Vincasar Pfs
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Questions & Answers
Side Effects & Adverse Reactions
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 VINCASAR PFS (vincristine sulfate injection) usually results in death.
To reduce the potential for fatal medication errors due to incorrect route of administration, VINCASAR PFS should be diluted in a flexible plastic container and prominently labeled as indicated for intravenous use only.
Syringes containing this product must be labeled, using the auxiliary sticker provided, to state “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.”
Extemporaneously prepared syringes containing this product must be packaged in an overwrap which is labeled “do not remove covering until moment of injection. For intravenous use only – fatal if given by other routes.”
See OVERDOSAGE section for the treatment of patients given intrathecal VINCASAR PFS.
Vincristine sulfate can cause fetal harm when administered to a pregnant woman. When pregnant mice and hamsters were given doses of vincristine sulfate that caused resorption of 23% to 85% of fetuses, fetal malformations were produced in those that survived. Five monkeys were given single doses of vincristine sulfate between days 27 and 34 of their pregnancies; 3 of the fetuses were normal at term, and 2 viable fetuses had grossly evident malformations at term. In several animal species, vincristine sulfate can induce teratogenesis as well as embryo death at doses that are nontoxic to the pregnant animal. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
VINCASAR PFS is indicated in acute leukemia.
VINCASAR PFS 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.
History
There is currently no drug history available for this drug.
Other Information
VINCASAR PFS (vincristine sulfate injection USP) is vincaleukoblastine, 22-oxo-, sulfate (1:1) (salt). It 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. The structural formula is as follows:
C46H56N4O10•H2SO4 M.W. 923.04
Vincristine Sulfate, USP is a white to slightly yellow powder. It is soluble in methanol, freely soluble in water, but only slightly soluble in 95% ethanol. In 98% ethanol, vincristine sulfate, USP has an ultraviolet spectrum with maxima at 221 nm (∈ +47,100).
VINCASAR PFS (vincristine sulfate injection USP) is a sterile, preservative-free, single use only solution available for intravenous use in 1 mg (1 mg/1 mL) and 2 mg (2 mg/2 mL) vials. Each mL contains vincristine sulfate, USP, 1 mg (1.08 µmol); mannitol, 100 mg; and water for injection USP, qs. Acetic acid and sodium acetate have been added for pH control. The pH of VINCASAR PFS ranges from 3.5 to 5.5. This product is a sterile solution for cancer/oncolytic use.
Sources
Vincasar Pfs Manufacturers
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Teva Parenteral Medicines, Inc.
![Vincasar Pfs (Vincristine Sulfate) Injection, Solution [Teva Parenteral Medicines, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vincasar Pfs | Teva Parenteral Medicines, Inc.
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 VINCASAR PFS, since overdosage may have a very serious or fatal outcome.
The usual dose of VINCASAR PFS for pediatric patients is 1.5 to 2 mg/m2. For pediatric patients weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. The usual dose of VINCASAR PFS for adults is 1.4 mg/m2. A 50% reduction in the dose of VINCASAR PFS is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL.
The drug is administered intravenously at weekly intervals.
TO REDUCE THE POTENTIAL FOR FATAL MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION, VINCASAR PFS SHOULD BE DILUTED IN A FLEXIBLE PLASTIC CONTAINER AND PROMINENTLY LABELED FOR INTRAVENOUS USE ONLY (see WARNINGS).
The concentration of VINCASAR PFS is 1 mg/mL. Do not add extra fluid to the vial prior to removal of the dose. Withdraw the solution of VINCASAR PFS into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely.
Preparation for flexible plastic container
VINCASAR PFS when diluted with 0.9% sodium chloride injection in concentrations from 0.0015 mg/mL to 0.08 mg/mL is stable for up to 24 hours when protected from light or 8 hours under normal light at 25°C.
Preparation for syringe
Special Dispensing Information
When dispensing VINCASAR PFS in a syringe, it is imperative that it be packaged in the provided overwrap which bears the following statement: “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES”(see WARNINGS).A syringe containing a specific dose must be labeled, using the auxiliary sticker provided, to state: “FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.”
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 VINCASAR PFS 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.
VINCASAR PFS 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 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 VINCASAR PFS should be accomplished within 1 minute.
Patients Receiving Radiation Therapy
VINCASAR PFS should not be given to patients while they are receiving radiation therapy through ports that include the liver. When VINCASAR PFS is used in combination with L-asparaginase, VINCASAR PFS should be given 12 to 24 hours before administration of the enzyme in order to minimize toxicity; administering L-asparaginase before VINCASAR PFS may reduce hepatic clearance of vincristine.
Drug InteractionsVINCASAR PFS 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 DisposalProcedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
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