FULVESTRANT EVER PHARMA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 250MG/5ML [SIN17045P]

Product Info

FULVESTRANT EVER PHARMA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 250MG/5ML

[SIN17045P]

4.1 Therapeutic indications

Fulvestrant EVER Pharma is indicated

• as monotherapy 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 antiestrogen therapy, or disease progression on antiestrogen therapy.

• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression after endocrine therapy (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

4.2 Posology and method of administration

Posology
Adult females (including 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 EVER Pharma is used in combination with palbociclib, please also refer to the Prescribing Information of palbociclib.
Prior to the start of treatment with the combination of Fulvestrant EVER Pharma plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, Fulvestrant EVER Pharma should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

Fulvestrant is not recommended for use in children and adolescents, as safety and efficacy have not been established in this age group.

Method of administration
Fulvestrant EVER Pharma 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 EVER Pharma at the dorsogluteal site due to the proximity of the underlying sciatic nerve.

For detailed instructions for administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Pregnancy and lactation (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Severe hepatic impairment (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Combination therapy with palbociclib
See palbociclib local Prescribing Information for Contraindications.