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VinBLAStine

Pronunciation

(vin BLAS teen)

Index Terms

  • Velban
  • Vinblastine Sulfate
  • Vincaleukoblastine
  • VLB

Dosage Forms

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

Solution, Intravenous, as sulfate:

Generic: 1 mg/mL (10 mL)

Solution Reconstituted, Intravenous, as sulfate:

Generic: 10 mg (1 ea [DSC])

Pharmacologic Category

  • Antineoplastic Agent, Antimicrotubular
  • Antineoplastic Agent, Vinca Alkaloid

Pharmacology

Vinblastine 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. Vinblastine may also interfere with nucleic acid and protein synthesis by blocking glutamic acid utilization.

Metabolism

Hepatic (via CYP3A) to active metabolite

Excretion

Feces (10%); urine (14%)

Half-Life Elimination

Terminal: ~25 hours

Use: Labeled Indications

Treatment of Hodgkin lymphoma; lymphocytic lymphoma; histiocytic lymphoma; mycosis fungoides; testicular cancer; Kaposi sarcoma; histiocytosis X (Letterer-Siwe disease); has also been used for the treatment of refractory/resistant breast cancer and choriocarcinoma

Off Label Uses

Bladder cancer

Data from multiple phase III studies support the use of vinblastine (in combination with methotrexate, doxorubicin, and cisplatin) in the treatment of metastatic bladder cancer [Bamias 2004], [Sternberg 2001], [Sternberg 2006], [ von der Maase 2000].

Data from 2 randomized phase III studies support the use of vinblastine (in combination with methotrexate, doxorubicin and cisplatin or in combination with methotrexate, cisplatin and leucovorin) for the neoadjuvant treatment of locally advanced or invasive bladder cancer [Griffiths 2011], [Grossman 2003].

Melanoma (metastatic)

Data from a randomized phase III study supports the use of vinblastine (in combination with cisplatin and dacarbazine, with or without aldesleukin and interferon alfa-2b) in the treatment of metastatic melanoma [Eton 2002].

Non-small cell lung cancer (NSCLC)

Data from a large randomized study supports the use of vinblastine (in combination with cisplatin) in the adjuvant treatment of completely resected non-small cell lung cancer [Arriagada 2004].

Data from a large randomized phase III study supports the use of vinblastine (in combination with cisplatin and concurrent radiation therapy) in the treatment of stage III non-small cell lung cancer [Curran 2011].

Soft tissue sarcoma (desmoid tumors, aggressive fibromatosis), advanced

Data from a phase II study supports the use of vinblastine (in combination with methotrexate) in the treatment of advanced (inoperable) desmoid tumors/aggressive fibromatosis [Azzarelli 2001]. Additional trials may be necessary to further define the role of vinblastine in this condition.

Contraindications

Significant granulocytopenia (unless as a result of condition being treated); presence of bacterial infection

Dosing: Adult

Note: Frequency and duration of therapy may vary by indication, concomitant combination chemotherapy and hematologic response. For IV use only. In order to prevent inadvertent intrathecal administration, the Institute for Safe Medication Practices (ISMP) strongly recommends dispensing vinblastine in a minibag (NOT a syringe).

Hodgkin lymphoma, lymphocytic lymphoma, histiocytic lymphoma, mycosis fungoides, testicular cancer, Kaposi sarcoma, histiocytosis X (Letterer-Siwe disease): Manufacturer’s labeling: IV: 3.7 mg/m2; adjust dose every 7 days (based on white blood cell response) up to 5.5 mg/m2 (second dose); 7.4 mg/m2 (third dose); 9.25 mg/m2 (fourth dose); and 11.1 mg/m2 (fifth dose); do not administer more frequently than every 7 days. Usual dosage range: 5.5 to 7.4 mg/m2 every 7 days; Maximum dose: 18.5 mg/m2; dosage adjustment goal is to reduce white blood cell count to ~3,000/mm3

Off-label and/or indication-specific dosing:

Hodgkin lymphoma (off-label dosing): IV:

ABVD regimen: 6 mg/m2 days 1 and 15 of a 28-day cycle (in combination with doxorubicin, bleomycin, dacarbazine, and radiation therapy) for 2 cycles (early/favorable disease) or for 4 cycles (early/unfavorable disease) (Eich 2010; Engert 2007)

Stanford V regimen: 6 mg/m2 weeks 1, 3, 5, 7, 9, and 11 (in combination with doxorubicin, mechlorethamine, vincristine, bleomycin, etoposide, and prednisone) (Bartlett 1995; Gordon 2013; Horning 2002)

Testicular cancer (off-label dosing): VeIP regimen: IV: 0.11 mg/kg daily for 2 days every 21 days (in combination with ifosfamide, cisplatin, and mesna) for 4 cycles (Loehrer 1988; Loehrer 1988 [correction]; Loehrer 1998)

Bladder cancer (off-label use): IV:

Metastatic disease:

Dose-dense MVAC regimen: 3 mg/m2 day 2 every 14 days (in combination with methotrexate, doxorubicin, cisplatin, and filgrastim) until disease progression or unacceptable toxicity (Sternberg 2001; Sternberg 2006)

MVAC regimen: 3 mg/m2 days 2, 15, and 22 every 28 days (in combination with methotrexate, doxorubicin, and cisplatin) for up to 6 cycles (von der Maase 2000) or 3 mg/m2 days 2, 15, and 22 every 28 days (in combination with methotrexate, doxorubicin, and cisplatin) until disease progression or unacceptable toxicity (Sternberg 2001; Sternberg 2006) or 3 mg/m2 days 1, 15, and 22 every 28 days (in combination with methotrexate, doxorubicin, cisplatin, and filgrastim) for up to 6 cycles (Bamias 2004)

Neoadjuvant treatment:

MVAC regimen: 3 mg/m2 days 2, 15, and 22 every 28 days (in combination with methotrexate, doxorubicin, and cisplatin) for 3 cycles (Grossman 2003)

CMV regimen: 4 mg/m2 days 1 and 8 every 21 days (in combination with methotrexate, cisplatin, and leucovorin) for 3 cycles (Griffiths 2011)

Melanoma, metastatic (off-label use): IV:

CVD regimen: 2 mg/m2 days 1 to 4 and 22 to 25 of a 6-week treatment cycle (in combination with cisplatin and dacarbazine); may repeat if tumor response (Eton 2002)

CVD + immunotherapy regimen: 1.5 mg/m2 days 1 to 4 and 22 to 25 of a 6-week treatment cycle (in combination with cisplatin, dacarbazine, aldesleukin, and interferon alfa-2b); may repeat if tumor response (Eton 2002)

Non-small cell lung cancer (off-label use): IV:

Adjuvant treatment after complete resection: 4 mg/m2 days 1, 8, 15, 22, and 29, then every 2 weeks (in combination with cisplatin) until last cisplatin dose (Arriagada 2004)

Concurrent radiation: 5 mg/m2 days 1, 8, 15, 22, and 29 (in combination with cisplatin and concurrent radiation therapy) (Curran 2011)

Soft tissue sarcoma (desmoid tumors, aggressive fibromatosis), advanced (off-label use): IV: 6 mg/m2 every 7 to 10 days (dose usually rounded to 10 mg) in combination with methotrexate for 1 year (Azzarelli 2001)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Frequency and duration of therapy may vary by indication, concomitant combination chemotherapy and hematologic response. For IV use only. In order to prevent inadvertent intrathecal administration, the Institute for Safe Medication Practices (ISMP) strongly recommends dispensing vinblastine in a minibag (NOT a syringe).

Hodgkin lymphoma: IV: Initial dose: 6 mg/m2; do not administer more frequently than every 7 days or ABVD regimen (off-label dosing; advanced disease): IV: 6 mg/m2 days 1 and 15 of a 28-day cycle (in combination with doxorubicin, bleomycin, dacarbazine, and radiation therapy) for 6 cycles (Hutchinson 1998)

Letterer-Siwe disease: IV: Initial dose: 6.5 mg/m2; do not administer more frequently than every 7 days

Testicular cancer: IV: Initial dose: 3 mg/m2; do not administer more frequently than every 7 days

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

The manufacturer’s labeling recommends the following adjustment: Serum bilirubin >3 mg/dL: Administer 50% of dose

The following adjustments have also been recommended (Floyd 2006; Superfin 2007):

Serum bilirubin 1.5 to 3 mg/dL or transaminases 2 to 3 times ULN: Administer 50% of dose

Serum bilirubin >3 times ULN: Avoid use.

Dosing: Obesity

ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient’s actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).

Reconstitution

Note: In order to prevent inadvertent intrathecal administration, the Institute for Safe Medication Practices (ISMP) strongly recommends dispensing vinblastine in a minibag (NOT in a syringe).

For infusion, dilute in 25 to 50 mL NS, D5W, or LR; dilution in larger volumes (≥100 mL) of IV fluids is not recommended.

Administration

In order to prevent inadvertent intrathecal administration, the Institute for Safe Medication Practices (ISMP) strongly recommends dispensing vinblastine in a minibag (NOT in a syringe). For IV administration only. Fatal if given intrathecally. The preferred administration is as a short infusion in a 25 to 50 mL minibag. If administration via a minibag is not possible, may also be administered as an undiluted 1-minute infusion into a free flowing IV line to prevent venous irritation/extravasation. Prolonged administration times (≥30 to 60 minutes) and/or increased administration volumes may increase the risk of vein irritation and extravasation.

Vesicant; ensure proper needle or catheter placement prior to and during infusion. 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 (Perez Fidalgo 2012). Remaining portion of the vinblastine 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 (Perez Fidalgo 2012; Schulmeister 2011). 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 (Schulmeister 2011) or administer 1 mL (150 units/mL) as 5 separate 0.2 mL injections (using a 25-gauge needle) subcutaneously into the extravasation site (Polovich 2009).

Compatibility

See Trissel’s IV Compatibility Database

Storage

Note: Vinblastine should be dispensed in a minibag (ISMP 2014). Although not recommended, if prepared in a syringe, the syringe must be dispensed in an overwrap which bears the statement "Do not remove covering until the moment of injection. Fatal if given intrathecally. For IV use only."

Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from light. Solutions diluted for infusion in NS, D5W, or LR (20 mcg/mL concentration) are stable for up to 21 days if protected from light (Beijnen 1989). The formulation of vinblastine may have changed since this stability study was conducted; consult the manufacturer’s prescribing information for further information. Follow USP 797 recommendations for beyond use dates based on the level of risk for preparation.

Drug Interactions

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Itraconazole: May increase the serum concentration of VinBLAStine. Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Consider therapy modification

Lopinavir: May increase the serum concentration of VinBLAStine. Management: Monitor closely for signs and symptoms of vinblastine toxicity; consider temporary interruption of lopinavir/ritonavir antiviral therapy if patients develop significant toxicity with concurrent use. Consider therapy modification

Macrolide Antibiotics: May increase the serum concentration of Antineoplastic Agents (Vinca Alkaloids). Macrolides may also increase the distribution of Vinca Alkaloids into certain cells and/or tissues. Management: Consider an alternative to using a macrolide antibiotic when possible in order to avoid the potential for increased vinca alkaloid toxicity. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. Consider therapy modification

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. 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. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. 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. Consider therapy modification

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Posaconazole: May enhance the adverse/toxic effect of Antineoplastic Agents (Vinca Alkaloids). Posaconazole may increase the serum concentration of Antineoplastic Agents (Vinca Alkaloids). Management: Avoid the concomitant use of posaconazole and vinca alkaloids when possible. If combined, monitor for increased vinca alkaloid toxicities (eg, neurotoxicity, gastrointestinal toxicity). Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Ritonavir: May increase the serum concentration of VinBLAStine. Management: Monitor closely for signs and symptoms of vinblastine toxicity; consider temporary interruption of ritonavir antiviral therapy if patients develop significant toxicity with concurrent use. Consider therapy modification

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Tolterodine: VinBLAStine may increase the serum concentration of Tolterodine. Management: Reduce tolterodine dose to 1 mg twice daily (regular release formulation) or 2 mg daily (extended release formulation) (adult doses) and monitor for increased levels/effects of tolterodine with initiation of vinblastine therapy. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Voriconazole: May enhance the adverse/toxic effect of Antineoplastic Agents (Vinca Alkaloids). Voriconazole may increase the serum concentration of Antineoplastic Agents (Vinca Alkaloids). Consider therapy modification

Adverse Reactions

Frequency not defined.

Cardiovascular: Angina pectoris, cerebrovascular accident, ECG abnormality, hypertension (common), ischemic heart disease, limb ischemia, myocardial infarction, Raynaud's phenomenon

Central nervous system: Decreased deep tendon reflex, depression, dizziness, headache, malaise (common), metallic taste, neurotoxicity (duration: >24 hours), paresthesia, peripheral neuritis, seizure, tumor pain (common), vertigo

Dermatologic: Alopecia (common), dermatitis, skin blister, skin photosensitivity (rare), skin rash

Endocrine & metabolic: Hyperuricemia, SIADH (syndrome of inappropriate antidiuretic hormone secretion)

Gastrointestinal: Abdominal pain, anorexia, constipation (common), diarrhea, enterocolitis (hemorrhagic), gastrointestinal hemorrhage, intestinal obstruction, nausea (mild), paralytic ileus, stomatitis, toxic megacolon, vomiting (mild)

Genitourinary: Azoospermia, urinary retention

Hematologic & oncologic: Anemia, bone marrow depression (common), granulocytopenia (common; nadir: 5 to 10 days; recovery: 7 to 14 days; dose-limiting toxicity), hemolytic uremic syndrome, leukopenia (common; nadir: 5 to 10 days; recovery: 7 to 14 days; dose-limiting toxicity), rectal hemorrhage, thrombocytopenia (recovery within a few days), thrombotic thrombocytopenic purpura

Local: Local irritation

Neuromuscular & skeletal: Jaw pain (common), myalgia, ostealgia (common), weakness

Ophthalmic: Nystagmus

Otic: Auditory disturbance, deafness, vestibular disturbance

Respiratory: Bronchospasm, dyspnea, pharyngitis

Miscellaneous: Radiation recall phenomenon

ALERT: U.S. Boxed Warning

Experienced physician:

This preparation should be administered by individuals experienced in the administration of vinblastine sulfate.

Extravasation:

It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis.

Appropriate administration:

For intravenous use only - fatal if given by other routes.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Leukopenia commonly occurs; granulocytopenia may be severe with higher doses. The leukocyte nadir generally occurs 5 to 10 days after administration; recovery typically occurs 7 to 14 days later. Monitor for infections if WBC <2,000/mm3. Leukopenia may be more pronounced in cachectic patients and patients with skin ulceration and may be less pronounced with lower doses used for maintenance therapy. Leukocytes and platelets may fall considerably with moderate doses when marrow is infiltrated with malignant cells (further use in this situation is not recommended). Thrombocytopenia and anemia may occur rarely.

• Extravasation: [US Boxed Warning]: Vinblastine is a vesicant; ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation. Extravasation may cause significant irritation. Individuals administering should be experienced in vinblastine administration. If extravasation occurs, discontinue immediately and initiate appropriate extravasation management, including local injection of hyaluronidase and moderate heat application to the affected area. Use a separate vein to complete administration.

• Gastrointestinal toxicity: Stomatitis may occur (rare); may be disabling, but is usually reversible.

• Neurotoxicity: May rarely cause disabling neurotoxicity; usually reversible. Seizures and severe and permanent CNS damage has occurred with higher then recommended doses and/or when administered more frequently than recommended.

• Pulmonary toxicity: Acute shortness of breath and severe bronchospasm have been reported, most often in association with concurrent administration of mitomycin; may occur within minutes to several hours following vinblastine administration or up to 14 days following mitomycin administration; use caution in patients with preexisting pulmonary disease.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment; toxicity may be increased; may require dosage modification.

• Ischemic heart disease: Use with caution in patients with ischemic heart disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Special handling:

• Hazardous agent: Avoid eye contamination (exposure may cause severe irritation).

Other warnings/precautions:

• Experienced physician: [US Boxed Warning]: Should be administered under the supervision of an experienced cancer chemotherapy physician.

• NOT for intrathecal use: [US Boxed Warning]: For IV use only. Intrathecal administration may result in death. To prevent administration errors, the Institute for Safe Medication Practices (ISMP) Targeted Medication Safety Best Practices for Hospitals initiative strongly recommends dispensing vinblastine diluted in a minibag (ISMP, 2014). If not dispensed in a minibag, affix an auxiliary label stating "For intravenous use only - fatal if given by other routes" and also place in an overwrap labeled "Do not remove covering until moment of injection." Vinblastine should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vinblastine in a location away from the separate storage location recommended for intrathecal medications. Vinblastine should NOT be delivered to the patient at the same time with any medications intended for central nervous system administration.

Monitoring Parameters

CBC with differential and platelet count, serum uric acid, hepatic function tests

Pregnancy Risk Factor

D

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies. May cause fetal harm if administered during pregnancy. Women of childbearing potential should avoid becoming pregnant during vinblastine treatment. Aspermia has been reported in males who have received treatment with vinblastine.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience hair loss or bone pain. Have patient report immediately to prescriber signs of infection, signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any bleeding that is very bad or that will not stop), severe injection site pain or irritation, angina, tachycardia, passing out, arrhythmia, burning or numbness feeling, severe constipation, severe abdominal pain, loss of strength and energy, shortness of breath, severe jaw pain, severe headache, depression, hearing impairment, or tinnitus (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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