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|Topotecan

TOPOTECAN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Hycamtin

In Canada—

• Hycamtin

Category

• Antineoplastic

Description

Topotecan (toe-poe-TEE-kan) belongs to the group of medicines known as antineoplastics. It is used to treat cancer of the ovaries and certain types of lung cancer.

Topotecan interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other effects may also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may occur after treatment with topotecan has been stopped.

This medicine is available only with your doctor"s prescription, in the following dosage form(s):

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For topotecan, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to topotecan. Also tell your health care professional if you are allergic to any other substances.

Pregnancy—Tell your doctor if you are pregnant. Studies in rats and rabbits have shown that topotecan causes birth defects and deaths of the fetus, as well as problems in the mother.

Be sure that you have discussed this with your doctor before starting treatment with this medicine. It is best to use birth control while you are receiving topotecan. Also, tell your doctor right away if you think you have become pregnant during treatment.

Breast-feeding—It is not known whether topotecan passes into breast milk. However, because this medicine may cause serious side effects, breast-feeding is generally not recommended while you are receiving it.

Children—Topotecan has been studied in a limited number of children. One study showed that seriously low blood counts may be more likely to occur in children than in adults.

Older adults—This medicine has been tested in elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 taking topotecan, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or other cancer medicines—The risk of seriously low blood counts may be increased

• Azathioprine (e.g., Imuran) or
• Chlorambucil (e.g., Leukeran) or
• Corticosteroids (cortisone-like medicine) or
• Cyclosporine (e.g., Sandimmune) or
• Mercaptopurine (e.g., Purinethol) or
• Muromonab-CD3 (monoclonal antibody) (e.g., Orthoclone OKT3) or
• Tacrolimus (e.g., Prograf)—There may be an increased risk of infection because topotecan decreases your body"s ability to fight it

Other medical problems—The presence of other medical problems may affect the use of topotecan. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Topotecan may cause these conditions to get worse and spread to other parts of your body

• Infection—Topotecan may decrease your body"s ability to fight an infection

• Kidney disease—Higher blood levels of topotecan can occur, which increases the risk of serious side effects

Proper Use of This Medicine

Topotecan often causes nausea and vomiting. It is very important that you continue to receive the medicine even if it makes you feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—The dose of topotecan will be different for different patients. The dose that is used may depend on a number of things, including the patient"s size and whether or not other treatments are also being given. If you are receiving topotecan at home, follow your doctor"s orders or the directions on the label. If you have any questions about the proper dose of this medicine, ask your doctor.

Precautions While Using This Medicine

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. Some of the side effects of this medicine do not have any symptoms and must be found with a blood test.

While you are being treated with topotecan, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval . Topotecan may lower your body"s resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the past several months. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Topotecan 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 needed 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 infections. 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 painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in 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. Also, 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 could occur.

Side Effects of This Medicine

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.

Some of the above side effects may occur, or continue to occur, after treatment with topotecan has ended. Check with your doctor if you notice any of them after you stop receiving the medicine.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

Topotecan sometimes causes bruising or redness at the place of injection. Check with your doctor or nurse if these effects are especially bothersome.

Topotecan may also cause a temporary loss of hair in some people. After treatment with topotecan has ended, normal hair growth should return.

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

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, topotecan is used in certain patients with the following medical conditions:

• Chronic myelomonocytic leukemia (CMML)
• Myelodysplastic syndrome (MDS)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 02/25/2004

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