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(vinorelbine tartrate) Injection
WARNING: NAVELBINE (vinorelbine tartrate) Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled "WARNING - FOR IV USE ONLY. FATAL if given intrathecally."
Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥ 1,000 cells/mm3 prior to the administration of NAVELBINE (vinorelbine tartrate) . The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.
Caution - It is extremely important that the intravenous needle or catheter be properly positioned before NAVELBINE (vinorelbine tartrate) is injected. Administration of NAVELBINE (vinorelbine tartrate) may result in extravasation causing local tissue necrosis and/or thrombophlebitis (see DOSAGE AND ADMINISTRATION: Administration Precautions).
NAVELBINE (vinorelbine tartrate) Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic. Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumor activity. The chemical name is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(salt)]. Vinorelbine tartrate has the following structure:
vinorelbine tartrate is a white to yellow or light brown amorphous powder with the molecular formula C45H54N4O8•2C4H6O6 and molecular weight of 1079.12. The aqueous solubility is > 1,000 mg/mL in distilled water. The pH of NAVELBINE (vinorelbine tartrate) Injection is approximately 3.5.
What are the possible side effects of vinorelbine (Navelbine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
- cough, bronchospasm (wheezing, chest tightness, trouble breathing);
- severe constipation, stomach pain, bloody or black stools;
- pale skin, feeling light-headed or short of breath,...
What are the precautions when taking vinorelbine tartrate (Navelbine)?
Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.
Last reviewed on RxList: 12/17/2008
This monograph has been modified to include the generic and brand name in many instances.
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