Vincristine sulfate

Vincristine sulfate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]

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Black Box Warning

Warnings See full prescribing information for complete Boxed Warning. Caution-This preparation should be administered by individuals experienced in the administration of vincristine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of vincristine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.

Overview

Vincristine sulfate is a mitotic inhibitor that is FDA approved for the treatment of acute leukemia, Hodgkin’s disease, non-Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, Wilms’ tumor. There is a Black Box Warning for this drug as shown here. Common adverse reactions include alopecia, constipation, nausea and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Vincristine sulfate is indicated in acute leukemia. Has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non-Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor.

• Dosage: 1.4 mg/m2

VINCASAR PFS

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vincristine sulfate in adult patients.

Non–Guideline-Supported Use

• AIDS-related Kaposi's sarcoma

• Dosage: 2 mg on odd numbered weeks

• Blastic phase chronic myeloid leukemia
• Breast cancer
• Cervical cancer
• Chronic lymphoid leukemia
• Colorectal cancer
• Ewing's sarcoma of bone
• Germ cell tumor of ovary

Gestational trophoblastic neoplasia

Head and neck cancer

Hepatoblastoma

Idiopathic thrombocytopenic purpura

Intracranial tumor

Kaposi's sarcoma

Malignant epithelial tumor of ovary

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Vincristine sulfate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vincristine sulfate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vincristine sulfate in pediatric patients.

Contraindications

There is limited information regarding Vincristine sulfate Contraindications in the drug label.

Warnings

Warnings See full prescribing information for complete Boxed Warning. Caution-This preparation should be administered by individuals experienced in the administration of vincristine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of vincristine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.

There is limited information regarding Vincristine sulfate Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Vincristine sulfate Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Vincristine sulfate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Vincristine sulfate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Vincristine sulfate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vincristine sulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Vincristine sulfate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Vincristine sulfate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Vincristine sulfate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Vincristine sulfate in geriatric settings.

Gender

There is no FDA guidance on the use of Vincristine sulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Vincristine sulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Vincristine sulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Vincristine sulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Vincristine sulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Vincristine sulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Vincristine sulfate Administration in the drug label.

Monitoring

There is limited information regarding Vincristine sulfate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Vincristine sulfate and IV administrations.

Overdosage

There is limited information regarding Vincristine sulfate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Vincristine sulfate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Vincristine sulfate Mechanism of Action in the drug label.

Structure

There is limited information regarding Vincristine sulfate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Vincristine sulfate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Vincristine sulfate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Vincristine sulfate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Vincristine sulfate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Vincristine sulfate How Supplied in the drug label.

Storage

There is limited information regarding Vincristine sulfate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Vincristine sulfate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Vincristine sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Vincristine sulfate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Vincristine sulfate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.