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

Vinorelbine can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood. Your doctor will delay or interrupt your treatment if the number of white blood cells is too low. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection.

Vinorelbine should be administered only into a vein. However, it may leak into surrounding tissue causing severe irritation or damage. Your doctor or nurse will monitor your administration site for this reaction. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected.

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.

Vinorelbine comes as a solution (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually given once a week. The length of treatment depends on how well your body responds to treatment with vinorelbine.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Vinorelbine is also sometimes used to treat breast cancer and certain types of soft tissue sarcomas (cancer that forms in muscles). Talk to your doctor about the risks of using this medication for your condition.

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

Before receiving vinorelbine,

• Tell your doctor and pharmacist if you are allergic to vinorelbine, any other medications, or any of the ingredients in vinorelbine injection. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); or nefazodone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you are being treated with or have ever been treated with radiation therapy or cancer chemotherapy, or if you have or have ever had a disorder that affects your nerves or lung or liver disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breastfeed while you are receiving vinorelbine injection. If you become pregnant while receiving vinorelbine injection, call your doctor. Vinorelbine may harm the fetus.

Unless your doctor tells you otherwise, continue your normal diet.

Vinorelbine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Nausea
• Vomiting
• Diarrhea
• Loss of appetite
• Weight loss
• Change in ability to taste food
• Sores in the mouth and throat
• Hearing loss
• Dizziness
• Headache
• Pain, numbness, burning, or tingling in the hands or feet
• Muscle, joint, or bone pain
• Hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• Shortness of breath
• Cough
• Constipation
• Stomach pain
• Chest pain
• Irregular heartbeat
• Pale skin
• Unusual tiredness or weakness
• Unusual bleeding or bruising
• Hives
• Itching
• Rash
• Difficulty breathing or swallowing

Vinorelbine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• Sores in the mouth and throat
• Stomach pain
• Constipation
• Fever, sore throat, chills, or other signs of infection
• Loss of the ability to move muscles and to feel a part of the body

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to vinorelbine.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.