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Paclibenz 30/100/260 Liquid Injection

Generic Name- Paclitaxel

Drug Class- Antineoplastic agent

Paclitaxel is an antimetabolite used for the therapy of different types of cancers including ovarian, breast, non small cell lung cancer and AIDS related Kaposi sarcoma. It acts by stabilizing microtubules and interfering with microtubule disassembly in cell division, resulting in cell cycle arrest and cell death.

Product Description

Paclibenz 30/100/260 (Paclitaxel for injection) is a single use liquid injection available in glass vial for intravenous administration.

Indications and Usage

Paclitaxel is indicated for:

  • Treatment of advanced carcinoma of the ovary as first-line and subsequent therapy
  • Adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy
  • Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
  • First-line treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
  • Second-line treatment of AIDS-related Kaposi’s sarcoma

Dosage and Administration

  • Dosage Regimen for previously untreated patients with ovarian cancer

Paclitaxel/ Cisplatin Regimen: Paclitaxel at a dose of 175 mg/m2 IV for 3 hours followed by cisplatin at a dose of 75 mg/m2 or 135 mg/m2 IV for 24 hours followed by cisplatin at a dose of 75 mg/m2

  • Dosage Regimen for previously treated patients with ovarian cancer

Paclitaxel Monotherapy: 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks.

  • Dosage Regimen for adjuvant and metastatic breast cancer

Paclitaxel Monotherapy: 175 mg/m2 IV over 3 hours every 3 weeks for 4 courses

  • Dosage Regimen for patients with non-small cell lung carcinoma

Paclitaxel/Cisplatin Regimen: 135 mg/m2 IV for 24 hours, every 3 weeks followed by cisplatin 75 mg/m2

  • Dosage Regimen for patients with AIDS-related Kaposi’s sarcoma

Paclitaxel Monotherapy: 135 mg/m2 IV over 3 hours every 3 weeks or at a dose of 100 mg/m2 IV over 3 hours every 2 weeks

Dosage Form and Strengths

  • Supplied as a single use vial containing aqueous drug concentrate for intravenous infusion
  • Available as 30mg, 100mg and 260mg for injection

Clinical Efficacy

  • Increases survival rate, when used in combination with cisplatin in patients with suboptimal stage III and stage IV ovarian cancer
  • Effective and tolerable option for the adjuvant treatment of patients with high-risk breast cancer
  • Offers an overall response rate of 86% in patients with metastatic and locally advanced breast cancer
  • Provides better response rate and survival outcomes in patients with NSCLC
  • Shows better tolerability with higher response rate in the treatment of advanced AIDS-related Kaposi sarcoma, including those who have experienced treatment failure of prior systemic therapy

 Adverse Reactions

  • The most common adverse events that occur after administration of paclitaxel are severe stomach pain, severe diarrhea, anemia, fever, fatigue, alopecia, neuropathy, joint and muscle pain, nausea and vomiting, allergic reactions, mucositis, bleeding events, irritation at the injection site and hypotension.


  • It is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel
  • It is not recommended for use in patients with solid tumors who have baseline neutrophil counts of <1500 cells/mm3 or in patients with AIDS-related Kaposi’s sarcoma with baseline neutrophil counts of <1000cells/mm3

Special Precautions

  • Frequent peripheral blood cell counts should be performed in all patients receiving paclitaxel to monitor the occurrence of myelotoxicity
  • Continuous cardiac monitoring is required for patients with serious cardiac abnormalities as hypotension, bradycardia, and hypertension have been observed during administration of paclitaxel
  • Consider dose reduction in patients with hepatic impairment and patients developing peripheral neuropathy
  • Closely monitor the infusion site for possible infiltration and extravasations during drug administration
  • Avoid contact of undiluted concentrate with plasticized polyvinyl chloride (PVC) equipment or devices used to prepare solutions for infusion
  • Caution should be exercised when paclitaxel is concomitantly administered with known CYP2C8 and CYP3A4 substrates, inducers, and inhibitors
  • Women of reproductive potential should be advised to avoid pregnancy due to potential harm to fetus
  • It is recommended to discontinue nursing while receiving paclitaxel therapy
Liquid Injection Paclitaxel 30 / 100 / 260 mg Manufacturer | ADMAC