Vinorelbine: Pediatric drug information

For additional information see "Vinorelbine: Drug information" and "Vinorelbine: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Myelosuppression:

Severe myelosuppression resulting in serious infection, septic shock, hospitalization, and death can occur. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications.

Brand Names: US

Navelbine [DSC]

Therapeutic Category

Antineoplastic Agent, Antimicrotubular;
Antineoplastic Agent, Vinca Alkaloid

Dosing: Pediatric

Note: Dosing may be based on either BSA (mg/m²) or weight (mg/kg); use extra precautions to verify dosing parameters during calculations. Protocol-specific details concerning dosing, frequency, and combination regimens should be consulted.

Hodgkin lymphoma, refractory or recurrent

Hodgkin lymphoma, refractory or recurrent: Limited data available; dosing regimens and combinations variable: Children ≥10 years and Adolescents:

GV regimen: IV: 25 mg/m² on days 1 and 8 of a 21-day cycle in combination with gemcitabine (Ref).

GVD regimen: IV: 20 mg/m² on day 1 and 8 of a 21-day cycle in combination with gemcitabine and pegylated liposomal doxorubicin (Ref).

IVB regimen: IV: 25 mg/m² on days 1 and 5 of a 21-day cycle in combination with ifosfamide and bortezomib (Ref).

Leukemias, refractory or recurrent

Leukemias (acute ALL, AML), refractory or recurrent: Limited data available:

TVTC regimen:

Infants: IV: 0.67 mg/kg once weekly on days 0, 7, 14 of a 14-day cycle in combination with topotecan, clofarabine, and thiotepa (Ref).

Children and Adolescents: IV: 20 mg/m² once weekly on days 0, 7, and 14 of a 14-day cycle in combination with topotecan, clofarabine, and thiotepa (Ref).

BDMV regimen: Infants ≥9 months, Children, and Adolescents: IV: 25 mg/m² on days 3, 10, and 17 in combination with bortezomib, dexamethasone, and mitoxantrone (Ref).

Solid tumors, refractory or recurrent

Solid tumors, refractory or recurrent: Limited data available: Children and Adolescents:

Monotherapy: IV: 30 mg/m² once weekly for weeks 1 to 6 of an 8-week cycle for 10 courses; may reduce dosage to 27 mg/m² for Grade 3 or 4 hematologic toxicity in patients who demonstrate objective response or who have had treatment delay beyond 63 days (week 9) from the previous course (Ref).

Combination therapy: IV: 25 mg/m² on days 1, 8, and 15 of each 28-day cycle in combination with cyclophosphamide (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: The presented dosing adjustments are based on experience in adult patients. Refer to specific protocol for management in pediatric patients if available.

Adult: Note: In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations.

Neutrophil counts should be ≥1,000 cells/mm³ prior to the administration of vinorelbine. Adjustments in the dosage of vinorelbine should be based on neutrophil counts obtained on the day of treatment as follows:

Neutrophils ≥1,500 cells/mm³ on day of treatment: Administer 100% of starting dose.

Neutrophils 1,000 to 1,499 cells/mm³ on day of treatment: Administer 50% of starting dose.

Neutrophils <1,000 cells/mm³ on day of treatment: Do not administer. Repeat neutrophil count in 1 week; if 3 consecutive doses are held because neutrophil count is <1,000 cells/mm³, discontinue vinorelbine.

For patients who, during treatment, have experienced fever and/or sepsis while neutropenic or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of vinorelbine should be:

Neutrophils ≥1,500 cells/mm³: Administer 75% of starting dose.

Neutrophils 1,000 to 1,499 cells/mm³ on day of treatment: Administer 37.5% of starting dose.

Neutrophils <1,000 cells/mm³ on day of treatment: Do not administer. Repeat neutrophil count in 1 week.

Neurotoxicity (peripheral neuropathy or autonomic neuropathy causing constipation) ≥ grade 2: Discontinue treatment.

Severe adverse events: Reduce dose or discontinue treatment.

Dosing: Kidney Impairment: Pediatric

There are no pediatric-specific recommendations; consult individual protocols. Based on experience in adult patients, dosing adjustment suggested.

Dosing: Liver Impairment: Pediatric

All patients: Note: In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations. Administer with caution in patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with vinorelbine, the dose should be adjusted for total bilirubin as follows:

Serum bilirubin ≤2 mg/dL: Administer 100% of dose

Serum bilirubin 2.1 to 3 mg/dL: Administer 50% of dose (Ref)

Serum bilirubin >3 mg/dL: Administer 25% of dose (Ref)

Dosing: Adult

(For additional information see "Vinorelbine: Drug information")

Dosage guidance:

Safety: Do not administer if ANC <1,000/mm³.

Clinical considerations: Begin a prophylactic bowel regimen (including adequate dietary fiber intake, hydration, and routine stool softeners) to minimize potential constipation, bowel obstruction, and/or paralytic ileus. Refer to the protocol or institutional guidance for additional details of off-label dosing.

Breast cancer, advanced or metastatic

Breast cancer, advanced or metastatic (off-label use):

Single agent vinorelbine: IV: 25 mg/m² every 7 days; continue until disease progression or unacceptable toxicity (Ref) or 30 mg/m² every 7 days; after 13 weeks, may change dosing interval to every 14 days (for patient convenience); continue until disease progression or unacceptable toxicity (Ref).

Vinorelbine/trastuzumab (HER2-positive): IV: 25 mg/m² every 7 days (in combination with trastuzumab); continue until disease progression or unacceptable toxicity (Ref) or 30 or 35 mg/m² on days 1 and 8 of a 21-day treatment cycle (in combination with trastuzumab); continue until disease progression or unacceptable toxicity (Ref).

Vinorelbine/margetuximab (HER2-positive): IV: 25 to 30 mg/m² on days 1 and 8 of a 21-day treatment cycle (in combination with margetuximab); continue until disease progression or unacceptable toxicity (Ref).

Cervical cancer, persistent or recurrent

Cervical cancer, persistent or recurrent (off-label use): IV: 30 mg/m² on days 1 and 8 of a 21-day treatment cycle; continue until disease progression or unacceptable toxicity (Ref).

Hodgkin lymphoma, relapsed or refractory

Hodgkin lymphoma, relapsed or refractory (off-label use):

GVD regimen: IV: 20 mg/m² (15 mg/m² if post transplant) on days 1 and 8 of a 21-day treatment cycle (in combination with gemcitabine and doxorubicin [liposomal]) for 2 to 6 cycles (Ref).

GVD + pembrolizumab regimen: IV: 20 mg/m² on days 1 and 8 of a 21-day treatment cycle (in combination with gemcitabine, doxorubicin [liposomal], and pembrolizumab) for 2 to 4 cycles (Ref).

IGEV regimen: IV: 20 mg/m² on day 1 of a 21-day treatment cycle (in combination with ifosfamide, mesna, gemcitabine, and prednisolone) for 4 cycles (Ref).

Kaposi sarcoma, AIDS-related, relapsed or refractory

Kaposi sarcoma, AIDS-related, relapsed or refractory (off-label use): IV: 30 mg/m² once every 14 days; continue until clinical complete remission or for 2 cycles beyond the maximum response (Ref).

Mesothelioma, pleural, relapsed or refractory

Mesothelioma, pleural, relapsed or refractory (off-label use): IV: 30 mg/m² (maximum dose: 60 mg) once weekly for 6 doses (each cycle consists of 6 once-weekly doses); continue until disease progression (Ref) or 30 mg/m² on days 1 and 8 of a 21-day treatment cycle; continue until disease progression, unacceptable toxicity, or for a maximum of 2 years (Ref).

Non–small cell lung cancer

Non–small cell lung cancer:

Neoad juvant therapy (stage IB to IIIA resectable disease; off-label): IV: 25 or 30 mg/m² on days 1 and 8 of a 21-day treatment cycle (in combination with cisplatin) for a maximum of 3 cycles (Ref).

Adjuvant therapy (resected stage I to III disease; off-label): IV: 30 mg/m² on days 1, 8, 15, and 22 of a 28-day treatment cycle (in combination with cisplatin) for 4 cycles (Ref) or 25 mg/m² on days 1, 8, 15, and 22 of a 28-day treatment cycle (in combination with cisplatin) for 4 cycles (Ref).

Cisplatin/vinorelbine (locally advanced or metastatic disease): IV: 25 mg/m² on days 1, 8, 15, and 22 of a 28-day treatment cycle (in combination with cisplatin) for 6 to 10 cycles (Ref) or 30 mg/m² once a week (Ref).

Single-agent therapy (metastatic disease): IV: 30 mg/m² once a week (Ref).

Gemcitabine/vinorelbine (advanced disease; off-label combination): IV: 25 mg/m² on days 1, 8, and 15 of a 28-day treatment cycle (in combination with gemcitabine) for 6 cycles or until disease progression or unacceptable toxicity (Ref).

Ovarian cancer, relapsed, recurrent, or resistant

Ovarian cancer, relapsed, recurrent, or resistant (off-label use): IV: 25 mg/m² once weekly (Ref) or 30 mg/m² on days 1 and 8 of a 21-day treatment cycle (Ref); continue until disease progression or unacceptable toxicity.

Salivary gland cancer, recurrent or metastatic

Salivary gland cancer, recurrent or metastatic (off-label use): IV: 25 mg/m² on days 1 and 8 of a 21-day treatment cycle (in combination with cisplatin) for a minimum of 3 cycles and for up to 6 cycles or until disease progression or unacceptable toxicity (Ref).

Small cell lung cancer, relapsed or refractory

Small cell lung cancer, relapsed or refractory (off-label use): IV: 25 or 30 mg/m² once weekly; continue until disease progression or unacceptable toxicity (Ref).

Soft tissue sarcoma, advanced

Soft tissue sarcoma, advanced (off-label use): IV: 25 mg/m² on days 1 and 8 of a 21-day treatment cycle (in combination with gemcitabine); continue until disease progression or unacceptable toxicity (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, no dosage adjustment is necessary (Ref).

Hemodialysis: No need for dosage adjustment is expected (Ref); however, some sources suggest reducing the dose as well as administering either after dialysis (on dialysis days) or on nondialysis days (Ref).

Dosing: Liver Impairment: Adult

Note: In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations.

Use with caution in patients with hepatic impairment. In patients with hepatic impairment or who develop hyperbilirubinemia during treatment with vinorelbine, adjust dose for total bilirubin as follows:

**Vinorelbine Dose Modification Based on Total Bilirubin^a**
Total bilirubin	Vinorelbine dosage modification
^a Ecklund 2005; Floyd 2006; Superfin 2007; manufacturer’s labeling.
≤2 mg/dL	Administer 100% of vinorelbine dose.
2.1 to 3 mg/dL	Administer 50% of vinorelbine dose.
>3 mg/dL	Administer 25% of vinorelbine dose.
In patients with breast cancer with extensive liver metastases (>75% of liver volume), administer 50% of vinorelbine dose^a.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Neurotoxicity (44%), peripheral neuropathy (20%; grades 3/4: 1%)

Dermatologic: Alopecia (12% to 30%)

Gastrointestinal: Nausea (≤34%), vomiting (≤31%), constipation (29%), diarrhea (12% to 13%)

Hematologic & oncologic: Neutropenia (80% to 85%; grades 3/4: 29% to 69%), leukopenia (81% to 83%; grades 3/4: 12% to 32%), anemia (77%; grades 3/4: 1% to 9%)

Hepatic: Increased serum aspartate aminotransferase (54%)

Local: Injection site reaction (22% to 38%; includes erythema at injection site, vein discoloration), pain at injection site (13%)

Neuromuscular & skeletal: Asthenia (27%)

Renal: Increased serum creatinine (13%)

1% to 10%:

Cardiovascular: Localized phlebitis (10%), chest pain (5%)

Central nervous system: Neuropathy (grades 3/4: 1%)

Hematologic & oncologic: Febrile neutropenia (≤8%), thrombocytopenia (3% to 4%; grades 3/4: 1%)

Hepatic: Increased serum bilirubin (9%)

Infection: Sepsis (≤8%)

Otic: Ototoxicity (1%)

Respiratory: Dyspnea (3%)

Frequency not defined:

Gastrointestinal: Intestinal necrosis, intestinal obstruction, intestinal perforation, paralytic ileus

Hematologic & oncologic: Bone marrow depression

Hepatic: Hepatotoxicity

Respiratory: Interstitial pulmonary disease, pulmonary toxicity (including acute respiratory distress syndrome, interstitial pneumonitis, severe acute bronchospasm)

<1%, postmarketing, and/or case reports: Abdominal pain, abnormal gait, anaphylaxis, angioedema, arthralgia, auditory impairment, back pain, decreased deep tendon reflex, deep vein thrombosis, dermatitis, dysphagia, electrolyte disorder, esophagitis, exfoliation of skin, flushing, headache, hemorrhagic cystitis, hypertension, hyponatremia, hypotension, jaw pain, localized rash, mucositis, myalgia, myasthenia, myocardial infarction, palmar-plantar erythrodysesthesia, pancreatitis, pneumonia, pruritus, pulmonary edema, pulmonary embolism, radiation recall phenomenon, SIADH, skin blister, skin rash, tachycardia, tumor pain, urticaria, urticaria at injection site, vasodilation, vestibular disturbance

Contraindications

There are no contraindications listed in the manufacturer’s US labeling.

Canadian labeling: Hypersensitivity to vinorelbine or any component of the formulation; drug-induced severe granulocytopenia or severe thrombocytopenia.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Severe myelosuppression resulting in serious infection, septic shock, hospitalization, and death may occur. Neutropenia, thrombocytopenia, and anemia may occur with vinorelbine (either as a single agent or in combination with other chemotherapy); neutropenia is the major dose-limiting toxicity (grade 3 or 4 neutropenia has commonly occurred). Neutropenia has resulted in hospitalization (for fever) and/or sepsis. The neutrophil nadir occurs between 7 to 10 days after administration, and recovery occurs within the following 7 to 14 days.

• Extravasation: Vesicant; ensure proper catheter or needle position prior to (and during) infusion. Avoid extravasation. Extravasation may cause local tissue necrosis and/or thrombophlebitis.

• GI toxicity: Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation may occur with vinorelbine. Begin a prophylactic bowel regimen (including adequate dietary fiber intake, hydration, and routine stool softeners) to minimize potential constipation, bowel obstruction and/or paralytic ileus.

• Hepatotoxicity: Drug-induced liver injury (transaminase and bilirubin elevations) may occur in patients receiving vinorelbine (either as a single-agent or in combination with other chemotherapy). Vinorelbine elimination is predominantly hepatic; use with caution in patients with hepatic impairment.

• Neuropathy: Sensory and motor neuropathies may occur in patients receiving vinorelbine; may be severe. Signs/symptoms of neuropathy include paresthesia, hyperesthesia, hyporeflexia, and muscle weakness.

• Pulmonary toxicity: Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, and/or acute respiratory distress syndrome (ARDS) may occur with vinorelbine; fatalities due to interstitial pneumonitis and ARDS have occurred. The mean time to onset of interstitial pneumonitis and ARDS was 1 week (range: 3 to 8 days).

Other warnings/precautions:

• For IV use only: Vinorelbine is for IV administration only. Administration of other vinca alkaloids by other routes has been fatal. The Institute for Safe Medication Practices (ISMP) strongly recommends dispensing vinca alkaloids in a minibag (NOT a syringe) (ISMP 2020). Vinorelbine should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vinorelbine in a location away from the separate storage location recommended for intrathecal medications (ASCO/ONS [Neuss 2016]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous [preservative free]:

Navelbine: 10 mg/mL (1 mL [DSC]); 50 mg/5 mL (5 mL [DSC])

Generic: 10 mg/mL (1 mL); 50 mg/5 mL (5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Vinorelbine Tartrate Intravenous)

10 mg/mL (per mL): $21.60 - $90.24

50 mg/5 mL (per mL): $21.60 - $90.29

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Generic: 10 mg/mL (1 mL, 5 mL)

Administration: Pediatric

IV: For IV use only; FATAL IF GIVEN INTRATHECALLY. Administer as a direct intravenous push or rapid bolus over 6 to 10 minutes (up to 30 minutes); in pediatric trials, vinorelbine was typically administered over 6 to 10 minutes; use of a side port of a free-flowing IV line is suggested. Longer infusions may increase the risk of pain and phlebitis. Intravenous doses should be followed by at least 75 to 125 mL of NS or D5W to reduce the incidence of phlebitis and inflammation.

Vesicant; avoid extravasation. Assure proper needle or catheter position prior to administration. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase antidote (See Management of Drug Extravasations for more details); apply dry warm compresses for 20 minutes 4 times a day for 1 to 2 days; elevate extremity (Ref). Remaining portion of the vinorelbine dose should be infused through a separate vein.

Administration: Adult

IV: For IV use only; fatal if administered by other routes. Administer over 6 to 10 minutes (the manufacturer recommends infusing into the side port of a free-flowing IV line); follow the infusion with at least 75 to 125 mL of a compatible solution to reduce the incidence of phlebitis and inflammation.

Vesicant; ensure proper needle or catheter position prior to administration. Avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase antidote; remove needle/cannula; apply dry warm compresses for 20 minutes 4 times a day for 1 to 2 days; elevate extremity (Ref). Remaining portion of the vinorelbine dose should be infused through a separate vein.

Hyaluronidase: If needle/cannula still in place, administer 1 to 6 mL hyaluronidase (150 units/mL) into the existing IV line; the usual dose is 1 mL hyaluronidase for each 1 mL of extravasated drug (Ref). If needle/cannula was removed, inject 1 to 6 mL (150 units/mL) subcutaneously in a clockwise manner using 1 mL for each 1 mL of drug extravasated (Ref) or administer 1 mL (150 units/mL) as 5 separate 0.2 mL injections (using a 25-gauge needle) subcutaneously into the extravasation site (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Storage/Stability

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Intact (unopened) vials are stable at 25°C (77°F) for up to 72 hours. Solutions diluted for infusion in polyvinyl chloride bags (D5W, NS, ¹/₂NS, D5¹/₂NS, LR, or Ringer's) are stable for up to 24 hours at 5°C to 30°C (41°F to 86°F) under normal room light.

After preparation, keep vinorelbine in a location away from the separate storage location recommended for intrathecal medications (ASCO/ONS [Neuss 2016]).

Use

Treatment of non-small cell lung cancer (FDA approved in adults); has also been used for refractory/recurrent solid tumors, Hodgkin lymphoma, and leukemias.

Medication Safety Issues

Sound-alike/look-alike issues:

Vinorelbine may be confused with vinBLAStine, vinCRIStine

Vinorelbine (50 mg/5 mL; Hospira manufacturer) may be confused with conventional cytarabine (100 mg/5 mL; Hospira manufacturer) due to similar packaging; potential for inadvertent intrathecal administration of vinorelbine may occur (ISMP [Smetzer 2015]).

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Administration issues:

Vinorelbine is for IV administration only: Inadvertent intrathecal administration of other vinca alkaloids has resulted in death. The ISMP strongly recommends dispensing vinca alkaloids in a minibag, and NOT a syringe (ISMP 2020). Vinorelbine should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vinorelbine in a location away from the separate storage location recommended for intrathecal medications.

Metabolism/Transport Effects

Substrate of CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

CISplatin: May increase adverse/toxic effects of Vinorelbine. Specifically, the combination may be associated with a higher risk of granulocytopenia. Risk C: Monitor

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Vinorelbine. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Vinorelbine. Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Gefitinib: May increase neutropenic effects of Vinorelbine. Risk C: Monitor

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

MitoMYcin (Systemic): Antineoplastic Agents (Vinca Alkaloids) may increase adverse/toxic effects of MitoMYcin (Systemic). Specifically, the risk of pulmonary toxicity may be increased. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

PACLitaxel (Conventional): May increase neurotoxic effects of Vinorelbine. PACLitaxel (Conventional) may increase adverse/toxic effects of Vinorelbine. Specifically hematologic toxicity may be increased. Risk C: Monitor

PACLitaxel (Protein Bound): May increase neurotoxic effects of Vinorelbine. PACLitaxel (Protein Bound) may increase adverse/toxic effects of Vinorelbine. Specifically hematologic toxicity may be increased. Risk C: Monitor

Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Patients who could become pregnant should use effective contraception during vinorelbine treatment and for 6 months after the last vinorelbine dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 3 months following the last vinorelbine dose.

Vinorelbine may damage spermatozoa and may cause decreased fertility in male patients.

Pregnancy Considerations

Based on the mechanism and on findings in animal reproduction studies, in utero exposure to vinorelbine may cause fetal harm.

Monitoring Parameters

CBC with differential and platelet count (prior to each dose, and after treatment), hepatic function tests; monitor for new-onset pulmonary symptoms (or worsening from baseline); monitor for neuropathy (new or worsening symptoms; monitor infusion site; monitor for signs symptoms of constipation/ileus.

Mechanism of Action

Vinorelbine is a semisynthetic vinca alkaloid which binds to tubulin and inhibits microtubule formation, therefore, arresting the cell at metaphase by disrupting the formation of the mitotic spindle; it is specific for the M and S phases. Vinorelbine may also interfere with nucleic acid and protein synthesis by blocking glutamic acid utilization.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: binds extensively to human platelets and lymphocytes (80% to 91%)

Children and Adolescents 2 to 17 years: 21.1 ± 12.2 L/kg (Johansen 2006)

Adults: 25 to 40 L/kg

Protein binding: 80% to 91%

Metabolism: Extensively hepatic, via CYP3A4, to two metabolites, deacetylvinorelbine (active) and vinorelbine N-oxide

Half-life elimination: Triphasic:

Children and Adolescents 2 to 17 years: Terminal: 16.5 ± 9.7 hours (Johansen 2006)

Adults: Terminal: ~28 to 44 hours

Excretion: Feces (~46%); urine (~18%, 10% to 12% as unchanged drug)

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Navelbine;
(AR) Argentina: Fada vinorelbina | Navelbine | Neocitec | Vinorel | Vinorelbina kemex | Vinorgen;
(AT) Austria: Eberelbin | Navelbine | Vinorelbin accord | Vinorelbin actavis | Vinorelbin Medac | Vinorelbin sandoz;
(AU) Australia: As Vinorelbine | Navelbine | Velabine | Vinorelbine Kabi | Vinorelbine Link | Vinorelbine tart;
(BE) Belgium: Navelbine | Vinorelbin actavis | Vinorelbine accord | Vinorelbine ebewe | Vinorelbine teva;
(BG) Bulgaria: Navelbin | Vinorelbin actavis | Vinorelbin ebewe;
(BR) Brazil: Evotabina | Navelbine | Neocitec | Tevavinor | Vilne;
(CH) Switzerland: Navelbine | Vinorelbin actavis | Vinorelbin Cancernova | Vinorelbin ebewe | Vinorelbin sandoz | Vinorelbin teva;
(CL) Chile: Navelbine;
(CN) China: Ai ke qing | Vinorelbine | Vinorelbine ditartrate;
(CO) Colombia: Fada vinorelbina | Labdosa vilne | Navelbine | Vinobina | Vinorel | Vinorelbina;
(CZ) Czech Republic: Navelbin | Navirel | Nibrevin | Vinorelbine accord | Vinorelbine glenmark;
(DE) Germany: Bendarelbin | Eurovinorelbin | Navelbine | Navin | Navirel | Riborelbin | Vinorelbin | Vinorelbin accord | Vinorelbin actavis | Vinorelbin aurobindo | Vinorelbin axios | Vinorelbin cell pharm | Vinorelbin haemato | Vinorelbin hexal | Vinorelbin NC | Vinorelbin Omnicare | Vinorelbin oncotrade | Vinorelbin Onkovis | Vinorelbin phares | Vinorelbin vitane;
(DO) Dominican Republic: Navelbine | Vinelbine;
(EC) Ecuador: Vinorelbina | Vinorelbina kemex;
(EE) Estonia: Navelbine | Vinorelbin accord | Vinorelbin ebewe;
(EG) Egypt: Navelbine | Vinorelbin ebewe | Vinorelbina aurovitas | Vinorelbine | Vinorelbine actavis;
(ES) Spain: Eunades | Navelbine | Vinorelbina accord | Vinorelbina Actavis | Vinorelbina Ferrer Farma | Vinorelbina Glenmark | Vinorelbina Ips | Vinorelbina sandoz;
(FI) Finland: Navelbine | Navirel | Vinorelbin actavis | Vinorelbin Bmm Pharma | Vinorelbine accord | Vinorelbine medac | Vinorelbine orifarm;
(FR) France: Navelbine | Vinorelbine accord | Vinorelbine actavis | Vinorelbine Dci | Vinorelbine ebewe | Vinorelbine Mylan | Vinorelbine pierre fabre | Vinorelbine sandoz;
(GB) United Kingdom: Navelbine | Vinorelbine;
(GR) Greece: Navelbine | Vinorelbin/ebewe | Zaolin;
(HK) Hong Kong: Navelbine | Vinorelbin ebewe | Vinorelbine;
(HU) Hungary: Navelbin | Neocitec | Vinorelbine Polpharma;
(ID) Indonesia: Navelbine | Relubin | Vinorelbine | Vinorelsin | Vinorkal;
(IE) Ireland: Navelbine | Vinorelbine;
(IL) Israel: Navelbine;
(IN) India: Navelbine | Vinbicel | Vinbine | Vinrel | Zyrolbine;
(IT) Italy: Eunades | Navelbine | Vinorelbina | Vinorelbina accord | Vinorelbina Actavis | Vinorelbina doc | Vinorelbina HOS;
(JO) Jordan: Navelbine;
(JP) Japan: Navelbine | Rozeus;
(KR) Korea, Republic of: Navelbine | Pfizer vinorelbine | Vinolbin | Vinorelbine;
(KW) Kuwait: Navelbine;
(LB) Lebanon: Eberelbin | Navelbine;
(LT) Lithuania: Navelbine | Vinorelbin | Vinorelbine accord;
(LV) Latvia: Cipla vinorelbine | Navelbine | Vinorelbin accord | Vinorelbin ebewe | Vinorelbine actavis;
(MA) Morocco: Navelbine;
(MX) Mexico: Bagovir | Navelbine | Setroxin | Vanevin | Viessia | Vincanorel | Vinilex;
(MY) Malaysia: DBL Vinorelbine | Navelbine | Vinelbine;
(NL) Netherlands: Navelbine | Navirel | Vinorelbine accord | Vinorelbine actavis | Vinorelbine allgen | Vinorelbine ebewe | Vinorelbine pch;
(NO) Norway: Navelbine | Navirel | Vinorelbin | Vinorelbin accord | Vinorelbin Bmm Pharma | Vinorelbin mayne | Vinorelbin meda | Vinorelbine orifarm;
(NZ) New Zealand: Navelbine | Sagent vinorelbine | Vinorelbine | Vinorelbine te arai;
(PE) Peru: Eunexon;
(PH) Philippines: Navelbine | Vinotel;
(PK) Pakistan: Navalbine | Navelbine;
(PL) Poland: Navelbine | Navirel | Neocitec | Vinorelbin ebewe | Vinorelbine accord | Vinorelbine Alvogen | Vinorelbine Polpharma;
(PR) Puerto Rico: Navelbine | Vinorelbine;
(PT) Portugal: Navelbine | Navirel | Vinorelbina | Vinorrelbin | Vinorrelbina accord | Vinorrelbina Actavis | Vinorrelbina medac | Vinorrelbina Sandoz;
(PY) Paraguay: Navelbine | Vinorelbina sandoz;
(QA) Qatar: Navelbine;
(RO) Romania: Navelbine | Vinorelbin | Vinorelbin actavis | Vinorelbin ebewe | Vinorelbina accord | Vinorelbina alvogen | Vinorelbine;
(RU) Russian Federation: Cituvin | Firelbin | Maverex | Navelbine | Velbin | Vincatera | Vinelbine | Vinorelbine | Vinorelbine kelun kazfarm | Vinorelbine medac | Vinorelbine teva;
(SA) Saudi Arabia: Navelbine;
(SE) Sweden: Navelbine | Vinorelbin actavis | Vinorelbin ebewe | Vinorelbin hospira | Vinorelbine accord | Vinorelbine medac | Vinorelbine orifarm;
(SG) Singapore: Vinorelbine dbl;
(SI) Slovenia: Vinorelbin accord | Vinorelbin caduceus | Vinorelbin ebewe;
(SK) Slovakia: Navelbin | Navirel | Vinorelbin Hikma | Vinorelbin sandoz | Vinorelbine glenmark | Vinorelbine Hikma | Vinorelbine medac | Visera;
(TH) Thailand: DBL Vinorelbine | Navelbine | Viessia;
(TN) Tunisia: Cytorelbine | Navelbine | Vinorel | Vinorelbine;
(TR) Turkey: Navelbine | Renovel | Vinalbin;
(TW) Taiwan: Navelbine | Vinelbine | Vinobin | Vinorelbine;
(UA) Ukraine: Navelbine | Navelik | Navirel | Oncobine | Velbimeda | Vinelbin | Vinorelbin accord | Vinorelbine ebewe | Vinorelbine teva;
(UY) Uruguay: Filcrin | Navelbine | Vinorelbina | Vinorelbina FU;
(ZA) South Africa: Aspen Vinorelbin | Carcyt | Cipla vinorelbine | Eurovin | Navelbine | Teva Vinorelbine | Vinorel | Vinorelbin ebewe | Vinorelbine

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Vinorelbine: Pediatric drug information