Navelbine

vinorelbine tartrate

Navelbine

Pharmacologic class: Vinca alkaloid

Therapeutic class: Antineoplastic

Pregnancy risk category D

Product is for I.V. use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled "WARNING. FOR I.V. USE ONLY. FATAL IF GIVEN INTRATHECALLY."

Make sure I.V. needle or catheter is properly positioned before injecting drug. Administration may lead to extravasation, causing local tissue necrosis and thrombophlebitis.

Action

Blocks cell division and interferes with nucleic acid synthesis. Cell-cycle-phase specific.

Availability

Injection: 10 mg/ml in 1- and 5-ml vials

Indications and dosages

Inoperable non-small-cell lung cancer

Adults: As monotherapy, 30 mg/m2 I.V. weekly given over 6 to 10 minutes. In combination therapy, 25 mg/m2 weekly given with cisplatin q 4 weeks. Alternatively, in combination therapy, 30 mg/m2 I.V. given with cisplatin on days 1 and 29, then q 6 weeks.

Dosage adjustment

• Hepatic impairment
• Neurotoxicity

Off-label uses

• Cervical, breast, or ovarian cancer

Contraindications

• Hypersensitivity to drug
• Pretreatment granulocyte count below 1,000 cells/mm3

Precautions

Use cautiously in:
• hepatic impairment, decreased bone marrow reserve, past or present neuropathy
• history of radiation therapy
• females of childbearing age
• pregnant or breastfeeding patients (use not recommended)
• children (safety not established).

Administration

Follow facility protocols for handling and preparing chemotherapeutic drugs. Be especially careful to avoid eye contamination.
• Know that patient is usually premedicated with antiemetic.

Give by I.V. route only. (Intrathecal injection is fatal.)
• Before use, dilute drug in syringe with dextrose 5% in water or normal saline solution to yield a concentration of 1.5 to 3 mg/ml. Or dilute in I.V. bag of compatible solution to yield a concentration of 0.5 to 2 mg/ml.
• Administer into tubing of running I.V. line or directly into vein over 6 to 10 minutes. Immediately after injection, flush line with 75 to 125 ml of compatible I.V. solution.

Adverse reactions

CNS: fatigue, neurotoxicity

CV: chest pain, phlebitis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, anorexia, pancreatitis, intestinal obstruction, paralytic ileus

Hematologic: anemia, bone marrow depression, severe granulocytopenia, neutropenia, thrombocytopenia

Metabolic: hyponatremia

Musculoskeletal: joint, back, or jaw pain; myalgia

Respiratory: acute respiratory distress syndrome, acute shortness of breath, bronchospasm, interstitial pulmonary changes

Skin: alopecia, rash, skin reactions

Other: tumor site pain; irritation, pain, and phlebitis at I.V. site; sepsis

Interactions

Drug-drug.Cisplatin, other antineoplastics: increased risk and severity of bone marrow depression

Mitomycin: increased risk of acute pulmonary reaction

Drug-diagnostic tests.Bilirubin, hepatic enzymes, liver function tests: increased values

Granulocytes, hemoglobin, platelets, white blood cells: decreased levels

Patient monitoring

• Monitor vital signs closely.
• Assess liver function tests and CBC with platelet count.
• Watch for signs and symptoms of infection.
• Observe injection site closely for reactions and extravasation.

Closely monitor neurologic and respiratory status. Drug may lead to acute pulmonary changes, especially in patients who previously received mitomycin.

Patient teaching

• Explain drug therapy to patient. Emphasize importance of follow-up laboratory tests.
• Advise patient to promptly report signs and symptoms of infection and to take his temperature daily.
• Tell patient that hair loss is a common side effect but typically reverses once treatment ends.
• Instruct female of childbearing age to avoid pregnancy. Caution her not to breastfeed during therapy.
• Urge patient to practice good oral hygiene, to help prevent infected mouth sores.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

vinorelbine

(vine-oh-rel-been) ,

Navelbine

(trade name)

Classification

Therapeutic: antineoplastics
Pharmacologic: vinca alkaloids
Pregnancy Category: D

Indications

Inoperable non–small-cell cancer of the lung in ambulatory patients (alone or with cisplatin).

Action

Binds to a protein (tubulin) of cellular microtubules, where it interferes with microtubule assembly. Cell replication is stopped as a result (cell cycle–specific for M phase).

Therapeutic effects

Death of rapidly replicating cells, particularly malignant ones.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.
Distribution: Highly bound to platelets and lymphocytes.
Metabolism and Excretion: Mostly metabolized by the liver. At least one metabolite is active. Large amounts eliminated in feces; 11% excreted unchanged by the kidneys.
Half-life: 28–44 hr.

Time/action profile (effect on WBCs)

ROUTEONSETPEAKDURATION
IVunknown7–10 days7–15 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Active infections;↓ bone marrow reserve; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: Impaired hepatic function (dose ↓ recommended if total bilirubin >2 m g/dL);Debilitated patients (↑ risk of hyponatremia);Granulocytopenic patients (temporarily discontinue or reduce dose); Pediatric: Safety not established; Obstetric: Instruct women of childbearing potential to avoid pregnancy during treatment.

Adverse Reactions/Side Effects

Central nervous system

  • fatigue (most frequent)

Respiratory

  • shortness of breath

Cardiovascular

  • chest pain

Gastrointestinal

  • constipation (most frequent)
  • nausea (most frequent)
  • abdominal pain
  • anorexia
  • diarrhea
  • transient ↑ in liver enzymes
  • vomiting

Dermatologic

  • alopecia (most frequent)
  • rashes

Fluid and Electrolyte

  • hyponatremia

Hematologic

  • anemia (most frequent)
  • neutropenia (most frequent)
  • thrombocytopenia

Local

  • irritation at IV site (most frequent)
  • skin reactions
  • phlebitis

Musculoskeletal

  • arthralgia
  • back pain
  • jaw pain
  • myalgia

Neurologic

  • neurotoxicity (most frequent)

Miscellaneous

  • pain in tumor-containing tissue

Interactions

Drug-Drug interaction

↑ bone marrow depression with other antineoplastics or radiation therapy.Concurrent use with cisplatin ↑ risk and severity of bone marrow depression.Concurrent use with mitomycin or chest radiation ↑ risk of pulmonary reactions.

Route/Dosage

Intravenous (Adults) 30 mg/m2 once weekly.

Hepatic Impairment

Intravenous (Adults) Total bilirubin 2.1–3 mg/dL—15 mg/m2 once weekly; total bilirubin ≥3 mg/dL—7.5 mg/m2 once weekly.

Availability (generic available)

Solution for injection: 10 mg/mL

Nursing implications

Nursing assessment

  • Monitor BP, pulse, and respiratory rate during therapy. Note significant changes. Acute shortness of breath and severe bronchospasm may occur infrequently shortly after administration. Treatment with corticosteroids, bronchodilators, and supplemental oxygen may be required, especially in patients with a history of pulmonary disease.
  • Assess frequently for signs of infection (sore throat, temperature, cough, mental status changes), especially when nadir of granulocytopenia is expected.
  • Monitor neurologic status. Assess for paresthesia (numbness, tingling, pain), loss of deep tendon reflexes (Achilles reflex is usually first involved), weakness (wrist drop or footdrop, gait disturbances), cranial nerve palsies (jaw pain, hoarseness, ptosis, visual changes), autonomic dysfunction (constipation, ileus, difficulty voiding, orthostatic hypotension, impaired sweating), and CNS dysfunction (decreased level of consciousness, agitation, hallucinations). These symptoms may persist for months. The incidence of neurotoxicity associated with vinorelbine is less than that of other vinca alkaloids.
  • Monitor intake and output and daily weight for significant discrepancies.
  • Assess nutritional status. Mild to moderate nausea is common. An antiemetic may be used to minimize nausea and vomiting.
  • Monitor for symptoms of gout (increased uric acid, joint pain, edema). Encourage patient to drink at least 2 L of fluid/day. Allopurinol and alkalinization of urine may decrease uric acid levels.
  • Lab Test Considerations: Monitor CBC prior to each dose and routinely during therapy. The nadir of granulocytopenia usually occurs 7–10 days after vinorelbine administration and recovery usually follows within 7–15 days. If granulocyte count is <1500/mm3, dose reduction or temporary interruption of vinorelbine may be warranted. If repeated episodes of fever and/or sepsis occur during granulocytopenia, future dose of vinorelbine should be modified. May also cause mild to moderate anemia. Thrombocytopenia rarely occurs.
    • Monitor liver function studies (AST, ALT, LDH, bilirubin) and renal function studies (BUN, creatinine) prior to and periodically during therapy. May cause ↑ uric acid; monitor periodically during therapy.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)
Risk for infection (Adverse Reactions)

Implementation

  • high alert: Fatalities have occurred with chemotherapeutic agents. Before administering, clarify all ambiguous orders; double check single, daily, and course-of-therapy dose limits; have second practitioner independently double check original order, dose calculations, and infusion pump settings.
  • Solution should be prepared in a biologic cabinet. Wear gloves, gown, and mask while handling medication. Discard IV equipment in specially designated containers.
    • Assess infusion site frequently for redness, irritation, or inflammation. Vinorelbine is a vesicant. If extravasation occurs, infusion must be stopped and restarted elsewhere to avoid damage to subcut tissue. Treatment of extravasation includes application of warm compresses applied over the area immediately for 30–60 min, then alternating on/off every 15 min for 1 day to increase systemic absorption of the drug. Hyaluronidase 150 units diluted in 1–2 mL of 0.9% NaCl, 1 mL for each mL extravasated, should be injected through existing IV cannula or subcut if the needle has been removed to enhance absorption and dispersion of the extravasated drug.
  • Intravenous Administration
  • pH: 3.5.
  • Diluent: Dilute vinorelbine with 0.9% NaCl or D5W.Concentration: 1.5–3 mg/mL.
  • Rate: Infuse over 6–10 min into Y-site closest to bag of a free-flowing IV or into a central line.
    • Flush vein with at least 75–125 mL of 0.9% NaCl or D5W administered over 10 min or more following administration of vinorelbine.
  • Intermittent Infusion: Diluent: Dilute vinorelbine with 0.9% NaCl, D5W, 0.45% NaCl, D5/0.45% NaCl, Ringer’s or lactated Ringer’s injection. Solution should be colorless to pale yellow. Do not administer solutions that are discolored or contain particulate matter. Diluted solution is stable for 24 hr at room temperature.Concentration: 0.5–2 mg/mL.
  • Rate: Infuse over 6–10 min (up to 30 min) into Y-site closest to bag of a free-flowing IV or into a central line.
    • Flush vein with at least 75–125 mL of 0.9% NaCl or D5W administered over 10 min or more following administration of vinorelbine.
  • Y-Site Compatibility: amikacin, aztreonam, bleomycin, bumetanide, buprenorphine, butorphanol, calcium gluconate, carboplatin, carmustine, cefotaxime, ceftazidime, chlorpromazine, cimetidine, cisplatin, clindamycin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, dexamethasone sodium phosphate, diphenhydramine, doxorubicin, doxorubicin liposome, doxycycline, droperidol, enalaprilat, etoposide, famotidine, filgrastim, floxuridine, fluconazole, fludarabine, gemcitabine, gentamicin, granisetron, haloperidol, hydrocortisone, hydromorphone, idarubicin, ifosfamide, imipenem/cilastatin, lorazepam, mannitol, mechlorethamine, melphalan, meperidine, mesna, methotrexate, metoclopramide, metronidazole, mitoxantrone, morphine, nalbuphine, ondansetron, oxaliplatin, potassium chloride, prochlorperazine, promethazine, ranitidine, streptozocin, teniposide, ticarcillin/clavulanate, tobramycin, vancomycin, vinblastine, vincristine, zidovudine
  • Y-Site Incompatibility: acyclovir, allopurinol, aminophylline, amphotericin B, amphotericin B cholesteryl sulfate, ampicillin, cefazolin, ceftriaxone, cefuroxime, fluorouracil, furosemide, ganciclovir, lansoprazole, methylprednisolone, mitomycin, sodium bicarbonate, thiotepa, trimethoprim/sulfamethoxazole

Patient/Family Teaching

  • Instruct patient to report symptoms of neurotoxicity (paresthesia, pain, difficulty walking, persistent constipation).
  • Inform patient that increased fluid intake, dietary fiber, and exercise may minimize constipation. Stool softeners or laxatives may be necessary. Patient should be advised to report severe constipation or abdominal discomfort, as this may be a sign of ileus, which may occur as a consequence of neuropathy.
  • Advise patient to notify health care professional if fever; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; blood in urine, stool, or emesis; or mouth sores occur.
  • Caution patient to avoid crowds and persons with known infections.
  • Advise patient that this medication may have teratogenic effects. Contraception should be used during and for at least 2 mo after therapy is concluded.
  • Discuss with patient the possibility of hair loss and explore coping strategies.
  • Instruct patient not to receive any vaccinations without advice of health care professional.
  • Emphasize the need for periodic lab tests to monitor for side effects.

Evaluation/Desired Outcomes

  • Decrease in the size or spread of malignancy without detrimental side effects.

Navelbine

a trademark for a chemotherapeutic mitotic inhibitor (vinorelbine).

Navelbine

A brand name for VINORELBINE.
References in periodicals archive ?
In 2014, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands.
In the past decade and a half, the Food and Drug Administration (FDA) has approved the following for first-line treatment of non-small cell lung cancer: navelbine, paclitaxel, gemcitabine, and docetaxel.
Conjugating their original management (for a public lab) with an extensive international network (academic as well as industrial), the researchers successfully patented their discoveries (two anti-cancer drugs, Navelbine and Taxotere).
PFM currently sells Navelbine (Vinorelbine tartrate) originally extracted from periwinkle as a plant alkaloid.
As well as Taxol, two others drugs, Gemzar (gemcitabine) and Navelbine (vonorelbine), were also suitable as initial therapies for advanced NSCLC, said Nice.
The report studies eight off-patent and patented drugs including Navelbine, Hycamtin, Taxotere, Gemzar, Alimta, Iressa, Avastin, and Tarceva.
Purvis brings more than 25 years of oncology drug development experience to Accelovance, having provided significant contribution in the development, approval, and postmarketing development of multiple cytotoxic, biological, targeted, and hormonal products; including: IV Alkeran, IV Zyloprim, Navelbine, Eloxatin, Nolvadex, Faslodex, Arimidex, Casodex, Iressa, and Torisel.
Mice bearing L1210 tumor were treated at day +4 with Navelbine (NVB 1mg/Kg), at day +5,+6 with PDT (0.
Worldwide sales of Navelbine and its generic equivalents in 2006 were in excess of $200 million.
Sales of Coniel, a treatment for hypertension and angina pectoris, were lower than those in the first nine months of the previous fiscal year, however, sales of products such as Allelock (olopatadine hydrochloride), an antiallergic agent and Navelbine, an anticancer agent, grew.
Sales of Coniel, a treatment for hypertension and angina pectoris, were slightly lower than in the first half of the previous fiscal year, but sales of both Allelock (olopatadine hydrochloride) an antiallergic agent, and Navelbine, an anticancer agent, increased.