vinorelbine

High Alert

Inoperable non-small-cell lung cancer (as monotherapy or in combination with cisplatin).

Contraindicated in:

Hypersensitivity
Active infection
↓ bone marrow reserve
OB: Pregnancy
Lactation: Lactation.

Use Cautiously in:

Hepatic impairment (dose ↓ recommended if total bilirubin >2 m g/dL)
Debilitated patients (↑ risk of hyponatremia)
Granulocytopenia (temporarily discontinue or reduce dose)
Rep: Women of reproductive potential
Pedi: Safety and effectiveness not established in children.

CV: chest pain.

Derm: alopecia, rash.

F and E: hyponatremia.

GI: constipation, nausea, ↑ in liver enzymes, abdominal pain, anorexia, diarrhea, vomiting.

Hemat: anemia, neutropenia, thrombocytopenia.

Local: irritation at IV site, phlebitis.

MS: arthralgia, back pain, jaw pain, myalgia.

Neuro: fatigue, neurotoxicity.

Resp: shortness of breath.

Drug-Drug:

↑ 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.

(Generic available)

Solution for injection: 10 mg/mL;

IV (Adults): 30 mg/m² once weekly.

Hepatic Impairment

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

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.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: vinca alkaloids

Absorption: IV administration results in complete bioavailability.

Distribution: Highly bound to platelets and lymphocytes.

Metabolism/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.

(effect on WBCs)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	7–10 days	7–15 days

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.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for at least 2 mo after last dose of vinorelbine and to avoid breastfeeding during and for 9 days after last dose.
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.

NDC Code^*

25021- Sagent Pharmaceuticals
25021-204- Vinorelbine 25021-204-01- 1 VIAL in 1 CARTON (25021-204-01) > 1 mL in 1 VIAL

25021- Sagent Pharmaceuticals
25021-204- Vinorelbine 25021-204-05- 1 VIAL in 1 CARTON (25021-204-05) > 5 mL in 1 VIAL

45963- Actavis Pharma, Inc.
45963-607- Vinorelbine 45963-607-55- 1 VIAL, SINGLE-USE in 1 CARTON (45963-607-55) > 1 mL in 1 VIAL, SINGLE-USE

45963- Actavis Pharma, Inc.
45963-607- Vinorelbine 45963-607-56- 1 VIAL, SINGLE-USE in 1 CARTON (45963-607-56) > 5 mL in 1 VIAL, SINGLE-USE

50742- Ingenus Pharmaceuticals, LLC
50742-420- Vinorelbine 50742-420-01- 1 VIAL, SINGLE-USE in 1 CARTON (50742-420-01) > 1 mL in 1 VIAL, SINGLE-USE

50742- Ingenus Pharmaceuticals, LLC
50742-427- Vinorelbine 50742-427-05- 1 VIAL, SINGLE-USE in 1 CARTON (50742-427-05) > 5 mL in 1 VIAL, SINGLE-USE

64370- Pierre Fabre Pharmaceuticals, Inc.
64370-532- NAVELBINE 64370-532-01- 1 VIAL, SINGLE-USE in 1 CARTON (64370-532-01) > 1 mL in 1 VIAL, SINGLE-USE

64370- Pierre Fabre Pharmaceuticals, Inc.
64370-532- NAVELBINE 64370-532-02- 1 VIAL, SINGLE-USE in 1 CARTON (64370-532-02) > 5 mL in 1 VIAL, SINGLE-USE

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