of large volumes.

NOTE:Due to the proximity of the sciatic nerve, caution should be exercised if fulvestrant is injected in the gluteal region (see section 4.4).

Warnings:Do not sterilize the safety needle (BD SafetyGlide) in an autoclave before use.

Hands should remain behind the needle at all times during use and disposal.

For each of the two syringes:

• Remove the glass barrel from the syringe from the blister pack and check that it is not damaged.
• Open the outer packaging of the safety needle(“SafetyGlide”).
• Before administration, visually inspect the parenteral solutions for particulate matter and discoloration.
• Hold the syringe in a vertical position.
• With the other hand, hold the cap and turn it carefully and remove it. To maintain sterility, do not touch the tip of the syringe (see Figure 1).

Figure 1

??Attach the safety needle tol the Luer-Lok connector and screw it in until it is securely attached (see Figure 2).

Figure 2

• Check that the needle is attached to the Luer-Lock connector before releasing it from the vertical position.
• Remove the protective cap of the needle in a straight line to avoid damaging the tip of the needle.
• Take the loaded syringe to the administration site.
• Remove the protective cap of the needle.
• Remove excess gas from the syringe.
• Administer slowly by intramuscular injection in the gluteal region (1-2 minutes/injection). For greater comfort, the position of the needle with the bevel up has the same orientation as the arm of the plunger raised (see Figure 3).

Figure 3

??After the injection, immediately give a single tap with your finger on the arm of the plunger to activate the protection mechanism (see Figure 4).

NOTE:Activate away from your body and others. Listen for the click and visually confirm that the tip of the needle is fully protected.

Figure 4

Disposal

The pre-filled syringes are for single use only.

This medicinal product may present a risk to aquatic environments. The disposal of unused medicinal product and all materials that have been in contact with it will be carried out in accordance with local regulations.