Fulvestrant-AFT fulvestrant 250 mg/5 mL solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fulvestrant, Quantity: 250 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intramuscular

Units in package:

2 pre-filled syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Fulvestrant-AFT 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.

Product summary:

Visual Identification: A clear, colourless to yellow, viscous liquid, practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2023-04-04

Patient Information leaflet

Fulvestrant-AFT
1
FULVESTRANT-AFT
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 USING FULVESTRANT-AFT?
Fulvestrant-AFT contains the active ingredient fulvestrant.
Fulvestrant-AFT is used to treat women who have been through
menopause 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 and to treat HR positive,
locally advanced or metastatic breast cancer who have progressive
disease following prior endocrine (anti-oestrogen or
aromatase inhibitor) therapy.
For more information, see Section 1. Why am I using Fulvestrant-AFT?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FULVESTRANT-AFT?
Do not use if you have ever had an allergic reaction to
Fulvestrant-AFT or any of the ingredients listed at the end of the
CMI.
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 use
Fulvestrant-AFT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Fulvestrant-AFT 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 DO I USE FULVESTRANT-AFT?
•
The usual dose is 500 mg fulvestrant (two (2) x 250 mg/5 ml
injections) given once a month with an additional 500 mg
dose given 2 weeks after the initial dose.
•
Fulvestrant-AFT will be administered by your doctor or nurse as a slow
intramuscular injection, one into each of your
buttocks.
More instructions can be found in Section 4. How do I use
Fulvestrant-AFT? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FULVESTRANT-AFT?
THINGS YOU
SHOULD DO
•
Be sure to keep all your appointments with your doctor so your
prog

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
FULVESTRANT-AFT
(FULVESTRANT) SOLUTION FOR
INJECTION
1. NAME OF THE MEDICINE
Fulvestrant.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled syringe contains 250 mg fulvestrant in 5 mL solution
for injection.
Excipients with known effects: benzyl alcohol, benzyl benzoate and
alcohol.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Fulvestrant-AFT, a clear, colourless to yellow, viscous liquid, is
supplied as 5-mL single-dose pre-filled syringes
containing 250 mg/5 mL fulvestrant.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Fulvestrant-AFT 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. DOSE AND METHOD OF ADMINISTRATION
In the absence of incompatibility studies, Fulvestrant-AFT must not be
mixed with other drugs. Product is for
single use in one patient only. Discard any residue. Fulvestrant-AFT
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-AFT 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
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been further evaluated in patients with moderate to severe h