Product image of Naveruclif (Paclitaxel) supplied by GNH India

Naveruclif

Active Ingredient:
Paclitaxel
Origin:
EU

Naveruclif (Paclitaxel)

Paclitaxel, the active ingredient in Naveruclif, is a Taxane presented as an intravenous solution for intravenous use. As a mitotic inhibitor, it is employed in the treatment of adult patients with solid tumours including breast, ovarian, non‑small cell lung, pancreatic cancers and Kaposi's sarcoma.

The product is manufactured in the European Union under strict GMP standards. GNH India supplies Naveruclif as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, ensuring quality and regulatory conformity across global markets.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

  • Paclitaxel is a taxane chemotherapy agent used in the management of several solid tumours.
  • Breast cancer: administered as part of adjuvant or metastatic therapy to inhibit tumour growth and reduce disease burden.
  • Ovarian cancer: used in combination regimens to improve response rates and prolong survival in advanced disease.
  • Non‑small cell lung cancer: employed in first‑line or subsequent lines to extend patient survival.
  • Pancreatic cancer: incorporated into combination protocols for metastatic disease to control tumour progression.
  • Kaposi's sarcoma: applied in HIV‑negative patients to control lesion development and spread.

How It Works

  • Paclitaxel binds to the β‑tubulin subunit of microtubules, stabilizing them and preventing depolymerisation. This action blocks the normal dynamic reorganisation of the microtubule network required for mitotic spindle formation, thereby arresting cells in the G2/M phase of the cell cycle and leading to apoptosis of rapidly dividing cancer cells.

Side Effects

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: hair loss during treatment cycles.
  • Peripheral neuropathy: tingling or numbness in extremities.
  • Nausea and fatigue: general malaise and reduced appetite.

Serious or Rare Side Effects

  • Severe hypersensitivity reactions: including anaphylaxis and bronchospasm.
  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Cardiac arrhythmias: irregular heart rhythms observed during infusion.
  • Pulmonary toxicity: interstitial pneumonitis or acute respiratory distress.

Precautions & Warnings

  • Before initiating therapy, clinicians should consider several safety measures.
  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess cardiac function: baseline ECG recommended due to potential arrhythmias.
  • Evaluate liver function: dose adjustments may be needed in hepatic impairment.
  • Avoid use in patients with known hypersensitivity to paclitaxel or its excipients.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Paclitaxel may interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • CYP2C8 inhibitors (e.g., gemfibrozil): may increase paclitaxel exposure.
  • CYP3A4 inducers (e.g., rifampin): may reduce efficacy.
  • Concurrent use with other myelosuppressive agents: heightened risk of severe neutropenia.
  • Concomitant anticoagulants: increased bleeding risk due to thrombocytopenia.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may modestly raise plasma levels.
  • Strong CYP2C8 inhibitors (e.g., clopidogrel): monitor for toxicity signs.
  • Neurotoxic agents (e.g., vincristine): may exacerbate peripheral neuropathy.

Frequently Asked Questions

Naveruclif contains paclitaxel and is indicated for the treatment of adult patients with solid tumours such as breast cancer, ovarian cancer, non‑small cell lung cancer, pancreatic cancer and Kaposi's sarcoma. It is used in both curative and palliative settings as part of chemotherapy regimens.

Paclitaxel stabilises microtubules by binding to the β‑tubulin subunit, preventing their depolymerisation. This blocks the dynamic reorganisation required for mitotic spindle formation, arrests cells in the G2/M phase, and ultimately triggers apoptosis of rapidly dividing cancer cells.

The dose of Naveruclif is determined by the prescribing oncologist based on the specific cancer type, treatment protocol, patient weight, and clinical condition. Dosing regimens are individualized and should follow established oncology guidelines.

The safety of paclitaxel during pregnancy and lactation has not been established. It is generally contraindicated in pregnant or nursing women because of potential fetal toxicity and the risk of drug transfer through breast milk.

To order Naveruclif, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.

The primary alternative to paclitaxel is docetaxel, another taxane. Both agents stabilise microtubules, but they differ in pharmacokinetic profiles, dosing schedules and toxicity patterns. Paclitaxel is often associated with a higher incidence of hypersensitivity reactions, whereas docetaxel may cause more pronounced fluid retention. Choice depends on clinical judgement and patient tolerance.

Naveruclif should be stored at 2‑8 °C in a refrigerator, protected from light. Do not freeze or shake the vial. Before use, allow the solution to reach room temperature if required, and inspect for particulate matter or discoloration.

Naveruclif is given as an intravenous infusion. The solution is diluted in an appropriate compatible fluid and administered over a period defined by the treating physician, typically ranging from 30 minutes to several hours, under close medical supervision.

Serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening hypersensitivity reactions, significant peripheral neuropathy, and cardiac arrhythmias. Patients should be monitored closely for signs of infection, allergic response, nerve dysfunction and heart rhythm changes during and after infusion.

Naveruclif is contraindicated in patients with known hypersensitivity to paclitaxel or any of its excipients, in those with severe hepatic impairment, and in pregnant or breastfeeding women. Caution is also advised for individuals with pre‑existing neuropathy or uncontrolled cardiac conditions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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