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Leeblastin 10 Liquid Injection

Generic Name- Vinblastine Sulfate

Drug Class- Antineoplastic agent

Description- Vinblastine is a mitotic inhibitor used in the clinical treatment of leukemia, non-Hodgkin’s disease, Hodgkin’s disease, breast cancers such as breast carcinoma, small-cell lung cancer, testicular carcinoma, and germ cell tumors. It acts by binding specifically to tubulin, inhibiting its polymerization and the subsequent association of microtubules, which results in cell cycle arrest and apoptosis.

Product Description

Leeblastin 10 (Vinblastine for injection) is a liquid injection intended for intravenous infusion only.

Indications and Usage

Vinblastine is indicated in the palliative treatment of:

  • Frequently responsive malignancies including generalized hodgkin’s disease, lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated), histiocytic lymphoma, mycosis fungoides (advanced stages), advanced carcinoma of the testis, kaposi’s sarcoma and letterer-siwe disease (histiocytosis X)
  • Less frequently responsive malignancies including choriocarcinoma resistant to other chemotherapeutic agents and breast carcinoma unresponsive to appropriate endocrine surgery and hormonal therapy

Dosage and Administration

Dosage and Administration

  • Recommended dose in adults with frequent and less frequent responsive malignancies: 3.7 mg/m 2 of body surface area (bsa) IV, then increased to 5.5 mg/m2 bsa (second dose), 7.4 mg/m2 bsa (third dose), 9.25 mg/m2 bsa (fourth dose) and 11.1 mg/m2 bsa (fifth dose)
  • Recommended dose in pediatric patients with frequent and less frequent responsive malignancies: 2.5 mg/m2 bsa IV, increased to 3.75 mg/m2 bsa (second dose), 5.0 mg/m2 bsa (third dose), 6.25 mg/m2 bsa (fourth dose) and 7.5 mg/m2 bsa (fifth dose)
  • The dose should not be increased after that dose which has reduced the white cell count to approximately 3,000 cells/mm2
  • Increase in dose may be used until a maximum dose (not exceeding 18.5 mg/m2 bsa for adults and 12.5 mg/m2 bsa for children) is reached

Dosage Form and Strengths

  • Supplied as a single use vial containing aqueous drug concentrate for intravenous infusion
  • Available as 10 mg for injection

Clinical Efficacy

  • Provides effective palliation with low toxicity in recurrent Hodgkin’s disease following transplant
  • Shows complete response rates of 50% when used in combination with adriamycin, bleomycin and DTIC in advanced diffuse lymphocytic poorly differentiated lymphoma
  • Highly effective and minimally toxic in the treatment of disseminated germ cell testicular cancer, inducing an 83% long-lasting clinical remission when used in combination with actinomycin D, bleomycin, cyclophosphamide and cis-platinum
  • Shows higher response rate, long survival and disease-free survival with tolerable toxicity in the treatment of extensive classic ‘Kaposi’s sarcoma
  • Effective and an excellent first-line chemotherapeutic treatment for women with metastatic breast cancer

    Adverse Reactions

    • The most common adverse reactions reported following administration of vinblastine are leukopenia , anemia, thrombocytopenia, alopecia, constipation, anorexia, nausea, vomiting, abdominal pain, pharyngitis, diarrhea, neuropathy, hypertension, skin rash, malaise, bone pain, weakness, dizziness, jaw pain, and Raynaud’s phenomenon

    Contraindications

    • It is contraindicated in patients with leucopenia and bacterial infections

     

Special Precautions

  • Consider dose adjustment in patients with patients with renal and hepatic impairment
  • Monitor blood counts closely to determine the infections related to myelosuppression
  • Leakage of vinblastine solution in surrounding tissues can result in skin infections. If extravasations occur, the injection should be discontinued immediately and any remaining portion of the dose should then be introduced into another vein.
  • Vinblastine in combination with mitomycin may result in fatal acute respiratory distress or failure
  • Caution is required when vinblastine is used in combination with other agents, as it can cause ototoxicity
  • Care should be recommended while administering vinblastine in patients with ischemic cardiac disease
  • Use of vinblastine should not be considered in patients with a history of skin ulcers and cachexia
  • Caution should be exercised while administering vinblastine in patients concurrently taking CYP 3A inhibitors as it may cause an earlier onset and an increased severity of side effects
  • Avoid contamination of the eye with vinblastine solutions. If accidental contamination occurs, severe irritation may result and if the drug was given under pressure, corneal ulceration may result
  • Do not administer vinblastine intrathecally as it may be fatal
  • Vinblastine can cause amenorrhea in women and aspermia in men
  • Women of childbearing potential should be advised to avoid becoming pregnant
  • It is not recommended for use in pregnant and breast feeding mothers
Leeblastin 10 Liquid Injection - ADMAC Life Science