Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
fulvestrant, Quantity: 250 mg
Accord Healthcare Pty Ltd
Injection, solution
Excipient Ingredients: benzyl alcohol; Castor Oil; benzyl benzoate; ethanol
Intramuscular
1, 2
(S4) Prescription Only Medicine
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.
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
Registered
2020-12-22
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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ