FULVESTRANT ACCORD fulvestrant 250 mg/5 mL solution for injection pre-filled syringe

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

fulvestrant, Quantity: 250 mg

제공처:

Accord Healthcare Pty Ltd

약제 형태:

Injection, solution

구성:

Excipient Ingredients: benzyl alcohol; Castor Oil; benzyl benzoate; ethanol

관리 경로:

Intramuscular

패키지 단위:

1, 2

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Fulvestrant Accord is indicated for the treatment of postmenopausal women with: ? hormone-receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy. ? HR positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

제품 요약:

Visual Identification: A clear, colourless to yellow viscous solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Registered

승인 날짜:

2020-12-22

환자 정보 전단

Fulvestrant Accord – version 2.0
1
FULVESTRANT ACCORD
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN FULVESTRANT ACCORD?
Fulvestrant Accord is used to treat women who have been through
menopause with; hormone receptor positive, human
epidermal growth factor receptor 2 negative, locally advanced or
metastatic breast cancer who have not been previously
treated with endocrine therapy. It is also used to treat hormone
receptor positive, locally advanced or metastatic breast
cancer who have progressive disease following prior endocrine therapy.
For more information, see Section 1. Why am I using Fulvestrant
Accord? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN FULVESTRANT ACCORD?
Do not use if you have ever had an allergic reaction to any medicine
containing fulvestrant or any of the ingredients listed at
the end of the CMI. Do not use Fulvestrant Accord if you are pregnant.
Do not use Fulvestrant Accord if you have not reached
menopause. Fulvestrant Accord should not be given to men or children.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Fulvestrant Accord?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fulvestrant Accord and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW WILL I BE GIVEN FULVESTRANT ACCORD?
Fulvestrant Accord will be given to you by a doctor or nurse as a slow
intramuscular injection.
More instructions can be found in Section 4. How will I be given
Fulvestrant Accord?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN FULVESTRANT ACCORD?
THINGS YOU
SHOULD DO
•
Be sure to keep all your doctor’s appointment.
•
Tell your doctor if

제품 특성 요약

Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
FULVESTRANT ACCORD (FULVESTRANT) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Fulvestrant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 250 mg fulvestrant in 5 mL solution
for injection.
Excipients with known effects: benzoates and alcohol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Fulvestrant Accord 250 mg/5 mL solution for injection is a clear,
colourless to yellow, viscous liquid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Fulvestrant Accord is indicated for the treatment of postmenopausal
women with:
•
hormone-receptor (HR) positive, human epidermal growth factor receptor
2 (HER2) negative,
locally advanced or metastatic breast cancer who have not been
previously treated with endocrine
therapy.
•
HR positive, locally advanced or metastatic breast cancer who have
progressive disease following
prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
In the absence of incompatibility studies, Fulvestrant Accord must not
be mixed with other drugs.
Fulvestrant Accord is not recommended for use in men.
ADULT FEMALES (INCLUDING THE ELDERLY)
The recommended dose (500 mg) is to be administered intramuscularly as
two 5 mL injections, one in
each buttock (gluteal area), at intervals of 1 month.
An additional 500 mg dose is to be given 2 weeks after the initial
dose.
It is recommended that the injection be administered slowly (1-2
minutes/injection).
Caution should be taken if injecting Fulvestrant Accord at the
dorsogluteal site due to the proximity of
the underlying sciatic nerve.
SPECIAL PATIENT POPULATIONS
PATIENTS WITH HEPATIC INSUFFICIENCY
No dose adjustments are recommended for patients with mild hepatic
impairment. Safety and efficacy
have not been further evaluated in patients with moderate to severe
hepatic impairment (see SECTION 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
PATIENTS WITH RENAL INSUFFICIENCY
No dose adjustments