A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Oncovin Indications, Dosage, Storage, Stability - Vincristine Sulfate
Oncovin Indications, Dosage, Storage, Stability - Vincristine Sulfate
INDICATIONS
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 disease³, non-Hodgkin's malignant
lymphomas 4-6 (lymphocytic, mixed cell,
histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma
7, neuroblastoma 8,
and Wilms' tumor 9.
DOSAGE AND ADMINISTRATION
This preparation is for intravenous use only (See WARNINGS).
Neurotoxicity appears to be dose related. Extreme care must be used in
calculating and administering the dose of vincristine sulfate injection
since overdosage may have a very serious or fatal outcome.
Special Dispensing INFORMATION
WHEN DISPENSING VINCRISTINE SULFATE INJECTION IN OTHER THAN THE
ORIGINAL CONTAINER, IT IS IMPERATIVE THAT IT BE PACKAGED IN THE PROVIDED
OVERWRAP WHICH BEARS THE FOLLOWING STATEMENT. "DO NOT REMOVE COVERING
UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS
USE ONLY" (See WARNINGS).
A syringe containing a specific dose must be labeled, using the auxiliary
sticker provided, to state. "FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS
USE ONLY."
The concentration of Vincristine Sulfate Injection is 1 mg/mL. Do not
add extra fluid to the vial prior to removal of the dose. Withdraw the
solution of Vincristine Sulfate Injection into an accurate dry syringe,
measuring the dose carefully. Do not add extra fluid to the vial in an
attempt to empty it completely.
Caution: 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 injection 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.
Vincristine sulfate injection must be administered via an intact, free-flowing
intravenous needle or catheter. Care should be taken that there is no
leakage or swelling occurring during administration (See DESCRIPTION
:
BOXED WARNINGS and WARNINGS:
BOXED WARNINGS.)
The solution may be injected either directly into a vein or into the
tubing of a running intravenous infusion (See Drug Interactions
below) Injection of vincristine sulfate injection should be accomplished
within 1 minute. The drug is administered intravenously at weekly intervals.
The usual dose of vincristine injection for children is 2 mg/m². For
children weighing 10 kg or less, the starting dose should be 0.05 mg/kg,
administered once a week. The usual dose of vincristine sulfate injection
for adults is 1.4 mg/m². A 50% reduction in the dose of vincristine sulfate
injection is recommended for patients having a direct serum bilirubin
value above 3 mg/100 mL.19
Vincristine sulfate injection should not be given to patients while
they are receiving radiation therapy through ports that include the liver.
When vincristine sulfate injection is used in combination with L-asparaginase,
vincristine sulfate injection should be given 12 to 24 hours before administration
of the enzyme in order to minimize toxicity; administering L-asparaginase
before vincristine sulfate injection may reduce hepatic clearance of vincristine.
Drug Interactions
Vincristine sulfate injection should not be diluted in solutions that
raise or lower the pH outside the range of 3.5 to 5.5. It should not be
mixed with anything other than normal saline or glucose in water.
Whenever solution and container permit, parenteral drug products should
be inspected visually for particulate matter and discoloration prior to
administration.
Handling and Disposal
Procedures for proper handling and disposal of anticancer drugs should
be considered. Several guidelines on this subject have been published.20-25
There is no general agreement that all of the procedures recommended in
the guidelines are necessary or appropriate.
HOW SUPPLIED
Vincristine Sulfate Injection, USP, preservative free solution.
NDC 61703-309-06 1 mg, 1 mg/1 mL (single dose), flip-top vial (blue cap)
NDC 61703-309-16 2 mg, 2 mg/2 mL (single dose), flip-top vial (blue cap)
Storage: This product should be refrigerated between 2°- 8° C
(36°- 46° F).
REFERENCES
1. Watanbe K, and West WL: Calmodulin activated cyclic nucleotide phosphodiesterase,
microtubules and vinca alkaloids. Fed Proc 1982;41:2292.
2. Nelson RL: The comparative clinical pharmacology and pharmacokinetics
of vindesine, vincristine, and vinblastine in human patients with cancer.
Med Pediatr Oncol 1982;10:115.
3. DeVita VT Jr, Serpick AA, and Carbone PP: Combination chemotherapy
in the treatment of advanced Hodgkin's disease. Ann Intern Med
1970;73:881.
4. Bagley CM Jr, DeVita VT Jr, Berard CW, et al: Advanced lymphyosarcoma:
Intensive cyclical chemotherapy with cyclophosphamide, vincristine and
prednisone. Ann Intern Med 1972;76:227.
5. Lowenbraun S, DeVita, and Serpick AA: Combination chemotherapy with
nitrogen mustard vincristine, procarbazine and prednisone in lymphosarcoma
and reticulum cell sarcoma. Cancer 1970:25:1018.
6. Luce JK, Gamble JF, Wilson HE, et al: Combined cyclophosphamide, vincristine,
and prednisone therapy of malignant lymphoma. Cancer 1971;28:306.
7. Wilbur JR, Sutow WW, Sullivan MP, et al: Successful treatment of rhabdomyosarcoma
with combination chemotherapy and radiotherapy. Am Soc Clin Oncology
April 7,1971.
8. Sullivan MP, Nora AH, Kulapongs P, et al: Evaluation of vincristine
sulfate and cyclophosphamide chemotherapy for metastatic neuroblastoma.
Pediatrics 1969;44:685.
9. Vietti, TJ, Sullivan MP, Haggard ME, et al: Vincristine sulfate and
radiation therapy in metastatic Wilm's tumor. Cancer 1970;25:12.
10. International Agency for Research on Cancer Monograph on the evaluation
of the carcinogenic risk of chemicals to humans. Supplement 4, October,
1982.
11. Grossman SA, Sheidler VR, and Gilbert MR; Decreased phenytoin levels
in patients receiving chemotherapy. Am J Med 1989;87:565.
12. Roeser HP, Stocks AE and Smith AH: Testicular damage due to cytotoxic
drugs and recovery after cessation of therapy. Aust NZ J Med 1978;8:250
13. Chapman R, Sutcliffe SB, and Malpas JS: Male gonadal dysfunction
in Hodgkin's disease. JAMA 1981;245:1323.
14. Sherins RJ, DeVita VT: Effects on drug treatment for lymphoma on
male reproductive capacity. Ann Intern Med 1981;79:216.
15. DeVita VT: The consequences of the chemotherapy of Hodgkin's disease.
Cancer 1981;47:1.
16. Horning SJ, Hoppe RT, Kaplan HS, et al: Female Reproductive Potential
After Treatment for Hodgkin's disease. N Engl J Med 1981;304:1377
.
17. Blatt J, Poplack DG, and Sherins RJ: Testicular function in boys
after chemotherapy for acute lymphoblastic leukemia. N Engl J Med
1981;304:1211 .
18. Siris ES, Leventhal BG, and Vaitukatis JL: Effect of childhood leukemia
and chemotherapy on puberty and reproductive functions in girls. N
Engl J Med 1976;294:1143.
19. DeVita VT Jr, Hellman S, Rosenberg SA (eds): Cancer, Principles
and Practice of Oncology, ed.2 Philadelphia, J. B. Lippincott Co,
1985.
20. Recommendations for the safe handling of parenteral antineoplastic
drugs. NIH Publication No. 83-2621, U.S.Government Printing Office, Washington,
D.C.20402.
21. Council on Scientific Affairs: Guidelines for handling parenteral
antineoplastics. JAMA 1985;253:1590.
22. National Study Commission on Cytotoxic Exposure - Recommendation
for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD, Chairman,
National Study Commission on Cytotoxic Exposure Massachusetts College
of Pharmacy and Allied Health Sciences, 179 Longwood Ave., Boston, Massachusetts
02115 .
23. Clinical Oncological Society of Australia: Guidelines and recommendations
for safe handling of antineoplastic agents. Med J Aust 1983;1:426.
24. Jones RB et al. Safe handling of chemotherapeutic agents: A report
from the Mount Sinai Medical Center. CA, Sept./Oct., 1683;33:258.
25. American Society Hospital Pharmacists: Technical Assistance Bulletin
on Handling Cytotoxic Drugs in Hospitals. Am J Hosp Pharm 47:1033-49,
1990.
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