Topotecan injection is used to treat ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed) and small cell lung cancer (a type of cancer that begins in the lungs) that have spread and did not improve after treatment with other medications. It is also used together with other medications to treat cervical cancer (cancer that begins in the opening of the uterus [womb]) that has not improved or has come back after other treatments. Topotecan is in a class of medications called topoisomerase type I inhibitors. It works by killing cancer cells.

Topotecan injection should be given only in a hospital or clinic under the supervision of a doctor with experience in the use of chemotherapy medications for cancer.

Topotecan injection may cause a decrease in the number of white blood cells (a type of blood cell that is needed to fight infection). This increases the risk that you will develop a serious or life-threatening infection. Topotecan injection also may cause thrombocytopenia (less than normal number of platelets) which can increase the risk of serious or life-threatening bleeding problems. Your doctor will order laboratory tests regularly before and during your treatment to check whether your body has enough white blood cells or platelets. If you experience any of the following symptoms, call your doctor immediately: fever, chills, cough, unusual bruising or bleeding, burning on urination, or other signs of infection.

Talk to your doctor about the risks of using topotecan injection.

Topotecan comes as a liquid to be given intravenously (into a vein) over 30 minutes by a doctor or nurse in a hospital or clinic. When topotecan injection is used to treat ovarian or lung cancer, it is usually given once a day for 5 days in a row every 21 days. When topotecan injection is used to treat cervical cancer, it is usually given once a day for 3 days in a row every 21 days. You will probably receive at least 4 cycles of treatment since it may take some time to tell if your condition has responded to the medication.

Before receiving topotecan injection,

• tell your doctor and pharmacist if you are allergic to topotecan injection, any other medications, or any of the ingredients in topotecan injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section.
• tell your doctor if you have or have ever had kidney disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving topotecan injection. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while receiving topotecan injection, call your doctor immediately. Topotecan injection may harm the fetus.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving topotecan injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving topotecan injection.
• you should know that topotecan injection may make you feel very tired or weak. Do not drive a car or operate machinery until you know how this medication affects you.

Call your doctor right away if you are unable to keep an appointment to receive a dose of topotecan injection.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• sore throat, fever, chills, and other signs of infection

Unless your doctor tells you otherwise, continue your normal diet.

Topotecan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• loss of appetite
• stomach or back pain
• mouth sores
• headache
• thinning or loss of hair
• redness or bruising at the site where the medication was injected

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• extreme tiredness
• weakness
• pale skin
• shortness of breath
• chest pain
• fast or irregular heartbeat
• numbness, tingling, or burning sensation in the hands or feet
• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

Topotecan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Hycamtin®