pharmacopeia

Boxed warning

Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine 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. See WARNINGS for the treatment of patients given intrathecal vinblastine sulfate injection.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Tubulin Interactions.

Indications

Sourced from openFDA
  • Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies • Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) • Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated) • Histiocytic lymphoma • Mycosis fungoides (advanced stages) • Advanced carcinoma of the testis • Kaposi’s sarcoma • Letterer-Siwe disease (histiocytosis X) II.ICD-10: C85.90

Contraindications

Sourced from openFDA
  • Vinblastine sulfate is contraindicated in patients who have significant granulocytopenia unless this is a result of the disease being treated. It should not be used in the presence of bacterial infections.contraindicated

Dosage & administration

Sourced from openFDA

This preparation is for intravenous use only (see WARNINGS ). Special Dispensing Information - To reduce the potential for fatal medication errors due to incorrect route of administration, vinblastine sulfate injection should be diluted in a flexible plastic container and prominently labeled (as indicated), “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.” (see WARNINGS ). Preparation for flexible plastic container Vinblastine sulfate injection when diluted with 0.9% sodium chloride injection to concentrations of 0.1 mg/mL to 0.4 mg/mL is stable at room temperature for up to 24 hours when protected from light or 8 hours in normal light. Caution–It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine 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 will help disperse the drug and may minimize discomfort and the possibility of cellulitis. There are variations in the depth of the leukopenic response that follows therapy with vinblastine sulfate. For this reason, it is recommended that the drug be given no more frequently than once every seven days .

Warnings & precautions

Sourced from openFDA

This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of vinblastine sulfate. The intrathecal administration of vinblastine sulfate usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, vinblastine sulfate injection should be diluted in a flexible plastic container and prominently labeled (as indicated) “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.’’ After inadvertent intrathecal administration of vinca alkaloids, immediate neurosurgical intervention is required in order to prevent ascending paralysis leading to death. In a very small number of patients, life-threatening paralysis and subsequent death was averted but resulted in devastating neurological sequelae, with limited recovery afterwards. There are no published cases of survival following intrathecal administration of vinblastine sulfate to base treatment on. However, based on the published management of survival cases involving the related vinca alkaloid vincristine sulfate 1-3 , if vinblastine sulfate is mistakenly given by the intrathecal route, the following treatment should be initiated immediately after the injection: 1. Removal of as much CSF as is safely possible through the lumbar access. 2. Insertion of an epidural catheter into the subarachnoid space via the intervertebral space above initial lumbar access and CSF irrigation with lactated Ringer’s solution.

Adverse reactions

Sourced from openFDA

Prior to the use of the drug, patients should be advised of the possibility of untoward symptoms . In general, the incidence of adverse reactions attending the use of vinblastine sulfate appears to be related to the size of the dose employed. With the exception of epilation, leukopenia and neurologic side effects, adverse reactions generally have not persisted for longer than 24 hours. Neurologic side effects are not common; but when they do occur, they often last for more than 24 hours. Leukopenia, the most common adverse reaction, is usually the dose-limiting factor. The following are manifestations that have been reported as adverse reactions, in decreasing order of frequency. The most common adverse reactions are underlined: Hematologic - Leukopenia (granulocytopenia), anemia, thrombocytopenia (myelosuppression). Dermatologic - Alopecia is common. A single case of light sensitivity associated with this product has been reported. Gastrointestinal - Constipation , anorexia, nausea, vomiting, abdominal pain, ileus, vesiculation of the mouth, pharyngitis, diarrhea, hemorrhagic enterocolitis, bleeding from an old peptic ulcer and rectal bleeding. Neurologic - Numbness of digits (paresthesias), loss of deep tendon reflexes, peripheral neuritis, mental depression, headache, convulsions. Treatment with vinca alkaloids has resulted rarely in both vestibular and auditory damage to the eighth cranial nerve. Manifestations include partial or total deafness which may be temporary or permanent, and difficulties with balance including dizziness, nystagmus and vertigo.

Use in specific populations

Sourced from openFDA

Usage in Pregnancy Pregnancy Category D - (See WARNINGS ). Vinblastine sulfate should be given to a pregnant woman only if clearly needed. Animal studies suggest that teratogenic effects may occur.

Overdosage

Sourced from openFDA

Signs and Symptoms Side effects following the use of vinblastine sulfate are dose related. Therefore, following administration of more than the recommended dose, patients can be expected to experience these effects in an exaggerated fashion. (See CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS , PRECAUTIONS and ADVERSE REACTIONS .) There is no specific antidote. In addition, neurotoxicity similar to that with vincristine sulfate may be observed. Since the major route of excretion may be through the biliary system, toxicity from this drug may be increased when there is hepatic insufficiency. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR) . In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics in your patient. Overdoses of vinblastine sulfate have been reported rarely. The following is provided to serve as a guide should such an overdose be encountered.

Approval history

Sourced from openFDA
  • Apr 29, 1987ANDAANDA089515Fresenius Kabi Usa

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,907 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Febrile Neutropenia1678.8%
  2. 2Neutropenia1447.6%
  3. 3Pyrexia1236.4%
  4. 4Nausea864.5%
  5. 5Pulmonary Toxicity784.1%
  6. 6Vomiting784.1%
  7. 7Neutrophil Count Decreased753.9%
  8. 8Neuropathy Peripheral743.9%
  9. 9Off Label Use743.9%
  10. 10Pancytopenia743.9%
  11. 11Anaemia703.7%
  12. 12White Blood Cell Count Decreased663.5%
  13. 13Sepsis643.4%
  14. 14Dyspnoea603.1%
  15. 15Diarrhoea583.0%

Literature

View JSON

Recent PubMed references pinned to Vinblastine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 231 ClinicalTrials.gov registrations naming Vinblastine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Vinblastine work?
Mechanism-of-action class: Tubulin Interactions.
What is Vinblastine used for?
According to FDA labeling, Vinblastine carries indications including: Vinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies • Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system) • Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated) • Histiocytic lymphoma • Mycosis fungoides (advanced stages) • Advanced carcinoma of the testis • Kaposi’s sarcoma • Letterer-Siwe disease (histiocytosis X) II.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Vinblastine?
Vinblastine is classified as Vinca alkaloids and analogues, Vinca Alkaloid, Tubulin Interactions, Cellular Growth Phase Arrest, Decreased Mitosis, Increased Cellular Death.
What are the contraindications for Vinblastine?
Vinblastine labeling lists contraindications including: Vinblastine sulfate is contraindicated in patients who have significant granulocytopenia unless this is a result of the disease being treated. It should not be used in the presence of bacterial infections.. Always consult the full prescribing information and a clinician.
Note. Data for vinblastine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients