Vinorelbine

Vinorelbine is used alone and in combination with other medications to treat certain types ofnon-small cell lung cancer that has spread to nearby tissues or to other parts of the body. Vinorelbine is in a class of medications called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body.

Get emergency medical help if you have any 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.

Vinorelbine may be found in some form under the following brand names:

• Navelbine

Vinorelbine should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.

Vinorelbine can increase the risk that you will develop a serious infection because it can cause a severe decrease in the number of blood cells in your bone marrow.  Laboratory tests will be ordered before and during the course of treatment with vinorelbine.  If your white blood cell count is too low, your doctor will delay or suspend your treatment.  Call your doctor immediately if you experience any of the following symptoms: fever, sore throat, ongoing cough and congestion, or other sign of infection. 

Vinorelbine should be administered only into a vein, but it may leak into the surrounding tissue which can cause severe irritation or damage.  You will be monitored during the administration of vinorelbine for this reaction.  Immediately call your doctor if you experience any of the following:  pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected. 

Vinorelbine is a prescription medication used to treat advanced non-small cell lung cancer (NSCLC). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take vinorelbine exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) once a week by a healthcare professional

If you miss a dose, be sure to make a follow up appointment.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• blood counts
• liver function
• your weight
• your height

The recommended starting dose of Navelbine (Vinorelbine) if given alone is 30 mg/m2 administered weekly.

The recommended dose of Navelbine (Vinorelbine) if given with Cisplatin: Vinorelbine 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.

Vinorelbine 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 at a dose of 120 mg/m2.

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 have received radiation therapy or other cancer treatments.

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.

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.

• If you need to store vinorelbine at home, talk with your doctor, nurse, or pharmacist about how to store it.

There is no known antidote for overdoses of Vinorelbine. 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 Vinorelbine. If overdosage occurs, general supportive measures together with appropriate blood transfusions, growth factors, and antibiotics should be instituted as deemed necessary by the physician.

Pretreatment granulocyte counts <1000/mm3

Refer to adult dosing.

Dilute in D5W or NS to a final concentration of 1.5-3 mg/mL (for syringe) or D5W, NS, 1/2NS, D51/2NS, LR, or Ringer's to a final concentration of 0.5 to 2 mg/mL (for IV bag). Vinorelbine should NOT be prepared during the preparation of any intrathecal medications.