VINDESINE (Systemic)*

Some commonly used brand names are:

In Canada?

• Eldisine[reg ]

Other commonly used names are desacetyl vinblastineamide sulfate and vincaleukoblastine.

* Not commercially available in the U.S.

Category

• Antineoplastic

Description

Vindesine (VIN-de-seen) belongs to the group of medicines known as antineoplasticagents. It is used to treat some kinds of cancer, including leukemia and lungcancer.

Vindesine interferes with the growth of cancer cells, which are eventuallydestroyed. Since the growth of normal body cells may also be affected by vindesine,other effects will also occur. Some of these may be serious and must be reportedto your doctor. Other effects, such as hair loss, may not be serious but maycause concern.

Before you begin treatment with vindesine, you and your doctor should talkabout the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

Parenteral
• Injection (Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For vindesine, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to vindesine.

Pregnancy?Vindesine has not been studied in pregnant women.

Before receiving vindesine make sure your doctor knows if you are pregnantor if you may become pregnant. It is best to use some kind of birth controlwhile you are receiving vindesine. Tell your doctor right away if you thinkyou have become pregnant while receiving vindesine.

Breast-feeding?It is not known whether vindesine passes intothe breast milk. However, vindesine is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Although there is no specific information comparinguse of vindesine in children with use in other age groups, this medicine isnot expected to cause different side effects or problems in children thanit does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof vindesine in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingvindesine, it is especially important that your doctor or pharmacist knowif you are taking any of the following:

• Acyclovir (e.g., Zovirax) or
• Anticonvulsants (seizure medicine) or
• Antidiabetics, oral (diabetes medicine taken by mouth) or
• Anti-infectives by mouth or by injection (medicine for infection)or
• Antipsychotics (medicine for mental illness) or
• Captopril (e.g., Capoten) or
• Carbamazepine (e.g., Tegretol)
• Enalapril (e.g., Vasotec) or
• Flecainide (e.g., Tambocor) or
• Gold salts (medicine for arthritis) or
• Imipenem or
• Inflammation or pain medicine, except narcotics or
• Lisinopril (e.g., Prinivil, Zestril) or
• Maprotiline (e.g., Ludiomil) or
• Penicillamine (e.g., Cuprimine) or
• Pimozide (e.g., Orap) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Ramipril (e.g., Altace) or
• Sulfasalazine (e.g., Azulfidine) or
• Tiopronin (e.g., Thiola) or
• Tocainide (e.g., Tonocard) or
• Tricyclic antidepressants (medicine for depression) or
• Trimeprazine (e.g., Temaril)?Concurrent use of these agentswith vindesine may cause blood disorders

• Alpha interferons (e.g., Intron A, Roferon-A) or
• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics, other (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancoban) or
• Ganciclovir (e.g., Cytovene) or
• Mercaptopurine (e.g., Purinethol)
• Methotrexate (e.g., Rheumatrex)
• Plicamycin (e.g., Mithracin)
• Zidovudine (e.g., AZT, Retrovir)?Concurrent use of these agentswith vindesine increases the risk of infection

• Anti-infectives by mouth or by injection (medicine for infection)
• Carbamazepine (e.g., Tegretol)
• Chloroquine (e.g., Aralen)
• Cisplatin (e.g., Platinol)
• Cytarabine (e.g., Cytosar-U)
• Diphtheria, tetanus, and pertussis (DTP) vaccine (recent,within 30 days of vindesine therapy)
• Disulfiram (e.g., Antabuse)
• Ethotoin (e.g., Peganone)
• Hydroxychloroquine (e.g., Plaquenil)
• Lindane, topical (e.g., Kwell)
• Lithium (e.g., Lithane)
• Mephenytoin (e.g., Mesantoin)
• Mexilitene (e.g., Mexitil)
• Pemoline (e.g., Cylert)
• Pyridoxine (e.g., Hexa-Betalin) (with long-term, high-dose use)
• Quinine (e.g., Quinamm)?Concurrent use of these agents withvindesine increases the risk of neurotoxicity

• Phenytoin (e.g., Dilantin)?Concurrent use of this agent withvindesine increases the risk of seizures

• If you have ever been treated with radiation or cancer medicines?Vindesinemay increase the effects of these medicines or radiation therapy on the blood

Other medical problems?The presence of other medicalproblems may affect the use of vindesine. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Charcot-Marie-Tooth syndrome, demyelinating form?May causeincreased neuropathic effects

• Drug-induced blood disorders?May worsen

• Infection?There may be an increased risk of infections or worseninginfections because of the body's reduced ability to fight them

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

• Liver disease?Effects of vindesine may increase because ofslower removal from the body

• Nerve or muscle disease?May worsen

Proper Use of This Medicine

This medicinesometimes causes nausea and vomiting. However, it is very important that youcontinue to receive the medicine, even if you begin to feel ill. Ask yourdoctor, nurse, or pharmacist for ways to lessen these effects.

Vindesine frequently causes constipation and stomach cramps. Your doctormay want you to take a laxative. However, do not decide to take these medicineson your own without first checking with your doctor.

Dosing?The dose of vindesine will be different fordifferent patients. The dose that is used may depend on a number of things,including what the medicine is being used for, the patient's body size, andwhether or not other medicines are also being taken. If you are taking or receiving vindesine at home, follow your doctor's ordersor the directions on the label.If you have any questions about theproper dose of vindesine, ask your doctor.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure that vindesine is working properly andto check for unwanted effects.

While you are being treated with vindesine, and after you stop treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval. Vindesine may lower your body's resistanceand there is a chance you might get the infection the immunization is meantto prevent. Other people living in your household should not take or shouldnot have recently taken oral polio vaccine since there is a chance they couldpass the polio virus on to you. Also, avoid other persons who have taken oralpolio vaccine. Do not get close to them, and do not stay in the same roomwith them for very long. If you cannot take these precautions, you shouldconsider wearing a protective face mask that covers the nose and mouth.

Vindesine can temporarily lower the number of white blood cells in yourblood, increasing the chance of getting an infection. It can also lower thenumber of platelets, which are necessary for proper blood clotting. If thisoccurs, there are certain precautions you can take, especially when your bloodcount is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor if you get a fever or chills, cough or hoarseness, lower back or side pain,or painful or difficult urination.
• Check with your doctor immediately ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould occur.

If vindesine accidentally seeps out of the vein into which it is injected,it may damage some tissues and cause scarring. Tell thedoctor or nurse right away if you notice redness, pain, or swelling at theplace of injection.

Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Check with your doctoror nurse immediately if any of the following side effects occur:

More common

Black, tarry stools; chest pain; chills; cough; fever; painful or difficult urination; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands

Less common or rare

Blindness; blurred or double vision; convulsions (seizures); difficulty in walking; drooping eyelids; headache; jaw pain; numbness or tingling in fingers and toes; pain infingers and toes; pain in testicles; unusual bleeding or bruising; unusualtiredness or weakness

Symptoms of overdose

Get emergency help immediately if any of the followingsymptoms of overdose occur

Abnormal drowsiness; Agitation; confusion; dazed feeling; decreased urine output; depression; dizziness; headache; hostility; irritability; muscle twitching; nausea; rapid weight gain; seizures; swelling of face, ankles, or hands

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

Less common or rare

Constipation; general feeling of discomfortor illness; increase in bowel movements; loose stools; loss of appetite; muscle or bone pain; nausea and vomiting; skin rash; soft stools; weight loss

This medicine often causes a temporary loss of hair.After treatment with vindesine has ended, normal hair growth should return.

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.