Navelbine

DRUG DESCRIPTION

NAVELBINE (vinorelbine tartrate) Injection is for intravenous administration. Each vial contains vinorelbine tartrate equivalent to 10 mg (1-mL vial) or 50 mg (5-mL vial) vinorelbine in Water for Injection. No preservatives or other additives are present. The aqueous solution is sterile and nonpyrogenic. Vinorelbine tartrate is a semi-synthetic vinca alkaloid with antitumor activity. The chemical name is 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2, 3-dihydroxybutanedioate (1:2)(salt)]. Vinorelbine tartrate has the following structure:

NAVELBINE®
  (vinorelbine tartrate) Structural Formula Illustration

vinorelbine tartrate is a white to yellow or light brown amorphous powder with the molecular formula C45H54N4O8•2C4H6O6 and molecular weight of 1079.12. The aqueous solubility is > 1,000 mg/mL in distilled water. The pH of NAVELBINE (vinorelbine tartrate) Injection is approximately 3.5.

What are the possible side effects of vinorelbine (Navelbine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • cough, bronchospasm (wheezing, chest tightness, trouble breathing);
  • severe constipation, stomach pain, bloody or black stools;
  • ...

Read All Potential Side Effects and See Pictures of Navelbine »

What are the precautions when taking vinorelbine tartrate (Navelbine)?

Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.

Vinorelbine can...

Read All Potential Precautions of Navelbine »


Navelbine Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, fatigue, constipation, diarrhea, dizziness, muscle aches, joint pain, or irritation at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: numbness/tingling/pain in the hands or feet, decreased reflexes, mouth sores, easy bruising/bleeding, weakness, new or increased trouble breathing, cough, severe constipation, stomach/abdominal pain, blood in the urine, mental/mood changes.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.

Vinorelbine can sometimes cause a serious skin reaction that looks likes a severe sunburn when given after radiation treatment (radiation recall). The reaction usually develops on the skin area previously treated with radiation within days to months after vinorelbine treatment. Throat problems can also be part of radiation recall with vinorelbine. Tell your doctor immediately if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. Your doctor may prescribe medication to treat your symptoms. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.

Wash your hands well to prevent the spread of infections.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This drug is not recommended for use during pregnancy. It may cause harm to an unborn baby. Women of childbearing age should use reliable form(s) of birth control during treatment with this drug and for some time afterwards. Consult your doctor for more details.

It is not known if this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Navelbine Patient Information Including Side Effects

Brand Names: Navelbine

Generic Name: vinorelbine (Pronunciation: vin OR el been)

  • What is vinorelbine (Navelbine)?
  • What are the possible side effects of vinorelbine (Navelbine)?
  • What is the most important information I should know about vinorelbine (Navelbine)?
  • What should I discuss with my healthcare provider before receiving vinorelbine (Navelbine)?
  • How is vinorelbine given (Navelbine)?
  • What happens if I miss a dose (Navelbine)?
  • What happens if I overdose (Navelbine)?
  • What should I avoid while receiving vinorelbine (Navelbine)?
  • What other drugs will affect vinorelbine (Navelbine)?
  • Where can I get more information?

What is vinorelbine (Navelbine)?

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.

What are the possible side effects of vinorelbine (Navelbine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • cough, bronchospasm (wheezing, chest tightness, trouble breathing);
  • severe constipation, stomach pain, bloody or black stools;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • numbness, burning, pain, or tingly feeling;
  • problems with vision, hearing, speech, balance, or daily activities;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • pain, burning, redness, swelling, or skin changes where the IV needle was placed.

Less serious side effects may include:

  • temporary hair loss;
  • jaw pain, joint or muscle pain;
  • tumor pain;
  • weight loss;
  • nausea, vomiting, diarrhea, loss of appetite; or
  • feeling dizzy, weak, or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about vinorelbine (Navelbine)?

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 hare 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.

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