Docelieva RTU — Docetaxel 80 mg/4 ml Injection, 1 Vial Cold chain · Storage +2…+8 °C

Docelieva RTU is supplied as a sterile liquid concentrate solution for intravenous infusion.

Qualitative and Quantitative Composition:

• • Active Substance: Docetaxel (as anhydrous docetaxel) — 20 mg per 1 ml (total 80 mg per 4 ml vial).
• • Excipients: Polysorbate 80, citric acid, polyethylene glycol 300, dehydrated ethanol (or matching solubilizing agents ensuring taxane stability).

Packaging and Presentation: Clear, colorless concentrate solution filled in 4 ml clear glass vials (net volume: 4 ml). Each vial is enclosed in an outer cardboard carton along with the prescribing information leaflet. The carton displays the batch number (e.g., R26DC06B6), manufacturing date (06/2026), expiration date (05/2028), maximum retail price (M.R.P. ₹ 11531.00), and corporate details of Allieva Pharma Pvt. Ltd. (Baddi, Himachal Pradesh, India).

Pharmacodynamics:
Docetaxel is an antineoplastic agent belonging to the taxane family. It acts by promoting the assembly of tubulin into stable microtubules and inhibits their depolymerization, leading to the marked decrease of free tubulin. The binding of docetaxel to microtubules does not alter the number of protofilaments. Docetaxel disrupts mitotic and interphase cellular functions by arresting cell division in the G2/M phase, culminating in tumor cell apoptosis.

Pharmacokinetics:

• • Distribution: The pharmacokinetics of docetaxel are dose-dependent and consistent with a three-compartment pharmacokinetic model. Mean steady-state volume of distribution is approximately 113 L, indicating extensive extravascular distribution. Plasma protein binding exceeds 95%.
• • Metabolism: Extensively metabolized in the liver via cytochrome P450 enzymes (specifically CYP3A4) into inactive metabolites.
• • Elimination: Excretion follows a triphasic pattern. The terminal elimination half-life (T1/2) is approximately 11 to 12 hours. Elimination occurs primarily via feces (approx. 75%) and renal clearance in urine (approx. 6%).

Docelieva RTU is indicated for use either as monotherapy or in combination chemotherapy regimens for the following malignancies:

• • Breast Cancer: Locally advanced or metastatic breast cancer (in combination with anthracyclines or trastuzumab, or as monotherapy following failure of prior cytotoxic therapy).
• • Non-Small Cell Lung Cancer (NSCLC): Locally advanced or metastatic NSCLC following failure of prior platinum-based chemotherapy.
• • Prostate Cancer: Metastatic castration-resistant prostate cancer (in combination with prednisone or prednisolone).
• • Gastric Adenocarcinoma: Metastatic gastric adenocarcinoma (including gastroesophageal junction cancer) in combination with cisplatin and 5-fluorouracil.
• • Head and Neck Cancer: Squamous cell carcinoma of the head and neck in combination with cisplatin and 5-fluorouracil.

Docelieva RTU is intended strictly for intravenous infusion following dilution. Administration must be performed in a specialized oncology setting under the supervision of a qualified physician experienced in cytotoxic chemotherapy.

Preparation of Infusion Solution:
The concentrate must be diluted prior to administration. Add the required volume of drug concentrate into an infusion bag or bottle containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection to yield a final docetaxel concentration between 0.3 mg/ml and 0.74 mg/ml. Mix the solution by gentle inversion.

Administration and Dosing Guidelines:

• • Administered as an intravenous infusion over approximately 1 hour every 3 weeks.
• • Standard therapeutic dosage ranges from 75 to 100 mg/m² of body surface area depending on indication and protocol.
• • Premedication Regimen: To mitigate the incidence and severity of fluid retention and hypersensitivity reactions, all patients must receive oral corticosteroid premedication (e.g., dexamethasone 8 mg twice daily for 3 days starting 1 day prior to docetaxel administration) unless contraindicated.

Administration of Docelieva RTU is contraindicated in:

• • Hypersensitivity: Severe hypersensitivity to docetaxel or any inactive excipient.
• • Baseline Neutropenia: Baseline neutrophil count of less than 1,500 cells/µl.
• • Severe Hepatic Impairment: Significant liver dysfunction (bilirubin > 1x ULN, or transaminases ALT/AST > 1.5x ULN concurrently with alkaline phosphatase > 2.5x ULN).
• • Pregnancy and Lactation: Contraindicated during pregnancy and breastfeeding due to severe embryotoxic risks.
• • Pediatric Population: Safety and efficacy in pediatric patients have not been established.

Potential pharmacological interactions must be evaluated during docetaxel therapy:

• • CYP3A4 Inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin): Can significantly inhibit docetaxel metabolism, increasing plasma exposure and the risk of severe toxicity. Concurrent use should be avoided.
• • CYP3A4 Inducers (rifampin, carbamazepine, phenytoin, St. John's Wort): May accelerate docetaxel clearance and diminish therapeutic efficacy.
• • Other Cytotoxic Agents: Combination with doxorubicin, cisplatin, or trastuzumab may exacerbate overlapping toxicities, requiring rigorous hematological monitoring.

Pregnancy:
Docetaxel is contraindicated during pregnancy. It exhibits pronounced teratogenic and embryotoxic properties. Women of childbearing potential and male partners must utilize effective contraceptive measures during treatment and for at least 6 months following cessation.

Lactation:
Breastfeeding must be discontinued during treatment with Docelieva RTU, as excretion into human breast milk cannot be excluded and presents potential risks to the infant.

Docetaxel therapy is associated with a well-documented spectrum of adverse drug reactions:

• • Hematologic Toxicity: Reversible neutropenia (dose-limiting toxicity), anemia, thrombocytopenia, febrile neutropenia.
• • Hypersensitivity Reactions: Allergic reactions ranging from mild (rash, flushing, pruritus) to severe anaphylactoid episodes with bronchospasm and hypotension (mitigated by premedication).
• • Skin and Appendages: Reversible alopecia (hair loss occurs in the majority of patients), skin rashes, nail disorders (onycholysis, pigmentation changes).
• • Gastrointestinal Tract: Stomatitis, nausea, vomiting, diarrhea, anorexia, abdominal pain.
• • Neurological Disorders: Peripheral neuropathy (paresthesia, dysesthesia), asthenia, fatigue.
• • Fluid Retention: Peripheral edema, weight gain, pleural or pericardial effusion in severe cases.

Symptoms:
Cases of acute docetaxel overdose are rare. Manifestations include an exacerbation of known adverse reactions: severe myelosuppression (profound neutropenia, thrombocytopenia), peripheral neurotoxicity, and severe mucositis.

Treatment:
There is no specific antidote for docetaxel. Patients should be managed in a specialized sterile ward. Supportive care includes granulocyte colony-stimulating factors (G-CSF) for neutropenia, broad-spectrum antibiotics for sepsis management, and vital sign monitoring.

Storage Requirements for Docelieva RTU:

• 🌡️ Temperature Range: Store in a refrigerator between 2 °C and 8 °C (36 °F to 46 °F), protected from light. Do not freeze (freezing compromises the physical-chemical stability of the formulation).
• 💡 Light Protection: Keep vials inside the outer carton until time of use.
• 💧 Diluted Solution Stability: Infusion solutions should be used immediately upon preparation. If storage is necessary, adhere strictly to aseptic chemical stability guidelines.
• 👶 Safety Precautions: Keep out of reach of children.
• ⏳ Shelf Life: 24 months. Prescription hospital-use medication.

To verify the authenticity of original Docelieva RTU manufactured by Allieva Pharma, check the following packaging and security features:

• ✅ Allieva Corporate Trademark: Distinctive corporate logo featuring a stylized letter "A" paired with a red curved element and "ALLIEVA PHARMA" lettering printed on the carton face and side panels.
• ✅ Product Typography: Generic name "Docetaxel Injection IP" printed in bold black typography, paired with brand name "DOCELIEVA RTU" rendered in deep burgundy along with "80 mg / 4 ml" strength.
• ✅ Carton Design Accent: Clean white carton layout accented by a sweeping burgundy-pink curved graphic line at the bottom featuring a round white "80 mg" dosage badge.
• ✅ Batch Identification: Side panel displays cleanly stamped batch number (e.g., R26DC06B6), manufacturing date (06/2026), expiration date (05/2028), maximum retail price (M.R.P. ₹ 11531.00), barcode, QR code, manufacturing standards (WHO-GMP & ISO 9001:2015 Certified Company), and corporate plant address in Baddi, Himachal Pradesh, India.