Vinorelbine tartrate
Vinorelbine tartrate Navelbine
Vinorelbine tartrate
(vin- OR-el-been)
Pregnancy Category: D Navelbine (Rx)

Classification: Antineoplastic agent

Action/Kinetics: Semisynthetic vinca alkaloid thought to act by inhibiting mitosis at metaphase through the drug's interaction with tubulin. Other possible actions may include interference with (a) amino acid, cyclic AMP, and glutathione metabolism, (b) calmodulin-dependent calcium transport ATPase activity, (c) cellular respiration, and (d) nucleic acid and lipid biosynthesis. Following IV use, plasma levels decay in a triphasic manner. The initial rapid decline is due to distribution of the drug to peripheral compartments. The prolonged terminal phase is due to a slow efflux of the drug from peripheral compartments. Terminal phase t 1/2: Averages 27.7-43.6 hr. Metabolized by the liver and excreted through the urine and feces.

Uses: Alone or in combination with cisplatin for first-line treatment of ambulatory clients with unresectable, advanced non-small-cell lung cancer. Investigational: Breast cancer, cisplatin-resistant ovarian carcinoma, and Hodgkin's disease.

Contraindications: Clients with pretreatment granulocyte counts less than 1,000 cells/mm ³. Lactation.

Special Concerns: Use with caution in clients with severe hepatic injury or impairment. Use with extreme caution in clients whose bone marrow reserve may have been compromised by chemotherapy or prior to irradiation; also, in those whose bone marrow function is recovering from the effects of previous chemotherapy. Older clients may be more sensitive to the effects of the drug. Safety and efficacy have not been determined in children.

Side Effects: Hematologic: Granulocytopenia (may require hospitalization), leukopenia, thrombocytopenia, anemia. GI: N&V;, constipation, diarrhea, paralytic ileus, anorexia, stomatitis. CNS: Mild to severe peripheral neuropathy including paresthesia and hypesthesia, loss of deep tendon reflexes. CV: Chest pain, especially in those with a history of CV disease or tumor within the chest; phlebitis. Respiratory: SOB (may be severe), dyspnea, interstitial pulmonary changes. Dermatologic: Erythema, pain at injection site and vein discoloration, chemical phlebitis along the vein proximal to the site of injection. Miscellaneous: Alopecia, asthenia, fatigue, jaw pain, myalgia, arthralgia, rash, hemorrhagic cystitis, syndrome of inappropriate ADH secretion.

Laboratory Test Alterations: Total bilirubin, AST. Transient elevations of liver enzymes.

Overdose Management: Symptoms: Bone marrow suppression, peripheral neurotoxicity. Treatment: There is no known antidote for vinorelbine. For overdosage, begin general supportive measures together with appropriate blood transfusions and antibiotics, as necessary.

Drug Interactions: Cisplatin / Incidence of granulocytopenia Mitomycin / Acute pulmonary reactions

How Supplied: Injection: 10 mg/mL

Dosage
?IV Only Non-small-cell lung cancer.
Granulocytes (1,500 or more cells/mm ³) on the day of treatment: 30 mg/m ² weekly given over 6-10 min into the side port of a free-flowing IV closest to the IV bag followed by flushing with at least 75-125 mL of the solution used to dilute the product. May also be given, at the same dose level, with cisplatin, 120 mg/m ² on days 1 and 29 and then q 6 weeks. Granulocytes (1,000-1,499 cells/mm ³) on the day of treatment: 15 mg/m ² weekly given over 6-10 min as described previously.
Breast cancer, Hodgkin's disease.
30 mg/m ²/week.