How does it work?

Navelbine injection and capsules both contain the activeingredient vinorelbine, which is a chemotherapy medicine used to treat cancer.(NB Vinorelbine injection is also available without a brand name, ie as thegeneric medicine.)

Cancers form when some cells within the body multiplyuncontrollably and abnormally. These cells spread, destroying nearby tissues.Vinorelbine works by stopping the cancer cells from multiplying.

Like normal healthy cells, cancer cells go through a continuousprocess of change. Each cell divides into two daughter cells. These cells grow,rest and then divide again. The medicines used in chemotherapy are powerfulchemicals designed to interupt this cycle and stop cells from growing andmultiplying.

Vinorelbine belongs to a group of chemotherapy medicines calledvinca alkaloids. These work by preventing the cancer cells from entering thedividing stage (mitosis) of their life cycle. This stops the cells frommultiplying.

Unfortunately, vinorelbine can also affect normal, healthycells, particularly those that multiply quickly, such as blood cells and haircells. The most important side effect is on the bone marrow where blood cellsare made. Vinorelbine can decrease the production of blood cells, leavingpeople susceptible to infection. Regular blood tests are therefore needed tomonitor the levels of blood cells.

In most chemotherapy regimens, doses are administered in coursesat various intervals to allow normal cells to recover from the adverse effectsof the chemotherapy between doses. However, during this period, cancer cellswill also recover and start to replicate again. Successful treatment depends onthe administration of the next course of therapy before the cancer has regrownto its previous size. The aim is to decrease the amount of cancer with eachsuccessive course.

Vinorelbine is used to treat advanced non-small cell lung cancerand advanced breast cancer. The medicine may be given by a drip into a vein, orby mouth as capsules.

What is it used for?

• Advanced breast cancer that has not responded to, or has relapsed following, treatment with a chemotherapy regimen containing an anthracycline, eg epirubicin.
• Advanced non-small cell lung cancer.

Warning!

• Vinorelbine injection must ONLY be given by a drip into a vein (intravenous infusion). The injection MUST NOT be administered into the spinal cord (intrathecal injection), as this is likely to be fatal.
• Vinorelbine injection can cause irritation in the vein used for the injection and for this reason the vein will be flushed with fluid after the medicine has been administered. If you feel any pain or irritation while the medicine is being administered you should let the doctor or nurse know, as this can be reduced if more fluid is flushed through with the medicine. If vinorelbine leaks into the tissues around the vein, it can cause damage to the tissue there. For this reason, it is important to tell the doctor or nurse administering the medicine if you feel any burning or stinging around the vein or if you notice any fluid leaking out of the injection site. You should also let them know if the area becomes red and swollen at any point.
• Navelbine capsules should be taken with plenty of water, with or after food. They should be swallowed whole and not broken, opened, sucked or chewed. The liquid inside the capsules is irritant and may cause damage if it comes into contact with your skin or eyes. Do not swallow any damaged capsules - return them to your doctor or pharmacist. If you come into contact with the liquid inside the capsules, wash the affected area immediately with water. If you accidentally suck or chew a capsule, rinse your mouth immediately with water.
• Navelbine capsules should be stored in their original container at between 2°C and 8°C in a refrigerator. Make sure you keep the capsules out of the sight and reach of children.
• Chemotherapy medicines can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need to have regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• This medicine may be harmful to a developing baby. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished.
• Your ability to become pregnant or father a child may be affected by taking this medicine. It is important to discuss fertility with your doctor before starting treatment.

Use with caution in

• Decreased liver function.
• History of heart disease caused by inadequate blood flow to the heart (ischaemic heart disease, eg angina).

Not to be used in

• Severely decreased number of white blood cells in the blood (neutropenia).
• Severely decreased number of platelets in the blood (thrombocytopenia).
• People with a current infection, or who have had an infection in the previous two weeks.
• Pregnancy.
• Breastfeeding.
• Navelbine capsules are not suitable for people who have had surgery to remove a significant portion of their stomach or small intestine, or who have other diseases or conditions that could affect the absorption of the medicine from the gut into the bloodstream. The are also not suitable for people requiring long-term oxygen therapy, or people who have severely decreased liver function that is not related to the cancer.
• Navelbine capsules contain sorbitol and are not suitable for people with rare hereditary problems of fructose intolerance.
• Vinorelbine should not be used to treat people who are currently having radiotherapy treatment to the liver.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine should not be used during pregnancy, as it may be harmful to the developing baby. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least a few months after treatment is finished. Seek medical advice from your doctor.
• It is not known whether this medicine passes into breast milk. Mothers who need treatment with this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Decrease in the number of a type of white blood cell (neutrophil) in the blood (neutropenia).
• Decrease in the number of red blood cells in the blood (anaemia).
• Decrease in the number of platelets in the blood (thrombocytopenia).
• Constipation.
• Nausea and vomiting.
• Diarrhoea.
• Loss of appetite.
• Inflammation of the mouth.
• Pins and needles sensations (paraesthesia).
• Disorder of the peripheral nerves causing weakness and numbness (peripheral neuropathy).
• Burning pain at injection site.
• Inflammation of the vein used for injection (phlebitis).
• Fatigue.
• Hair loss.
• Jaw pain.

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines duringtreatment this one, to ensure that thecombination is safe.

This medicine can decrease the body's immune response. Thismeans that vaccines may be less effective if given during treatment, and livevaccines may cause serious infections. Live vaccines include: measles, mumps,rubella, MMR, oral polio, oral typhoid, chicken pox and yellow fever. If livevaccines are needed, they should be postponed until at least six months afterfinishing chemotherapy.

Other medicines containing the same active ingredient

Vinorelbine injection is also available without a brand name, ieas thegeneric medicine.