Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fulvestrant may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Fulvestrant Seacross contains the active substance fulvestrant, which belongs to the group of oestrogen blockers. Oestrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer. Fulvestrant Seacross is used either: alone, to treat postmenopausal women with a type of breast cancer called oestrogen receptor positive breast cancer that 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 breast cancer, that is locally advanced or has spread to other parts of the body (metastatic). Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist. When Fulvestrant Seacross is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib. If you have any questions about palbociclib, please ask your doctor. 2.
What you need to know before you take it
e Fulvestrant Seacross
Do not use Fulvestrant Seacross: 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 breast-feeding if you have severe liver problems Warnings and precautions Talk to your doctor or pharmacist or nurse before using Fulvestrant Seacross if any of these apply to you: –
kidney or liver problems low numbers of platelets (which help blood clotting) or bleeding disorders
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–
previous problems with blood clots osteoporosis (loss of bone density) alcoholism
Children and adolescents Fulvestrant Seacross is not indicated in children and adolescents under 18 years. Other medicines and Fulvestrant Seacross 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 using anticoagulants (medicines to prevent blood clots). Pregnancy and breast-feeding You must not use Fulvestrant Seacross if you are pregnant. If you can become pregnant, you should use effective contraception while you are being treated with Fulvestrant Seacross and for 2 years after your last dose. You must not breast-feed while on treatment with Fulvestrant Seacross. Driving and using machines Fulvestrant Seacross 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 Seacross contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy. Fulvestrant Seacross contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml. Benzyl alcohol may cause allergic reactions. Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding or have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called "metabolic acidosis"). Fulvestrant Seacross contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml. 3.
How to take it
Fulvestrant Seacross
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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. Your doctor or nurse will give you Fulvestrant Seacross as a slow intramuscular injection, one into each of your buttocks. 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. uk-pl-v2.1-clean-20241211
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You may need immediate medical treatment if you experience any of the following side effects:
Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions Thromboembolism (increased risk of blood clots)* Inflammation of the liver (hepatitis) Liver failure
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very common side effects (may affect more than 1 in 10 people) Injection site reactions, such as pain and/or inflammation Abnormal levels of liver enzymes (in blood tests)* Nausea (feeling sick) Weakness, tiredness* Joint and musculoskeletal pain Hot flushes Skin rash 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) Headache Vomiting, diarrhoea, or loss of appetite* Urinary tract infections Back pain* Increase of bilirubin (bile pigment produced by the liver) Thromboembolism (increased risk of blood clots)* Decreased levels of platelets (thrombocytopenia) Vaginal bleeding Lower back pain irradiating to leg on one side (sciatica) Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy) Uncommon side effects (may affect up to 1 in 100 people) Thick, whitish vaginal discharge and candidiasis (infection) Bruising and bleeding at the site of injection Increase of gamma-GT, a liver enzyme seen 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 Seacross 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 Yellow Card Scheme website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Fulvestrant Seacross
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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. This medicine does not require any special storage conditions. Your healthcare professional will be responsible for the correct storage, use and disposal of Fulvestrant Seacross. 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 Seacross contains The active substance is fulvestrant. Each pre-filled syringe (5 ml) contains 250 mg fulvestrant. The other ingredients (excipients) are ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined. What Fulvestrant Seacross looks like and contents of the pack Fulvestrant Seacross is a clear, colourless to yellow, viscous solution in a pre-filled syringe with ETFE coated bromobutyl rubber plunger stopper, containing 5 ml solution for injection. Two syringes must be administered to receive the 500 mg recommended monthly dose. Fulvestrant Seacross has a pack containing 2 glass pre-filled syringes. Safety needles (Terumo SurGuard) for connection to each barrel are also provided. Marketing Authorisation Holder and Manufacturer Seacross Pharmaceuticals Limited Beaumont Business Centres 6 Snow Hill London EC1A 2AY United Kingdom
This leaflet was last revised in 12/2024 ————————————————————————————————————————–The following information is intended for healthcare professionals only: Fulvestrant Seacross 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3. Instructions for administration Warning – Do not autoclave safety needle before use. Hands must remain behind the needle at all times during use and disposal. For each of the two syringes:
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●
Carefully remove the needle and syringe from the packaging. Remove the protective cap from the tip of the syringe barrel. Tighten the syringe to the needle using aseptic technique. Grip the base of the needle, not the sheath, and turn the syringe clockwise (see Figure 1).
Figure 1
●
Move the safety shield away from the needle and toward the syringe barrel to the angle shown. Then remove the needle cap (see Figure 2).
Figure 2
●
While holding the syringe with the needle pointing upward, gently push in the plunger until the medicine is up to the top of the syringe. There should be no air within the barrel.
●
Administer intramuscularly slowly (1-2 minutes/injection) into the buttock.
●
After completing the injection, remove the needle from the skin and use a one-handed technique to activate the safety mechanism using any of the three methods (see Figure 3):
● ●
Figure 3
o Finger activation o Thumb activation o Surface activation
Activation is verified by an audible and/or tactile "click", and can be visually confirmed. If uncertain that the safety shield is fully engaged, repeat this step.
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.
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Frequently asked questions about Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe
How do I take Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe?
Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe comes as injection containing 250mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe?
The active substance in Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe is fulvestrant.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: fulvestrant
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Fulvestrant Seacross is indicated:
• as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- not previously treated with endocrine therapy, or
- with disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy.
• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).
In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinising hormone releasing hormone (LHRH) agonist.
4.2. Posology and method of administration
Posology
Adult females (including Elderly)
The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.
When Fulvestrant Seacross is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Prior to the start of treatment with the combination of Fulvestrant Seacross plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Special populations
Renal impairment
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Hepatic impairment
No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, Fulvestrant Seacross should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Paediatric population
The safety and efficacy of Fulvestrant Seacross in children from birth to 18 years of age have not been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Method of administration
Fulvestrant Seacross should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Caution should be taken if injecting Fulvestrant Seacross at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
For detailed instructions for administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Pregnancy and lactation (see section 4.6).
Severe hepatic impairment (see sections 4.4 and 5.2).
4.4. Special warnings and precautions for use
Fulvestrant Seacross should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Fulvestrant Seacross should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Due to the intramuscular route of administration, Fulvestrant Seacross should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with Fulvestrant (see section 4.8). This should be taken into consideration when prescribing Fulvestrant Seacross to patients at risk.
Injection site related events including sciatica, neuralgia, neuropathic pain and peripheral neuropathy have been reported with Fulvestrant Seacross injection. Caution should be taken while administering Fulvestrant Seacross at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8).
There are no long-term data on the effect of fulvestrant on bone. Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
The efficacy and safety of Fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
When Fulvestrant Seacross is combined with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Interference with estradiol antibody assays
Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Ethanol
Fulvestrant Seacross contains 10% w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine. This may be harmful for those suffering from alcoholism and should be taken into account in high risk groups such as patients with liver disease and epilepsy.
Benzyl alcohol
Fulvestrant Seacross contains benzyl alcohol as an excipient which may cause allergic reactions.
Paediatric population
Fulvestrant Seacross is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
4.5. Interaction with other medicinal products and other forms of interaction
A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4. Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance. Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Patients of childbearing potential should use effective contraception during treatment with Fulvestrant Seacross and for 2 years after the last dose.
Pregnancy
Fulvestrant Seacross is contraindicated in pregnancy (see section 4.3). Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit. Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths (see section 5.3). If pregnancy occurs while taking Fulvestrant Seacross, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Breast-feeding
Breast-feeding must be discontinued during treatment with Fulvestrant Seacross. Fulvestrant is excreted in milk in lactating rats. It is not known whether fulvestrant is excreted in human milk. Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated (see section 4.3).
Fertility
The effects of Fulvestrant Seacross on fertility in humans has not been studied.
4.7. Effects on ability to drive and use machines
Fulvestrant Seacross has no or negligible influence on the ability to drive or use machines. However, since asthenia has been reported very commonly with Fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
4.8. Undesirable effects
Summary of the safety profile
Monotherapy
This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports. In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
In Table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the Fulvestrant 500 mg treatment group in pooled safety analyses of studies that compared Fulvestrant 500 mg with Fulvestrant 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared Fulvestrant 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented. The frequencies in Table 1 were based on all reported adverse drug reactions, regardless of the investigator assessment of causality. The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Tabulated list of adverse reactions
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100). Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Table 1 Adverse Drug Reactions reported in patients treated with Fulvestrant monotherapy
Adverse reactions by system organ class and frequency
Infections and infestations
Common
Urinary tract infections
Blood and lymphatic system disorders
Common
Reduced platelet counte
Immune system disorders
Very common
Hypersensitivity reactionse
Uncommon
Anaphylactic reactions
Metabolism and nutrition disorders
Common
Anorexiaa
Nervous system disorders
Common
Headache
Vascular disorders
Very common
Hot flushese
Common
Venous thromboembolisma
Gastrointestinal disorders
Very common
Nausea
Common
Vomiting, diarrhoea
Hepatobiliary disorders
Very common
Elevated hepatic enzymes (ALT, AST, ALP)a
Common
Elevated bilirubina
Uncommon
Hepatic failurec, f, hepatitisf, elevated gamma-GTf
Skin and subcutaneous tissue disorders
Very common
Rashe
Musculoskeletal and connective tissue disorders
Very common
Joint and musculoskeletal paind
Common
Back paina
Reproductive system and breast disorders
Common
Vaginal haemorrhagee
Uncommon
Vaginal moniliasisf, leukorrheaf
General disorders and administration site conditions
Very common
Astheniaa, injection site reactionsb
Common
Neuropathy peripherale, sciaticae
Uncommon
Injection site haemorrhagef, injection site haematomaf, neuralgiac,f
a Includes adverse drug reactions for which the exact contribution of Fulvestrant cannot be assessed due to the underlying disease.
b The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
c The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST). The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate.
This is calculated as 3/560 (where 560 is the number of patients in the major clinical studies), which equates to a frequency category of 'uncommon'.
d Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.
e Frequency category differs between pooled safety dataset and FALCON.
f ADR was not observed in FALCON.
Description of selected adverse reactions
The descriptions included below are based on the safety analysis set of 228 patients who received at least one (1) dose of fulvestrant and 232 patients who received at least one (1) dose of anastrozole, respectively in the Phase 3 FALCON study.
Joint and musculoskeletal pain
In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively. Of the 65 patients in the Fulvestrant arm, 40% (26/65) of patients reported joint and musculoskeletal pain within the first month of treatment, and 66.2% (43/65) of patients within the first 3 months of treatment. No patients reported events that were CTCAE Grade ≥3 or that required a dose reduction, dose interruption, or discontinued treatment due to these adverse reactions.
Combination therapy with palbociclib
The overall safety profile of fulvestrant when used in combination with palbociclib is based on data from 517 patients with HR-positive, HER2-negative advanced or metastatic breast cancer in the randomised PALOMA3 study (see section 5.1). The most common (≥20%) adverse reactions of any grade reported in patients receiving fulvestrant in combination with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anaemia, stomatitis, diarrhoea, thrombocytopenia and vomiting. The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, infections, anaemia, AST increased, thrombocytopenia, and fatigue.
Table 2 reports the adverse reactions from PALOMA3.
Median duration of exposure to fulvestrant was 11.2 months in the fulvestrant + palbociclib arm and 4.8 months in the fulvestrant + placebo arm. Median duration of exposure to palbociclib in the fulvestrant + palbociclib arm was 10.8 months.
Table 2 Adverse reactions based on PALOMA3 Study (N=517)
System Organ Class
Frequency Preferred Terma
Fulvestrant + Palbociclib
(N=345)
Fulvestrant + placebo
(N=172)
All Grades
n (%)
Grade ≥ 3
n (%)
All Grades n (%)
Grade ≥ 3 n (%)
Infections and infestations
Very common
Infectionsb
188 (54.5)
19 (5.5)
60 (34.9)
6 (3.5)
Blood and lymphatic system disorders
Very common
Neutropeniac
290 (84.1)
240 (69.6)
6 (3.5)
0
Leukopeniad
207 (60.0)
132 (38.3)
9 (5.2)
1 (0.6)
Anaemiae
109 (31.6)
15 (4.3)
24 (14.0)
4 (2.3)
Thrombocytopeniaf
88 (25.5)
10 (2.9)
0
0
Uncommon
Febrile neutropenia
3 (0.9)
3 (0.9)
0
0
Metabolism and nutrition disorders
Very common
Decreased appetite
60 (17.4)
4 (1.2)
18 (10.5)
1 (0.6)
Nervous system disorders
Common
Dysgeusia
27 (7.8)
0
6 (3.5)
0
Eye disorders
Common
Lacrimation increased
25 (7.2)
0
2 (1.2)
0
Vision blurred
24 (7.0)
0
3 (1.7)
0
Dry eye
15 (4.3)
0
3 (1.7)
0
Respiratory, thoracic and mediastinal disorders
Common
Epistaxis
25 (7.2)
0
4 (2.3)
0
Gastrointestinal disorders
Very common
Nausea
124 (35.9)
2 (0.6)
53 (30.8)
1 (0.6)
Stomatitisg
104 (30.1)
3 (0.9)
24 (14.0)
0
Diarrhoea
94 (27.2)
0
35 (20.3)
2 (1.2)
Vomiting
75 (21.7)
2 (0.6)
28 (16.3)
1 (0.6)
Skin and subcutaneous tissue disorders
Very common
Alopecia
67 (19.4)
NA
11 (6.4)
NA
Rashh
63 (18.3)
3 (0.9)
10 (5.8)
0
Common
Dry skin
28 (8.1)
0
3 (1.7)
0
General disorders and administration site conditions
Very common
Fatigue
152 (44.1)
9 (2.6)
54 (31.4)
2 (1.2)
Pyrexia
47 (13.6)
1 (0.3)
10 (5.8)
0
Common
Asthenia
27 (7.8)
1 (0.3)
13 (7.6)
2 (1.2)
Investigations
Very common
AST increased
40 (11.6)
11 (3.2)
13 (7.6)
4 (2.3)
Common
ALT increased
30 (8.7)
7 (2.0)
10 (5.8)
1 (0.6)
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients; NA=Not applicable
a Preferred Terms (PTs) are listed according to MedDRA 17.1.
b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Description of selected adverse reactions
Neutropenia
In patients receiving fulvestrant in combination with palbociclib in the PALOMA3 study, neutropenia of any grade was reported in 290 (84.1%) patients, with Grade 3 neutropenia being reported in 200 (58.0%) patients, and Grade 4 neutropenia being reported in 40 (11.6%) patients. In the fulvestrant + placebo arm (n=172), neutropenia of any grade was reported in 6 (3.5%) patients. There were no reports of Grade 3 and 4 neutropenia in the fulvestrant + placebo arm.
In patients receiving fulvestrant in combination with palbociclib, the median time to first episode of any grade neutropenia was 15 days (range: 13-512 days) and the median duration of Grade ≥3 neutropenia was 16 days. Febrile neutropenia has been reported in 3 (0.9%) patients receiving fulvestrant in combination with palbociclib.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
4.9. Overdose
There are isolated reports of overdose with Fulvestrant in humans. If overdose occurs, symptomatic supportive treatment is recommended. Animal studies suggest that no effects other than those related directly or indirectly to antioestrogenic activity were evident with higher doses of fulvestrant (see section 5.3).
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- FALVAX 250 mg prescriptionFULVESTRANTUM · injection / infusion
- FULVESTRANT SUN 250 mg prescriptionFULVESTRANTUM · injection / infusion
- FULVESTRANT EVER PHARMA 250 mg prescriptionFULVESTRANTUM · injection / infusion
- IMARSA 250 mg prescriptionFULVESTRANTUM · injection / infusion
- FULVESTRANT TEVA 250 mg prescriptionFULVESTRANTUM · injection / infusion
- FULVESTRANT ACCORD 250 mg prescriptionFULVESTRANTUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- FaslodexFulvestrantum · injection / infusion
- Fulvestrant TevaFulvestrantum · injection / infusion
- Fulvestrant SandozFulvestrantum · injection / infusion
- Fulvestrant SUNFulvestrantum · injection / infusion
- Fulvestrant EVER PharmaFulvestrantum · injection / infusion
- Fulvestrant MylanFulvestrantum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Fulvestrant 250 mg/5 ml Solution for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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- Faslodex 250 mg solution for injection
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- Fulvestrant 250mg solution for injection in pre-filled syringe
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