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Vinorelbine (Intravenous route)

Pronunciation:

vin-OR-el-been

Brand Names:

  • Navelbine

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

This product is for IV use only; intrathecal administration of other vinca alkaloids has resulted in death. Administration of vinorelbine is contraindicated in patients with pretreatment granulocyte counts less than 1000 cells/mm(3). The dosage should be adjusted according to complete blood counts with differentials obtained on the day of treatment. It is extremely important that the intravenous needle or catheter be properly positioned before vinorelbine is injected to prevent extravasation causing local tissue necrosis and/or thrombophlebitis .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

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.

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)

Before Using This Medicine:

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.

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

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 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.

  • Rotavirus Vaccine, Live

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 Type 4, Live
  • Adenovirus Vaccine Type 7, Live
  • Aprepitant
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cisplatin
  • Clarithromycin
  • Fosaprepitant
  • Gefitinib
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Posaconazole
  • Quinupristin
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Voriconazole
  • Yellow Fever Vaccine

Other interactions—

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

Proper Use of This Medicine:

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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 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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Constipation
loss of appetite
nausea and vomiting
Less common
Diarrhea
jaw pain
joint or muscle pain

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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