Thursday, December 18, 2014
Home
Navelbine

Navelbine


View the Breast Cancer Slideshow Pictures

Navelbine Drug Description


NAVELBINE®
(vinorelbine tartrate) Injection

WARNING: NAVELBINE (vinorelbine tartrate) Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. This product is for intravenous (IV) use only. Intrathecal administration of other vinca alkaloids has resulted in death. Syringes containing this product should be labeled "WARNING - FOR IV USE ONLY. FATAL if given intrathecally."

Severe granulocytopenia resulting in increased susceptibility to infection may occur. Granulocyte counts should be ≥ 1,000 cells/mm3 prior to the administration of NAVELBINE (vinorelbine tartrate) . The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment.

Caution - It is extremely important that the intravenous needle or catheter be properly positioned before NAVELBINE (vinorelbine tartrate) is injected. Administration of NAVELBINE (vinorelbine tartrate) may result in extravasation causing local tissue necrosis and/or thrombophlebitis (see DOSAGE AND ADMINISTRATION: Administration Precautions).

DRUG DESCRIPTION

NAVELBINE (vinorelbine tartrate) Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic. Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumor activity. The chemical name is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(salt)]. Vinorelbine tartrate has the following structure:

 

NAVELBINE®   (vinorelbine tartrate) Structural Formula Illustration

vinorelbine tartrate is a white to yellow or light brown amorphous powder with the molecular formula C45H54N4O8•2C4H6O6 and molecular weight of 1079.12. The aqueous solubility is > 1,000 mg/mL in distilled water. The pH of NAVELBINE (vinorelbine tartrate) Injection is approximately 3.5.

 

What are the possible side effects of vinorelbine (Navelbine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • cough, bronchospasm (wheezing, chest tightness, trouble breathing);
  • severe constipation, stomach pain, bloody or black stools;
  • ...

Read All Potential Side Effects and See Pictures of Navelbine »

 

What are the precautions when taking vinorelbine tartrate (Navelbine)?

Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.

Vinorelbine can...

 

Navelbine


Navelbine Indications & Dosage


INDICATIONS

NAVELBINE (vinorelbine tartrate) is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, NAVELBINE (vinorelbine tartrate) is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, NAVELBINE (vinorelbine tartrate) is indicated in combination with cisplatin.

DOSAGE AND ADMINISTRATION

Single-Agent NAVELBINE (vinorelbine tartrate) : The usual initial dose of single-agent NAVELBINE (vinorelbine tartrate) is 30 mg/m2 administered weekly. The recommended method of administration is an intravenous injection over 6 to 10 minutes. In controlled trials, single-agent NAVELBINE (vinorelbine tartrate) was given weekly until progression or dose-limiting toxicity.

NAVELBINE (vinorelbine tartrate) in Combination with Cisplatin: NAVELBINE (vinorelbine tartrate) may be administered weekly at a dose of 25 mg/m2 in combination with cisplatin given every 4 weeks at a dose of 100 mg/m2.

Blood counts should be checked weekly to determine whether dose reductions of vinorelbine and/or cisplatin are necessary. In the SWOG study, most patients required a 50% dose reduction of NAVELBINE (vinorelbine tartrate) at day 15 of each cycle and a 50% dose reduction of cisplatin by cycle 3. NAVELBINE (vinorelbine tartrate) may also be administered weekly at a dose of 30 mg/m2 in combination with cisplatin, given on days 1 and 29, then every 6 weeks with cisplatin at a dose of 120 mg/m2.

Dose Modifications for NAVELBINE (vinorelbine tartrate) : The dosage should be adjusted according to hematologic toxicity or hepatic insufficiency, whichever results in the lower dose for the corresponding starling dose of NAVELBINE (vinorelbine tartrate) (see Table 5).

Dose Modifications for Hematologic Toxicity: Granulocyte counts should be ≥ 1,000 cells/mm3/ prior to the administration of NAVELBINE (vinorelbine tartrate) . Adjustments in the dosage of NAVELBINE (vinorelbine tartrate) should be based on granulocyte counts obtained on the day of treatment according to Table 5.

Table 5: Dose Adjustments Based on Granulocyte Counts

Granulocytes on Day of Treatment (Cells/mm3) Percentage of Starting Dose of NAVELBINE
≥ 1,500 100%
1,000 to 1,499 50%
<1,000 Do not administer. Repeat granulocyte count in 1 week. If 3 consecutive weekly doses are held because granulocyte count is <1,000 cells/mm3, discontinue NAVELBINE (vinorelbine tartrate) .
Note: For patients who, during treatment with vinorelbine, experienced fever and/or sepsis while granulocytopenic or had 2 consecutive weekly doses held due to granulocytopenia, subsequent doses of vinorelbine should be:
>1,500 75
1,000 to 1,499 37.5%
<1,000 See above

Dose Modifications for Hepatic Insufficiency: NAVELBINE (vinorelbine tartrate) should be administered with caution to patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with NAVELBINE (vinorelbine tartrate) , the dose should be adjusted for total bilirubin according to Table 6.

Table 6: Dose Modification Based on Total Bilirubin

Total Bilirubin (mg/dL) Percentage of Starting Dose of NAVELBINE
≤ 2.0 100%
2.1 to 3.0 50%
>3.0 25%

Dose Modifications for Concurrent Hematologic Toxicity and Hepatic Insufficiency: In patients with both hematologic toxicity and hepatic insufficiency, the lower of the doses based on the corresponding starting dose of NAVELBINE (vinorelbine tartrate) determined from Table 5 and Table 6 should be administered.

Dose Modifications for Renal Insufficiency: No dose adjustments for NAVELBINE (vinorelbine tartrate) are required for renal insufficiency. Appropriate dose reductions for cisplatin should be made when NAVELBINE (vinorelbine tartrate) is used in combination.

Dose Modifications for Neurotoxicity: If Grade ≥ 2 neurotoxicity develops, NAVELBINE (vinorelbine tartrate) should be discontinued.

Administration Precautions: Caution - NAVELBINE (vinorelbine tartrate) must be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any NAVELBINE (vinorelbine tartrate) is injected. Leakage into surrounding tissue during intravenous administration of NAVELBINE (vinorelbine tartrate) may cause considerable irritation, local tissue necrosis, and/or thrombophlebitis. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Since there are no established guidelines for the treatment of extravasation injuries with NAVELBINE (vinorelbine tartrate) , institutional guidelines may be used. The ONS Chemotherapy Guidelines provide additional recommendations for the prevention of extravasation injuries.1

As with other toxic compounds, caution should be exercised in handling and preparing the solution of NAVELBINE (vinorelbine tartrate) . Skin reactions may occur with accidental exposure. The use of gloves is recommended. If the solution of NAVELBINE (vinorelbine tartrate) contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. Severe irritation of the eye has been reported with accidental contamination of the eye with another vinca alkaloid. If this happens with NAVELBINE (vinorelbine tartrate) , the eye should be flushed with water immediately and thoroughly. Procedures for proper handling and disposal of anticancer drugs should be used. Several guidelines on this subject have been published.2-8

There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

NAVELBINE (vinorelbine tartrate) Injection is a clear, colorless to pale yellow solution. Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, NAVELBINE (vinorelbine tartrate) should not be administered.

Preparation for Administration: NAVELBINE (vinorelbine tartrate) Injection must be diluted in either a syringe or IV bag using one of the recommended solutions. The diluted NAVELBINE (vinorelbine tartrate) should be administered over 6 to 10 minutes into the side port of a free-flowing IV closest to the IV bag followed by flushing with at least 75 to 125 mL of one of the solutions. Diluted vinorelbine may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).

Syringe: The calculated dose of NAVELBINE (vinorelbine tartrate) should be diluted to a concentration between 1.5 and 3.0 mg/mL.

The following solutions may be used for dilution:

5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP

IV Bag: The calculated dose of NAVELBINE (vinorelbine tartrate) should be diluted to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:

5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
Ringer's Injection, USP
Lactated Ringer's Injection, USP

Stability: Unopened vials of NAVELBINE (vinorelbine tartrate) are stable until the date indicated on the package when stored under refrigeration at 2°to 8°C (36° to 46°F) and protected from light in the carton. Unopened vials of NAVELBINE (vinorelbine tartrate) are stable at temperatures up to 25°C (77°F) for up to 72 hours. This product should not be frozen.

HOW SUPPLIED

NAVELBINE (vinorelbine tartrate) Injection is a clear, colorless to pale yellow solution in Water for Injection, containing 10 mg vinorelbine per mL. Vinorelbine Injection is available in single-use, clear glass vials with elastomeric stoppers and royal blue caps, individually packaged in a carton in the following vial sizes:

10 mg/1 mL Single-Use Vial, Carton of 1 (NDC 60831-3086-1).

50 mg/5 mL Single-Use Vial, Carton of 1 (NDC 60831-3086-2).

Store the vials under refrigeration at 2° to B°C (36° to 46°F) in the carton. Protect from light. DO NOT FREEZE.

REFERENCES

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing Society; 1999: 32-41.

2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.

3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA.1985; 253: 1590-1591.

4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.

5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983; 1: 426-428.

6. Jones RB, Frank R, Mass T Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983; 33: 258-263.

7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990; 47: 1033-1049.

8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996; 53: 1669-1685.

Manufactured by: Pierre Fabre Médicament, 45 place Abel Gance - 92100 Boulogne - FRANCE. For further information please contact: PIERRE FABRE PHARMACEUTICALS Inc. 9 campus Drive - Parsippany, NJ 07054. FDA Rev date: 11/5/2002

 

Navelbine


Navelbine Side Effects & Drug Interactions


SIDE EFFECTS

The pattern of adverse reactions is similar whether NAVELBINE (vinorelbine tartrate) is used as a single agent or in combination. Adverse reactions from studies with single-agent and combination use of NAVELBINE (vinorelbine tartrate) are summarized in Tables 2-4.

Single-Agent NAVELBINE (vinorelbine tartrate) : Data in the following table are based on the experience of 365 patients (143 patients with NSCLC; 222 patients with advanced breast cancer) treated with IV NAVELBINE (vinorelbine tartrate) as a single agent in 3 clinical studies. The dosing schedule in each study was 30 mg/m2 NAVELBINE (vinorelbine tartrate) on a weekly basis.

Table 2: Summary of Adverse Events in 365 Patients Receiving Single-Agent NAVELBINE (vinorelbine tartrate) *

Adverse Event All Patients
(n=365)
NSCLC
(n=143)
Bone Marrow
Granulocytopenia <2,000 cells/mm3 90% 80%
<500 cells/mm3 36% 29%
Leukopenia <4,000 celIs/mm3 92% 81%
<1,000 cells/mm3 15% 12%
Thrombocytopenia <100,000 cells/mm3 5% 4%
<50,000 cells/mm3 1% 1%
Anemia <11 g/dL 83% 77%
<8 g/dL 9% 1%
Hospitalizations due to granulocytopenic complications 9% 8%
Adverse Event All Grades Grade 3 Grade4
All Patients NSCLC All Patients NSCLC All Patients NSCLC
Clinical Chemistry Elevations
Total Bilirubin (n=351) 13% 9% 4% 3% 3% 2%
SGOT (n=346) 67% 54% 5% 2% 1% 1%
General
Asthenia 36% 27% 7% 5% 0% 0%
Injection Site   Reactions 28% 38% 2% 5% 0% 0%
Injection Site Pain 16% 13% 2% 1% 0% 0%
Phlebitis 7% 10% <1% 1% 0% 0%
Digestive
Nausea 44% 34% 2% 1% 0% 0%
Vomiting 20% 15% 2% 1% 0% 0%
Constipation 35% 29% 3% 2% 0% 0%
Diarrhea 17% 13% 1% 1% 0% 0%
Peripheral Neuropathy 25% 20% 1% 1% <1% 0%
Dyspnea 7% 3% 2% 2% 1% 0%
Alopecia 12% 12% ≤ 1% 1% 0% 0%
* None of the reported toxicities were influenced by age. Grade based on modified criteria from the National Cancer Institute.
Patients with NSCLC had not received prior chemotherapy. The majority of the remaining patients had received prior chemotherapy.
Incidence of paresthesia plus hypesthesia.

Hematologic: Granulocytopenia is the major dose-limiting toxicity with NAVELBINE (vinorelbine tartrate) . Dose adjustments are required for hematologic toxicity and hepatic insufficiency (see DOSAGE AND ADMINISTRATION). Granulocytopenia was generally reversible and not cumulative over time. Granulocyte nadirs occurred 7 to 10 days after the dose, with granulocyte recovery usually within the following 7 to 14 days. Granulocytopenia resulted in hospitalizations for fever and/or sepsis in 8% of patients. Septic deaths occurred in approximately 1% of patients. Prophylactic hematologic growth factors have not been routinely used with NAVELBINE (vinorelbine tartrate) . If medically necessary, growth factors may be administered at recommended doses no earlier than 24 hours after the administration of cytotoxic chemotherapy. Growth factors should not be administered in the period 24 hours before the administration of chemotherapy. Whole blood and/or packed red blood cells were administered to 18% of patients who received NAVELBINE (vinorelbine tartrate) .

Neurologic: Loss of deep tendon reflexes occurred in less than 5% of patients. The development of severe peripheral neuropathy was infrequent (1%) and generally reversible.

Skin: Like other antirancer vinca alkaloids, NAVELBINE (vinorelbine tartrate) is a moderate vesicant. Injection site reactions, including erythema, pain at injection site, and vein discoloration, occurred in approximately one third of patients; 5% were severe. Chemical phlebitis along the vein proximal to the site of injection was reported in 10% of patients.

Gastrointestinal: Prophylactic administration of antiemetics was not routine in patients treated with single-agent NAVELBINE (vinorelbine tartrate) . Due to the low incidence of severe nausea and vomiting with single-agent NAVELBINE (vinorelbine tartrate) , the use of serotonin antagonists is generally not required.

Hepatic: Transient elevations of liver enzymes were reported without clinical symptoms.

Cardiovascular: Chest pain was reported in 5% of patients. Most reports of chest pain were in patients who had either a history of cardiovascular disease or tumor within the chest. There have been rare reports of myocardial infarction.

Pulmonary: Shortness of breath was reported in 3% of patients; it was severe in 2% (see WARNINGS). Interstitial pulmonary changes were documented.

Other: Fatigue occurred in 27% of patients. It was usually mild or moderate but tended to increase with cumulative dosing.

Other toxicities that have been reported in less than 5% of patients include jaw pain, myalgia, arthralgia, and rash. Hemorrhagic cystitis and the syndrome of inappropriate ADH secretion were each reported in < 1% of patients.

Combination Use: Adverse events for combination use are summarized in Tables 3 and 4.

NAVELBINE (vinorelbine tartrate) in Combination with Cisplatin

NAVELBINE (vinorelbine tartrate) plus Cisplatin versus Single-Agent Cisplatin (Table 3): Myelosuppression was the predominant toxicity in patients receiving combination therapy, Grade 3 and 4 granulocytopenia of 82% compared to 5% in the single-agent cisplatin arm. Fever and/or sepsis related to granulocytopenia occurred in 11% of patients on NAVELBINE (vinorelbine tartrate) and cisplatin compared to 0% on the cisplatin arm. Four patients on the combination died of granulocytopenia-related sepsis. During this study, the use of granulocyte colony-stimulating factor ([G-CSF] filgrastim) was permitted, but not mandated, after the first course of treatment for patients who experienced Grade 3 or 4 granulocytopenia (x1,000 cells/mm3) or in those who developed neutropenic fever between cycles of chemotherapy. Beginning 24 hours after completion of chemotherapy, G-CSF was started at a dose of 5 mcg/kg per day and continued until the total granulocyte count was > 1,000 cells/mm3/ on 2 successive determinations. G-CSF was not administered on the day of treatment. Grade 3 and 4 anemia occurred more frequently in the combination arm compared to control, 24% vs. 8%, respectively. Thrombocytopenia occurred in 6% of patients treated with NAVELBINE (vinorelbine tartrate) plus cisplatin compared to 2% of patients treated with cisplatin. The incidence of severe non-hematologic toxicity was similar among the patients in both treatment groups. Patients receiving NAVELBINE (vinorelbine tartrate) plus cisplatin compared to single-agent cisplatin experienced more Grade 3 and/or 4 peripheral numbness (2% vs. < 1%), phlebitis/thrombosis/embolism (3% vs. < 1%), and infection (6% vs. < 1%). Grade 3-4 constipation and/or ileus occurred in 3% of patients treated with combination therapy and in 1% of patients treated with cisplatin. Seven deaths were reported on the combination arm; 2 were related to cardiac ischemia, 1 massive cerebrovascular accident, 1 multisystem failure due to an overdose of NAVELBINE (vinorelbine tartrate) , and 3 from febrile neutropenia. One death, secondary to respiratory infection unrelated to granulocytopenia, occurred with single-agent cisplatin.

NAVELBINE (vinorelbine tartrate) plus Cisplatin versus Vindesine plus Cisplatin versus Single-Agent Vinorelbine (Table 4): Myelosuppression, specifically Grade 3 and 4 granulocytopenia, was significantly greater with the combination of NAVELBINE (vinorelbine tartrate) plus cisplatin (79%) than with either single-agent NAVELBINE (vinorelbine tartrate) (53%) or vindesine plus cisplatin (48%), P < 0.0001. Hospitalization due to documented sepsis occurred in 4.4% of patients treated with NAVELBINE (vinorelbine tartrate) plus cisplatin: 2% of patients treated with vindesine and cisplatin, and 4% of patients treated with single-agent NAVELBINE (vinorelbine tartrate) . Grade 3 and 4 thrombocytopenia was infrequent in patients receiving combination chemotherapy and no events were reported with single-agent NAVELBINE (vinorelbine tartrate) . The incidence of Grade 3 and/or 4 nausea and vomiting, alopecia, and renal toxicity were reported more frequently in the cisplatin-containing combinations compared to single-agent NAVELBINE (vinorelbine tartrate) . Severe local reactions occurred in 2% of patients treated with combinations containing NAVELBINE (vinorelbine tartrate) ; none were observed in the vindesine plus cisplatin arm. Grade 3 and 4 neurotoxicity was significantly more frequent in patients receiving vindesine plus cisplatin (17%) compared to NAVELBINE (vinorelbine tartrate) plus cisplatin (7%) and single-agent vinorelbine (9%) (P < 0.005). Cisplatin did not appear to increase the incidence of neurotoxicity observed with single-agent NAVELBINE (vinorelbine tartrate) .

Table 3: Selected Adverse Events From a Comparative Trial of NAVELBINE (vinorelbine tartrate) plus Cisplatin versus Single-Agent Cisplatin*

Adverse Event NAVELBINE (vinorelbine tartrate) 25 mg/m2 plus Cisplatin 100 mg/m2
(n=212)
Cisplatin 100 mg/m2
(n=210)
All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4
Bone Marrow
Granulocytopenia 89% 22% 60% 26% 4% 1%
Anemia 88% 21% 3% 72% 7% <1%
Leukopenia 88% 39% 19% 31% <1% 0%
Thrombocytopenia 29% 4% 1% 21% 1% <1%
Febrile neutropenia N/A N/A 11% N/A N/A 0%
Hepatic
Elevated transaminase 1% 0% 0% <1% <1% 0%
Renal
Elevated creatinine 37% 2% 2% 28% 4% <1%
Non-Laboratory
Malaise/fatigue/lethargy 67% 12% 0% 49% 8% 0%
Vomiting 60% 7% 6% 60% 10% 4%
Nausea 58% 14% 0% 57% 12% 0%
Anorexia 46% 0% 0% 37% 0% 0%
Constipation 35% 3% 0% 16% 1% 0%
Alopecia 34% 0% 0% 14% 0% 0%
Weight loss 34% 1% 0% 21% <1% 0%
Fever without infection 20% 2% 0% 4% 0% 0%
Hearing 18% 4% 0% 18% 3% <1%
Local (injection site reactions) 17% <1% 0% 1% 0% 0%
Diarrhea 17% 2% <1% 11% 1% <1%
Paresthesias 17% <1% 0% 10% <1% 0%
Taste alterations 17% 0% 0% 15% 0% 0%
Peripheral numbness 11% 2% 0% 7% <1% 0%
Myalgia/arthralgia 12% <1% 0% 3% <1% 0%
Phlebitis/thrombosis/embolism 10% 3% 0% <1% 0% <1%
Weakness 12% 2% <1% 7% 2% 0%
Dizziness/vertigo 9% <1% 0% 3% <1% 0%
Infection 11% 5% <1% <1% <1% 0%
Respiratory infection 10% 4% <1% 3% 3% 0%
* Graded according to the standard SWOG criteria.

Table 4: Selected Adverse Events From a Comparative Trial of NAVELBINE (vinorelbine tartrate) Plus Cisplatin versus Vindesine Plus Cisplatin versus Single-Agent NAVELBINE (vinorelbine tartrate) *


Observed During Clinical Practice: In addition to the adverse events reported from clinical trials, the following events have been identified during post-approval use of NAVELBINE (vinorelbine tartrate) . Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to NAVELBINE (vinorelbine tartrate) .

Body as a Whole: Systemic allergic reactions reported as anaphylaxis, pruritus, urticaria, and angioedema; flushing; and radiation recall events such as dermatitis and esophagitis (see PRECAUTIONS) have been reported.

Hematologic: Thromboembolic events, including pulmonary embolus and deep venous thrombosis, have been reported primarily in seriously ill and debilitated patients with known predisposing risk factors for these events.

Neurologic: Peripheral neurotoxicities such as, but not limited to, muscle weakness and disturbance of gait; have been observed in patients with and without prior symptoms. There may be increased potential for neurotoxicity in patients with pre-existing neuropathy, regardless of etiology, who receive NAVELBINE (vinorelbine tartrate) . Vestibular and auditory deficits have been observed with NAVELBINE (vinorelbine tartrate) , usually when used in combination with cisplatin.

Skin:Injection site reactions, including localized rash and urticaria, blister formation, and skin sloughing have been observed in clinical practice. Some of these reactions may be delayed in appearance.

Gastrointestinal: Dysphagia, mucositis, and pancreatitis have been reported.

Cardiovascular: Hypertension, hypotension, vasodilation, tachycardia, and pulmonary edema have been reported.

Pulmonary: Pneumonia has been reported.

Musculoskeletal:Headache has been reported, with and without other musculoskeletal aches and pains.

Other: Pain in tumor-containing tissue, back pain, and abdominal pain have been reported. Electrolyte abnormalities, including hyponatremia with or without the syndrome of inappropriate ADH secretion, have been reported in seriously ill and debilitated patients.

Combination Use: Patients with prior exposure to paclitaxel and who have demonstrated neuropathy should he monitored closely for new or worsening neuropathy. Patients who have experienced neuropathy with previous drug regimens should be monitored for symptoms of neuropathy while receiving NAVELBINE (vinorelbine tartrate) . NAVELBINE (vinorelbine tartrate) may result in radiosensitizing effects with prior or concomitant radiation therapy (see PRECAUTIONS).

DRUG INTERACTIONS

Acute pulmonary reactions have been reported with NAVELBINE (vinorelbine tartrate) and other anticancer vinca alkaloids used in conjunction with mitomycin. Although the pharmacokinetics of vinorelbine are not influenced by the concurrent administration of cisplatin, the incidence of granulocytopenia with NAVELBINE (vinorelbine tartrate) used in combination with cisplatin is significantly higher than with single-agent NAVELBINE (vinorelbine tartrate) . Patients who receive NAVELBINE (vinorelbine tartrate) and paclitaxel, either concomitantly or sequentially, should be monitored for signs and symptoms of neuropathy. Administration of NAVELBINE (vinorelbine tartrate) to patients with prior or concomitant radiation therapy may result in radio sensitizing effects. Caution should be exercised in patients concurrently taking drugs known to inhibit drug metabolism by hepatic cytochrome P450 isoenzymes in the CYP3A subfamily, or in patients with hepatic dysfunction. Concurrent administration of vinorelbine tartrate with an inhibitor of this metabolic pathway may cause an earlier onset and/or an increased severity of side effects.

 

Navelbine


Navelbine Warnings & Precautions


WARNINGS

NAVELBINE (vinorelbine tartrate) should be administered in carefully adjusted doses by or under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Patients treated with NAVELBINE (vinorelbine tartrate) should be frequently monitored for myelosuppression both during and after therapy. Granulocytopenia is dose-limiting. Granulocyte nadirs occur between 7 and 10 days after dosing with granulocyte count recovery usually within the following 7 to 14 days. Complete blood counts with differentials should be performed and results reviewed prior to administering each dose of NAVELBINE (vinorelbine tartrate) . NAVELBINE (vinorelbine tartrate) should not be administered to patients with granulocyte counts < 1,000 cells/mm3. Patients developing severe granulocytopenia should be monitored carefully for evidence of infection and/or fever. See DOSAGE AND ADMINISTRATION for recommended dose adjustments for granulocytopenia. Acute shortness of breath and severe bronchospasm have been reported infrequently, following the administration of NAVELBINE (vinorelbine tartrate) and other vinca alkaloids, most commonly when the vinca alkaloid was used in combination with mitomycin. These adverse events may require treatment with supplemental oxygen, bronchodilators, and/or corticosteroids, particularly when there is pre-existing pulmonary dysfunction. Reported cases of interstitial pulmonary changes and acute respiratory distress syndrome (ARDS), most of which were fatal, occurred in patients treated with single-agent NAVELBINE (vinorelbine tartrate) . The mean time to onset of these symptoms after vinorelbine administration was 1 week (range 3 to 8 days). Patients with alterations in their baseline pulmonary symptoms or with new onset of dyspnea, cough, hypoxia, or other symptoms should be evaluated promptly.

NAVELBINE (vinorelbine tartrate) has been reported to cause severe constipation (e.g., Grade 3-4), paralytic ileus, intestinal obstruction, necrosis, and/or perforation. Some events have been fatal.

Pregnancy

Pregnancy Category D. NAVELBINE (vinorelbine tartrate) may cause fetal harm if administered to a pregnant woman. A single dose of vinorelbine has been shown to be embryo- and/or fetotoxic in mice and rabbits at doses of 9 mg/m2 and 5.5 mg/m2, respectively (one third and one sixth the human dose). At nonmaternotoxic doses, fetal weight was reduced and ossification was delayed. There are no studies in pregnant women. If NAVELBINE (vinorelbine tartrate) is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with NAVELBINE (vinorelbine tartrate) .

PRECAUTIONS

General

Most drug-related adverse events of NAVELBINE (vinorelbine tartrate) are reversible. If severe adverse events occur, NAVELBINE (vinorelbine tartrate) should be reduced in dosage or discontinued and appropriate corrective measures taken. Reinstitution of therapy with NAVELBINE (vinorelbine tartrate) should be carried out with caution and alertness as to possible recurrence of toxicity. NAVELBINE (vinorelbine tartrate) should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from the effects of previous chemotherapy (see DOSAGE AND ADMINISTRATION). Administration of NAVELBINE (vinorelbine tartrate) to patients with prior radiation therapy may result in radiation recall reactions (see ADVERSE REACTIONS and DRUG INTERACTIONS). Patients with a prior history or pre-existing neuropathy, regardless of etiology, should be monitored for new or worsening signs and symptoms of neuropathy while receiving NAVELBINE (vinorelbine tartrate) . Care must be taken to avoid contamination of the eye with concentrations of NAVELBINE (vinorelbine tartrate) used clinically. Severe irritation of the eye has been reported with accidental exposure to another vinca alkaloid. If exposure occurs, the eye should immediately be thoroughly flushed with water.

Laboratory Tests

Since dose-limiting clinical toxicity is the result of depression of the white blood cell count, it is imperative that complete blood counts with differentials be obtained and reviewed on the day of treatment prior to each dose of NAVELBINE (see ADVERSE REACTIONS: Hematologic).

Hepatic

There is no evidence that the toxicity of NAVELBINE (vinorelbine tartrate) is enhanced in patients with elevated liver enzymes. No data are available for patients with severe baseline cholestasis, but the liver plays an important role in the metabolism of NAVELBINE (vinorelbine tartrate) . Because clinical experience in patients with severe liver disease is limited, caution should be exercised when administering NAVELBINE (vinorelbine tartrate) to patients with severe hepatic injury or impairment (see DOSAGE AND ADMINISTRATION).

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of NAVELBINE (vinorelbine tartrate) has not been studied. Vinorelbine has been shown to affect chromosome number and possibly structure in vivo (polyploidy in bone marrow cells from Chinese hamsters and a positive micronucleus test in mice). It was not mutagenic in the Ames test and gave inconclusive results in the mouse lymphoma TK Locus assay. The significance of these or other short-term test results for human risk is unknown. Vinorelbine did not affect fertility to a statistically significant extent when administered to rats on either a once-weekly (9 mg/m2, approximately one third the human dose) or alternate-day schedule (4.2 mg/m2, approximately one seventh the human dose) prior to and during mating. However, biweekly administration for 13 or 26 weeks in the rat at 2.1 and 7.2 mg/m2 (approximately one fifteenth and one fourth the human dose) resulted in decreased spermatogenesis and prostate/seminal vesicle secretion.

Pregnancy

Pregnancy Category D. See WARNINGS section.

Nursing Mothers

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from NAVELBINE (vinorelbine tartrate) , it is recommended that nursing be discontinued in women who are receiving therapy with NAVELBINE (vinorelbine tartrate) .

Pediatric Use

Safety and effectiveness of NAVELBINE (vinorelbine tartrate) in pediatric patients have not been established. Data from a single-arm study in 46 patients with recurrent solid malignant tumors, including rhabdomyosarcoma/undifferentiated sarcoma, neuroblastoma, and CNS tumors, at doses similar to those used in adults, showed no meaningful clinical activity. Toxicities were similar to those reported in adults.

Geriatric Use

Of the total number of patients in North American clinical studies of IV NAVELBINE (vinorelbine tartrate) , approximately one third were 65 years of age or greater. No overall differences in effectiveness or safety were observed between these patients and younger adult patients. Other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.

The pharmacokinetics of vinorelbine in elderly and younger adult patients are similar (see CLINICAL PHARMACOLOGY).

 

Navelbine

 


Navelbine Overdosage & Contraindications


OVERDOSE

There is no known antidote for overdoses of NAVELBINE (vinorelbine tartrate) . Overdoses involving quantities up to 10 times the recommended dose (30 mg/m2) have been reported. The toxicities described were consistent with those listed in the ADVERSE REACTIONS section including paralytic ileus, stomatitis, and esophagitis. Bone marrow aplasia, sepsis, and paresis have also been reported. Fatalities have occurred following overdose of NAVELBINE (vinorelbine tartrate) . If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors, and antibiotics should be instituted as deemed necessary by the physician.

CONTRAINDICATIONS

Administration of NAVELBINE (vinorelbine tartrate) is contraindicated in patients with pretreatment granulocyte counts < 1,000 cells/mm3 (see WARNINGS).

 

Navelbine


 

Navelbine Clinical Pharmacology


CLINICAL PHARMACOLOGY

Vinorelbine is a vinca alkaloid that interferes with microtubule assembly. The vinca alkaloids are structurally similar compounds comprised of 2 multiringed units, vindoline and catharanthine. Unlike other vinca alkaloids, the catharanthine unit is the site of structural modification for vinorelbine. The antitumor activity of vinorelbine is thought to be due primarily to inhibition of mitosis at metaphase through its interaction with tubulin. Like other vinca alkaloids, vinorelbine may also interfere with: 1) amino acid, cyclic AMP, and glutathione metabolism, 2) calmodulin-dependent Ca++-transport ATPase activity, 3) cellular respiration, and 4) nucleic acid and lipid biosynthesis. In intact tectal plates from mouse embryos, vinorelbine, vincristine and vinblastine inhibited mitotic microtubule formation at the same concentration (2 µM), inducing a blockade of cells at metaphase. Vincristine produced depolymerization of axonal microtubules at 5 µM, but vinblastine and vinorelbine did not have this effect until concentrations of 30 µM and 40 µM, respectively. These data suggest relative selectivity of vinorelbine for mitotic microtubules.

Pharmacokinetics

The pharmacokinetics of vinorelbine were studied in 49 patients who received doses of 30 mg/m2 in 4 clinical trials. Doses were administered by 15- to 20-minute constant-rate infusions. Following intravenous administration, vinorelbine concentration in plasma decays in a triphasic manner. The initial rapid decline primarily represents distribution of drug to peripheral compartments followed by metabolism and excretion of the drug during subsequent phases. The prolonged terminal phase is due to relatively slow efflux of vinorelbine from peripheral compartments. The terminal phase half-life averages 27.7 to 43.6 hours and the mean plasma clearance ranges from 0.97 to 1.26 L/hr/kg. Steady-state volume of distribution (VSS) values range from 25.4 to 40.1 L/kg. Vinorelbine demonstrated high binding to human platelets and lymphocytes. The free fraction was approximately 0.11 in pooled human plasma over a concentration range of 234 to 1,169 ng/mL. The binding to plasma constituents in cancer patients ranged from 79.6% to 91.2%. Vinorelbine binding was not altered in the presence of cisplatin, 5-fluorouracil, or doxorubicin.

Vinorelbine undergoes substantial hepatic elimination in humans, with large amounts recovered in feces after intravenous administration to humans. Two metabolites of vinorelbine have been identified in human blood, plasma, and urine; vinorelbine N-oxide and deacetylvinorelbine. Deacetylvinorelbine has been demonstrated to be the primary metabolite of vinorelbine in humans, and has been shown to possess antitumor activity similar to vinorelbine. Therapeutic doses of vinorelbine (30 mg/m2) yield very small, if any, quantifiable levels of either metabolite in blood or urine. The metabolism of vinca alkaloids has been shown to be mediated by hepatic cytochrome P450 isoenzymes in the CYP3A subfamily. This metabolic pathway may be impaired in patients with hepatic dysfunction or who are taking concomitant potent inhibitors of these isoenzymes (see PRECAUTIONS). The effects of renal or hepatic dysfunction on the disposition of vinorelbine have not been assessed, but based on experience with other anticancer vinca alkaloids, dose adjustments are recommended for patients with impaired hepatic function (see DOSAGE AND ADMINISTRATION).

The disposition of radiolabeled vinorelbine given intravenously was studied in a limited number of patients. Approximately 18% and 46% of the administered dose was recovered in the urine and in the feces, respectively. Incomplete recovery in humans is consistent with results in animals where recovery is incomplete, even after prolonged sampling times. A separate study of the urinary excretion of vinorelbine using specific chromatographic analytical methodology showed that 10.9% ± 0.7% of a 30-mg/m2 intravenous dose was excreted unchanged in the urine. The influence of age on the pharmacokinetics of vinorelbine was examined using data from 44 cancer patients (average age, 56.7 ± 7.8 years; range, 41 to 74 years; with 12 patients ≥ 60 years and 6 patients ≥ 65 years) in 3 studies. CL (the mean plasma clearance), t½ (the terminal phase half-life), and Vz (the volume of distribution during terminal phase) were independent of age. A separate pharmacokinetic study was conducted in 10 elderly patients with metastatic breast cancer (age range, 66 to 81 years; 3 patients > 75 years; normal liver function tests) receiving vinorelbine 30 mg/m2 intravenously. CL, Vss, and t½ were similar to those reported for younger adult patients in previous studies. No relationship between age, systemic exposure (AUC0-∞), and hematological toxicity was observed.

The pharmacokinetics of vinorelbine are not influenced by the concurrent administration of cisplatin with NAVELBINE (see PRECAUTIONS: DRUG INTERACTIONS).

Clinical Trials

Data from 1 randomized clinical study (211 evaluable patients) with single-agent NAVELBINE (vinorelbine tartrate) and 2 randomized clinical trials (1,044 patients) using NAVELBINE (vinorelbine tartrate) combined with cisplatin support the use of NAVELBINE (vinorelbine tartrate) in patients with advanced non-small cell lung cancer (NSCLC).

Single-Agent NAVELBINE (vinorelbine tartrate) : Single-agent NAVELBINE (vinorelbine tartrate) was studied in a North American, randomized clinical trial in which patients with Stage IV NSCLC, no prior chemotherapy, and Karnofsky Performance Status ≥ 70 were treated with NAVELBINE (vinorelbine tartrate) (30 mg/m2) weekly or 5-fluorouracil (5-FU) (425 mg/m2 IV bolus) plus leucovorin (LV) 20 mg/m2 IV bolus) daily for 5 days every 4 weeks. A total of 211 patients were randomized at a 2:1 ratio to NAVELBINE (vinorelbine tartrate) (143) or 5-FU/LV (68). NAVELBINE (vinorelbine tartrate) showed improved survival time compared to 5-FU/LV. In an intent-to-treat analysis, the median survival time was 30 weeks versus 22 weeks for patients receiving NAVELBINE (vinorelbine tartrate) versus 5-FU/LV, respectively (P=0.06). The 1-year survival rates were 24% (±4% SE) for NAVELBINE (vinorelbine tartrate) and 16% (±5% SE) for the 5-FU/LV group, using the Kaplan-Meier product-limit estimates. The median survival time with 5-FU/LV was similar to or slightly better than that usually observed in untreated patients with advanced NSCLC, suggesting that the difference was not related to some unknown detrimental effect of 5-FU/LV therapy. The response rates (all partial responses) for NAVELBINE (vinorelbine tartrate) and 5-FU/LV were 12% and 3%, respectively.

NAVELBINE (vinorelbine tartrate) in Combination with Cisplatin: NAVELBINE (vinorelbine tartrate) plus Cisplatin versus Single-Agent Cisplatin: A Phase III open-label, randomized study was conducted which compared NAVELBINE (vinorelbine tartrate) (25 mg/m2/ week) plus cisplatin (100 mg/m2 every 4 weeks) to single-agent cisplatin (100 mg/m2/ every 4 weeks) in patients with Stage IV or Stage IIIb NSCLC patients with malignant pleural effusion or multiple lesions in more than one lobe who were not previously treated with chemotherapy. Patients included in the study had a performance status of 0 or 1, and 34% had received prior surgery and/or radiotherapy. Characteristics of the 432 randomized patients are provided in Table 1. Two hundred and twelve patients received NAVELBINE (vinorelbine tartrate) plus cisplatin and 210 received single-agent cisplatin. The primary objective of this trial was to compare survival between the 2 treatment groups. Survival (Figure 1) for patients receiving NAVELBINE (vinorelbine tartrate) plus cisplatin was significantly better compared to the patients who received single-agent cisplatin. The results of this trial are summarized in Table 1.

NAVELBINE (vinorelbine tartrate) plus Cisplatin versus Vindesine plus Cisplatin versus Single-Agent NAVELBINE (vinorelbine tartrate) : In a large European clinical trial, 612 patients with Stage III or IV NSCLC, no prior chemotherapy, and WHO Performance Status of 0, 1, or 2 were randomized to treatment with single-agent NAVELBINE (vinorelbine tartrate) (30 mg/m2/week), NAVELBINE (vinorelbine tartrate) (30 mg/m2/week) plus cisplatin (120 mg/m2 days 1 and 29, then every 6 weeks), and vindesine (3 mg/m2/week for 7 weeks, then every other week) plus cisplatin (120 mg/m2 days 1 and 29, then every 6 weeks). Patient characteristics are provided in Table 1. Survival was longer in patients treated with NAVELBINE (vinorelbine tartrate) plus cisplatin compared to those treated with vindesine plus cisplatin (Figure 2). Study results are summarized in Table 1.

Dose-Ranging Study: A dose-ranging study of NAVELBINE (vinorelbine tartrate) (20, 25, or 30 mg/m2/week) plus cisplatin (120 mg/m2 days 1 and 29, then every 6 weeks) in 32 patients with NSCLC demonstrated a median survival of 10.2 months. There were no responses at the lowest dose level; the response rate was 33% in the 21 patients treated at the 2 highest dose levels.

Table 1: Randomized Clinical Trials of NAVELBINE (vinorelbine tartrate) in Combination with Cisplatin in NSCLC

NAVELBINE/Cisplatin vs. Single-Agent Cisplatin NAVELBINE/Cisplatin vs.Vindesine/Cisplatin vs. Single-Agent Vinorelbine
NAVELBINE/
Cisplatin
Cisplatin NAVELBINE/
Cisplatin
Vindesine/
Cisplatin
NAVELBINE
Demographics
Number of patients 214 218 206 200 206
Number of males 146 141 182 179 188
Number of females 68 77 24 21 18
Median age (years) 63 64 59 59 60
Range (years) 33-84 37-81 32-75 31-75 30-74
Stage of disease
Stage IIIA NA NA 11% 11% 10%
Stage IIIB 8% 8% 28% 25% 32%
Stage IV 92% 92% 50% 55% 47%
Local recurrence NA NA 2% 3% 3 %
Metastatic after surgery NA NA 9% 8% 9 %
Histology
Adenocarcinoma 54% 52% 32% 40% 28%
Squamous 19% 22% 56% 50% 56%
Large cell 14% 14 % 13% 11% 16%
Unspecified 13% 13% NA NA NA
Results
Median survival (months) 7.8 6.2 9.2* 7.4 7.2
P value P = 0.01 *P =0.09 vs.vindesine/cisplatin
= 0.05 vs. single-agent NAVELBINE (vinorelbine tartrate)
12-Month survival rate 38% 22% 35% 27% 30%
Overall response 19% 8% 28%ठ19% 14%
P value P<0.001 P =0.03 vs.vindesine/cisplatin
§P<0.001 vs.single-agent NAVELBINE (vinorelbine tartrate)

Figure 1: Overall Survival NAVELBINE (vinorelbine tartrate) /Cisplatin versus Single-Agent Cisplatin

Overall Survival NAVELBINE/Cisplatin versus Single-Agent Cisplatin - Illustration

Figure 2: Overall Survival NAVELBINE (vinorelbine tartrate) /Cisplatin versus Vindesine/Cisplatin versus Single-Agent NAVELBINE (vinorelbine tartrate)

Overall Survival NAVELBINE/Cisplatin versus Vindesine/Cisplatin versus Single-Agent NAVELBINE - Illustration

Last reviewed on RxList: 12/17/2008
This monograph has been modified to include the generic and brand name in many instances.

 

Navelbine


Navelbine Medication Guide


PATIENT INFORMATION

Patients should be informed that the major acute toxicities of NAVELBINE (vinorelbine tartrate) are related to bone marrow toxicity, specifically granulocytopenia with increased susceptibility to infection. They should be advised to report fever or chills immediately. Women of childbearing potential should be advised to avoid becoming pregnant during treatment. Patients should be advised to contact their physician it they experience increased shortness of breath, cough, or other new pulmonary symptoms, or if they experience symptoms of abdominal pain or constipation.

 

Navelbine


Navelbine Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

VINORELBINE - INJECTION

 

(vye-nor-ELL-bean)

 

COMMON BRAND NAME(S): Navelbine

 

WARNING: This medication must be given only by injection into a vein (intravenously-IV) by a trained healthcare professional. Deaths have occurred with medications similar to vinorelbine that were injected into the spine.

Vinorelbine can lower your blood cell counts (bone marrow suppression) and lower your ability to fight an infection. Your doctor will follow your blood counts closely. Tell your doctor immediately if you develop any signs of an infection such as fever, chills, or persistent sore throat.

If this medication accidentally leaks out of your vein into surrounding tissue, the skin and/or muscle may be severely damaged. Tell your doctor immediately if you have pain, redness, swelling, or discoloration at the injection site.

 

USES: Vinorelbine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.

 

HOW TO USE: Vinorelbine is given by injection only into a vein by a healthcare professional. It is usually given over 6-10 minutes, once a week, or as directed by your doctor. The dosage is based on your medical condition, response to therapy, and body size.

If this medication comes into contact with your skin, wash your skin immediately and completely with soap and water. If vinorelbine gets into your eyes, flush them immediately and completely with water, and contact the doctor.

 

Navelbine


Navelbine Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, fatigue, constipation, diarrhea, dizziness, muscle aches, joint pain, or irritation at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling/pain in the hands or feet, decreased reflexes, mouth sores, easy bruising/bleeding, weakness, new or increased trouble breathing, cough, severe constipation, stomach/abdominal pain, blood in the urine, mental/mood changes.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.

Vinorelbine can sometimes cause a serious skin reaction that looks likes a severe sunburn when given after radiation treatment (radiation recall). The reaction usually develops on the skin area previously treated with radiation within days to months after vinorelbine treatment. Throat problems can also be part of radiation recall with vinorelbine. Tell your doctor immediately if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. Your doctor may prescribe medication to treat your symptoms. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby. Women of childbearing age should use reliable form(s) of birth control during treatment with this drug and for some time afterwards. Consult your doctor for more details.

It is not known if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

 

Navelbine


Navelbine Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: mitomycin, drugs affecting liver enzymes that remove vinorelbine from your body (such as azole antifungals, including itraconazole; macrolide antibiotics, including erythromycin; cimetidine; rifamycins, including rifabutin; St. John's wort; certain anti-seizure medicines, including carbamazepine; aprepitant).

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

 

NOTES: Laboratory and/or medical tests (e.g., complete blood counts, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

 

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

 

Navelbine


Navelbine Patient Information Including Side Effects

Brand Names: Navelbine

Generic Name: vinorelbine (Pronunciation: vin OR el been)

 

  • What is vinorelbine (Navelbine)?
  • What are the possible side effects of vinorelbine (Navelbine)?
  • What is the most important information I should know about vinorelbine (Navelbine)?
  • What should I discuss with my healthcare provider before receiving vinorelbine (Navelbine)?
  • How is vinorelbine given (Navelbine)?
  • What happens if I miss a dose (Navelbine)?
  • What happens if I overdose (Navelbine)?
  • What should I avoid while receiving vinorelbine (Navelbine)?
  • What other drugs will affect vinorelbine (Navelbine)?
  • Where can I get more information?

 

What is vinorelbine (Navelbine)?

Vinorelbine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vinorelbine is used to treat non-small cell lung cancer.

Vinorelbine is sometimes used in combination with other cancer medications.

Vinorelbine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of vinorelbine (Navelbine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • cough, bronchospasm (wheezing, chest tightness, trouble breathing);
  • severe constipation, stomach pain, bloody or black stools;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • numbness, burning, pain, or tingly feeling;
  • problems with vision, hearing, speech, balance, or daily activities;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • pain, burning, redness, swelling, or skin changes where the IV needle was placed.

Less serious side effects may include:

  • temporary hair loss;
  • jaw pain, joint or muscle pain;
  • tumor pain;
  • weight loss;
  • nausea, vomiting, diarrhea, loss of appetite; or
  • feeling dizzy, weak, or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about vinorelbine (Navelbine)?

You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

Do not use vinorelbine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vinorelbine, tell your doctor if you have liver disease, bone marrow suppression, a nerve disorder, or if you hare received radiation therapy or other cancer treatments.

Vinorelbine is sometimes used in combination with other cancer medications.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when vinorelbine is injected.

Vinorelbine can lower blood cells that help your body fight infections. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with vinorelbine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Related Drug Centers
  • Navelbine

 

Navelbine


Navelbine Patient Information including How Should I Take

In this Article

  • What is vinorelbine (Navelbine)?
  • What are the possible side effects of vinorelbine (Navelbine)?
  • What is the most important information I should know about vinorelbine (Navelbine)?
  • What should I discuss with my healthcare provider before receiving vinorelbine (Navelbine)?
  • How is vinorelbine given (Navelbine)?
  • What happens if I miss a dose (Navelbine)?
  • What happens if I overdose (Navelbine)?
  • What should I avoid while receiving vinorelbine (Navelbine)?
  • What other drugs will affect vinorelbine (Navelbine)?
  • Where can I get more information?

What should I discuss with my healthcare provider before receiving vinorelbine (Navelbine)?

You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • liver disease;
  • bone marrow suppression;
  • a nerve disorder; or
  • if you hare received radiation therapy or other cancer treatments.

FDA pregnancy category D. Vinorelbine can cause harm to an unborn baby or cause birth defects. Before you receive vinorelbine, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether vinorelbine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are being treated with vinorelbine.

How is vinorelbine given (Navelbine)?

Vinorelbine is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion.

Vinorelbine is usually given once every 7 days. You may also receive the medication once every 6 weeks. Follow your doctor's instructions.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Vinorelbine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your cancer treatments may be delayed based on the results of these tests. Do not miss any scheduled visits to your doctor.

Related Drug Centers
  • Navelbine

 

 

Navelbine


Navelbine Patient Information including If I Miss a Dose

In this Article

  • What is vinorelbine (Navelbine)?
  • What are the possible side effects of vinorelbine (Navelbine)?
  • What is the most important information I should know about vinorelbine (Navelbine)?
  • What should I discuss with my healthcare provider before receiving vinorelbine (Navelbine)?
  • How is vinorelbine given (Navelbine)?
  • What happens if I miss a dose (Navelbine)?
  • What happens if I overdose (Navelbine)?
  • What should I avoid while receiving vinorelbine (Navelbine)?
  • What other drugs will affect vinorelbine (Navelbine)?
  • Where can I get more information?

What happens if I miss a dose (Navelbine)?

Call your doctor for instructions if you miss an appointment for your vinorelbine injection.

What happens if I overdose (Navelbine)?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include white patches or sores in your mouth or throat, painful swallowing, heartburn, severe constipation, and stomach pain.

What should I avoid while receiving vinorelbine (Navelbine)?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with vinorelbine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Talk to your doctor about ways to avoid constipation while being treated with vinorelbine.

What other drugs will affect vinorelbine (Navelbine)?

Tell your doctor about all other medications you use, especially:

  • conivaptan (Vaprisol);
  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • an antidepressant such as nefazodone;
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • cancer medicines such as cisplatin (Platinol), carboplatin (Paraplatin), mitomycin (Mutamycin), or oxaliplatin (Elixatin);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with vinorelbine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about vinorelbine.



 

Related Drug Centers
  • Navelbine
Share
 
Ruai Pharm Stats