Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 10mg/1mL
- 50mg/5mL
Non-small Cell Lung Cancer
Monotherapy
Combination therapy
- Indicated in combination with cisplatin for first-line treatment of locally advanced or metastatic NSCLC
- 25 mg/m² IV qWeek on Days 1, 8, 15, and 22 of a 28-day cycle with IV cisplatin 100 mg/m² on Day 1 OR
- 30 mg/m² IV qWeek with cisplatin 120 mg/m² IV on Days 1 and 29, and then q6Weeks
Dosage Modifications
Neutrophils on day of treatment
- >1500 cells/mm³: 100 % of dose
- 1000-1499 cells/mm³: Decrease dose 50%
- <1000 cells/mm³: Do not administer; repeat neutrophil count in 1 week
- If 3 consecutive weekly doses are held owing to neutrophils <1000 cell/mm³, discontinue
- Fever or sepsis while neutrophil count <1500 or dose held for 2 weeks
- >1500 cells/mm³: 75% of dose
- 1000-1499 cells/mm³: 37.5% of dose
- <1000 cells/mm³: Do not administer; repeat neutrophil count in 1 week
Neurotoxicity
- Grade ≥2: Discontinue
Renal impairment
- Dose adjustment not necessary
Hepatic impairment or toxicity
- Total bilirubin (TB) <2 mg/dL: Dose adjustment not necessary
- TB 2.1-3 mg/dL: Decrease dose 50%
- TB >3 mg/dL: Decrease dose 75%
Breast Cancer (Off-label)
20-30 mg/m² qWeek, has been administered as IV infusion, slow (3-5 minutes) or rapid IV injection
Soft Tissue Sarcoma (Orphan)
Liposomal vinorelbine
Orphan designation for treatment of soft tissue sarcoma
Sponsor
- Taiwan Liposome Company, Ltd; 3 Yuanqu Street; Taiwan
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Leukopenia (92%)
Granulocytopenia (90%)
Anemia (83%)
Elev AST (67%)
Nausea (44%)
Asthenia (36%)
Constipation (35%)
Fatigue (27%)
Peripheral neuropathy (25%)
Vomiting (20%)
Anorexia (20%)
Stomatitis (20%)
Alopecia (12%)
1-10%
Dyspnea (7%)
Chest pain (5%)
Rash (5%)
SOB (3%)
Hemorrhagic cystitis (1%)
SIADH (1%)
Postmarketing Reports
Palmar-plantar erythrodysesthesia syndrome
Hepatic toxicity
Bowel obstruction
Pulmonary toxicity
Respiratory failure
Warnings
Black Box Warnings
Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur
Decrease and/or withhold dose in accord with recommended dose modifications
Contraindications
None
Cautions
Myelosuppression, manifested by neutropenia, anemia, and thrombocytopenia reported; neutropenia is the major dose-limiting toxicity; monitor complete blood counts before each dose
Risk of extravasation and tissue injury
Sensory and motor neuropathies reported
Can cause fetal harm if administered to pregnant women based on findings from animal studies and mechanism of action
Hepatic toxicity
- Drug-induced liver injury manifested by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving drug as single agent and in combination with cytotoxic agents
- Assess hepatic function prior to initiation of therapy and periodically during treatment
- Reduce dose for patients who develop elevations in total bilirubin greater than or equal to 2 times upper limit of normal
Gastrointestinal effects
- Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation reported
- Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus
- Consider adequate dietary fiber intake, hydration and routine use of stool softeners
Pulmonary toxicity
- Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome (ARDS) occur in patients receiving therapy
- Interrupt therapy in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity
- Permanently discontinue therapy for confirmed interstitial pneumonitis or ARDS
Pregnancy & Lactation
Pregnancy
Based on animal findings, can cause fetal harm when administered to pregnant women
Verify pregnancy status in females of reproductive potential before initiating
Animal studies
- In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with vinorelbine doses ~0.33 and 0.18 times the human therapeutic dose, respectively
Contraception
- Females: Use effective contraception during treatment and for 6 months after final dose
- Males: May damage spermatozoa; advise males with female sexual partners of reproductive potential to use effective contraception during treatment and for 3 months after final dose
Infertility
- Males: Based on animal findings, may impair fertility
Lactation
Data are not available regarding drug in human milk or effects on breastfed infant or milk production
Because of potential harm; advise women not to breastfeed during treatment and for 9 days after final dose
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Semi-synthetic vinca alkaloid; inhibits mitosis at metaphase by depolymerizing microtubules; specific for S ans M phases; may also inhibit nucleic acid and protein synthesis by blocking glutamic acid use
Pharmacokinetics
Half-Life: 28-44 hr
Peak Plasma: 234-1160 ng/mL
Plasma clearance: 0.97-1.26 L/hr/kg
Protein Bound: 80-92%
Vd: 25-40 L/kg
Metabolism: CYP3A isoenzymes
Metabolites: vinorelbine N-oxide, deacetylvinorelbine
Clearance: 0.97-1.26 L/hr/kg
Excretion: Feces (46%); urine (18%)
Administration
IV Incompatibilities
Y-site: acyclovir, allopurinol, aminophylline, amphotericin B, ampho B cholesteryl sulfate, ampicillin, cefazolin, cefoperazone, cefotetan, ceftriaxone, cefuroxime, co-trimoxazole, fluorouracil, furosemide, ganciclovir, methylprednisolone sodium succinate, mitomycin, piperacillin, sodium bicarbonate, thiotepa
IV Compatibilities
Solution: D5W, 0.9% NaCl
Y-site (partial list): buprenorphine, cisplatin, cyclophosphamide, diphenhydramine, gemcitabine, fluconazole, granisetron, hydromorphone, imipenem-cilastatin, lorazepam, meperidine, morphine, ondansetron, KCl, vancomycin, zidovudine
IV Preparation
May be diluted in syringe or bag
Syringe: Dilute to 1.5-3 mg/mL in 0.9% NaCl or D5W
IV Bag: Dilute to 0.5-2 mg/mL in 0.9% NaCl, 0.45% NaCl, D5W, D5/0.45% NaCl, LR or Ringer's
IV Administration
Vesicant
For IV use only; fatal if given intrathecally
Administer IV over 6-10 min through sidearm of free-flowing IV closest to IV bag
Then flush with 75-125 mL of one of the IV fluids
Extravasation Management
Mix 250 U hyaluronidase with 6 mL NS
Inject hyaluronidase solution subcutaneously through 6 clockwise injections into infiltrated area using a 25-gauge needle
Change needle with each new injection
Elevate extremities
Apply heat immediately for 1 hr
Give QID for 3-5 days
Application of cold or hydrocortisone is contraindicated
Storage
Store intact vials under refrigeration protected from light
Diluted solution may be stored in polypropylene syringes for 24 hr under normal light at 5-30°C
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
