Fulzos — Fulvestrant Injection 250 mg/5 ml Cold chain · Storage +2…+8 °C

Fulzos is supplied as a sterile oily solution for intramuscular injection in a prefilled syringe configuration. Each prefilled syringe contains:

• Active Ingredient: Fulvestrant — 250 mg per 5 mL of solution.
• Excipients: Ethanol 96%, benzyl alcohol, benzyl benzoate, and castor oil (formulated as a depot system ensuring prolonged slow release).

Pharmacodynamics: Fulvestrant is a competitive estrogen receptor (ER) antagonist that binds to ER with an affinity comparable to estradiol. It blocks transcription of estrogen-regulated genes and induces downregulation of ER protein levels in tumor cells.

Pharmacokinetics: Following deep intramuscular injection, fulvestrant is slowly absorbed from the muscular depot site, reaching peak plasma concentrations (Cmax) within 5 to 7 days. Stable systemic concentrations are sustained over a 28-day interval. It is metabolized primarily by hepatic cytochrome P450 enzymes (CYP3A4) and eliminated predominantly via feces (greater than 90%).

Fulzos 250 mg / 5 mL is clinically indicated for postmenopausal women presenting with:

• 🔹 Metastatic Breast Cancer: Locally advanced or metastatic estrogen-receptor-positive (ER+) breast cancer with disease relapse following prior anti-estrogen therapy.
• 🔹 First-Line Treatment: Monotherapy for postmenopausal women with hormone-positive advanced breast cancer who have not received prior endocrine therapies.

Fulzos is intended strictly for deep intramuscular administration into the gluteal region, performed slowly:

• Standard Dosing: The recommended dose is 500 mg (administered as two 250 mg/5 mL prefilled syringes), given as two separate 5 mL injections into each gluteal muscle (left and right).
• Administration Schedule: Loading doses are administered on Days 1, 15, and 29, followed by maintenance dosing of 500 mg once every 28 days thereafter.
• Special Populations: Dose adjustments are unnecessary in mild to moderate hepatic or renal impairment. Use is discouraged in severe hepatic failure.

Fulzos is contraindicated in the following conditions:

• ⛔ Hypersensitivity: Known hypersensitivity to fulvestrant, castor oil, or any excipient component in the formulation.
• ⛔ Pregnancy and Lactation: Strictly contraindicated during pregnancy and breastfeeding due to severe fetal risks.
• ⛔ Severe Hepatic Impairment: Patients with severe hepatic function impairment (Child-Pugh Class C).

Fulvestrant is metabolized via CYP3A4, though clinical drug-drug interaction potential remains minimal:

• ⚠️ CYP3A4 Inhibitors and Inducers: Co-administration with strong CYP3A4 inhibitors or inducers does not necessitate formal dose adjustments.
• ⚠️ Anticoagulant Therapy: Due to intramuscular administration, exercise caution when treating patients with bleeding disorders or those receiving anticoagulants to prevent local hematomas.

Indicated exclusively for postmenopausal females:

• Precautions: Females of childbearing potential must utilize reliable contraceptive measures throughout treatment and for at least 2 years following the final dose administration.

Potential adverse events associated with Fulzos therapy include:

• 🔴 Injection Site Reactions: Local pain, inflammation, induration, or erythema at the injection site.
• 🟡 Gastrointestinal and Hepatic: Nausea, vomiting, diarrhea, decreased appetite, and transient elevation of liver enzymes (ALT, AST).
• 🟠 Systemic Effects: Fatigue, hot flashes, headache, skin rash, and musculoskeletal pain (arthralgia, myalgia).

Acute overdose is unlikely due to controlled administration by medical personnel:

• Symptoms: Exacerbation of known pharmacological side effect profiles.
• Management: No specific antidote exists. Supportive and symptomatic care should be administered.

Storage conditions required to maintain product integrity:

• 🌡️ Temperature Control: Store and transport refrigerated between 2 °C and 8 °C. Do not freeze prefilled syringes. Keep protected from light.
• 👶 Safety: Keep out of reach of children.
• ⏳ Shelf Life: As indicated on packaging. Do not use past the expiration date.

Authentic Fulzos 250 mg/5 ml (Prefilled Syringe) by Hetero Healthcare Ltd. features distinct verification markers:

• 🛡️ Manufacturer Details on Top Flap: The upper carton flap clearly specifies the corporate name «HETERO HEALTHCARE LIMITED» along with its headquarters address: 7-2-A2, Hetero Corporate, Industrial Estate, Sanath Nagar, Hyderabad - 500 018, alongside M.R.P. pricing indicators.
• 🔒 Branding and Logo Design: The front face features the blue-and-red stylized «H» corporate logo of Hetero Healthcare in the bottom right corner and top panel. The brand name «Fulzόs» is styled in multi-colored lettering, accompanied by Hindi text (फुलज़ोस) and «FULVESTRANT 250 mg PFS» designation.
• 🔍 Regulatory Labeling: Includes «5 ml Prefilled Syringe», the Rx prescription symbol, a syringe graphic icon, and warnings such as «CYTOTOXIC AGENT», «For Intramuscular use only», and «For Single use only».
• 🔢 Traceability Markers: Side panels display stamped batch numbers, manufacturing dates, and expiration details which must match the laser-etched markings on the glass body of the enclosed prefilled syringe.