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.
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: 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 (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: 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.
There are no pediatric-specific recommendations; consult individual protocols. Based on experience in adult patients, dosing adjustment suggested.
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)
(For additional information see "Vinorelbine: Drug information")
Note: 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. Do not administer if ANC <1,000/mm3.
Breast cancer, metastatic (off-label use): IV: 25 mg/m2 every 7 days (as a single agent) until disease progression or unacceptable toxicity (Ref) or 30 mg/m2 every 7 days (as a single agent); after 13 weeks, may change dosing interval to every 14 days (for patient convenience), continue until disease progression or unacceptable toxicity (Ref) or 25 mg/m2 every 7 days (in combination with trastuzumab) until disease progression or unacceptable toxicity (Ref) or 30 or 35 mg/m2 days 1 and 8 every 21 days (in combination with trastuzumab) until disease progression or unacceptable toxicity (Ref).
Cervical cancer (off-label use): IV: 30 mg/m2 days 1 and 8 of a 21-day treatment cycle (Ref).
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 cycle (in combination with gemcitabine and doxorubicin liposomal) for 2 to 6 cycles (Ref).
IGEV regimen: IV: 20 mg/m2 on day 1 of a 21-day cycle (in combination with ifosfamide, mesna, gemcitabine, and prednisolone) for 4 cycles (Ref).
Malignant pleural mesothelioma (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).
Non–small cell lung cancer:
Metastatic (single-agent therapy): IV: 30 mg/m2 once a week.
Locally advanced or metastatic (in combination with cisplatin): IV: 25 mg/m2 on days 1, 8, 15, and 22 of a 28-day cycle or 30 mg/m2 once a week.
Advanced disease (off-label dosing): IV: 25 to 30 mg/m2 days 1, 8, and 15 every 28 days (in combination with gemcitabine) for 6 cycles or until disease progression or unacceptable toxicity (Ref).
Salivary gland cancer, recurrent (off-label use): IV: 25 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with cisplatin) for a minimum of 3 cycles and for up to 6 cycles (Ref).
Small cell lung cancer, refractory (off-label use): IV: 25 or 30 mg/m2 every 7 days until disease progression or unacceptable toxicity (Ref).
Soft tissue sarcoma, advanced (off-label use): IV: 25 mg/m2 days 1 and 8 of a 21-day treatment cycle (in combination with gemcitabine) 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.
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).
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:
Serum bilirubin ≤2 mg/dL: Administer 100% of vinorelbine dose.
Serum bilirubin 2.1 to 3 mg/dL: Administer 50% of vinorelbine dose (Ref).
Serum bilirubin >3 mg/dL: Administer 25% of vinorelbine dose (Ref).
Patients (breast cancer) with extensive liver metastases (>75% of liver volume): Administer 50% of vinorelbine dose (Ref).
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
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.
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]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Generic: 50 mg/5 mL (5 mL [DSC])
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)
Yes
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Generic: 10 mg/mL (1 mL, 5 mL)
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.
IV: For IV use only; fatal if given 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 agent (NIOSH 2016 [group 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 2016; USP-NF 2020).
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 (Jacobson 2009).
Treatment of non-small cell lung cancer (FDA approved in adults); has also been used for refractory/recurrent solid tumors, Hodgkin lymphoma, and leukemias.
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]).
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).
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
Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Antithyroid Agents: Myelosuppressive Agents may enhance the neutropenic effect of Antithyroid Agents. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
CISplatin: May enhance the adverse/toxic effect of Vinorelbine. Specifically, the combination may be associated with a higher risk of granulocytopenia. Risk C: Monitor therapy
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Vinorelbine. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Vinorelbine. Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Gefitinib: May enhance the neutropenic effect of Vinorelbine. Risk C: Monitor therapy
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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 diminish the therapeutic effect 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect 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 enhance the adverse/toxic effect of MitoMYcin (Systemic). Specifically, the risk of pulmonary toxicity may be increased. Risk C: Monitor therapy
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
PACLitaxel (Conventional): May enhance the adverse/toxic effect of Vinorelbine. Specifically hematologic toxicity may be increased. PACLitaxel (Conventional) may enhance the neurotoxic effect of Vinorelbine. Risk C: Monitor therapy
PACLitaxel (Protein Bound): May enhance the adverse/toxic effect of Vinorelbine. Specifically hematologic toxicity may be increased. PACLitaxel (Protein Bound) may enhance the neurotoxic effect of Vinorelbine. Risk C: Monitor therapy
Palifermin: May enhance the adverse/toxic effect 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 diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Patients who could become pregnant should use effective contraception during vinorelbine treatment and for 6 months after the final 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.
Based on the mechanism and on findings in animal reproduction studies, vinorelbine may cause fetal harm if administered during pregnancy.
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.
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.
Distribution: Vd: 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)
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