Introduction

Prospect: information for the patient

Onnimia 250 mg injectable solution in pre-filled syringe EFG

fulvestrant

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Onnimia and for what it is used

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

3.How to use Onnimia

4.Possible adverse effects

5.Storage of Onnimia

6.Contents of the package and additional information

1. What is Onnimia and how is it used

Onnimia contains 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.

Fulvestrant is used:

?in monotherapy, 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 withpalbociclib to treat women with a type of breast cancer called hormone receptor-positive breast cancer, 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.

Fulvestrant can be administered in combination with palbociclib. It is essential that you also read the prospectus for palbociclib. If you have any questions about palbociclib, consult your doctor.

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

No use Onnimia:

-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

Warnings and precautions

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

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

Use of Onnimia with other medications

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

Particularly, tell your doctor if you are using anticoagulants (medications to prevent blood clots).

Pregnancy and breastfeeding

You should not use fulvestrant if you are pregnant. If you can become pregnant, you must use an effective contraceptive method while you are being treated with Onnimia and for two years after your last dose.

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.

Use in athletes

This medication contains fulvestrant, which may produce a positive result in doping control tests.

Onnimia contains ethanol (alcohol), benzyl alcohol, benzyl benzoate, and refined ricin oil.

This medication contains 10% v/v of ethanol (alcohol), which corresponds to 500 mg per dose, equivalent to 10 ml of beer or 4 ml of wine. This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant women, breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medication contains 500 mg of benzyl alcohol per injection, equivalent to 100 mg/ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (known as "metabolic acidosis").

This medication contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.

This medication may cause severe allergic reactions because it contains refined ricin oil.

3. How to use Onnimia

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, 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 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible Adverse Effects

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)*

?Liver inflammation (hepatitis)

?Liver failure

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

Frequent side effects(may affect more than 1 in 10 people)

?Reactions at the injection site, such as pain and/or inflammation

?Abnormal liver enzyme levels (in blood tests)*

?Nausea (feeling of discomfort)

?Weakness, fatigue*

?Joint and musculoskeletal pain

?Hot flashes

?Skin rash

?Allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat.

All other side effects:

Frequent 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 pigment produced by the liver)

?Thromboembolism (increased risk of blood clots)*

?Decreased platelet levels (thrombocytopenia)

?Vaginal bleeding

?Lower back pain that radiates to one side of the 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).

Rare side effects(may affect up to 1 in 100 people)

?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

?Liver inflammation (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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Onnimia Storage

Keep this medication out 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. The expiration date is the last day of the month indicated.

Store and transport refrigerated (between 2°C and 8°C).

Temperature deviations outside the range of between 2°C and 8°C must be controlled. 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 medication is below 25°C (but above between 2°C and 8°C). After temperature deviations, the medication must be returned immediately to the recommended storage conditions (store and transport refrigerated between 2°C and 8°C). Temperature deviations have an accumulative effect on the quality of the medication, and should not exceed the period of 28 days beyond the expiration date of 2 years of Onnimia. Exposure to temperatures below 2°C will not damage the medication, 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 correct storage, use, and disposal of Onnimia.

This medication may pose a risk to aquatic environments. Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

6. Content of Onnimia

Composition of Onnimia

-The active ingredient is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg of fulvestrant. Each ml contains 50 mg of fulvestrant.

-The other components (excipients) are ethanol (96 percent), benzyl alcohol, benzyl benzoate, and refined ricin oil.

Appearance of the product and contents of the pack

Onnimia is a viscous, transparent, colourless to yellow solution in a pre-filled syringe equipped with a safety closure, containing 5 ml of injectable solution. Two syringes should be administered to receive the recommended monthly dose of 500 mg.

Onnimia is available in two formats, either a pack containing one glass pre-filled syringe or a pack containing two glass pre-filled syringes. In addition, safety needles (“BD SafetyGlide”) are provided for connection to the body of each syringe.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca - Madrid

Spain

Manufacturer responsible

Laboratori FUNDACIO DAU

C/De la letra C, 12-14, Industrial Zone of the Free Zone

Barcelona 08040

Spain

This medicinal product is authorised in the member states of the European Economic Area with the following names:

France	Fulvestrant Intas 250 mg, solution injectable in a pre-filled syringe
Germany	Fulvestrant Intas 250 mgInjektionslösung in einer Fertigspritze.
Spain	Onnimia250 mg injectable solution in a pre-filled syringe EFG

Date of the last review of this leaflet:August 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

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

Administration instructions

Warning – Do not sterilize the safety needle (Hypodermic Needle Protected “BD SafetyGlide”) in an autoclave before use. Hands must remain behind the needle at all times during use and disposal..

To administer each of the two syringes:

?Remove the glass barrel from the syringe from the tray and check that it is not damaged. ?Open the outer packaging of the safety needle(“SafetyGlide”). ?Before administration, visually inspect the parenteral solutions for particles and discoloration. ?Hold the syringe in a vertical position, gripping it by the ridged part (C). With the other hand, hold the cap (A) and tilt it carefully back and forth until the cap comes off and can be removed, do not turn it(see Figure 1).	Figure 1
?Remove thecap (A) by pulling it upwards. To maintain sterility, avoid touching the tip of the syringe (B) (see Figure 2)	Figure 2
?Attach the safety needle to the “Luer-Lok” and screw it in until it is securely attached (see Figure 3). ?Check that the needle is attached to the Luer connector before releasing it from the vertical position. ?Remove the protective cap of the needle in a straight line to avoid damaging the tip of the needle. ?Take the loaded syringe to the administration site. ?Remove the protective cap of the needle. ?Remove any excess gas from the syringe.	Figure 3
?Administer slowly by intramuscular injection in the gluteal region (1-2 minutes/injection). For greater comfort, the position of the needle with the bevel upwards has the same orientation as the arm of the lever raised (see Figure 4).	Figure 4
?After the injection, immediately give a single tap with your finger on the lever arm to activate the protection mechanism (see Figure 5). NOTE: Activate away from your body and others. Listen for the click and visually confirm that the tip of the needle is fully protected.	Figure 5

Disposal

The pre-filled syringes areonlyfor single use.

This medicinal productmay pose a risk to aquatic environments. The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.