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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.
When Fulvestrant Injection is used in combination with palbociclib, abemaciclib or ribociclib, refer to the Summary of Product Characteristics of palbociclib, abemaciclib or ribociclib.
Prior to the start of treatment with the combination of Fulvestrant Injection plus palbociclib, abemaciclib or ribociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Special populations: Paediatric patient: The safety and efficacy of Fulvestrant Injection in children from birth to 18 years of age have not been established. Currently available data are described in Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions, but no recommendation on a posology can be made.
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 Precautions).
Hepatic impairment: No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
However, as fulvestrant exposure may be increased, Fulvestrant Injection should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of administration: Fulvestrant Injection 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 Injection at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
For detailed instructions for administration, see Instructions for administration as follows.
Instructions for administration: Administer the injection according to the local guidelines for performing large volume intramuscular injections.
NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Fulvestrant at the dorsogluteal injection site.
Warning - Do not autoclave safety needle (SurGuard3 Safety Hypodermic Needle) before use. Hands must remain behind the needle at all times during use and disposal.
For each of the two syringes: Remove glass syringe barrel from blister tray and check that it is not damaged.
Break the seal of the white plastic cover on the syringe Luer connector Luer-Lok to remove the cover with the attached rubber tip cap.
Peel open the safety needle (Terumo SurGuard) outer packaging.
Attach the safety needle to the Luer-Lok.
Twist until firmly seated.
Twist to lock the needle to the Luer connector.
Transport filled syringe to point of administration.
Move the safety sheath away from the needle and toward the syringe barrel to the angle shown, prior to removing the needle cap.
Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Remove the needle cap.
Expel excess gas from the syringe.
Administer intramuscularly slowly (1-2 minutes/injection) into the buttock. For user convenience, the needle bevel-up position is oriented to the lever arm.
Use the finger grip if necessary.
After injection, use a one-handed technique to activate the safety mechanism using any of the two methods (Activation is verified by an audible and/or tactile "click" and can be visually confirmed.)
NOTE: Activate away from self and others. Listen for click and visually confirm needle tip is fully covered.
Finger Activation; Thumb Activation; Visual Confirmation.
Disposal: Pre-filled syringes are for single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
