Navelbine

Navelbine is a prescription medication used to treat non-small cell lung cancer. 

Navelbine belongs to a group of drugs called vinca alkaloids, which slows down and/or stop the growth of cancer cells.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Navelbine include nausea, vomiting, constipation, diarrhea, weight loss, and hair loss.

Navelbine is a prescription medication used to treat advanced non-small cell lung cancer (NSCLC). 

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

• Pierre Fabre Pharmaceuticals, Inc.

Serious side effects have been reported with Navelbine. See the “Navelbine Precautions” section.

Common side effects of Navelbine include the following:

• change in blood counts
• injection site reactions such as pain at injection site
• inflammation of vein at injection site
• nausea
• vomiting
• constipation
• diarrhea
• peripheral neuropathy (tingling sensation and numbness in the fingers and toes)
• dyspnea (shortness of breath)
• hair loss

This is not a complete list of Navelbine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• mitomycin
• cisplatin
• paclitaxel
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone

This is not a complete list of Navelbine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Navelbine including the following:

• Granulocytopenia (decrease in a type of white blood cell)  This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, or other signs of infection.
• Extravasation causing local tissue necrosis and/or thrombophlebitis (tissue causing severe irritation or damage). Leaking of medication 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.
• Severe constipation. Tell your doctor if you experience symptoms of abdominal pain or constipation.
• Acute shortness of breath and severe bronchospasm. Tell your doctor if you experience increased shortness of breath, cough, or other new pulmonary symptoms.
• Pulmonary changes and acute respiratory distress syndrome (ARDS). Tell your doctor if you notice dyspnea (shortness of breath) and cough.
• Harm to your baby if pregnant. Tell your doctor if are pregnant or plan to become pregnant.

Do not take Navelbine if you:

• are allergic to Navelbine or to any of its ingredients
• granulocyte (a type of white blood cell) counts <1,000 cells/mm3

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Navelbine, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Navelbine, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Navelbine or to any of its ingredients
• pre-existing neuropathy (damage to your peripheral nerves, often causes weakness, numbness and pain, usually in your hands and feet)
• have had prior irradiation or chemotherapy
• are pregnant or planning to become pregnant
• are breastfeeding or planning on breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Navelbine falls into category D. 

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Navelbine may cause fetal harm if administered to a pregnant woman. Women of childbearing potential should avoid becoming pregnant during treatment.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Navelbine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Navelbine.

Take Navelbine exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) once a week by a healthcare professional

If you miss a dose, be sure to make a follow up appointment.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• blood counts
• liver function
• your weight
• your height

The recommended starting dose of Navelbine (vinorelbine) if given alone is 30 mg/m2 administered weekly.

The recommended dose of Navelbine (vinorelbine) if given with Cisplatin: Navelbine may be administered weekly at a dose of 25 mg/m2 in combination with cisplatin given every 4 weeks at a dose of 100 mg/m2.

Navelbine may also be administered weekly at a dose of 30 mg/m2 in combination with cisplatin, given on days 1 and 29, then every 6 weeks at a dose of 120 mg/m2.

Since Navelbine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood counts weekly to determine whether dose reductions of medication(s) are needed.

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.