STRANTAS 250 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Strantas 250 mg solution for injection in pre-filled syringe EFG

fulvestrant

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 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

1. What is Strantas and what is it used for
2. What you need to know before you use Strantas
3. How to use Strantas
4. Possible side effects
5. Storage of Strantas
6. Contents of the pack and other information

1. What is Strantas and what is it used for

Strantas contains the active substance 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.

Strantas is used:

• alone, to treat postmenopausal women with a type of breast cancer called hormone 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, 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 reached menopause will also be treated with a medicine called luteinizing hormone-releasing hormone (LHRH) agonist.

Strantas may be administered in combination with palbociclib. It is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, ask your doctor.

2. What you need to know before you use Strantas

Do not use Strantas:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Strantas if any of the following apply to you:

• kidney or liver problems
• low platelet count (which helps blood to clot) or bleeding disorders
• previous blood clot problems
• osteoporosis (loss of bone density)
• alcoholism

Children and adolescents

Strantas is not indicated for use in children and adolescents under 18 years of age.

Strantas and other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breastfeeding

Do not use Strantas if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while being treated with Strantas and for 2 years after the last dose.

Do not breastfeed while being treated with Strantas.

Driving and using machines

Strantas 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.

Strantascontains 10% v/v ethanol (alcohol),i.e., up to 500 mg per dose, which is equivalent to 10 ml of beer or 4 ml of wine per dose.

This medicine is harmful to people with alcoholism.

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

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

Benzyl alcohol may cause allergic reactions.

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

3. How to use Strantas

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections) 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 by slow intramuscular injection into each of your buttocks.

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

4. Possible side effects

Like all medicines, Strantas can cause side effects, although not everybody gets 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)*
• Hepatitis (inflammation of the liver)
• Liver failure

Tell 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)

• Injection site reactions, such as pain and/or inflammation
• Abnormal liver enzyme levels (in blood tests)*
• Nausea (feeling sick)
• Weakness, fatigue*
• Joint and musculoskeletal pain
• Hot flushes
• 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 (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Decreased platelet count (thrombocytopenia)
• Vaginal bleeding
• Lumbar pain radiating to one leg (sciatica)
• Sudden weakness, numbness, tingling, or loss of movement in your leg,

especially on one side of the body, sudden problems with walking or balance (peripheral neuropathy).

Uncommon 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
• Hepatitis (inflammation of the liver)
• Liver failure
• Numbness, tingling, and pain

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

Reporting of side effects

If you experience 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 through the national reporting system listed in the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Strantas

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 or on the label of the pre-filled syringe after the abbreviation EXP. The expiry date refers to the last day of the month stated.

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

Temperature deviations outside the range of 2°C to 8°C should 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 medicine is below 25°C (but above 2°C to 8°C). After temperature deviations, the medicine should be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature deviations have a cumulative effect on the quality of the medicine, and the 28-day period should not exceed the 2-year shelf life of Strantas. Exposure to temperatures below 2°C will not damage the medicine, 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 proper storage, use, and disposal of Strantas.

This medicine may pose a risk to the aquatic environment. Medicines should 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

Composition of Strantas

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

Appearance and packaging of the product

Strantas is a viscous, clear, colorless to yellow solution.

Strantas is contained in a glass cylinder type I of a pre-filled syringe with a Luer-Lok closure and a cap for closure, closed with a plunger that contains 250 mg of fulvestrant in 5 ml of solution.

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

Strantas is presented in a pack of two pre-filled syringes.

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

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 medicine isauthorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: February 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/.

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This information is intended only for healthcare professionals:

Strantas 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 autoclave sterilize the safety needle before use. Hands should remain behind the needle at all times during use and disposal.

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

For each of the two syringes:

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

Figure 1

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

Figure 2

• Screw the safety needle onto the Luer-Lok until it is firmly attached.
• Pull the protective cap straight off the needle to avoid damaging the tip.
• Take the loaded syringe to the administration site.
• Remove the protective cap from the needle.
• Parenteral solutions should be inspected visually for the absence of particles and discoloration before administration.
• Remove excess gas from the syringe.
• Administer slowly by intramuscular injection into the buttock (gluteal area) (1-2 minutes/injection). For greater comfort, the position of the needle with the bevel upwards has the same orientation as the raised arm of the lever (see Figure 3).

Figure 3

• After injection, immediately activate the safety system by pushing the lever 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 visually confirm that the needle tip is fully protected.

Disposal

The pre-filled syringes are onlyfor single use.

This medicine may pose a risk to the aquatic environment. Disposal of unused medicine and all materials that have been in contact with it will be carried out in accordance with local regulations.