Fulvestrant SDZ 250 mg/5 ml (IM Injection)

Indications

• Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer
• Treatment of HR-positive advanced breast cancer in postmenopausal women
• Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women

Pharmacology

• Estrogen receptor antagonist
• Competitive binding to estrogen receptor
• Downregulation of estrogen receptor protein
• Inhibition of growth of tamoxifen-resistant breast cancer cells
• In vivo tumor studies

Dosage & Administration

• Administration via intramuscular injection
• 500 mg administered as two 5 mL injections on specific days
• 250 mg dose recommended for patients with moderate hepatic impairment
• Pediatric use not established

Interaction

• No known drug-drug interactions
• Metabolized by CYP 3A4
• No dose adjustment needed with CYP 3A4 inhibitors or inducers

Side Effects

• Common adverse reactions
• Injection site pain
• Nausea
• Bone pain
• Arthralgia
• Headache
• Back pain
• Fatigue
• Pain in extremity
• Hot flash
• Vomiting
• Anorexia
• Musculoskeletal pain
• Cough
• Dyspnea
• Constipation
• Increased hepatic enzymes

Pregnancy & Lactation

• No available data in pregnant women
• No information on presence in human milk or effects on milk production or breastfed infant

Precautions & Warnings

• Use with caution in patients with bleeding diatheses, thrombocytopenia, or anticoagulant use
• Increased exposure in patients with moderate hepatic impairment
• Injection site reaction precautions
• Embryo-fetal toxicity
• Interference with estradiol measurement by immunoassay

Overdose Effects

• Limited human experience of overdose
• No adverse reactions in healthy volunteers with intravenous administration
• No specific treatment for overdose

Storage Conditions

• Refrigerate at 2°-8°C
• Store in original carton to protect from light

Related Brands

• Fulvest 250 mg/5 ml (IM Injection) - eskayef-pharmaceuticals-ltd