Patient leaflet - FULVESTRANT FRESENIUS KABI 250 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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| Package leaflet: Information for the patient | Fulvestrant is used either: | ||||||||
| – Alone, to treat postmenopausal women with a type of | |||||||||
| Fulvestrant Fresenius Kabi 250 mg | breast cancer called estrogen receptor positive breast | ||||||||
| solution for injection | cancer that is locally advanced or has spread to other | ||||||||
| in pre-filled syringe | parts of the body (metastatic), or – In combination with palbociclib to treat women with a | ||||||||
| fulvestrant | type of breast cancer called hormone receptor-positive, human epidermal growth factor receptor 2-negative | ||||||||
| Read all of this leaflet carefully before you start | breast cancer, that is locally advanced or has spread | ||||||||
| using this medicine because it contains important | to other parts of the body (metastatic). Women who | ||||||||
| information for you. | have not reached menopause will also be treated with a | ||||||||
| – Keep this leaflet. You may need to read it again. | medicine called a luteinizing hormone releasing hormone | ||||||||
| – If you have any further questions, ask your doctor, pharmacist or nurse. | (LHRH) agonist. | ||||||||
| – This medicine has been prescribed for you only. Do not | When Fulvestrant is given in combination with palbociclib, | ||||||||
| pass it on to others. It may harm them, even if their signs | it is important that you also read the package leaflet for | ||||||||
| of illness are the same as yours. | palbociclib. If you have any questions about palbociclib, | ||||||||
| – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed | please ask your doctor. | ||||||||
| in this leaflet. See section 4. | |||||||||
2. What you need to know before you are
given Fulvestrant
What is in this leaflet
Package leaflet: Information for the patient
solution for injection in pre-filled syringe
Package leaflet: Information for the patient
solution for injection in pre-filled syringe
1. What Fulvestrant is and what it is used for
You should NOT be given Fulvestrant
Fulvestrant Fresenius Kabi 250 mg
Fulvestrant Fresenius Kabi 250 mg
2. What you need to know before you are given Fulvestrant
– If you are allergic to fulvestrant or to any of the other
3. How Fulvestrant will be given
ingredients of this medicine (listed in section 6)
fulvestrant
fulvestrant
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4. Possible side effects
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5. How to store Fulvestrant
– If you are pregnant or breast-feeding
– If you have severe liver problems
6. Contents of the pack and other information
Warnings and precautions
1. What Fulvestrant is and what it is used for
Talk to your doctor or pharmacist or nurse before being treated with Fulvestrant if any of these apply to you:
This medicine contains the active substance fulvestrant,
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– Kidney or liver problems
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– Low numbers of platelets (which help blood clotting) or
which belongs to the group of estrogen blockers. Estrogens,
bleeding disorders
a type of female sex hormones, can in some cases be
– Previous problems with blood clots
involved in the growth of breast cancer.
– Osteoporosis (loss of bone density) – Alcoholism.
Children and adolescents
Fulvestrant is not for use in children and adolescents under 18 years.
Other medicines and Fulvestrant
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 taking anticoagulants (medicines to prevent blood clots).
Pregnancy and breast-feeding
You must not be given Fulvestrant if you are pregnant. Women who are able to become pregnant should use effective contraception while being treated with Fulvestrant and for 2 years after your last dose.
You must not breast-feed while on treatment with this medicine.
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.
Fulvestrant contains 500 mg of alcohol (ethanol) in each injection which is equivalent to 100 mg/ ml (10% w/v). The amount in each injection of this medicine is equivalent to 13 ml beer or 5 ml wine.
The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.
If you are adicted to alcohol, talk to your doctor or pharmacist before taking this medicine.
Fulvestrant contains 500 mg benzyl alcohol per injection , equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Fulvestrant contains 750 mg benzyl benzoate per injection , equivalent to 150 mg /ml.
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3. How Fulvestrant will be given
Your doctor or nurse will give you Fulvestrant as a slow intramuscular injection, one into each of your buttocks.
The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month, with an additional 500 mg dose given 2 weeks after the initial dose.
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.
Serious side effects
You may need immediate medical treatment if you experience any of the following side effects
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– Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
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– Thromboembolism (increased risk of blood clots)
The following information is intended for healthcare professionals only
Fulvestrant 500 mg (2 × 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Instructions for administration —
Warning – Do no autoclave safety needle (BD SafetyglideTM Safety Hypodermic Needle) before use. Hands must remain behind the eedle at all mes during use anddisposal.
For ach of the two syrines
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– Remove glass syringe barr l fr m tray and check that it is not damaged.
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– Peel open the safety needle (SafetyGlide) outer packaging.
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– Parenteral solutions must be inspect visuly for particula e matter anddiscolouration prior to administration.
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– Hold the syringe upright on the ribbed part ©. With the other hand, take hold of the cap (A) and carefully twist the plasticrigid tip cap n anticlockwise direction. (see Figure 1):
Figure 1
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– Remove the plastic rigid tip cap (A) in a straight upward direction. To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Figure 2
Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
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– Checkthat the needle is locked to the Luer connector before moving out of the vertical plane.
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– Pull shield s raight offneedle to avoid dmaging needle point.
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– Transport filled syringe to point of administraton.
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– Remove needle sheath.
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– Expel excess gas from the syringe.
Figure 3
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– Administer intramuscularly slowly (1–2 minutes/ injection) into the buttock (gluteal area). For user convenience, the needle beve- up position s oriented to the l ver arm(s e Figur 4).
Figure 4
After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.
Figure 5
Disposal
Pre-filled syringes are for single use only.
This medicine may pose a risk to the aquatic environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Uk FRESENIUS I KABI
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– Inflammation of the liver (hepatitis)
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– Liver failure
Tell your doctor pharmacist, or nurse if you notice any of the following side effects:
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V ery common side effects (may affect more than 1 in
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10 people)
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– Injection site reactions, such as pain and/or inflammation
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– Abnormal levels of liver enzymes (in blood tests)
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– Nausea (feeling sick)
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– Weakness, tiredness*
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– Joint and musculoskeletal pain
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– Hot flushes
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– Skin rash.
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– Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat.
All other side effects:
Common side effects (may affect up to 1 in 10 people)
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– Headache
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– Vomiting, diarrhoea, or loss of appetite*
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– Urinary tract infections
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– Back pain*
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– Increase of bilirubin (bile pigment produced by the liver)
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– Thromboembolism (increased risk of blood clots)
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– Decreased levels of platelets (thrombocytopenia)
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– Vaginal bleeding
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– Lower back pain irradiating to the leg on one side (sciatica)
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– sudden weakness, numbness, tingling, or loss of movement in your leg, especially if only on one side of your body, sudden problems with walking or balance (peripheral neuropathy).
Uncommon side effects (may affect up to 1 in 100 people)
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– Thick, whitish vaginal discharge and candidiasis (infection)
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– Bruising and bleeding at the site of injection
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– Increase of gamma-GT, a liver enzyme seen in a blood test
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– Inflammation of the liver (hepatitis)
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– Liver failure
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– Numbness, tingling and pain
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– 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 get 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 via the Yellow Card Scheme Website: yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. how to store fulvestrant
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 syringe labels after EXP. The expiry date refers to the last day of that month.
Store and transport refrigerated (2°C – 8°C).
Temperature excursions outside 2°C to 8°C should be limited. This includes avoiding storage at temperatures exceeding 30°C, and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C to 8°C). After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C to 8°C). Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the shelf life of Fulvestrant Exposure to temperatures below 2°C will not damage the product providing it is not stored below –20°C.
Store the pre-filled syringe in the original package, in order to protect from light.
Your healthcare professional will be responsible for the correct storage, use and disposal of Fulvestrant.
This medicine may pose a risk to the aquatic environment. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6. contents of the pack and other information
What Fulvestrant contains
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– The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
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– The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol (E1519), benzyl benzoate and castor oil refined.
What Fulvestrant looks like and contents of the pack
Fulvestrant is a clear, colourless to yellow, viscous solution in a pre-filled syringe containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose.
Fulvestrant has 3 pack presentations, a pack containing 1 glass pre-filled syringe, a pack containing 2 glass prefilled syringes and a pack containing 6 glass pre-filled syringes. One, two or six safety needles (BD SafetyGlide) for connection to each barrel are also provided.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Ltd
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire, WA7 1NT
United Kingdom
Manufacturer
Laboratorios Farmalan, S.A. Calle La Vallina s/n, Edificio 2, Po^gono Industrial Navatejera, 24193, Villaquilambre, Leon, SPAIN
This leaflet was last revised in October 2020.
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