FASLODEX

Israel - English - Ministry of Health

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Active ingredient:
FULVESTRANT
Available from:
ASTRA ZENECA (ISRAEL) LTD
ATC code:
L02BA03
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
FULVESTRANT 250 MG / 5 ML
Administration route:
I.M
Prescription type:
Required
Manufactured by:
ASTRA ZENECA UK LIMITED
Therapeutic group:
FULVESTRANT
Therapeutic area:
FULVESTRANT
Therapeutic indications:
Monotherapy :Faslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, orwith disease relapse on or after adjuvant endocrine therapy; or disease progression on endocrine therapy.Combination Therapy with Palbociclib: Faslodex is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with disease progression after endocrine therapy
Authorization number:
132 67 31114 02
Authorization date:
2020-03-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

21-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

12-05-2020

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

This medicine is dispensed with a doctor’s prescription only

FASLODEX

®

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

For intramuscular injection

Composition:

Each pre-filled syringe (5 ml) contains:

Fulvestrant 250 mg

For the list of inactive ingredients in the preparation, see section 6 - “Further Information”.

Read the leaflet carefully in its entirety before using the medicine.

Keep the leaflet; you may need it again.

This leaflet contains concise information about the medicine. If you have further questions, please

refer to the doctor or pharmacist.

This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them

even if it seems to you that their ailment is similar.

1.

WHAT IS THE MEDICINE INTENDED FOR?

Faslodex is indicated for the treatment of oestrogen receptor positive, locally advanced or

metastatic breast cancer in postmenopausal women not previously treated with hormonal therapy,

or with disease relapse/progression on or after adjuvant endocrine therapy

Faslodex, in combination with the preparation palbociclib, is intended for women with advanced or

metastatic estrogen receptor-positive and HER2-negative breast cancer, whose disease has

progressed after receiving prior hormonal treatment for this ailment.

When used in combination with palbociclib (Ibrance), please read the palbociclib (Ibrance) patient

package insert as well.

Therapeutic group:

Estrogen antagonist.

Faslodex contains the active ingredient fulvestrant, which belongs to the group of medicines that block

the activity of estrogen. Estrogen is a female sex hormone, that can, in some cases, be involved in

development of breast cancer.

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive to fulvestrant or to any of the ingredients in the medicine (detailed in section 6).

You are pregnant or breastfeeding.

You have severe liver problems.

Special warnings regarding use of Faslodex

Before treatment with the medicine, tell the doctor if you have:

Kidney or liver problems.

Previous blood clotting problems.

A low platelet (help in blood clotting) count or bleeding disorders.

Osteoporosis (bone thinning).

Alcohol addiction (alcoholism).

This preparation may disrupt the results of tests that measure estradiol levels. Whenever you refer

for laboratory tests, inform the doctor that you are taking Faslodex.

Children and adolescents

Faslodex is not indicated for use in young and adolescent girls under 18 years of age.

!

Drug interactions

If you are taking other medicines

Tell the doctor or pharmacist if you are taking:

Please inform the attending doctor if you are concomitantly taking additional medicines or if you have

just

finished

treatment

with

another

medicine,

including

non-prescription

medicines,

vitamins,

nutritional supplements and herbal medicines. This is because Faslodex may affect the way certain

medicines work and certain medicines may affect the way Faslodex works. Especially if you are taking

anti-coagulants.

!

Pregnancy and breastfeeding

Pregnancy:

Do not use Faslodex if you are pregnant. If you are of child-bearing age and may become pregnant,

you must use an effective contraceptive method during the course of treatment with Faslodex and for

2 years after your last dose.

Breastfeeding:

Do not breastfeed during the course of treatment with Faslodex.

!

Driving and use of machinery

Faslodex should not affect your ability to drive or to operate machinery. If you feel tired after treatment,

do not drive or operate machinery.

Important information regarding some of the ingredients:

Faslodex contains 10% w/v (weight per volume) ethanol (alcohol), for example, a 1000 mg

alcohol per dose is equivalent to 20 ml of beer or 8 ml of wine. This quantity can be harmful to people

suffering from alcoholism. Take this into consideration in pregnant or breastfeeding women, children

and at-risk people, such as patients with liver disease or epilepsy.

Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml. Benzyl alcohol may

cause allergic reactions.

Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use according to the doctor’s instructions. Check with the doctor or pharmacist if you are

uncertain.

The doctor will explain to you how to take the medicine (the dose and time of injection). The strength

and duration of treatment are determined by the doctor, depending on the disease from which you

are suffering from.

The usual dosage, unless instructed otherwise by the doctor, is:

The usual dose is 500 mg fulvestrant (2 injections of 250 mg/5 ml), given once a month, with an

additional 500 mg dose, given two weeks after the first dose.

When fulvestrant is given in combination with Ibrance, the usual dosage of fulvestrant is 500

mg on days 1, 15 and 29, and once a month thereafter. Refer to the Ibrance patient package

insert.

Instructions for use

Your doctor or nurse will inject Faslodex, as a slow, intramuscular injection. One injection to each side

of the buttocks.

If you accidentally took a higher dosage, or if a child accidentally swallowed the medicine, refer to a

doctor immediately or proceed to a hospital emergency room and bring the package of the medicine

with you.

If you forgot to take this medicine at the designated time, take a dose as soon as you remember.

However, if you remember close to the time for the next dose, do not take the forgotten dose, but

rather, take the next dose at the designated time.

If it is time for the monthly injection, you should not receive it without first consulting your

doctor.

Complete the treatment recommended by the doctor.

Even if there is an improvement in your health, do not stop treatment with the medicine without

consulting the doctor.

Be sure to follow the dosing instructions very carefully and to ask the doctor if there is any doubt.

4. SIDE EFFECTS

As with any medicine, use of Faslodex may cause side effects in some users. Do not be alarmed

when reading the list of side effects. You may not suffer from any of them.

Side effects that require special attention: If the following side effects occur, you may need

emergency medical attention:

Faslodex as a monotherapy:

Hypersensitivity (allergic) reaction, including swelling of the face, lips, tongue and/or throat.

Thromboembolism - increased risk of blood clots*.

Inflammation of the liver (hepatitis).

Liver failure.

Faslodex in combination with palbociclib:

Pulmonary embolism

Inform your doctor or pharmacist if the following side effects occur:

Very common side effects (affect more than 1 in 10 patients):

Faslodex as monotherapy:

Injection site reactions, such as pain and/or inflammation.

Abnormal levels of liver enzymes (in blood tests)*.

Nausea.

Weakness.

Tiredness*.

Joint, muscle and bone pain.

Hot flushes.

Skin rash.

Hypersensitivity (allergic) reaction, including swelling of the face, lips, tongue and/or throat.

Additional side effects:

Common side effects (affect up to one in 10 patients):

Headache.

Vomiting, diarrhea or loss of appetite*.

Urinary tract infection.

Back pain*.

Thromboembolism - increased risk of blood clots*.

Increase of bilirubin (a yellow-colored liver breakdown product) level that can be detected in blood

tests.

Reduced blood platelet count (thrombocytopenia).

Vaginal bleeding.

Lower back pain radiating 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).

Faslodex in combination with palbociclib

Very common side effects (occur in at least one in ten patients):

Reduced white blood cell count (neutropenia, leukopenia).

Infections.

Tiredness.

Nausea, vomiting.

Anemia.

Inflammation in the mouth (stomatitis).

Headache.

Diarrhea.

Reduced blood platelet count (thrombocytopenia).

Constipation.

Balding.

Rash.

Reduced appetite.

Fever.

Additional side effects:

Blurred vision, dry eyes, increased tearing.

Nose bleed.

Impaired sense of taste.

Dry skin.

Weakness.

Faslodex as monotherapy

Uncommon side effects (affect up to one in 100 patients):

Thick, white vaginal discharge and fungal infection.

Bruising, bleeding at the injection site.

Elevated level of liver enzymes called gamma GT (in blood tests).

Inflammation of the liver (hepatitis).

Liver failure.

Tingling, numbness and pain.

Anaphylactic reaction

* Includes side effects whose influence of Faslodex is unclear due to an underlying disease.

If a side effect occurs, if any of the side effects worsen, or if you are suffering from a side effect not

mentioned in the leaflet, consult the doctor.

Reporting side effects

Side effects can be reported to the Ministry of Health by clicking on the link “Report Side Effects of

Drug Treatment” found on the Ministry of Health homepage (www.health.gov.il) that directs you to the

online form for reporting side effects, or by entering the link:

https://sideeffects.health.gov.il/

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other medicine must be kept in a safe place out of the

reach and sight of children and/or infants in order to avoid poisoning.

Do not induce vomiting without explicit instruction from the doctor!

Store between 2ºC-8ºC (in a refrigerator).

Store Faslodex in the original package to protect from light.

Do not use the medicine after the expiry date (exp. date) that appears on the package. The expiry

date refers to the last day of that month. In any case of doubt, consult the pharmacist who

dispensed the medicine to you.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine also contains:

Benzyl benzoate, benzyl alcohol, ethanol 96%, castor oil.

What does the medicine look like?

Faslodex is a clear-transparent to yellowish, viscous solution for injection in a pre-filled syringe

with a safety latch.

Each package contains two filled glass syringes and safety needles (BD SafetyGlide

) to be

connected to the syringe.

Manufacturer:

AstraZeneca UK Ltd.,

Macclesfield, United Kingdom.

License holder and importer:

AstraZeneca (Israel) Ltd.,

P.O.B. 1455, Hod Hasharon 4524075.

Registration number of the medicine in the National Drug Registry of the Ministry of Health

132 67 31114

The format of this leaflet was determined by the Ministry of Health and its content was checked

and approved by the Ministry of Health in November 2017, and was updates according to

Ministry of Health guidelines in February 2020.

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Faslodex

250 mg/5 ml solution for injection.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.

Excipients with known effect

Ethanol

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless to yellow, viscous solution.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Monotherapy

Faslodex is indicated for the treatment of estrogen 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 endocrine therapy; or

disease progression on endocrine therapy

Combination Therapy with Palbociclib

FASLODEX is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2

(HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with

disease progression after endocrine therapy.

4.2

Posology and method of administration

Monotherapy

Adult females (including the 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.

Combination Therapy with Palbociclib

When FASLODEX is used in combination with palbociclib, the recommended dose is 500 mg to be

administered intramuscularly into the buttocks (gluteal area) slowly (1-2 minutes per injection) as two 5

mL injections, one in each buttock, on days 1, 15, 29 and once monthly thereafter. The recommended

dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7

days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food.

Please refer to the full prescribing information of palbociclib.

Pre/perimenopausal women treated with the combination FASLODEX plus palbociclib should be

treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical

practice standards [

Pharmacodynamic properties 5.1]

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 4.4).

Hepatic impairment:

No dose adjustments are recommended for patients with mild to moderate hepatic impairment.

However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these

patients. There are no data in patients with severe hepatic impairment (see 4.3, 4.4 and 5.2).

Paediatric population

The safety and efficacy of Faslodex 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.

Combination Therapy with Palbociclib

When FASLODEX is used in combination with palbociclib, refer to monotherapy instructions for

FASLODEX.

Refer

full

prescribing

information

palbociclib

dose

modification,

management of toxicities, and for use with concomitant medication.

Method of administration

Faslodex 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 Faslodex 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

Faslodex should be used with caution in patients with mild to moderate, hepatic impairment (see

sections 4.2, 4.3 and 5.2).

Faslodex 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, Faslodex 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

clinical

studies

with

Faslodex

(see

section

4.8).

This

should

taken

into

consideration when prescribing Faslodex to patients at risk.

Injection site related events including sciatica, neuralgia, neuropathic pain and peripheral neuropathy

have been reported with Faslodex injection. Caution should be taken while administering Faslodex 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.

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.

The falsely elevated estradiol levels could lead the clinician to incorrect medical decisions and

unnecessary procedures. If this situation has occurred, reassessing the status of the patient by other

means or using an alternate method for estradiol measurement should be considered.

The results should always be assessed in correlation with the clinical evaluation. The laboratory

performing the Estradiol immunoassay should be informed that the patient is taking Faslodex.

Paediatric population

Faslodex 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 CYP 3A4.

Clinical

interaction

studies

with

rifampicin

(inducer

CYP 3A4)

ketoconazole

(inhibitor

CYP 3A4) showed no clinically relevant change in fulvestrant clearance. Dose adjustment is therefore

not necessary in patients who are co-prescribed fulvestrant and CYP 3A4 inhibitors or inducers

concomitantly.

Fulvestrant has a similar chemical structure to estradiol. Due to the structural similarity of fulvestrant

and oestradiol, fulvestrant may interfere with antibody based oestradiol assays and may result in

falsely increased levels of oestradiol. The falsely elevated estradiol levels could lead the clinician to

incorrect medical decisions and unnecessary procedures. If this situation has occurred, reassessing

the status of the patient by other means or using an alternate method for estradiol measurement

should be considered.

The results should always be assessed in correlation with the clinical evaluation.

The laboratory performing the Estradiol immunoassay should be informed that the patient is taking

Faslodex.

4.6

Fertility, Pregnancy and lactation

Women of childbearing potential

Patients of child-bearing potential should use effective contraception during treatment with Fslodex

and for 2 years after the last dose.

Pregnancy

Faslodex 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 Faslodex, 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 Faslodex. Fulvestrant is excreted in milk in

lactating rats. It is not known whether fulvestrant is excreted in human milk. Considering the potential

serious

adverse

reactions

fulvestrant

breast-fed

infants,

during

lactation

contraindicated (see section 4.3).

Fertility

The effects of Faslodex on fertility in humans has not been studied.

4.7

Effects on ability to drive and use machines

Faslodex has no or negligible influence on the ability to drive or use machines. However, since

asthenia has been reported very commonly with Faslodex, 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 Faslodex 500 mg treatment group in pooled safety analyses of studies that compared

Faslosex 500 mg with Faslodex 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 Faslodex 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 Faslodex

monotherapy

Adverse reactions by system organ class and frequency

Infections and infestations

Common

Urinary tract infections

Blood and lymphatic system disorders

Common

Reduced platelet count

Immune system disorders

Very Common

Hypersensitivity reactions

Uncommon

Anphylactic reactions

Metabolism and nutrition disorders

Common

Anorexia

Nervous system disorders

Common

Headache

Vascular disorders

Very Common

Hot flushes

Common

Venous thromboembolism

Gastrointestinal disorders

Very common

Nausea

Common

Vomiting, diarrhoea

Hepatobiliary disorders

Very common

Elevated Hepatic Enzymes

(ALT, AST, ALP)

Common

Elevated bilirubin

Uncommon

Hepatic failure

, hepatitis

elevated gamma-GT

Skin and subcutaneous tissue disorders

Very common

Rash

Musculoskeletal and connective tissue

disorders

Very common

Joint and musculoskeletal pain

Common

Back pain

Reproductive system and breast

disorders

Common

Vaginal haemorrhage

Uncommon

Vaginal Moniliasis

Leukorrhoea

General disorders and administration

site conditions

Very common

Asthenia

, Injection site

reactions

Common

Neuropath

peripheral

, sciatica

Uncommon

Injection site haemorrhage

injection site haematoma

neuralgia

Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed

due to the underlying disease.

The term injection site reactions does not include the terms injection site haemorrhage, injection site

haematoma, sciatica, neuralgia and neuropathy peripheral.

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’.

Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.

Frequency category differs between pooled safety dataset and FALCON.

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 Faslodex 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 safety of FASLODEX (500 mg) plus palbociclib (125 mg/day) versus FASLODEX plus placebo

was evaluated in a Study comparing. The efficacy of FASLODEX 500 mg in combination with

palbociclib 125 mg to FASLODEX 500 mg plus placebo. The data described below reflect exposure to

FASLODEX plus palbociclib in 345 out of 517 patients with HR-positive, HER2-negative advanced or

metastatic breast cancer who received at least 1 dose of treatment. No dose reduction was allowed for

FASLODEX in this study. Dose reductions of palbociclib due to an adverse reaction of any grade

occurred in 36% of patients receiving FASLODEX plus palbociclib. Permanent discontinuation

associated with an adverse reaction occurred in 19 of 345 (6%) patients receiving FASLODEX plus

palbociclib, and in 6 of 172 (3%) patients receiving FASLODEX plus placebo. Adverse reactions

leading to discontinuation for those patients receiving FASLODEX plus palbociclib included fatigue

(0.6%), infections (0.6%), and thrombocytopenia (0.6%). The most common adverse reactions (≥10%)

of any grade reported in patients in the FASLODEX plus palbociclib arm were neutropenia, leukopenia,

infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, thrombocytopenia, constipation,

vomiting, alopecia, rash, decreased appetite, and pyrexia.

The most frequently reported serious adverse reactions in patients receiving FASLODEX plus

palbociclib were infections (3%), pyrexia (1%), neutropenia (1%), and pulmonary embolism (1%).

Adverse reactions reported in patients who received FASLODEX plus palbociclib in this Study are

listed in Table 2, and laboratory abnormalities are listed in Table 3.

Table 2: Adverse Reaction

Adverse

Reaction

FASLODEX plus palbociclib

(N=345)

FASLODEX plus placebo

(N=172)

All

Grades

Grade 3

Grade

4

All

Grades

Grade 3

Grade 4

%

%

%

%

%

%

Infections and

infestations

Infections

Blood and

lymphatic

system disorders

Febrile

neutropenia

Neutropenia

Leukopenia

Anemia

Thrombocytopenia

Eye disorders

Vision blurred

Lacrimation

increased

Dry eye

Metabolism and

nutrition

disorders

Decreased

appetite

Nervous system

disorders

Headache

Dysgeusia

Respiratory,

thoracic and

mediastinal

disorders

Epistaxis

Gastrointestinal

disorders

Nausea

Stomatitis

Diarrhea

Constipation

Vomiting

Skin and

subcutaneous

tissue disorders

Alopecia

Rash

Dry skin

General

disorders and

administration

site conditions

Fatigue

Pyrexia

<1

Asthenia

Grading according to CTCAE 4.0.

CTCAE=Common Terminology Criteria for Adverse Events; N=number of patients; N/A=not applicable.

a Most common infection (>1%) include: nasopharyngitis, upper respiratory infection, urinary tract

infection, influenza, bronchitis, rhinitis, conjunctivitis, pneumonia, sinusitis, cystitis, oral herpes,

respiratory tract infection.

b Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal

inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, stomatitis.

c Grade 1 events – 17%; Grade 2 events – 1%.

d Grade 1 events – 6%.

e Rash includes: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis,

dermatitis acneiform, toxic skin eruption.

Table 3: Laboratory Abnormalities

Laboratory

Abnormality

FASLODEX plus palbociclib (N=345)

FASLODEX plus placebo (N=172)

All Grades

Grade 3

Grade 4

All Grades

Grade 3

Grade 4

%

%

%

%

%

%

decreased

Neutrophils

decreased

Anemia

Platelets

decreased

N=number of patients; WBC=white blood cells.

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.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form:

https://sideeffects.health.gov.il

4.9

Overdose

There are isolated reports of overdose with Faslodex in humans. If overdose occurs, symptomatic

supportive treatment is recommended. Animal studies suggest that no effects other than those related

directly or indirectly to anti-oestrogenic activity were evident with higher doses of fulvestrant (see

section 5.3).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03

Mechanism of action and pharmacodynamic effects

Fulvestrant is a competitive oestrogen receptor (ER) antagonist with an affinity comparable to

estradiol. Fulvestrant blocks the trophic actions of oestrogens without any partial agonist (oestrogen-

like) activity. The mechanism of action is associated with down-regulation of oestrogen receptor

protein levels.

Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant

significantly down-regulates ER protein in ER positive tumours compared with placebo. There was also

a significant decrease in progesterone receptor expression consistent with a lack of intrinsic oestrogen

agonist effects. It has also been shown that fulvestrant 500 mg downregulates ER and the proliferation

יאמ

2019

אפור

/

ה

דבכנ

/

ה

חקור

/

ת

דבכנ

/

םולש ה

בר

,

: רישכתה ןולעב ןוכדע םוסרפ

Faslodex

:בכרה

One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.

Excipients with known effect

Ethanol

:היוותה

Monotherapy

Faslodex is indicated for the treatment of estrogen 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 endocrine therapy; or

disease progression on endocrine therapy

Combination Therapy with Palbociclib

FASLODEX is indicated for the treatment of HR-positive, human epidermal growth factor receptor 2

(HER2)-negative advanced or metastatic breast cancer in combination with palbociclib in women with

disease progression after endocrine therapy.

ךיראתב תואירבה דרשמ תוארוהל םאתהב ןולע ןוכדע לע עידוהל תשקבמ לארשי הקינזהרטסא תרבח

לירפא

2019

.

:אוה אפורל ןולעב ירקיעה ןוכדעה

4.8

Undesirable effects

Summary of the safety profile

Monotherapy

Table 1

Adverse Drug Reactions reported in patients treated with Faslodex monotherapy

Adverse reactions by system organ class and frequency

Infections and infestations

Common

Urinary tract infections

Blood and lymphatic system disorders

Common

Reduced platelet count

Immune system disorders

Very Common

Hypersensitivity reactions

uncommon

Anphylactic reactions

Metabolism and nutrition disorders

Common

Anorexia

Nervous system disorders

Common

Headache

Vascular disorders

Very Common

Hot flushes

Common

Venous thromboembolism

Gastrointestinal disorders

Very common

Nausea

Common

Vomiting, diarrhoea

Hepatobiliary disorders

Very common

Elevated Hepatic Enzymes

(ALT, AST, ALP)

Common

Elevated bilirubin

Uncommon

Hepatic failure

, hepatitis

elevated gamma-GT

Skin and subcutaneous tissue disorders

Very common

Rash

Musculoskeletal and connective tissue

disorders

Very common

Joint and musculoskeletal pain

Common

Back pain

Reproductive system and breast

disorders

Common

Vaginal haemorrhage

Uncommon

Vaginal Moniliasis

Leukorrhoea

General disorders and administration

site conditions

Very common

Asthenia

, Injection site

reactions

Common

Neuropath

peripheral

, sciatica

Uncommon

Injection site haemorrhage

injection site haematoma

neuralgia

:אוה ןכרצל ןולעב ירקיעה ןוכדעה

4

.

יאוול תועפות

דדוב לופיטכ סקדולספ

ךותמ דחא לפוטמ דע לע תועיפשמ( תוחיכש ןניאש יאוול תועפות

100

:)

.יתיירטפ םוהיזו קיתרנהמ הנבלו הכימס השרפה

.הקרזהה םוקמב םומיד ,הלבח

אמג םיארקנה דבכ ימיזנא לש המרב היילע

.)םד תוקידבב(

.)סיטיטפה( דבכב תקלד

.ידבכ לשכ

.באכו השוחת רסוח ,םיצוצקע

)תיגרלא( תיטקילפאנא הבוגת

םינולעה

תואירבה דרשמ רתאבש תופורתה רגאמב םימסרופמ

לעבל הינפ ידי לע םיספדומ םלבקל ןתינו .םושירה

,בר דובכב

ןוסבוד לבנק ןיראק

הנוממ תחקור

מ"עב )לארשי( הקינזהרטסא

)לארשי( הקינזהרטסא

עב

"

ת

.

ד

1455

,

ןורשה דוה

4524075

ןופלט

09-7406528

סקפ

09-7406527

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