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

Spain
Brand name Afultrant 250 mg solution for injection in pre-filled syringe EFG
Form solution for injection
Active substance / Dosage
FULVESTRANT · 250 mg
Prescription type Prescription Only Medicine
ATC code
L02B L02BA L02BA03
Registration number 80254
Manufacturer Bexal Farmaceutica S.A.
Afultrant 250 mg solution for injection in pre-filled syringe EFG solution for injection

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Afultrant 250 mg injection solution in pre-filled syringe EFG

fulvestrant

Read the entire leaflet carefully before you start using this medicine because 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

  1. What Afultrant is and what it is used for
  2. What you need to know before using Afultrant
  3. How to use Afultrant
  4. Possible side effects
  5. How to store 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 hormones, may in some cases be involved in the development of breast cancer.

Afultrant is used:

  • as monotherapy, for the treatment of 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 and 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 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 palbociclib package leaflet. If you have any questions about palbociclib, consult your doctor.

2. What you need to know before using Afultrant

Do not use Afultrant:

  • if you are allergic to fulvestrant or to 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 starting Afultrant if any of the following apply to you:

  • kidney or liver problems,
  • low platelet count (platelets help blood to clot) or bleeding disorders,
  • previous history of blood clots,
  • osteoporosis (loss of bone density),
  • alcoholism.

Children and adolescents

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

Other medicines and Afultrant

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

In particular, you must inform your doctor if you are taking anticoagulants (medicines used to prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine and for two years after your last dose.

You must not use fulvestrant if you are pregnant. If you can become pregnant, you should use an effective method of contraception during treatment 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 operate machinery.

Afultrant contains ethanol, benzyl alcohol, and benzyl benzoate

This medicine contains 1,000 mg of alcohol (96% ethanol) 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 contained in this medicine does not produce any noticeable effect.

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

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically advised by your doctor.

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

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).

This medicine contains 1,500 mg of benzyl benzoate per administered dose, 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 instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor or nurse will administer fulvestrant to you by slow intramuscular injection into each of your gluteal muscles.

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, this medicine 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.

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

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

  • reactions at the injection site, such as pain and/or swelling,
  • abnormal liver enzyme levels (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 patients)

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

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

  • thick, whitish vaginal discharge and candidiasis (infection),

  • 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,

  • anaphylactic reactions.

  • 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging or on the labels of the syringes following the abbreviation CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Your healthcare professional is responsible for the proper storage, use, and disposal of Afultrant.

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

This medicine may pose a risk to the aquatic environment. Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Afultrant

  • The active substance 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.

Appearance of the product and contents of the container

Afultrant is a viscous, transparent, colourless to yellowish solution in a pre-filled syringe.

Afultrant is supplied in one or two single-use pre-filled syringes. One sterile needle is provided separately.

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 the most recent review of this leaflet: January 2022

Detailed information on this medicine is available on the website of the Spanish Agency of 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) must 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.

Needles are supplied with BD SafetyGlide® or Terumo SurGuard® safety systems.

Instructions for BD SafetyGlide® safety needles

For each of the two syringes:

  • Carefully remove the syringe and needle from the packaging.
  • Remove the protective cap from the top of the syringe barrel.
  • Open and remove the outer packaging of the safety needle (BD SafetyGlide). Attach the safety needle to the "Luer-Lok".
  • Rotate the needle to secure it to the Luer connector. Turn until firmly tightened.
  • Pull the needle cap straight off to avoid damaging the needle tip.

Two hands holding a syringe to connect the

  • Remove the needle cap.
  • While holding the syringe with the needle pointing upward, gently press the plunger until the medication reaches the top of the syringe. There should be no air in the barrel.
  • Administer slowly by intramuscular injection into the gluteal muscle (1 to 2 minutes per injection). For greater comfort, positioning the needle with the bevel facing upward corresponds to the lever arm in the raised position.

Technical diagram of a medical device with a thin needle and a circular magnification showing the sharp tip of the

  • After injection, immediately press once with your finger on the lever arm to activate the safety mechanism.

One hand holding a syringe with the needle pointing upward

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

Instructions for needles with Terumo SurGuard® safety system

For each of the two syringes:

  • Carefully remove the syringe and needle from the packaging.
  • Remove the protective cap from the top of the syringe barrel.
  • Attach the syringe to the needle using an aseptic technique. Hold the base of the needle, not the safety shield, and twist the syringe clockwise.

Two hands holding a horizontal injection pen to prepare the drug dosage with the

  • Move the safety shield away from the needle and toward the syringe barrel at the angle shown. Then remove the needle cap.

Technical drawing showing two hands holding a syringe and tilting it from a horizontal to a vertical position via a curved arrow

  • While holding the syringe with the needle pointing upward, gently press the plunger until the medication reaches the top of the syringe. There should be no air inside the barrel.
  • Administer slowly by intramuscular injection into the gluteal muscle (1–2 minutes per injection).
  • After completing the injection, withdraw the needle from the skin and use one of the one-handed techniques to activate the safety mechanism, using one of the following three methods:
  • Finger activation

One hand holding a medical device and an arrow indicating a downward rotation or click motion for the

  • Thumb activation

One hand holding a pen-shaped medical device and tilting it downward following the direction indicated by a curved arrow

  • Surface activation

Technical drawing showing a hand tilting a syringe with needle downward following a curved arrow for the

Activation can be verified by listening for a "click" or by tactile sensation, and can also be visually checked.

If you are not sure that the safety shield is fully activated, repeat this step.

Disposal

Pre-filled syringes are for single use only.

Any unused medication and all materials that have come into contact with it must be disposed of in accordance with local regulations.