AFULTRANT 250 mg Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Patient

Afultrant 250 mg solution for injection in a 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 symptoms are the same as yours.
• If you experience 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 Afultrant is and what it is used for
2. What you need to know before you use Afultrant
3. How to use Afultrant
4. Possible side effects
5. Storage of Afultrant
6. Contents of the pack and other information

1. What Afultrant is and what it is used for

Afultrant 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.

Afultrant is used:

• as monotherapy, for the treatment of 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 and 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 a luteinizing hormone-releasing hormone (LHRH) agonist.

When Afultrant is 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 Afultrant

Do not useAfultrant:

• 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 you start using Afultrant 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

Afultrant is not indicated in children and adolescents under 18 years of age.

Other medicines and Afultrant

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine and for 2 years after your last dose.

You must not use fulvestrant if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while being treated with fulvestrant.

You must not breastfeed while being treated with fulvestrant.

Driving and using machines

Fulvestrant 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.

Afultrant contains ethanol, benzyl alcohol, and benzyl benzoate

This medicine contains 1,000 mg of alcohol (ethanol 96%) per dose, equivalent to 100 mg/ml (10% w/v). The amount per dose administered is equivalent to less than 24 ml of beer or 10 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains 1,000 mg of benzyl alcohol per dose administered, equivalent to 100 mg/ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including breathing problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This product should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

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

This medicine contains 1,500 mg of benzyl benzoate per dose administered, equivalent to 150 mg/ml.

Benzyl benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to use Afultrant

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

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

Your doctor or nurse will give you fulvestrant by slow intramuscular injection into each of your buttocks.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may need urgent medical attention 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)*,
• inflammation of the liver (hepatitis),
• 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 patients)

• reactions at the injection site, such as pain and/or inflammation,
• abnormal levels of liver enzymes (in blood tests)*,
• nausea (feeling sick),
• weakness, tiredness*,
• joint and musculoskeletal pain,
• hot flushes,
• skin 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 patients)

• 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,
• 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 with walking or balance (peripheral neuropathy).

Uncommon side effects(may affect up to 1 in 100 patients)

• thick, white, vaginal discharge and candidiasis (infection),
• hematoma and bleeding at the injection site,
• increased gamma-GT, a liver enzyme that is identified in a blood test,
• inflammation of the liver (hepatitis),
• liver failure,
• numbness, tingling, and pain,
• anaphylactic reactions.

• Includes side effects for which the exact role of fulvestrant cannot be assessed 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 Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Afultrant

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 labels of the syringes after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

Do not use this medicine if you notice that the device or the contents are damaged in any way, such as damage to the syringe, the solution is not clear, there are particles in suspension, or there is a change in the color of the solution.

This medicine may pose a risk to the aquatic environment. Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Afultrant Composition

• The active ingredient is fulvestrant.

Each pre-filled syringe contains 250 mg of fulvestrant in 5 ml of solution (50 mg/ml).

• The excipients are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and castor oil.

Product Appearance and Container Contents

Afultrant is a viscous, clear, colorless to yellow solution in a pre-filled syringe.

Afultrant is provided in one or two single-use pre-filled syringes. A sterile needle is provided additionally.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bexal Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova 57,

SLO-1526 Ljubljana,

Slovenia

or

Ebewe Pharma Ges.m.b.H. Nfg.KG

Mondseestrasse 11,

4866 Unterach

Austria

or

Fareva Unterach GmbH

Mondseestraße 11

4866 Unterach

Austria

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

Germany: Fulvestrant - 1 A Pharma 250 mg Injektionslösung in einer Fertigspritze

Austria: Fulvestrant Sandoz 250 mg Injektionslösung in einer Fertigspritze

Belgium: Fulvestrant Sandoz 250 mg oplossing voor injectie in een voorgevulde spuit

Bulgaria: Fulvestrant Sandoz 250 mg/5 ml Solution for injection in pre-filled syringe

Croatia: Fulvestrant Sandoz 250 mg otopina za injekciju u napunjenoj štrcaljki

Denmark: Fulvestrant Sandoz

Slovakia: Fulvestrant Sandoz 250 mg, injekcný roztok naplnený v injekcnej striekacke

Slovenia: Fulvestrant Lek 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi

Estonia: Fulvestrant Sandoz, 250 mg süstelahus süstlis

Spain: Afultrant 250 mg solución inyectable EFG

Finland: Fulvestrant Sandoz 250 mg injektioneste, liuos, esitäytetty ruisku

France: FULVESTRANT SANDOZ 250 mg, solution injectable en seringue pré-remplie

Netherlands: Fulvestrant Sandoz 50 mg/ml, oplossing voor injectie in voorgevulde spuit

Hungary: Fulvestrant Sandoz 250 mgoldatos injekció eloretöltött fecskendoben

Ireland: Fulvestrant Rowex 250 mg/5 ml solution for injection in pre-filled syringe

Iceland: Fulvestrant Sandoz 250 mg stungulyf, lausn í áfylltri sprautu

Italy: Fulvestrant Sandoz

Lithuania: Fulvestrant Sandoz 250 mg injekcinis tirpalas užpildytame švirkšte

Norway: Fulvestrant Sandoz 250 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte

Poland: Fulvestrant Sandoz, 250 mg/5 ml roztwór w ampulko-strzykawce

Portugal: Fulvestrant Sandoz 250 mg solução injetável em seringa pré-cheia

United Kingdom: Fulvestrant 250 mg solution for injection in pre-filled syringe

Czech Republic: Fulvestrant Sandoz 250 mg injekcní roztok v predplnené injekcní stríkacce

Romania: Fulvestrant Sandoz 250 mg solutie injectabila in seringa preumpluta

Sweden: Fulvestrant Sandoz 250 mg injektionsvätska, lösning i förfylld spruta

Date of Last Revision of this Leaflet:January 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Afultrant 500 mg (2 x 250 mg injectable solution) should be administered using two pre-filled syringes. See section 3.

Administration Instructions

Warning – Do not sterilize the safety needle system in an autoclave before use. Hands should remain behind the needle at all times during use and disposal.

The needles are supplied with a BD SafetyGlide® or Terumo SurGuard® safety system

Instructions for BD SafetyGlide® Safety Needles

For each of the two syringes:

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

Instructions for Terumo SurGuard® Safety Needles

For each of the two syringes:

The activation can be verified by listening for a "click" or by tactile means and can be visually confirmed.

If you are unsure that the safety protector is fully activated, repeat this step.

Disposal

The pre-filled syringes are for singleuse.

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.