When This Medicine Should Not Be Used:
You should not use this medicine if you are pregnant or if you have had an allergic reaction to topotecan or have severe bone marrow depression (low blood counts).

How to Use This Medicine:
Capsule

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole with water. Do not open, crush, break, or chew it.
• You may also receive medicines to help prevent nausea and vomiting.
• Do not touch broken or leaking capsules with your bare hands. If you get the contents from the capsule on your skin, wash the area with soap and water and call your doctor right away. If the medicine gets in your eyes, rinse them immediately with gently flowing water for at least 15 minutes and call your doctor right away.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use cyclosporine (Gengraf®, Neoral®, or Sandimmune®), elacridar, ketoconazole (Nizoral®), ritonavir (Norvir®), or saquinavir (Fortovase® or Invirase®).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breastfeeding or if you have kidney disease, blood or bone marrow problems, any type of infection, or a history of lung disease.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Check with your doctor right away if you have trouble breathing, cough, fever, or wheezing. These could be symptoms of a serious lung problem.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• This medicine may make you weak or tired. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, and body aches
• Severe diarrhea
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss or thinning of the hair
• Mild diarrhea, nausea, vomiting, or stomach pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088