Medlineplus information on vinorelbine tartrate a lay language summary of important information about this drug that may include the following. See full prescribing information for vinorelbine injection. Vinorelbine is administered in 50 ml sodium chloride 0. Orphan designation for treatment of soft tissue sarcoma. Highlights of prescribing information these highlights do not include all the information needed to use mekinist safely and effectively. Read all of this leaflet carefully before you start taking this medicine. Jan 01, 2017 vinorelbine interferes with the growth of cancer cells, which are eventually destroyed. Although not all of these side effects may occur, if they do occur they may need medical attention. Feb 16, 2018 vinorelbine should be administered under the supervision of a physician experienced in the use of chemotherapy. Trastuzumab and vinorelbine in advanced breast cancer. The pharmacokinetics of vinorelbine are not influenced by the concurrent administration of cisplatin with navelbine. Early breast cancer ebc the safety of the various combination chemotherapy regimens prior to herceptin therapy. Nov 09, 2018 vinorelbine is given as an injection through a needle placed into a vein. It is restricted to use by specialist oncologists as an alternative to the intravenous formulation of vinorelbine.
Vinorelbine injection usp showed improved survival time compared to 5fu. Information from its description page there is shown below. Like other mitotic inhibitors, vinorelbine also promotes apoptosis. Product monograph template standard fresenius kabi. Vinorelbine injection, usp is a sterile nonpyrogenic aqueous solution for intravenous use. Mekinist trametinib tablets, for oral use initial u. The medicine must be given slowly through an iv infusion. Vinorelbine belongs to the general group of medicines known as antineoplastics.
Vinorelbine binding was not altered in the presence of cisplatin, 5fluorouracil, or doxorubicin. Jan 31, 2020 vinorelbine binding was not altered in the presence of cisplatin, 5fluorouracil, or doxorubicin. Vinorelbine injections are for intravenous administration only. Vinorelbine must only be administered by the intravenous route. Vinorelbine by injection national library of medicine. Vinca alkaloids such as vincristine and vinblastine are originally derived from periwinkle leaves vinca rosea.
Vinorelbine interferes with the growth of cancer cells, which are eventually destroyed. It has a role as an antineoplastic agent and a photosensitizing agent. Vinorelbine is a semisynthetic vinca alkaloid that affects microtubule activity. See what others have said about vinorelbine, including the effectiveness, ease of use and side effects.
Adjustments in the dosage of navelbine should be based on neutrophil counts obtained on the day of treatment see table 1. Call your doctor for medical advice about side effects. Other effects, such as hair loss, may not be serious but may cause concern. This includes breast cancer and nonsmall cell lung cancer. It is freely soluble in water, in methanol and in 96% ethanol. Vinorelbine undergoes substantial hepatic elimination in humans, with large amounts recovered in feces. Apr 20, 2017 navelbine is a antineoplastic drug of the vinca alkaloid family but unlike all the other vinca alkaloids, the catharantine moiety of vinorelbine has been structurally modified. Dermatologic toxicity related to cetuximab was managed according to the package insert. Since the growth of normal cells also may be affected by vinorelbine, other effects will occur. Aug 10, 2011 dermatologic toxicity related to cetuximab was managed according to the package insert. If symptoms of serotonin syndrome occur, discontinue aloxi and initiate supportive treatment. Trastuzumab is an fda approved drug that targets her2. Navelbine vinorelbine injection contains vinorelbine tartrate, usp, salt of a semisynthetic vinca alkaloid the molecular formula for vinorelbine tartrate, usp is c 45 h 54 n 4 o 8 2c 4 h 6 o 6. Product information for auspar navelbine pierre fabre m edicament australia pty ltd pm20100325234 final 30 may 2012.
Navelbine vinorelbine tartrate injection, for intravenous use initial u. You will receive this injection in a clinic or hospital setting. Vinorelbine is a clear liquid that is injected into a vein. At the molecular level, it acts on the dynamic equilibrium of tubulin in the microtubular apparatus of the cell. Vinorelbine side effects, dosage, interactions drugs. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Administration should always be followed by a sodium chloride 9 mgml 0. Highlights of prescribing information tafinlar with. Vinorelbine is given as an injection through a needle placed into a vein. Appropriate procedures for the preparation of chemotherapeutic drugs should be used.
Nil vinorelbine is cleared from the circulation primarily by the liver, and therefore. Vinorelbine should be administered under the supervision of a physician experienced in the use of chemotherapy. Xelodawarfarin interaction xeloda warfarin interaction. Vinorelbine binding was not altered in the presence of cisplatin, 5.
Vinorelbine comes as a solution liquid to be injected intravenously into a vein by a doctor or nurse in a medical facility. Navelbine is a antineoplastic drug of the vinca alkaloid family but unlike all the other vinca alkaloids, the catharantine moiety of vinorelbine has been structurally modified. In most european countries, vinorelbine is approved to treat nonsmall cell lung cancer and breast cancer. Navelbine vinorelbine dosing, indications, interactions. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.
Side effects of navelbine vinorelbine tartrate, warnings, uses. Entyvio vedolizumab for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to entyvio or any of its excipients. Check with your doctor or nurse immediately if any of the following side effects occur while taking vinorelbine. Vinorelbine demonstrated high binding to human platelets and lymphocytes.
This product information was approved at the time this auspar was published. Severe myelosuppression resulting in serious infection, septic shock, and death may occur 5. Aug 20, 2010 the drug combination of trastuzumab and vinorelbine is an effective treatment for patients with breast cancers that are positive for her2. The binding to plasma constituents in cancer patients ranged from 79. Vinorelbine is a vinca alkaloid with a norvinblastine skeleton. Vinorelbine adjuvant treatment of completely resected stage ii or iiia nonsmall cell lung cancer vinorelbine metastatic breast cancer vinorelbine nonsmall cell lung cancer nsclc trastuzumab in combination with vinorelbine metastatic breast cancer. Vinorelbine injection usp should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Two metabolites of vinorelbine have been identified in human blood, plasma, and urine. Monitor myelosuppression see full prescribing information 5. Vinorelbine is used to treat various types of cancer. Steadystate volume of distribution v ss values range from 25.
Vinorelbine undergoes substantial hepatic elimination in humans, with large amounts recovered in feces after intravenous administration to humans. Early breast cancer ebc the safety of the various combination chemotherapy regimens prior to herceptin therapy was not separately analyzed in the hera trial. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and. Inadvertent intrathecal administration can cause severe neurotoxicity, which is usually fatal. Jan 01, 2020 vinorelbine tartrate, usp, is a white to almost white powder. The drug combination of trastuzumab and vinorelbine is an effective. Chemotherapy with vinorelbine is given at a standard dose of 35mgm2 i. Nov 21, 2019 along with its needed effects, vinorelbine may cause some unwanted effects. Some of these may be serious and must be reported to your doctor. Cisplatin is administered in 500ml sodium chloride 0. Gemcitabine is given at the standard dose of 1250 mgm2 i. Patients receiving concomitant capecitabine and oral coumarin. Along with its needed effects, vinorelbine may cause some unwanted effects. Navelbine 10 mgml concentrate for solution for infusion.
You should know that vinorelbine should be administered only into a vein. It is given by injection into a vein or by mouth common side effects include bone marrow suppression, pain at the site of injection, vomiting, feeling tired, numbness, and diarrhea. Vinorelbine injection navelbine side effects, medical. It may also be used to treat other kinds of cancer, as determined by your doctor. The length of treatment depends on how well your body responds to treatment with vinorelbine. The aqueous solubility is 34 1,000 mgml in distilled water. Infusionrelated reactions and hypersensitivity reactions including anaphylaxis have occurred. Dosage may be reduced, delayed or discontinued in patients with bone. Pdf oral vinorelbine in the treatment of nonsmallcell. The purpose of this research study is to see what effects trastuzumab in combination with vinorelbine has on breast cancer when the participant has circulating tumor cells that are positive for the protein called her2. Highlights of prescribing information perforation can occur. Feb 05, 2020 our navelbine vinorelbine tartrate side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Vinorelbine concentrations in plasma decay in a triphasic manner. Administration of navelbine to patients with prior radiation. Side effects of navelbine vinorelbine tartrate, warnings. In combination with cisplatin 100 mgm2 the recommended dosage of vinorelbine injection. Patients should be informed of the increased risk of serotonin syndrome, especially if aloxi is used concomitantly with other serotonergic drugs see drug interactions 7, patient counseling information 17. Vinorelbine fda prescribing information, side effects and uses. It is a vinca alkaloid, an organic heteropentacyclic compound, an organic heterotetracyclic compound, a methyl ester, an acetate ester and a ring assembly. Navelbine vinorelbine injection contains vinorelbine tartrate, usp, salt of a semisynthetic vinca alkaloid the molecular formula for vinorelbine tartrate, usp is c 45 h 54 n 4 o 8 2c 4 h 6 o 6 it has a molecular weight of 1079. Randomized phase ii study of pemetrexed, carboplatin, and. Vinorelbine inhibits cell growth by binding to the tubulin of the mitotic microtubules. The aqueous solution is sterile and 24 nonpyrogenic. This is not a complete list of side effects and others may occur. Jan 31, 2020 vinorelbine concentrations in plasma decay in a triphasic manner.
It is usually given over 610 minutes, once a week, or as directed by your. Vinorelbine received approval by the united states food and drug administration fda in december 1994 sponsored by burroughs wellcome company. Use aseptic technique for reconstitution and preparation of dosing solution. The national patient safety agency has advised august 2008 that adult and teenage patients treated in an adult or adolescent unit should receive their vinca alkaloid dose in a 50 ml minibag. Vinorelbine 10 mgml concentrate for solution for infusion. This trial seeks to determine if the combination can also benefit participants whose original breast cancer was her2 negative but whose circulating tumor cells are her2 positive. Trastuzumab and vinorelbine in advanced breast cancer full.
Discontinue or reduce the dosage upon evidence of abnormal depression of the bone marrow. Our navelbine vinorelbine tartrate side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Vinorelbine and gemcitabine in myeloma full text view. Vinorelbine is given by injection only into a vein by a healthcare professional. Iv vinorelbine has also been studied in combination with other agents in the secondline treatment of advanced breast cancer. Vinorelbine nvb, sold under the brand name navelbine among others, is a chemotherapy medication used to treat a number of types of cancer. Vinorelbine is a semisynthetic vinca alkaloid derived from vinblastine. For patients experiencing radiationrelated esophagitis of grade. These highlights do not include all the information needed to use. Jul 21, 2019 ancobon prescribing information pdf package insert flucytosine ancobon is a the appropriate approved prescribing information should be consulted.
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