Nab Paclitero (Nab-Paclitaxel) 100 mg

Nab Paclitero 100 mg is supplied as a lyophilized powder for injectable suspension:

• Dosage Form & Packaging: Clear glass vial containing 100 mg of nab-paclitaxel as a sterile white to light yellow lyophilized cake. 1 vial per outer carton.
• Active Ingredient: Paclitaxel (as protein-bound particles) — 100 mg per vial.
• Excipients: Human albumin solution (serum albumin) — equivalent to approximately 900 mg. Free from synthetic solvents and Cremophor.

Pharmacodynamics: Paclitaxel is a taxane antimicrotubule agent. It promotes the assembly of microtubules from tubulin dimers and stabilizes them by preventing depolymerization. This inhibition disrupts dynamic microtubule reorganization essential for vital interphase and mitotic cellular functions, arresting the cell cycle at G2/M phases and inducing apoptosis in malignant cells.

Pharmacokinetics: Albumin-bound paclitaxel undergoes rapid tissue distribution. Plasma protein binding exceeds 99%. Metabolized in the liver by CYP2C8 and CYP3A4 enzymes. Excreted predominantly via the biliary route in feces (~80%), with less than 20% eliminated in urine.

Nab Paclitero 100 mg is indicated for the treatment of:

• 🔹 Metastatic Breast Cancer: Treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
• 🔹 Pancreatic Adenocarcinoma: First-line treatment of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.
• 🔹 Non-Small Cell Lung Cancer (NSCLC): First-line treatment of locally advanced or metastatic NSCLC in patients who are not candidates for curative surgery or radiation, in combination with carboplatin.

Administration and dosage guidelines for Nab Paclitero:

• 💉 For Intravenous (IV) Infusion Only! Do not administer intra-arterially.
• 🏥 Premedication: Unlike solvent-based paclitaxel, routine premedication with corticosteroids or H2-antagonists is generally not required prior to infusion.
• ⏱️ Infusion Duration: Administer the reconstituted suspension intravenously over 30 minutes.
• 📊 Dosing Regimens:
  • Metastatic Breast Cancer: 260 mg/m² intravenously every 3 weeks.
  • Pancreatic Cancer: 125 mg/m² on Days 1, 8, and 15 of each 28-day cycle in combination with gemcitabine.
  • NSCLC: 100 mg/m² on Days 1, 8, and 15 of each 21-day cycle in combination with carboplatin.
• 🧪 Reconstitution: Inject 20 mL of 0.9% Sodium Chloride Injection slowly into the vial, directing the stream onto the interior wall. Gently swirl for at least 2 minutes until a homogeneous milky-white suspension is formed without foaming.

Nab Paclitero is contraindicated in:

• ❌ Hypersensitivity to paclitaxel or human albumin.
• ❌ Severe baseline neutropenia (baseline neutrophil count < 1,500 cells/mm³ prior to first course or < 1,000 cells/mm³ for subsequent courses).
• ❌ Severe hepatic impairment.
• ❌ Pregnancy and lactation.
• ❌ Pediatric patients under 18 years of age (safety and efficacy not established).

Key drug interactions for Nab Paclitero:

• ⚠️ CYP2C8 & CYP3A4 Inhibitors/Inducers (ketoconazole, erythromycin, rifampin, carbamazepine): May alter paclitaxel plasma exposure.
• ⚠️ Platinum Compounds (carboplatin, cisplatin): Administer Nab Paclitero prior to platinum agents to optimize drug clearance.
• ⚠️ Vaccines: Administration of live or attenuated vaccines during immunosuppressive chemotherapy is contraindicated.

Nab Paclitero can cause fetal harm when administered to pregnant women. It is strictly contraindicated during pregnancy. Female patients of childbearing potential and male partners should use effective contraception during treatment and for at least 6 months after the final dose. Breastfeeding should be discontinued during therapy.

Common adverse reactions to Nab Paclitero (requires regular blood count monitoring):

• 🔴 Hematologic: Neutropenia, leukopenia, anemia, thrombocytopenia.
• 🔴 Neurologic: Peripheral neuropathy (numbness, tingling, paresthesia).
• 🟡 Gastrointestinal & General: Nausea, vomiting, diarrhea, stomatitis, alopecia (hair loss), fatigue, arthralgia, myalgia.

Symptoms: Severe bone marrow suppression (profound neutropenia), severe peripheral neuropathy, mucositis.

Treatment: No known specific antidote. Supportive therapy, including G-CSF administration and blood transfusions, should be initiated.

Storage Rules and Conditions for Nab Paclitero (Nab-Paclitaxel):

• 🌡️ Unreconstituted Powder (Unopened Vial): Store at controlled room temperature between 20 °C and 25 °C (68 °F to 77 °F) in the original carton. Refrigeration is not required prior to reconstitution. Do not freeze.
• ☀️ Light Protection: Keep the vial inside the original outer carton to protect the lyophilized powder from direct sunlight and bright artificial light.
• 💧 Reconstituted Suspension (In the Vial): After reconstitution with 0.9% Sodium Chloride, the suspension should be used immediately. If necessary, it may be stored in a refrigerator at 2 °C to 8 °C (36 °F to 46 °F) for a maximum of 8 hours inside the original carton to protect from light.
• 🛍️ Infusion Bag (Prepared Admixture): Once transferred into an IV infusion bag, the diluted suspension is stable at room temperature (up to 25 °C) under ambient lighting for up to 4 hours. (The maximum total combined storage time for the reconstituted drug in the vial and IV bag under refrigeration must not exceed 24 hours).
• 👶 Safety: Keep out of the reach and sight of children. This product is a cytotoxic antineoplastic agent.

Authenticity features of genuine Nab Paclitero (Hetero Healthcare):

• 🛡️ Carton & Branding: High-quality cardboard box featuring distinct red and dark brown accents, along with the official Hetero Healthcare / Oncology logo.
• 🔍 Vial Packaging: Clear 100 mg glass vial fitted with a red Flip-Off plastic cap and gold-tone aluminum seal.
• 📦 Factory Marking: Legible, stamped Batch No., Manufacturing Date, Expiry Date, and Manufacturing License Number on both the outer box and vial label.