Generic Name: topotecan (Intravenous route)
Topotecan should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm(3). In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, frequent peripheral blood cell counts should be performed on all patients receiving topotecan .Oral routeCapsule
Topotecan hydrochloride should be administered only to patients with baseline neutrophil counts of at least 1,500 cells/mm(3) and a platelet count of at least 100,000 cells/mm(3). In order to assess the occurrence of bone marrow suppression, blood cell counts should be monitored .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Topoisomerase I Inhibitor
Topotecan belongs to the group of medicines known as antineoplastics. It is used to treat cancer of the ovaries and certain types of lung cancer. It is also used to treat cancer of the cervix which cannot be treated with surgery and/or radiotherapy .
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.
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:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of topotecan in the pediatric population. Safety and efficacy have not been established .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of topotecan in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dosage in patients receiving topotecan .
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
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.
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.
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.
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.
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:
A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins .
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.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the 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.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Also, do not breastfeed while you are using this medicine .
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:
This medicine may cause some people to become tired or weak than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert .
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 immediately if any of the following side effects occur:More common
Check with your doctor as soon as possible if any of the following side effects occur:More common
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.
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
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 topo tecan has ended, normal hair growth should return.
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.
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