Single-agent chemotherapy for:
1. Non-small cell lung cancer.
2. Metastatic breast cancer.

Vinorelbine is a semisynthetic vinca alkaloid antineoplastic agent. It binds to tubulin and inhibits microtubule polymerization, causing cell-cycle arrest at the G2/M phase and subsequent cell death.

Bioavailability : Approximately 40%.
Time to peak concentration : 1.5 to 3 hours.
Protein binding : Plasma proteins, 13.5%; platelets, approximately 78%.
Volume of distribution : 11 to 21 L/kg.
Metabolism : Extensively hepatic, primarily via CYP3A4; active metabolite is 4-O-deacetylvinorelbine.
Half-life : Approximately 35 to 40 hours.
Excretion : Mainly through the hepatobiliary/fecal route; urinary excretion is limited. Food does not significantly affect systemic exposure.

1. Hypersensitivity to vinorelbine, other vinca alkaloids, or any component of the formulation.
2. Neutrophil count <1,500/mm³.
3. Platelet count <100,000/mm³.
4. Current severe infection or severe infection within the previous 2 weeks.
5. Significant gastrointestinal disorder affecting drug absorption.
6. History of extensive gastric or small-intestinal resection.
7. Requirement for long-term oxygen therapy.
8. Breastfeeding.
9. Concomitant administration of yellow fever vaccine.

D
No formal FDA pregnancy category is assigned.
Vinorelbine may cause embryo-fetal harm. Use during pregnancy only when the anticipated maternal benefit clearly outweighs the potential fetal risk. Perform pregnancy testing before treatment. Patients of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.

Breastfeeding is contraindicated during treatment. It is unknown whether vinorelbine is excreted in human milk. Breastfeeding must be discontinued before initiating therapy.

eutropenia (71.5%), leukopenia (70.6%), anemia (67.4%), nausea (74.7%), vomiting (54.7%), diarrhea (49.7%), anorexia (38.6%), fatigue/malaise (36.7%), alopecia (29.4%), weight loss (25%), constipation (19%), abdominal pain (14.2%), fever (13%), infection (12.7%), sensory neuropathy (11.1%), thrombocytopenia (10.8%), and stomatitis (10.4%).

Serious adverse reactions include severe myelosuppression, febrile neutropenia, neutropenic sepsis, pancytopenia, paralytic ileus, SIADH, severe hyponatremia, hepatotoxicity, pulmonary toxicity, and myocardial ischemia.

Oral administration only; approved for single-agent chemotherapy.
Initial dosing
- First 3 doses: 60 mg/mm orally once weekly.
- Beginning with the fourth dose: Increase to 80 mg/mm orally once weekly if hematologic tolerance is acceptable.
- Maximum weekly dose: 120 mg at the 60 mg/mm dose level or 160 mg at the 80 mg/mm dose level.

Dose escalation
Do not increase to 80 mg/mm if, during the first 3 doses:
- Neutrophil count was <500/mmm on any occasion; or
- Neutrophil count was 500 to <1,000/mmm on more than one occasion.

Dose interruption and reduction
- Withhold treatment if neutrophil count is <1,500/mmm and/or platelet count is <100,000/mmm; resume after hematologic recovery.
- During the 80 mg/mm regimen, if neutrophil count is <500/mmm or 500 to <1,000/mmm on more than one occasion, withhold treatment until recovery and reduce to 60 mg/mm once weekly.
- Re-escalation to 80 mg/mm may be considered after 3 consecutive doses at 60 mg/mm without recurrent significant neutropenia.

Administration
- Administer with food.
- Swallow the capsule whole with water; do not chew, suck, crush, or open.
- Primary antiemetic prophylaxis, such as a 5-HT3 antagonist, is recommended.
- If vomiting occurs within several hours after administration, do not repeat the dose.
- Obtain CBC with differential and platelet count before each dose.
- Do not ingest damaged capsules. Avoid contact of capsule contents with the skin, mucosa, or eyes; return damaged capsules for cytotoxic-drug disposal.

Safety and effectiveness have not been established in pediatric patients. Use is not recommended.

No dosage adjustment is required, including in severe renal impairment, because renal excretion is limited. Continue clinical and hematologic monitoring.

Mild hepatic impairment—bilirubin <1.5 × ULN and AST and/or ALT 1.5 to 2.5 × ULN: 60 mg/mm orally once weekly.

Moderate hepatic impairment—bilirubin 1.5 to 3 × ULN, regardless of AST/ALT: 50 mg/mm orally once weekly.

Severe hepatic impairment: Use is not recommended because clinical and pharmacokinetic data are insufficient.

Store refrigerated at 2°C to 8°C in the original PVC/PVDC/aluminum blister packaging. Damaged or unused capsules must be handled and disposed of according to institutional procedures for cytotoxic medications.