In the U.S.—

In Canada—

• Antineoplastic

Vinorelbine (vi-NOR-el-been ) belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of lung cancer. It may also be used to treat other kinds of cancer, as determined by your doctor.

Vinorelbine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells also may be affected by vinorelbine, other effects will occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with vinorelbine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Vinorelbine is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of receiving the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For vinorelbine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to vinorelbine.

Pregnancy—Tell your doctor if you are pregnant or if you intend to have children. This medicine may cause birth defects if either the male or female is receiving it at the time of conception or if it is taken during pregnancy. In addition, many cancer medicines may cause sterility, which could be permanent. Although decreased fertility has been reported only in male rats with this medicine, the possibility of an effect in human males and females should be kept in mind.

Be sure that you have discussed this with your doctor before receiving this medicine. It is best to use some kind of birth control while you are receiving vinorelbine. Tell your doctor right away if you think you have become pregnant while receiving vinorelbine.

Breast-feeding—Tell your doctor if you are breast-feeding or if you intend to breast-feed during treatment with this medicine. Because vinorelbine may cause serious side effects in nursing babies, breast-feeding is generally not recommended while you are receiving this medicine.

Children—There is no specific information comparing use of vinorelbine in children with use in other age groups. Safety and efficacy of vinorelbine in children have not been established.

Older adults—Vinorelbine has been studied in the elderly. Although patients older than 65 years of age have shown a slight increase in side effects compared with patients younger than 65 years of age, the overall safety and efficacy of vinorelbine are not different for older people.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking vinorelbine, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Mitomycin (e.g., Mutamycin) or
• Paclitaxel (e.g., Taxol) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., Retrovir) or
• If you have ever been treated with x-rays or cancer medicines—Vinorelbine may increase the effects of these medicines or radiation therapy on the blood

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Infection—Vinorelbine may decrease your body's ability to fight infections

Vinorelbine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving vinorelbine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive it, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of vinorelbine will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, and whether or not other medicines are also being taken. If you are receiving vinorelbine at home, follow your doctor's orders or the directions on the label. If you have any question about the proper dose of vinorelbine, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with vinorelbine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Vinorelbine may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral poliovirus vaccine, since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and the mouth.

Vinorelbine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infection. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Do not touch your eyes or the inside of your nose, unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury can occur.

If vinorelbine accidentally seeps out of the vein into which it is injected, it may damage some tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:

• 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
  • Black, tarry stools;  bloating ;  blood in urine or stools;  chills;  darkened urine;  fast heartbeat;  fever;  indigestion;  loss of appetite;  nausea;  painful urination;  pains in stomach;  pinpoint red spots on skin;  skin rash ;  unusual bleeding or bruising;  vomiting;  yellow eyes or skin 
  
  

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

• 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  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Constipation;  loss of appetite;  nausea and vomiting 
  
  

• Less common
  • Diarrhea;  jaw pain;  joint or muscle pain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, vinorelbine is used in certain patients with the following medical condition:

• Breast cancer
• Cervical cancer
• Ovarian cancer (epithelial)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.