Fulvestrant Ever Pharma250mg/5ml

• HR-positive, HER2-negative advanced breast cancer: in postmenopausal women not previously treated with endocrine therapy.
• HR-positive advanced breast cancer: in postmenopausal women with disease progression following endocrine therapy.
• HR-positive, HER2-negative advanced or metastatic breast cancer: in combination with ribociclib in postmenopausal women.
• HR-positive, HER2-negative advanced or metastatic breast cancer: in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.

Adult Dose (Intramuscular):

• 500 mg (250 mg into each buttock) on Days 1, 15, 29, then once monthly thereafter.
• Moderate hepatic impairment (Child-Pugh Class B): 250 mg (into 1 buttock) on Days 1, 15, 29, then once monthly thereafter.
• Severe hepatic impairment: Contraindicated.

Renal Impairment: Negligible amounts eliminated in urine - no dose adjustment needed (eCrCl ≥30 mL/min).

Children: Safety and effectiveness not established.

* Use as directed by the registered physician

Common Side Effects (≥5%):

• Injection site pain
• Nausea
• Bone pain
• Arthralgia
• Headache
• Back pain
• Fatigue
• Hot flash
• Vomiting
• Anorexia
• Asthenia
• Cough
• Dyspnea
• Constipation

Increased hepatic enzymes: ALT, AST, ALP in >15% of patients.

Precautions:

• Risk of Bleeding: Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use.
• Increased Exposure in Hepatic Impairment: Use 250 mg dose for moderate hepatic impairment.
• Injection Site Reaction: Caution at dorsogluteal injection site due to proximity of sciatic nerve.
• Embryo-Fetal Toxicity: Can cause fetal harm - use effective contraception in females of reproductive potential.