Overview
Vincristine is an antitumor vinca alkaloid isolated from Vinca Rosea. It is marketed under several brand names, many of which have different formulations such as Marqibo (liposomal injection) and Vincasar. Vincristine is indicated for the treatment of acute leukaemia, malignant lymphoma, Hodgkin's disease, acute erythraemia, and acute panmyelosis. vincristine sulfate is often chosen as part of polychemotherapy because of lack of significant bone–marrow suppression (at recommended doses) and of unique clinical toxicity (neuropathy).
Indication
Treatment of acute lymphocytic leukemia (ALL), Hodgkin lymphoma, non-Hodgkin lymphomas, Wilms' tumor, neuroblastoma, rhabdomyosarcoma. Liposomal vincristine is indicated for the treatment of relapsed Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL).
Associated Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Choriocarcinoma
- Chronic Lymphocytic Leukemia
- Ewing's Sarcoma
- Gestational Trophoblastic Neoplasia
- Hepatoblastomas
- Hodgkin's Lymphoma
- Immune Thrombocytopenia (ITP)
- Kaposi's Sarcoma
- Multiple Myeloma (MM)
- Neuroblastoma (NB)
- Non-Hodgkin's Lymphoma (NHL)
- Ovarian germ cell tumour
- Pheochromocytoma
- Relapsed Acute Lymphoblastic Leukemia (ALL)
- Retinoblastoma
- Rhabdomyosarcomas
- Small Cell Lung Cancer (SCLC)
- Wilms' tumor
- Advanced Thymoma
Research Report
A Comprehensive Monograph on Vincristine (DB00541): Pharmacology, Clinical Utility, and Risk Management
1.0 Executive Summary
Vincristine is a complex, naturally occurring antineoplastic agent belonging to the vinca alkaloid class of chemotherapeutics. Isolated from the Madagascar periwinkle plant, Catharanthus roseus, it has been a cornerstone of cancer treatment for over half a century.[1] Its primary mechanism of action involves the disruption of microtubule dynamics, leading to cell cycle arrest in the mitotic phase and subsequent apoptosis of rapidly dividing cancer cells.[4] Vincristine demonstrates a broad spectrum of clinical activity, proving indispensable in combination chemotherapy regimens for a variety of hematologic malignancies—including acute lymphocytic leukemia (ALL) and Hodgkin and non-Hodgkin lymphomas—as well as numerous pediatric solid tumors such as Wilms' tumor, neuroblastoma, and rhabdomyosarcoma.[1]
A defining characteristic that establishes Vincristine's unique therapeutic niche is its relative lack of significant bone marrow suppression at standard doses, a property that allows it to be combined effectively with more myelosuppressive agents.[1] However, the clinical utility of Vincristine is fundamentally constrained by its significant and cumulative dose-limiting toxicity: a severe peripheral neuropathy that can manifest with sensory, motor, and autonomic dysfunction.[4] The management of patients receiving Vincristine is therefore a delicate balance between maximizing its potent anticancer effects and mitigating its debilitating neurotoxicity. Compounding these challenges is a critical and absolute safety mandate: Vincristine is for intravenous administration only. Inadvertent intrathecal injection is almost uniformly fatal, necessitating stringent, system-wide safety protocols to prevent this catastrophic medical error.[9]
2.0 Drug Identification and Formulation
2.1 Chemical Identity and Origin
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/21 | Not Applicable | Not yet recruiting | City of Hope Medical Center | ||
2025/07/18 | Not Applicable | Not yet recruiting | |||
2025/05/18 | Phase 1 | Recruiting | |||
2025/05/02 | Phase 2 | Recruiting | Jennifer Amengual | ||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/04/09 | Phase 2 | Not yet recruiting | City of Hope Medical Center | ||
2025/04/04 | Phase 3 | Recruiting | |||
2025/02/11 | Phase 2 | Not yet recruiting | |||
2025/01/06 | Phase 1 | Recruiting | Sun Yat-sen University | ||
2024/12/17 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Hospira, Inc. | 61703-309 | INTRAVENOUS | 1 mg in 1 mL | 2/3/2023 | |
Hospira, Inc. | 61703-309 | INTRAVENOUS | 1 mg in 1 mL | 2/1/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
VINRACINE INJ. 1 mg/ml | SIN10319P | INJECTION | 1 mg/ml | 10/29/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
HOSPIRA VINCRISTINE SULFATE 5mg/5mL Injection Vial | 47250 | Medicine | A | 1/31/1994 | |
Hospira Vincristine Sulfate Injection, USP 5mg/5mL vial | 74646 | Medicine | A | 5/31/2000 | |
Hospira Vincristine Sulfate 1 mg/1mL injection USP | 144059 | Medicine | A | 8/30/2007 | |
Hospira Vincristine Sulphate Injection, 2 mg/2 mL vial | 142605 | Medicine | A | 7/30/2007 | |
Hospira Vincristine Sulphate 5 mg/5 mL Injection vial (preserved) | 191421 | Medicine | A | 11/2/2011 | |
Vincristine Sulfate Injection 1 mg in 1 mL (6) | 325642 | Medicine | A | 10/28/2019 | |
Vincristine Sulfate Injection 2 mg in 2 mL (2) | 324908 | Medicine | A | 10/15/2019 | |
DBL VINCRISTINE SULFATE 2mg/2mL Injection Vial | 47249 | Medicine | A | 1/31/1994 | |
Hospira Vincristine Solution Injection, 2 mg/2 mL vial | 142507 | Medicine | A | 7/25/2007 | |
Hospira Vincristine Sulfate 2 mg/2 mL injection USP | 142501 | Medicine | A | 7/25/2007 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
VINCRISTINE SULFATE INJ 5MG/VIAL USP | david bull laboratories (pty) ltd. | 00690317 | Powder For Solution - Intravenous | 5 MG / VIAL | 12/31/1989 |
VINCRISTINE SULFATE INJ 1MG/ML USP | david bull laboratories (pty) ltd. | 00726575 | Liquid - Intravenous | 1 MG / ML | 12/31/1989 |
ONCOVIN SOLUTION 1MG/ML | eli lilly canada inc | 00611182 | Liquid - Intravenous | 1 MG / ML | 12/31/1984 |
VINCRISTINE SULFATE INJECTION | teva canada limited | 02143305 | Solution - Intravenous | 1 MG / ML | 12/31/1995 |
VINCRISTINE SULFATE INJECTION | 02324148 | Solution - Intravenous | 1 MG / ML | N/A | |
VINCRISTINE SULFATE INJECTION USP | uman pharma inc | 02333198 | Solution - Intravenous | 1 MG / ML | N/A |
VINCRISTINE SULFATE INJECTION USP | 02183013 | Solution - Intravenous | 1 MG / ML | 8/7/1997 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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