Fulvestrant BSS

Fulvestrant 250 mg / 5 ml  Sandoz.  Solution for Injection. Each pre-filled syringe contains 250 mg of fulvestrant in 5 ml of solution. Therapeutic indications. Monotherapy For the treatment of postmenopausal women with locally advanced or metastatic breast cancer and positive estrogen receptor: not previously treated with endocrine therapy, or whose disease has recurred during or after adjuvant treatment with antiestrogens, or whose disease has progressed to treatment antiestrogenic. In combination; with palbociclib for the treatment of metastatic or locally advanced breast cancer, positive for the hormone receptor (HR) and negative for receptor 2 of human epidermal growth factor (HER2). In pre or perimenopausal women, combination therapy with palbociclib should be associated with a luteinizing hormone-releasing hormone (LHRH) agonist. Posology. Adult women (including elderly women). The recommended dose is 500 mg at once monthly intervals, with an additional 500 mg dose given two weeks after the initial dose. If you use Fulvestrant in combination with palbociclib, please refer to the palbociclib data sheet. Before and during the entire duration of treatment with Fulvestrant and palbociclib, pre or perimenopausal women should be treated with luteinizing hormone-releasing hormone (LHRH) agonists in accordance with clinical practice. local. Renal insufficiency. Dose adjustments are not 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. Liver failure. No dosage adjustment is recommended in patients with mild to moderate hepatic impairment. However, Fulvestrant should be used with caution in these patients as it may increase exposure to fulvestrant. Safety and efficacy in children and adolescents have not been established. There are no data in patients with severe hepatic impairment. Administration form. Fulvestrant should be administered by two consecutive slow 5 ml intramuscular injections (1-2 minutes / injection), one in each buttock (gluteal area). Caution should be exercised if Fulvestrant is injected into the dorsogluteal area due to the proximity of the sciatic nerve. Contraindications. Hypersensitivity to fulvestrant or to any of the excipients: ethanol, benzyl alcohol, benzyl benzoate, castor oil. Parenterally, this medicine can cause serious allergic reactions. Fulvestrant is contraindicated during pregnancy. Lactation. During lactation, fulvestrant should be discontinued. Fertility. The effects of fulvestrant on fertility in humans have not been studied. Patients of childbearing potential should be instructed to use effective contraception during treatment. Fulvestrant is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with mild to moderate hepatic impairment. Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml / min).excipients: ethanol, benzyl alcohol, benzyl benzoate, castor oil. Parenterally, this medicine can cause serious allergic reactions. Fulvestrant is contraindicated during pregnancy. Lactation. During lactation, fulvestrant should be discontinued. Fertility. The effects of fulvestrant on fertility in humans have not been studied. Patients of childbearing potential should be instructed to use effective contraception during treatment. Fulvestrant is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with mild to moderate hepatic impairment. Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml / min). Warnings.   Given the intramuscular route of administration, fulvestrant should be used with caution when treating patients with bleeding diathesis, thrombocytopenia, or on anticoagulant therapy. Thromboembolic events are frequently seen in women with advanced breast cancer, as seen in clinical studies with fulvestrant. This fact should be considered when prescribing fulvestrant to patients at risk. Events at the injection site have been observed: sciatica, neuralgia, neuropathic pain, and peripheral neuropathy. Caution should be exercised when administering fulvestrant at the injection site in the dorsogluteal area due to the proximity of the sciatic nerve. There is a potential risk of osteoporosis. The efficacy and safety of fulvestrant (both as monotherapy and in combination with palbociclib) have not been studied in patients with severe visceral