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Navelbine Side Effects

Generic Name: vinorelbine

Note: This document contains side effect information about vinorelbine. Some of the dosage forms listed on this page may not apply to the brand name Navelbine.

For the Consumer

Applies to vinorelbine: intravenous solution

Along with its needed effects, vinorelbine (the active ingredient contained in Navelbine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vinorelbine:

More Common

  • Cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • redness, increased warmth, pain, or discoloration of vein at place of injection
  • sore throat, accompanied by fever or chills

Less Common

  • Chest pain
  • shortness of breath
  • sores in mouth and on lips

Rare

Check with your doctor as soon as possible if any of the following side effects occur while taking vinorelbine:

More Common

  • Loss of strength and energy
  • unusual tiredness or weakness

Less Common

  • Numbness or tingling in fingers and toes

Symptoms of Overdose

  • Chest pain
  • cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • heartburn
  • lower back or side pain, accompanied by fever or chills
  • mild abdominal pain and constipation
  • numbness or tingling in fingers and toes
  • painful or difficult urination, accompanied by fever or chills
  • sore throat, accompanied by fever or chills
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Some side effects of vinorelbine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

  • Diarrhea
  • jaw pain
  • joint or muscle pain

For Healthcare Professionals

Applies to vinorelbine: intravenous solution

Hematologic

Pulmonary embolus and deep venous thrombosis have primarily been reported in seriously ill and debilitated patients with known predisposing risk factors for these events.[Ref]

Hematologic side effects have included granulocytopenia, which has been the major dose-limiting toxicity with the use of vinorelbine. Granulocytopenia has been reported at a frequency of 90% of patients with less than 2,000 cells/mm3 and 36% of patients with less than 500 cells/mm3. Leukopenia has been reported at a frequency of 92% of patients with less than 4,000 cells/mm3 and 5% of patients with less than 1,000 cells/mm3. Thrombocytopenia has been reported at a frequency of 5% of patients with less than 100,000 cells/mm3 and 1% of patients with less than 50,000 cells/mm3. And finally, anemia has been reported at a frequency of 83% of patients with less than 11 g/dL and 9% of patients with less than 8 g/dL. Pulmonary embolus and deep venous thrombosis have also been reported.[Ref]

Hepatic

Hepatic side effects including an increase in SGOT (67%) and an increase in total bilirubin (13%) have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea (44%), constipation (35%), vomiting (20%), diarrhea (17%), dysphagia, and mucositis have been reported. A case of typhlitis (neutropenic enterocolitis) has also been reported.[Ref]

General

General side effects including asthenia (36%), fatigue (27%), back pain, abdominal pain, and pain in tumor containing tissues have been reported.[Ref]

Fatigue was usually mild or moderate and tended to increase with increased cumulative dosing.[Ref]

Local

Local side effects including injection site reactions (28%) and injection site pain (16%) have been reported.[Ref]

Nervous system

Nervous system side effects including peripheral neuropathy (paresthesia and hypesthesia) (25%) and headache have been reported.[Ref]

Dermatologic

Some of these dermatologic reactions have been delayed in their occurrence.[Ref]

Dermatologic side effects including alopecia (12%), rash (<5%), pruritus, blister formation, skin sloughing, and urticaria have been reported.[Ref]

Cardiovascular

Most of the chest pain has been reported to have occurred in patients who had either a history of cardiovascular disease or tumor within the chest.[Ref]

Cardiovascular side effects including phlebitis (7%), chest pain (5%), myocardial infarction, angioedema, hypertension, hypotension, vasodilation, tachycardia, and flushing have been reported.[Ref]

Respiratory

Respiratory side effects including dyspnea (7%), shortness of breath (3%), severe shortness of breath (2%), pulmonary edema, and pneumonia have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including jaw pain, myalgia, and arthralgia have been reported in less than 5% of patients.[Ref]

Genitourinary

Genitourinary side effects including hemorrhagic cystitis (<1%) have been reported.[Ref]

Metabolic

Metabolic side effects including the syndrome of inappropriate antidiuretic hormone (<1%) have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.[Ref]

References

1. "Product Information. Navelbine (vinorelbine)." Glaxo Wellcome, Research Triangle Pk, NC.

2. Ferrazzi E, Toso S, Zanotti M, Giuliano G "Typhlitis (Neutropenic enterocolitis) after a single dose of vinorelbine." Cancer Chemother Pharmacol 47 (2001): 277-9

3. Garrett CA, Simpson TA "Syndrome of inappropriate antidiuretic hormone associated with vinorelbine therapy." Ann Pharmacother 32 (1998): 1306-9

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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