WARNINGS
This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of vincristine sulfate injection. The intrathecal administration of vincristine sulfate injection usually results in death. Syringes containing this product should be labeled, using the auxiliary sticker provided, to state “FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.”
Extemporaneously prepared syringes containing this product must be packaged in an overwrap which is labeled “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.”
Treatment of patients following intrathecal administration of vincristine sulfate injection has included immediate removal of spinal fluid and flushing with Lactated Ringer’s, as well as other solutions and has not prevented ascending paralysis and death. In one case, progressive paralysis in an adult was arrested by the following treatment initiated immediately after the intrathecal injection:
- As much spinal fluid was removed as could be safely done through lumbar access.
- The subarachnoid space was flushed with Lactated Ringer’s solution infused continuously through a catheter in a cerebral lateral ventricle at the rate of 150 mL/h. The fluid was removed through a lumbar access.
- As soon as fresh frozen plasma became available, the fresh frozen plasma, 25 mL, diluted in 1 L of Lactated Ringer’s solution was infused through the cerebral ventricular catheter at the rate of 75 mL/h with removal through the lumbar access. The rate of infusion was adjusted to maintain a protein level in the spinal fluid of 150 mg/dL.
- Glutamic acid, 10 g, was given intravenously over 24 hours followed by 500 mg 3 times daily by mouth for 1 month or until neurological dysfunction stabilized. The role of glutamic acid in this treatment is not certain and may not be essential.
|
| |
VINCRISTINE SUMMARY
WARNINGS
Vincristine Sulfate Injection is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant (Vinca rosea Linn). Originally known as leurocristine, it has also been referred to as LCR and VCR.
Vincristine sulfate injection is indicated in acute leukemia.
Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non–Hodgkin’s malignant lymphomas (lymphocytic, mixed cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor.
|
NEWS HIGHLIGHTS
Published Studies Related to Vincristine
The treatment of multiple myeloma using vincristine, carmustine, melphalan, cyclophosphamide, and prednisone (VBMCP) alternating with high-dose cyclophosphamide and alpha(2)beta interferon versus VBMCP: results of a phase III Eastern Cooperative Oncology Group Study E5A93. [2009.05.15]
BACKGROUND: A randomized controlled trial tested the hypothesis that aggressive initial therapy using high-dose cyclophosphamide (HiCy) and alpha(2)beta interferon (IFN) may be superior to standard combination alkylating agent regimens in the treatment of newly diagnosed myeloma... CONCLUSIONS: The study showed no significant benefit with the addition of HiCy and IFN to VBMCP.
Maintenance rituximab after cyclophosphamide, vincristine, and prednisone prolongs progression-free survival in advanced indolent lymphoma: results of the randomized phase III ECOG1496 Study. [2009.04.01]
PURPOSE: To determine if maintenance rituximab (MR) after standard chemotherapy improves progression-free survival (PFS) in advanced-stage indolent lymphoma... CONCLUSION: The E1496 study provides the first phase III data in untreated indolent lymphoma that MR after chemotherapy significantly prolongs PFS.
A pilot study with vincristine sulfate liposome infusion in patients with metastatic melanoma. [2008.12]
Vincristine sulfate liposome infusion (VSLI) is a sphingomyelin/cholesterol liposome encapsulated formulation of vincristine that results in an extended drug circulation time and the potential for enhanced malignancy targeting, exposure, and anticancer activity...
Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. [2008.10.01]
PURPOSE: To compare the long-term outcome of patients with previously untreated follicular lymphoma (FL) needing therapy, after treatment with cyclophosphamide, vincristine and prednisone (CVP) versus CVP plus rituximab (R-CVP) and to evaluate the predictive value of known prognostic factors after treatment with R-CVP... CONCLUSION: Analysis of all outcome measures, including OS, confirm the benefit of adding R to CVP in the front-line treatment of FL.
Comparison of results of a pilot study of alternating vincristine/doxorubicin/cyclophosphamide and etoposide/ifosfamide with IRS-IV in intermediate risk rhabdomyosarcoma: a report from the Children's Oncology Group. [2008.01]
CONCLUSIONS: VDC/IE is as effective therapy for intermediate risk RMS as IRS-IV therapy. It is being explored along with irinotecan in relapsed patients and newly diagnosed high-risk patients. (c) 2007 Wiley-Liss, Inc.
Clinical Trials Related to Vincristine
Vincristine, DOXILŽ (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Completed]
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients
respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection)
and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and
Dexamethasone (VAD).
Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS [Completed]
To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone
or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related
Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free
survival and quality of life.
Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which
permits disease palliation at relatively low doses and thus decreases some of the
dose-limiting toxicity. Multi-agent therapy is considered to be more effective than
single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction [Completed]
The purpose of this study is to see how vincristine, when placed in an oil droplet called a
liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body
(pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will
slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in
liver impairment, and who have relapsed after previous therapies.
A Pharmacokinetic and Pharmacodynamic Study of Vincristine in Children With Leukemia [Completed]
The pharmacokinetic behavior of vincristine in pediatric patients has not been well
characterized. The present study will obtain detailed information on vincristine
pharmacokinetics in patients being treated for standard risk ALL on CCG protocols 1952/1962.
A limited sampling strategy will be developed, and the interpatient and intrapatient
variability of vincristine pharmacokinetics in children will be studied. A correlation
between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.
Randomized, Comparative Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) Versus Bleomycin and Vincristine in the Treatment of AIDS-Related Kaposi's Sarcoma [Completed]
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the
treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the
established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of
DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS.
|
|
|
|
Page last updated: 2009-10-20
|
