Package Insert: Information for the User

Strantas 250 mg Pre-filled Syringe EFG

fulvestrant

Read this package insert carefully before starting to use this medication, as it contains important information for you.

- Keep this package insert, 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 others 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 package insert. See Section 4.

1. What isStrantasand how it is used

2. What you need to know before starting to useStrantas

3. How to useStrantas

4. Possible adverse effects

5. Storage ofStrantas

6. Contents of the package and additional information

Strantascontains the active ingredient fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormone, may be involved in the development of breast cancer in some cases.

Strantasis used:

• alone, to treat postmenopausal women with a 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 to treat women with a type of breast cancer called hormone receptor-positive breast cancer, human epidermal growth factor receptor 2-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 be treated with a medication called a luteinizing hormone-releasing hormone (LHRH) agonist.

Strantasmay be administered in combination with palbociclib. It is essential that you also read the prospectus for palbociclib. If you have any questions about palbociclib, consult your doctor.

No use Strantas:

- if you are allergic to fulvestrant or any of the other components of this medication (listed in section 6)

- if you are pregnant or breastfeeding

- if you have severe liver problems

Warnings and precautions

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

- kidney or liver problems

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

- previous history of blood clots

- osteoporosis (bone density loss)

- alcoholism

Children and adolescents

Strantas is not indicated for children and adolescents under 18 years old.

Strantas and other medications

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

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

Pregnancy and breastfeeding

You must not use Strantas if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are on treatment with Strantas and for up to 2 years after the last dose.

You must not breastfeed while on treatment with Strantas.

Driving and operating machinery

Strantas is not expected to affect your ability to drive or operate machinery. However, if you feel tired after treatment, do not drive or operate machinery.

Strantas contains 10% v/v of ethanol (alcohol),that is, up to 500 mg per dose, equivalent to 10 ml of beer or 4 ml of wine per dose.

This medication is harmful to people with alcoholism.

The alcohol content must be taken into account in high-risk groups, such as patients with liver disease, or epilepsy.

Strantas contains 500 mg of benzyl alcohol in each injection, equivalent to 100 mg/ml.

Benzyl alcohol can cause allergic reactions.

Strantas contains 750 mg of benzyl benzoate in each injection, equivalent to 150 mg/ml.

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 Strantas 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 medications,Strantasmay 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 tests)*

-Nausea (feeling of discomfort)

-Weakness, fatigue*

-Joint and musculoskeletal pain

-Hot flashes

-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)

-Headache

-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 your 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)

- Anaphylactic reactions

- Hematoma and bleeding at the injection site

- Increased gamma-GT, a liver enzyme identified in a blood test

- Liver inflammation (hepatitis)

- Liver failure

- Numbness, tingling, and pain

* 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 the national notification system included in the Spanish System of Pharmacovigilance of Medicinal Products for Human Use at www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Temperature deviations outside the range of between 2°C and 8°C must be limited. 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 between 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 2 years ofStrantas. Exposure to temperatures below 2°C will not damage the medication, as long as it is not stored below -20°C.

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

Your healthcare professional will be responsible for the correct storage, use, and disposal ofStrantas.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Strantas

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

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

Appearance of the product and contents of the pack

Strantasis a viscous, transparent, colourless to yellow solution.

Strantasis contained in a type I glass cylinder of a pre-filled syringe with a Luer-type stopper and a cap for the stopper, closed with a plunger containing 250 mg of fulvestrant in 5 ml of solution.

A safety needle (BD Safety Glide®) is also included for connection to the syringe body.

Strantasis presented in a pack containing two pre-filled syringes.

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6th floor,

08039 Barcelona,

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola, PLA 3000, Malta

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Last review date of this leaflet: February 2021

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

---------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

Strantas500 mg (2 x 250 mg/5 ml injectable solution) should be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning – Do not autoclave the safety needle before use. Hands must remain behind the needle at all times during use and disposal.

The syringes are presented with a safety needle BD Safety Glide.

For each of the two syringes:

• Remove the glass barrel from the syringe from the tray and check that it is not damaged.
• Unscrew the plastic stopper cap from the Luer-Lok syringe to remove the cover along with the rubber plug included (see Figure 1).

Figure 1

• Open the external packaging of the safety needle (BD Safety Glide). Attach the safety needle to the Luer-Lok (see Figure 2).

Figure 2

• Tighten the safety needle to the Luer-Lok until it is securely attached.
• Pull the protective cap of the needle straight off to avoid damaging the needle tip.
• Carry the loaded syringe to the administration site.
• Remove the protective cap of the needle.
• Parenteral solutions must be visually inspected before administration to check for the absence of particles and discoloration.
• Remove any excess gas from the syringe.
• Administer slowly by intramuscular injection in the buttock (gluteal region) (1-2 minutes/injection). For greater comfort, the needle position with the bevel up has the same orientation as the arm of the plunger raised (see Figure 3).

Figure 3

• After injection, activate the safety mechanism immediately by pressing the plunger arm until the needle tip is completely covered (see Figure 4).

Figure 4

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

Disposal

The pre-filled syringes areonlyfor single use.

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.