Onnimia 250 mg solution for injection in pre-filled syringe EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Onnimia 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, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if these adverse reactions are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Onnimia is and what it is used for
- What you need to know before using Onnimia
- How to use Onnimia
- Possible side effects
- How to store Onnimia
- Contents of the pack and other information
1. What Onnimia is and what it is used for
Onnimia 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.
Fulvestrant is used:
• as 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 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.
Fulvestrant 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 Onnimia
Do not use Onnimia:
- 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 starting Onnimia 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
Onnimia is not indicated for use in children and adolescents under 18 years of age.
Use of Onnimia with other medicines
Tell 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 using anticoagulants (medicines to prevent blood clots).
Pregnancy and breastfeeding
You must not use fulvestrant if you are pregnant. If you could become pregnant, you must use an effective method of contraception during treatment with Onnimia and for two years after the last dose.
You must not breastfeed while being treated with fulvestrant.
Driving and using machines
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 medicine contains fulvestrant, which may result in a positive doping test.
Onnimia contains ethanol (alcohol), benzyl alcohol, benzyl benzoate, and refined castor oil.
This medicine contains 10% p/v ethanol (alcohol), corresponding to 500 mg per dose, equivalent to 10 ml of beer or 4 ml of wine. This medicine may be harmful to individuals suffering from alcoholism.
The alcohol content should be considered in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
This medicine 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 medicine contains 750 mg of benzyl benzoate per injection, equivalent to 150 mg/ml.
This medicine may cause severe allergic reactions as it contains refined castor oil.
3. How to use Onnimia
Follow exactly the instructions for administration of this medicine given 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/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 fulvestrant as a slow intramuscular injection into each of your buttocks.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
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 require 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)*
? 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 people)
? 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, pharmacist, or nurse, 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 Onnimia
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging or on the labels of the syringes, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.
Store and transport refrigerated (between 2°C and 8°C).
Temperature excursions outside the range of 2°C to 8°C must be controlled. This includes avoiding storage at temperatures above 30°C for longer than a total of 28 days, during which the mean storage temperature of the medicinal product must remain below 25°C (but above 2°C to 8°C). After any temperature excursion, the medicinal product must be returned immediately to the recommended storage conditions (store and transport refrigerated between 2°C and 8°C). Temperature excursions have a cumulative effect on the quality of the medicinal product, and the total duration of such excursions must not exceed 28 days within the 2-year shelf life of Onnimia. Exposure to temperatures below 2°C will not damage the medicinal product, 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 Onnimia.
This medicinal product 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. If in doubt, please consult your pharmacist on how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of Onnimia
Composition of Onnimia
- The active substance 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 castor oil.
Appearance of the product and contents of the pack
Onnimia is a viscous, transparent, colourless to yellowish solution in a pre-filled syringe equipped with a tamper-evident seal, containing 5 ml of injectable solution. Two syringes must be administered to receive the recommended monthly dose of 500 mg.
Onnimia is available in two pack sizes: one pack containing 1 glass pre-filled syringe, and one pack containing 2 glass pre-filled syringes. Safety needles (“BD SafetyGlide”) are also provided for attachment to the barrel of each syringe.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 - 2nd floor
28023 Aravaca - Madrid
Spain
Manufacturer
Laboratori FUNDACIO DAU
C/ De la letra C, 12-14, Polígono Industrial de la Zona Franca
Barcelona 08040
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
France | Fulvestrant Intas 250 mg, solution for injection in pre-filled syringe |
Germany | Fulvestrant Intas 250 mg solution for injection in pre-filled syringe. |
Spain | Onnimia 250 mg solution for injection in pre-filled syringe EFG |
Date of last review of this leaflet: August 2020
Detailed and up-to-date 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:
Onnimia 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 (BD SafetyGlide™ protected hypodermic needle) in an autoclave prior to use. Hands must remain behind the needle at all times during use and disposal.
For each of the two syringes:
? Remove the glass barrel of the syringe from the tray and check that it is not damaged. ? Open the outer packaging of the safety needle device (“SafetyGlide”). ? Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration. ? Hold the syringe vertically by the ribbed part (C). With the other hand, hold the cap (A) and gently tilt it backward and forward until the seal breaks and the cap can be removed; do not twist (see Figure 1). | Figure 1
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? Remove the cap (A) by pulling upward. To maintain sterility, avoid touching the tip of the syringe (B) (see Figure 2). | Figure 2
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? Attach the safety needle to the Luer-Lok connector and screw it on until firmly secured (see Figure 3). ? Confirm that the needle is securely attached to the Luer connector before ceasing to hold the syringe in an upright position. ? Remove the needle protective cap in a straight line to avoid damaging the needle tip. ? Carry the loaded syringe to the administration site. ? Remove the needle protective cap. ? Expel excess air from the syringe. | Figure 3
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? Administer slowly by intramuscular injection into the gluteal region (gluteal area) (1–2 minutes per injection). For greater comfort, positioning the needle with the bevel facing upward aligns with the lever arm in the raised position (see Figure 4). | Figure 4
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? After injection, immediately press once with your finger on the lever arm to activate the safety mechanism (see Figure 5). NOTE: Activate away from your body and others. Listen for the click and visually confirm that the needle tip is fully covered. |
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Figure 5Disposal
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.