Vinorelbine is used to treat non-small cell lung cancer, sometimes used in combination with other cancer medications.

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

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, tiredness, cough, skin sores, bruising, pale skin, unusual bleeding, or trouble breathing.

Vinorelbine is given as an infusion into a vein. A healthcare provider will give you this injection.

Vinorelbine is usually given once every 7 days to 6 weeks. Your schedule will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.

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

Vinorelbine affects your immune system. You may get infections more easily, even serious or fatal infections. Your blood will need to be tested often and your treatment may be delayed based on the results.

Usual Adult Dose for Non-Small Cell Lung Cancer:

IN COMBINATION WITH CISPLATIN:
25 mg/m2 IV over 6 to 10 minutes on Days 1, 8, 15, and 21 of a 28-day cycle in combination with cisplatin 100 mg/m2 IV on Day 1 only of each 28-day cycle
OR
30 mg/m2 IV over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m2 IV on Days 1 and 29, then every 6 weeks

AS A SINGLE AGENT:
30 mg/m2 IV over 6 to 10 minutes once a week

Uses:
-In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
-As a single agent, for the treatment of patients with metastatic NSCLC

You should not be treated with vinorelbine if you are allergic to it, or if you have severely low white blood cell counts.

Tell your doctor if you have ever had:

• liver disease;

• bone marrow suppression;

• a nerve disorder; or

• radiation therapy or other cancer treatments.

Vinorelbine can harm an unborn baby or cause birth defects if the mother or the father is using vinorelbine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use vinorelbine if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using vinorelbine.

Vinorelbine can damage sperm and it may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

You should not breastfeed while using vinorelbine, and for at least 9 days after your last dose.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Do not receive a "live" vaccine while using 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), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

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

Vinorelbine may cause serious side effects. Call your doctor at once if you have:

• severe constipation, stomach pain, bloody or black stools;

• numbness, tingling, muscle weakness;

• pain, redness, and peeling skin on your hands or feet;

• new or worsening cough, wheezing, chest tightness, trouble breathing;

• dark urine, jaundice (yellowing of the skin or eyes);

• pain, burning, irritation, or skin changes where the injection was given; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

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

Common side effects of vinorelbine may include:

• nausea, vomiting, constipation;

• weakness;

• numbness or tingling in your hands or feet;

• low blood cell counts;

• abnormal liver function tests; or

• pain, redness, bruising, or irritation around the IV needle.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect vinorelbine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.