Description and Brand Names

US Brand Name

  1. Navelbine

Descriptions


Vinorelbine injection is used to treat metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). It is also used together with other medicines (eg, cisplatin) for the first-line treatment of advanced or metastatic NSCLC.

Vinorelbine belongs to the group of medicines called antineoplastics. It 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 can 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.

Vinorelbine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Solution

Before Using

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

Appropriate studies have not been performed on the relationship of age to the effects of vinorelbine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vinorelbine injection in the elderly.

Breastfeeding

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.

Drug Interactions

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, Live
  • Zoster 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
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Cisplatin
  • Clarithromycin
  • Dengue Tetravalent Vaccine, Live
  • Fosnetupitant
  • Gefitinib
  • Influenza Virus Vaccine, Live
  • Itraconazole
  • Ketoconazole
  • Netupitant
  • Poliovirus Vaccine, Live
  • Posaconazole
  • Quinupristin
  • Smallpox Vaccine
  • Typhoid 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:

  • Brain or nerve problems or
  • Lung disease or breathing problems or
  • Stomach or bowel problems (eg, blockage, perforation)—Use with caution. May make these conditions worse.
  • Infection—Use with caution. This medicine may decrease your body's ability to fight infections.
  • Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

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.

Your doctor may want you to drink plenty of fluids, eat meals rich in fiber, or use stool softeners (laxatives) to prevent constipation.

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.

Precautions

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

Receiving this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

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 the urine or stools, or pinpoint red spots on your skin.
  • 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.
  • 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.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause severe constipation, stomach or bowel blockage, or perforation, which can be life-threatening. Check with your doctor right away if you have stomach cramps or pain, black, tarry stools, diarrhea, fever, or severe vomiting, sometimes with blood.

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

Check with your doctor right away if you have burning, tingling, numbness, or pain in the hands, arms, feet, or legs ,sensation of pins and needles, stabbing pain, or muscle weakness. These may be signs of a brain or nerve problem.

Serious lung or breathing problems (eg, bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome) may occur after you get a shot of this medicine into one of your muscles. Call your doctor right away if have any changes in your breathing after you receive this medicine.

If you plan to have children, talk with your doctor before receiving this medicine. Some men receiving this medicine have become infertile (unable to have children).

Side Effects

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

  1. Black, tarry stools
  2. bleeding gums
  3. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  4. blood in the urine or stools
  5. bluish color of the skin
  6. burning, numbness, tingling, or painful sensations
  7. changes in skin color
  8. chest pain
  9. chills
  10. clay-colored stools
  11. constipation
  12. cough
  13. dark urine
  14. decreased appetite
  15. dizziness
  16. feeling of fullness in the ears
  17. fever
  18. headache
  19. hoarseness
  20. itching, skin rash
  21. loss of appetite
  22. loss of balance
  23. loss of hearing
  24. lower back or side pain
  25. muscle pains, cramps, or stiffness
  26. nausea
  27. painful or difficult urination
  28. pale skin
  29. pinpoint red spots on the skin
  30. ringing or buzzing in the ears
  31. sneezing
  32. sore throat
  33. sores, ulcers, or white spots on the lips or in the mouth
  34. stomach pain or tenderness
  35. swelling of the feet or lower legs
  36. swollen glands
  37. tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  38. trouble in hearing
  39. troubled breathing with exertion
  40. unsteadiness or awkwardness
  41. unusual bleeding or bruising
  42. unusual tiredness or weakness
  43. yellow eyes or skin

Less common

  1. Chest tightness
  2. increased sensitivity to pain or touch
  3. overactive reflexes, followed by underactive reflexes
  4. trouble breathing

Rare

  1. Agitation
  2. chest discomfort
  3. confusion
  4. decreased awareness or responsiveness
  5. decreased urine output
  6. depression
  7. frequent urination
  8. hostility
  9. irritability
  10. loss of consciousness
  11. lower abdominal cramping
  12. muscle twitching
  13. pain or discomfort in the arms, jaw, back, or neck
  14. rapid weight gain
  15. seizures
  16. severe sleepiness
  17. swelling of the face, ankles, or hands
  18. unusual drowsiness, dullness, or feeling of sluggishness
  19. vomiting

Incidence not known

  1. Anxiety
  2. blistering or sloughing of the skin
  3. bloating
  4. blurred vision
  5. change in walking and balance
  6. clumsiness or unsteadiness
  7. coughing that sometimes produces a pink frothy sputum
  8. difficult, fast, noisy breathing
  9. difficulty in swallowing
  10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  11. fainting
  12. fast, pounding, or irregular heartbeat or pulse
  13. heartburn
  14. hives or welts
  15. increased sweating
  16. increased thirst
  17. indigestion
  18. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  19. lightheadedness
  20. nervousness
  21. pain or burning in the throat
  22. pain, redness, or swelling in the arm or leg
  23. pains in the stomach, side, or abdomen, possibly radiating to the back
  24. pale skin
  25. pounding in the ears
  26. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  27. redness, swelling, or pain of the skin
  28. scaling of the skin on the hands and feet
  29. slow heartbeat
  30. ulceration of the skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Chest pain
  2. chills
  3. confusion
  4. fainting
  5. fast heartbeat
  6. fever
  7. lightheadedness
  8. lower back or side pain
  9. painful or difficult urination
  10. partial or slight paralysis
  11. rapid, shallow breathing
  12. severe constipation
  13. severe stomach pain
  14. severe vomiting
  15. sores, ulcers, or white spots on the lips or in the mouth
  16. swollen glands
  17. unusual bleeding or bruising
  18. unusual tiredness or weakness

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

  1. Change in taste
  2. diarrhea
  3. difficulty in moving
  4. impaired hearing
  5. joint pain or swelling
  6. lack or loss of strength
  7. thinning or loss of hair

Incidence not known

  1. Back pain
  2. cracked, dry, scaly skin
  3. feeling of warmth or heat
  4. flushing or redness of the skin, especially on the face and neck
  5. jaw pain
  6. pain and redness of the skin at the place of earlier radiation treatment

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.