Uses of Topotecan Injection:

• It is used to treat cancer.

What do I need to tell my doctor BEFORE I take Topotecan Injection?

• If you have an allergy to topotecan or any other part of topotecan injection.
• If you are allergic to topotecan injection; any part of topotecan injection; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Low white blood cell count, low platelet count, or low red blood cell count.
• If you take any other drugs (prescription or OTC, natural products, vitamins). There are many drugs that interact with topotecan injection.
• If you are breast-feeding. Do not breast-feed while you take topotecan injection and for 1 week after your last dose.

This is not a list of all drugs or health problems that interact with topotecan injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take topotecan injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Topotecan Injection?

• Tell all of your health care providers that you take topotecan injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how topotecan injection affects you.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• The oral form of topotecan injection can cause very bad diarrhea. Sometimes, this may be life-threatening and may need to be treated in the hospital. Talk with the doctor.
• If you have diarrhea, talk with your doctor. Do not try to treat diarrhea without first checking with your doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with topotecan injection may either raise the chance of an infection or make the vaccine not work as well.
• If you are 65 or older, use topotecan injection with care. You could have more side effects.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start topotecan injection to show that you are NOT pregnant.
• Women must use birth control while taking topotecan injection and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking topotecan injection and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is this medicine (Topotecan Injection) best taken?

Use topotecan injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Severe diarrhea or diarrhea with stomach cramps, upset stomach, throwing up, fever, or fluid loss.
• Feeling very tired or weak.
• Some people have had lung problems with topotecan injection. Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.
• This medicine can cause a severe bowel problem (neutropenic enterocolitis). This problem can be deadly, sometimes as early as the first day signs happen. Call your doctor right away if you have stomach pain with or without a fever, tender stomach, or diarrhea.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

What are some other side effects of Topotecan Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Stomach pain.
• Hair loss.
• Not hungry.
• Mouth irritation or mouth sores.
• Constipation, diarrhea, throwing up, and upset stomach are common with topotecan injection. If these happen, talk with your doctor about ways to lower these side effects. Call your doctor right away if any of these effects bother you, do not go away, or get very bad.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Topotecan Injection?

• If you need to store topotecan injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about topotecan injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.