Faslodex 250

• 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.

Many breast cancers have estrogen receptors (ER) and the growth of these tumors can be stimulated by estrogen. Fulvestrant is an estrogen receptor antagonist that binds to the estrogen receptor in a competitive manner with affinity comparable to that of estradiol and downregulates the ER protein in human breast cancer cells.

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.

Use in Pregnancy: Unsafe during pregnancy. There is definite evidence of risk to the developing baby.

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.

Overdose: Human experience of overdose is limited. No specific treatment. Give general supportive measures and symptomatic treatment.

Storage: Refrigerate 2°-8°C. Store in the original carton to protect from light until the time of use.