Topotecan

IMPORTANT WARNING:

Topotecan may cause a decrease in the number of blood cells made by your bone marrow. This increases the risk that you will develop a serious infection. You should not take topotecan if you already have a low number of blood cells. Your doctor will order laboratory tests regularly before and during your treatment to check whether your body has enough blood cells. If you experience any of the following symptoms, call your doctor immediately: sore throat, chills, fever, cough, burning or painful urination, or other signs of infection; stomach pain; unusual bruising or bleeding; excessive tiredness; headache; dizziness; confusion; pale skin; fast heartbeat; or shortness of breath.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to topotecan.

Talk to your doctor about the risks of taking topotecan.

WHY is this medicine prescribed?

Topotecan is used to treat small cell lung cancer (a type of cancer that begins in the lungs) that was successfully treated with a different chemotherapy medication but has returned no sooner than 45 days after the last dose of the first chemotherapy medication was taken. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by killing cancer cells.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Topotecan comes as a capsule to take by mouth. It may be taken with or without food. It is usually taken once a day for 5 days in a row every 21 days. Your doctor will decide how many times you should repeat this cycle. Take topotecan at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take topotecan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with water; do not open, chew, or crush them.

Topotecan capsules come in two different strengths. Your doctor may want you to take a combination of both strengths of capsules to make up your full dose. Be sure that you know what each type of capsule looks like and how many you are to take of each. Ask your doctor or pharmacist if you have any questions.

If any of the capsules are broken or leaking, do not touch them with your bare hands. Carefully dispose of the broken capsules without touching them directly and then wash your hands well with soap and water. If the capsule contents do touch your skin, wash the area well with soap and water right away. If any capsule contents get in your eyes, wash your eyes right away with gently flowing water for at least 15 minutes. Call your doctor if you have any skin reaction or if medication gets in your eyes.

You may vomit after you take the medication. If this happens, let your doctor know right away. Do not take another dose of topotecan on the same day.

Your doctor may need to delay your treatment or adjust your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with topotecan.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking topotecan,

• tell your doctor and pharmacist if you are allergic to topotecan, any other medications, or any of the ingredients in topotecan capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cyclosporine (Gengraf, Neoral, Sandimmune); ketoconazole (Nizoral); ritonavir (Norvir, in Kaletra); or saquinavir (Fortovase, Invirase). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• 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 taking topotecan. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking topotecan, call your doctor immediately. Topotecan may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breast-feed while you are taking topotecan.

• you should know that topotecan may make you drowsy, tired, or weak. Do not drive a car, use heavy tools, or operate machinery until you know how this medication affects you.

• you should know that topotecan can cause severe diarrhea that may need to be treated in a hospital. Talk to your doctor about how to prevent and treat diarrhea. Call your doctor right away if you have any of the following symptoms: diarrhea with fever, diarrhea 3 or more times a day, or diarrhea with stomach pain or cramps.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Let your doctor know if you miss a dose.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• diarrhea
• loss of appetite
• hair loss

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

• hives
• rash
• itching
• hoarseness
• difficulty breathing or swallowing

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).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and protect it from light.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

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:

• sore throat, chills, fever, cough, burning or painful urination, or other signs of infection
• unusual bruising or bleeding
• excessive tiredness
• headache
• dizziness
• confusion
• pale skin
• fast heartbeat
• shortness of breath

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.