Navelbine

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.

Mechanism of Action

Semi-synthetic vinca alkaloid; inhibits mitosis at metaphase by depolymerizing microtubules; specific for S ans M phases; may also inhibit nucleic acid and protein synthesis by blocking glutamic acid use

Pharmacokinetics

Half-Life: 28-44 hr

Peak Plasma: 234-1160 ng/mL

Plasma clearance: 0.97-1.26 L/hr/kg

Protein Bound: 80-92%

Vd: 25-40 L/kg

Metabolism: CYP3A isoenzymes

Metabolites: vinorelbine N-oxide, deacetylvinorelbine

Clearance: 0.97-1.26 L/hr/kg

Excretion: Feces (46%); urine (18%)

Vinorelbine is cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vinorelbine is used to treat non-small cell lung cancer.

Vinorelbine is sometimes used in combination with other cancer medications.

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

You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

Do not use vinorelbine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vinorelbine, tell your doctor if you have liver disease, bone marrow suppression, a nerve disorder, or if you have received radiation therapy or other cancer treatments.

Vinorelbine is sometimes used in combination with other cancer medications.

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

Vinorelbine can lower blood cells that help your body fight infections. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with 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.

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.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while you are being treated with 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), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

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

Tell your doctor about all other medications you use, especially:

• conivaptan;
• diclofenac;
• imatinib;
• isoniazid (for treating tuberculosis);
• an antibiotic such as clarithromycin, dalfopristin/quinupristin, erythromycin, or telithromycin;
• antifungal medication such as clotrimazole, itraconazole, ketoconazole, or voriconazole;
• an antidepressant such as nefazodone;
• heart or blood pressure medication such as diltiazem, felodipine, nifedipine, verapamil and others;
• cancer medicines such as cisplatin, carboplatin, mitomycin, or oxaliplatin;
• HIV/AIDS medicine such as atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, saquinavir or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact with vinorelbine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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

Navelbine 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 Navelbine. 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. 

Navelbine 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 Navelbine 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 cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Vinorelbine is used to treat non-small cell lung cancer.

Vinorelbine is sometimes used in combination with other cancer medications.

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

You should not use this medication if you are allergic to it, or if you have severely low white blood cell counts.

Do not use vinorelbine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive vinorelbine, tell your doctor if you have liver disease, bone marrow suppression, a nerve disorder, or if you have received radiation therapy or other cancer treatments.

Vinorelbine is sometimes used in combination with other cancer medications.

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

Vinorelbine can lower blood cells that help your body fight infections. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with 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.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while you are being treated with 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), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

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

Antineoplastic agent; semisynthetic vinca alkaloid.1 4 21 b c

In the U.S.

• Navelbine

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Vinorelbine 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.

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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.

Geriatric

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.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Cisplatin
• Clarithromycin
• Gefitinib
• Influenza Virus Vaccine, Live
• Ketoconazole
• Poliovirus Vaccine, Live
• Posaconazole
• Quinupristin
• Smallpox Vaccine
• Typhoid Vaccine
• Voriconazole
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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 has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and fetotoxicity. There are no controlled data in human pregnancy. Vinorelbine should only be given during pregnancy when there are no alternatives and benefit outweighs risk. It is recommended that women of childbearing age be advised to avoid becoming pregnant while receiving therapy with vinorelbine.

If vinorelbine is used during pregnancy, or if the patient becomes pregnant while receiving the drug, then it is recommended that the patient be made aware of the potential hazard to the fetus.