Navelbine

Navelbine,

trademark for a chemotherapeutic mitotic inhibitor (vinorelbine).

---

vinorelbine tartrate Warning - Hazardous drug!

Navelbine

Pharmacologic class: Vinca alkaloid

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Boxed Warning

• Give under supervision of physician experienced in use of cancer chemotherapy, in facility with adequate diagnostic and treatment resources.
• 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."
• Severe granulocytopenia causing increased susceptibility to infection may occur. Before starting drug, patient's granulocyte count should be at least 1,000 cells/mm³. Adjust dosage according to complete blood counts (CBCs) with differentials obtained on day of treatment.
• 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-ml 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.

Route	Onset	Peak	Duration
I.V.	Unknown	7-10 days	7-15 days

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.