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.

Some side effects of Navelbine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to vinorelbine: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking vinorelbine (the active ingredient contained in Navelbine) 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 of vinorelbine 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.

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.

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.

Hepatic

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

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.

General

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

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

Local

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

Nervous system

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

Dermatologic

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

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

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.

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

Respiratory

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

Musculoskeletal

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

Genitourinary

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

Metabolic

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

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

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