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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

fulvestrant

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See Section 4.

Leaflet contents

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

1. What Strantas is and what it is used for

Strantas contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, may in some cases be involved in the development of breast cancer.

Strantas is 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, human epidermal growth factor receptor 2-negative (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 be treated with a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

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

2. What you need to know before using Strantas

Do not use Strantas:

• if you are allergic to fulvestrant or to any of the other components 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 (platelets help blood to clot) or bleeding disorders
• history of blood clots
• 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

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

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

Pregnancy and breastfeeding

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

You must not breastfeed while being treated with Strantas.

Driving and using machines

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% w/v ethanol (alcohol), meaning up to 500 mg per dose, equivalent to 10 ml of beer or 4 ml of wine per dose.

This medicine may be harmful for people suffering from alcoholism.

The alcohol content should 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 may cause allergic reactions.

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

3. How to use Strantas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, 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 500 mg dose given 2 weeks after the initial dose.

Your doctor or nurse will administer Strantas to you as a slow intramuscular injection into each buttock.

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

4. Possible adverse effects

Like all medicines, Strantas can cause adverse effects, although not everyone will experience them.

You may need urgent medical treatment if you experience any of the following adverse 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)*
• Inflammation of the liver (hepatitis)
• Liver failure

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

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

• Reactions at the injection site, such as pain and/or swelling
• Abnormal levels of liver enzymes (in blood tests)*
• Nausea (feeling unwell)
• Weakness, fatigue*
• Joint and musculoskeletal pain
• Hot flushes
• Skin rash
• Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue and/or throat

All remaining adverse effects:

Common adverse effects (may affect up to 1 in 10 people)

• Headache
• Vomiting, diarrhoea or loss of appetite*
• Urinary tract infections
• Back pain*
• Increased bilirubin (a bile pigment produced by the liver)
• Thromboembolism (increased risk of blood clots)*
• Low platelet levels (thrombocytopenia)
• Vaginal bleeding
• Lower back 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 walking or with balance
  (peripheral neuropathy)

Uncommon adverse effects (may affect up to 1 in 100 people)

• Thick, whitish vaginal discharge and candidiasis (infection)

• Anaphylactic reactions

• Bruising and bleeding at the injection site

• Increased gamma-GT, a liver enzyme detected in blood tests

• Inflammation of the liver (hepatitis)

• Liver failure

• Numbness, tingling, and pain

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

Reporting of adverse effects

If you experience any kind of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse 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 stated on the packaging or on the labels of the syringes following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Temperature excursions outside the range of 2°C to 8°C should be limited. This includes avoiding storage at temperatures above 30°C for no more than 28 days, during which the mean storage temperature of the medicine must remain below 25°C (but above the 2°C to 8°C range). After any temperature excursion, the medicine must be returned immediately to the recommended storage conditions (store and transport in a refrigerator between 2°C and 8°C). Temperature excursions have a cumulative effect on the quality of the medicine, and the total duration of such excursions must not exceed 28 days over the 2-year shelf life of Strantas. Exposure to temperatures below 2°C will not damage the medicine, provided it is not stored below -20°C.

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

Your healthcare professional is 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 drains or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. 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 components (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and refined castor oil.

Appearance of the product and contents of the pack

Strantas is a viscous, transparent solution, colourless to yellow.

Strantas is contained in the type I glass barrel of a pre-filled syringe with a luer lock and cap for the lock, closed with a plunger, containing 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 available in a pack containing two pre-filled syringes.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: February 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.es/.

This information is intended for healthcare professionals only:

Strantas 500 mg (2 x 250 mg/5 ml injectable solution) must be administered using two pre-filled syringes, see section 3.

Administration instructions

Warning – Do not sterilize the safety needle in an autoclave prior to use. Hands must remain behind the needle at all times during use and disposal.

The syringes are supplied with a BD Safety Glide® safety needle.

For each of the two syringes:

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

Figure 1

• Open the outer 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 securely attached.
• Pull the needle protective cap straight off to avoid damaging the needle tip.
• Take the loaded syringe to the administration site.
• Remove the protective cap from the needle.
• Parenteral solutions should be visually inspected prior to administration to confirm the absence of particles and discoloration.
• Expel excess air from the syringe.
• Administer slowly by intramuscular injection into the gluteal region (1-2 minutes/injection). For greater comfort, the needle position with the bevel facing upward has the same orientation as the raised lever arm (see Figure 3).

Figure 3

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

Figure 4

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

Disposal

The pre-filled syringes are for single use only.

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