Label: information for the patient

Afultrant 250 mg injectable solution in pre-filled syringe EFG

fulvestrant

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribedonlyto you, and you should not give it to others even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse, evenifthey are not listed in this label. See section 4.

1. What Afultrant is and for what it is used

2. What you need to know before starting to use Afultrant

3. How to use Afultrant

4. Possible adverse effects

5. Storage of Afultrant

6. Contents of the package and additional information

Afultrantcontains 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.

Afultrant is used:

• in 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 breast cancer 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 medication called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Afultrant is administered in combination with palbociclib, it is essential that you also read the prospectus for palbociclib. If you have any doubts about palbociclib, consult your doctor.

No useAfultrant:

• 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.

Advertencias and precautions

Consult your doctor, pharmacist, or nurse before starting to use Afultrant 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

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

Other medications and Afultrant

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

In particular, inform your doctor if you are using anticoagulants (medications to prevent blood clots).

Pregnancy and lactation

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

You should not use fulvestrant if you are pregnant.You should use an effective contraceptive method while you are being treated with fulvestrant.

You should not breastfeed while being treated with fulvestrant.

Driving and operating machinery

Fulvestrant 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.

Afultrant contains ethanol, benzyl alcohol, and benzyl benzoate

This medication contains 1,000 mg of ethanol (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 in this medication does not produce any noticeable effect.

This medication 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 associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This product should not be used for more than one week in children under 3 years old unless your doctor or pharmacist advises it.

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 medication 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 old).

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) administered once a month with an additional dose of 500 mg administered 2 weeks after the initial dose.

Your doctor or nurse will administer fulvestrant 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 medicines, this medicine may 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)*,
• inflammation of the liver (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 patients)

• reactions at the injection site, such as pain and/or inflammation,
• abnormal levels of liver enzymes (in blood tests)*,
• nausea (feeling of discomfort),
• weakness, fatigue*,
• joint and musculoskeletal pain,
• headaches,
• skin rash,
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat.

All remaining side effects:

Common side effects(may affect up to 1 in 10 patients)

• headaches,
• 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 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 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 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 evaluated due to underlying disease.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout 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/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Do not usethis medicationif you observe that the device or the content is in any way damaged, such as a 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 medication may pose a risk to the aquatic environment.Loose medications should not be flushed down the drains or thrown away. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Afultrant

• 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.

Appearance of the product and contents of the pack

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

Afultrantis provided in one or two pre-filled syringes for single use. An additional sterile needle is provided.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Bexal Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Person

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

Germany:Fulvestrant - 1 A Pharma 250 mg Injection solution in a pre-filled syringe

Austria:Fulvestrant Sandoz 250 mg Injection solution in a pre-filled syringe

Belgium:Fulvestrant Sandoz 250 mg solution for injection in a pre-filled syringe

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

Croatia:Fulvestrant Sandoz 250 mg solution for injection in a pre-filled syringe

Denmark:Fulvestrant Sandoz

Slovakia:Fulvestrant Sandoz 250 mg, injection solution filled in a pre-filled syringe

Slovenia:Fulvestrant Lek 250 mg solution for injection in a pre-filled syringe

Estonia:Fulvestrant Sandoz, 250 mg solution for injection in a pre-filled syringe

Spain:Afultrant 250 mg injection solution EFG

Finland:Fulvestrant Sandoz 250 mg injection solution, ready-to-use syringe

France:FULVESTRANT SANDOZ 250 mg, solution for injection in a pre-filled syringe

Netherlands:Fulvestrant Sandoz 50 mg/ml, solution for injection in a pre-filled syringe

Hungary:Fulvestrant Sandoz 250 mg solution for injection in a pre-filled syringe

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

Iceland:Fulvestrant Sandoz 250 mg solution for injection in a pre-filled syringe

Italy:Fulvestrant Sandoz

Lithuania:Fulvestrant Sandoz 250 mg solution for injection in a pre-filled syringe

Norway:Fulvestrant Sandoz 250 mg injection solution, solution in a pre-filled syringe

Poland:Fulvestrant Sandoz, 250 mg/5 ml solution for injection in a pre-filled syringe

Portugal:Fulvestrant Sandoz 250 mg injection solution in a pre-filled syringe

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

Czech Republic:Fulvestrant Sandoz 250 mg injection solution in a pre-filled syringe

Romania:Fulvestrant Sandoz 250 mg injection solution in a pre-filled syringe

Sweden:Fulvestrant Sandoz 250 mg injection solution, solution in a pre-filled syringe

Last update of the summary of product characteristics:enero 2022

For further information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

This information is intended solely for healthcare professionals:

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

Administration instructions

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

Needles are supplied with safety systemBD SafetyGlide®or Terumo SurGuard®

Instructions for safety needles BD SafetyGlide®

For each of the two syringes:

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

Instructions for safety needles Terumo SurGuard®

For each of the two syringes:

The activation can be verified by listening for a “click” or by touch and can be visually confirmed.

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

Disposal

The pre-filled syringes are forsingleuse.

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.