Ebunat — Eribulin Mesylate 1 mg/2 ml Injection, 1 Vial

Ebunat is supplied in the form of a solution for intravenous injection.

Qualitative and Quantitative Composition per 1 ml / 1 Vial:

• Active Ingredient: Eribulin mesylate — 0.5 mg/ml (equivalent to 0.43 mg eribulin free base). Each 2 ml vial contains 1 mg eribulin mesylate.
• Excipients: Ethanol, water for injection, hydrochloric acid and/or sodium hydroxide (for pH adjustment).

Packaging and Presentation: Clear, colorless solution in a 2 ml clear glass vial sealed with a rubber stopper and an aluminum crimp cap with a flip-off plastic lid. 1 vial along with product prescribing information is packaged in an outer carton displaying Ebunat (Eribulin Mesylate Solution for Injection) 0.5 mg/mL and official Natco Pharma corporate design graphics.

Pharmacodynamics:
Ebunat is a macrocyclic ketone lactone analog of halichondrin B. It binds selectively to growing ends of microtubules, inhibiting their elongation while leaving shortening unaffected, resulting in non-functional tubulin aggregates. Unlike taxanes, eribulin does not promote microtubule assembly. This triggers prolonged mitotic blockade and subsequent apoptotic cell death. Additionally, eribulin enhances tumor perfusion and reduces hypoxia through tumor vascular remodeling.

Pharmacokinetics:

• Distribution: Following IV administration, disposition follows a multi-compartmental model. Volume of distribution ranges from 43 to 114 L/kg. Plasma protein binding is low (~15–35%).
• Metabolism: Eribulin is eliminated primarily unchanged. Minor hepatic metabolism occurs via the cytochrome P450 isoenzyme CYP3A4.
• Elimination: The terminal elimination half-life is approximately 40 hours. Excreted predominantly via feces (~82%) and renally (~9%).

Ebunat is indicated in adult patients for:

• Metastatic Breast Cancer: Treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease (prior therapy should have included an anthracycline and a taxane unless unsuitable).
• Liposarcoma: Treatment of patients with unresectable or advanced liposarcoma who have received prior anthracycline-containing therapy.

Ebunat is administered strictly via intravenous route (as an injection or infusion) under oncologist supervision.

Dosing Regimen:

• Recommended Dose: 1.4 mg/m2 body surface area administered intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle.
• Administration Guidelines: Immediately prior to administration, the calculated dose may be diluted in 100 ml of 0.9% Sodium Chloride injection (or administered as an IV push over 2–5 minutes).
• Dose Modifications: Dose delays or reductions may be required based on hematological and non-hematological toxicities (e.g., severe neutropenia, thrombocytopenia).

Administration of Ebunat is contraindicated in:

• Hypersensitivity: Known hypersensitivity to eribulin or any excipient.
• Pregnancy and Lactation: Strictly contraindicated in pregnant or breastfeeding women.
• Pediatric Population: Safety and efficacy in individuals under 18 years of age have not been established.

Evaluated drug interactions for Ebunat include:

• CYP3A4 Inhibitors and Inducers: Eribulin undergoes minimal hepatic metabolism via CYP3A4. Potent inducers or inhibitors of CYP3A4 do not clinically alter eribulin pharmacokinetics.
• QT-Prolonging Agents: Caution is advised when co-administering with medicinal products known to prolong the QT interval.

Pregnancy:
Ebunat is contraindicated during pregnancy. Eribulin exhibits teratogenic, embryotoxic, and genotoxic risks. Women of childbearing potential and male partners must use effective contraception during treatment and for at least 3 months post-therapy.

Lactation:
Breastfeeding is strictly prohibited during treatment.

The most frequent and clinically significant adverse reactions associated with eribulin include:

• Hematologic Toxicity (Very Common): Neutropenia (with associated febrile neutropenia risks), leukopenia, anemia, thrombocytopenia.
• Nervous System: Peripheral sensory neuropathy (paresthesias, numbness), headache, fatigue, asthenia.
• Gastrointestinal Tract: Nausea, vomiting, constipation, diarrhea, stomatitis, abdominal pain, decreased appetite.
• Skin & Appendages: Alopecia (hair loss — very common), pruritus, rash.
• Other: Arthralgia/myalgia, urinary tract infections, pyrexia.

Symptoms:
Clinical overdose cases have been reported. Symptoms mirror established adverse reactions, predominantly severe bone marrow suppression (prolonged profound neutropenia) and peripheral neuropathy.

Treatment:
No specific antidote exists. Supportive care and hematological monitoring must be initiated (administration of granulocyte colony-stimulating factors [G-CSF], antimicrobial cover for febrile neutropenia). Hemodialysis is ineffective.

Storage Requirements for Ebunat:

• 🌡️ Temperature Control: Store protected from light at temperatures below 25 °C (77 °F). Do not freeze.
• ☀️ Light Protection: Keep in outer carton.
• 💧 Working Solutions: Diluted solutions in vials or infusion bags should be used immediately or stored under refrigeration at 2–8 °C (36–46 °F) for no longer than 24 hours.
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: Stated on vial label and carton. Do not use past expiration date. Prescription-only medicine for hospital use.

To verify the authenticity of original Ebunat produced by Natco Pharma, check the following details:

• ✅ Natco Logo: Official blue-green Natco Pharma logo on the outer box and vial label.
• ✅ Packaging Details: Clear factory printing displaying Batch No., Mfg. Date, Exp. Date, and product designation Ebunat (Eribulin Mesylate Solution for Injection) 0.5 mg/mL.
• ✅ Vial Cap Seal: Intact plastic flip-off seal over aluminum crimp ring of the 2 ml glass vial.
• ✅ Box Integrity: High-quality cardboard artwork with crisp typography and securely packaged components.