Names and pronunciation
(vi-nor′el-bine) Navelbine
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Drug reference
(vi-nor′el-bine) Navelbine
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Func. class.: Antineoplastic—miscel laneous
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Chem. class.: Semisynthetic vinca alkaloid
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ACTION: Inhibits mitotic spindle activity, arrests cell cycle at metaphase; inhibits RNA synthesis, blocks cellular use of glutamic acid needed for purine synthesis; vesicant
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USES: Unresectable advanced non– small-cell lung cancer (NSCLC) stage IV; may be used alone or in combination with CISplatin for stage III or IV NSCLC
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Unlabeled uses: Hodgkin’s disease, breast/ovarian/head/neck cancer, des moid tumor
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CONTRAINDICATIONS: Preg nancy, breastfeeding, infants, hypersensi tivity, granulocyte count <1000 cells/mm3 pretreatment
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Black Box Warning: Severe neutropenia, intrathecal administration Precautions: Children, geriatric patients, renal/hepatic/pulmonary/ neurologic disease, anemia, bone mar row suppression, severe neutropenia, intrathecal administration, extravasa tion Black Box Warning: Extravasation Black Box Warning: Do not give intrathe cally, fatal; syringes with this product should be labeled “Warning, for IV use only, fatal if given intrathecally” Intermittent IV INFUSION route • Use minibag if possible • Dilute to 0.5-2 mg/mL with 0.9% NaCl, 0.45% NaCl, D5W, D5/0.45% NaCl, LR, Ring er’s sol, give over 6-10 min into side port of free-flowing IV line or central line, flush line with 75-125 mL of diluent or more Black Box Warning: Extravasation: stop infusion, give hyaluronidase 150 units/mL in 1 mL NaCl through IV catheter or subcut in circular pattern around site, warm com press for extravasation for vesicant activity treatment • If accidental exposure occurs to skin, mucosa, eye, immediately flush with large amounts of water/NS, wash skin with soap and water Y-site compatibilities: Amikacin, aztreonam, bleomycin, bumetanide, buprenorphine, butorphanol, calcium gluconate, CARBOpla tin, carmustine, cefotaxime, cefTAZidime, ceftizoxime, chlorproMAZINE, cimetidine, CISplatin, clindamycin, cyclo phosphamide, cytarabine, dacarbazine, DACTINomycin, DAUNOrubicin, dexametha V sone, diphenhydrAMINE, DOXOrubicin, DOXOrubicin liposome, doxycycline, dro peridol, enalaprilat, etoposide, famotidine, filgrastim, floxuridine, fluconazole, fludar abine, gallium, gentamicin, granisetron, hal operidol, heparin, hydrocortisone, HYDRO morphone, hydrOXYzine, IDArubicin, ifosfamide, imipenem-cilastatin, LORaze pam, mannitol, mechlorethamine, melpha lan, meperidine, mesna, methotrexate, metoclopramide, metroNIDAZOLE, minocy cline, mitoXANtrone, morphine, nalbuphine, netilmicin, ondansetron, plicamycin, strepto zocin, teniposide, ticarcillin, ticarcillin-clavu lanate, tobramycin, vancomycin, vinBLAS tine, vinCRIStine, zidovudine Black Box Warning: Bone marrow sup- pression: CBC, differential, platelet count before each dose; withhold product if WBC is <4000/mm3 or platelet count is <75,000/mm3; notify prescriber of re sults; recovery will take 3 wk • Respiratory status: Bronchospasm: more common with mitoMYcin; also dyspnea, wheezing; may be treated with oxygen, bronchodilators, corti- costeroids, especially if there is un- derlying pulmonary disease • Neurologic status: paresthesia, pe ripheral neuropathy, weakness; these may occur even after termination of treatment • Renal studies: BUN, serum uric acid, urine CCr before, during ther apy; I&O ratio; report fall in urine output to <30 mL/hr; decreased hy peruricemia • Infection, cold, fever, sore throat; no tify prescriber if these occur; effects of alopecia on body image • Bleeding: hematuria, guaiac, bruising, petechiae, mucosa or orifices, no rectal temperatures; avoid IM inj; apply pres sure to venipuncture sites • Hepatic function tests: AST, ALT, bilirubin, LDH • Severe allergic reactions: rash, pru- ritus, urticaria, itching, flushing, bron- chospasm, hypotension; EPINEPHrine and crash cart should be nearby • Pregnancy: determine pregnancy be- fore starting treatment; do not use in pregnancy; do not breastfeed
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SIDE EFFECTS CNS: Paresthesias, peripheral neuropa thy, depression, headache, seizures, weakness, jaw pain, asthenia CV: Chest pain GI: Nausea, vomiting, ileus, anorexia, stomatitis, constipation, abdominal pain, diarrhea, hepatotoxicity, GI obstruction/perforation HEMA: Neutropenia, anemia, thrombocy- topenia, granulocytopenia INTEG: Rash, alopecia, photosensitivity, inj site reaction, necrosis META: SIADH MS: Myalgia RESP: SOB, dyspnea, pulmonary edema, acute bronchospasm, acute respiratory distress syndrome (ARDS)
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INTERACTIONS Increase: bleeding risk—NSAIDs, anticoagulants Increase: toxicity—CYP3A4 inhibitors (apre- pitant, antiretroviral protease inhibitors, cla rithromycin, danazol, delavirdine, diltiaZEM, erythromycin, fluconazole, FLUoxetine, flu- voxaMINE, imatinib, ketoconazole, mibefradil, nefazodone, telithromycin, voriconazole) Decrease: vinorelbine effect—CYP3A4 inducers (barbiturates, bosentan, carBA Mazepine, efavirenz, phenytoins, nevira pine, rifabutin, rifampin) Drug/Herb • Avoid use with St. John’s wort Drug/Lab Test Increase: LFTs, bilirubin Decrease: HB, WBC, platelets
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DOSAGE AND ROUTES • Adult: IV 30 mg/m2/wk (monother apy) or 25 mg/m2 weekly with cisplatin 100 mg/m2 q4wk HER-2+ breast cancer (advanced) (unlabeled) • Adult: IV 25 or 30 mg/m2 q7days (monotherapy)
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Available forms: Inj 10 mg/mL
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Administer:
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Assess: • B/P (baseline) during administration
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Evaluate: • Therapeutic response: decreased tu mor size, spread of malignancy
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report change in gait or numbness in extremities, continuing constipation; may indicate neurotoxicity • To brush teeth bid-tid with soft brush or cotton-tipped applicator for stomati tis; to use unwaxed dental floss • To examine mouth daily for bleeding, white spots, ulcerations; to notify pre scriber • Infection: report sore throat, fever, flulike symptoms • To avoid crowds, people with infec tions, vaccinations, OTC products • Pregnancy: to notify prescriber if pregnancy is planned or suspected; to use effective contraception during treat- ment and for ≥2 mo after product is dis- continued; not to breastfeed • That hair may be lost; that hair will grow back but with different texture, color HIGH ALERT
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PHARMACOKINETICS Half-life 27-43 hr; peak 1-2 hr; highly bound to platelets, lymphocytes; metabo lized in liver; excreted in feces; small amount unchanged in kidneys
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• Adult: IV 30 mg/m2/wk (monother apy) or 25 mg/m2 weekly with cisplatin 100 mg/m2 q4wk HER-2+ breast cancer (advanced) (unlabeled)
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• Adult: IV 25 or 30 mg/m2 q7days (monotherapy)
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