Topotecan Hydrochloride Oral capsule

What is this medicine?

TOPOTECAN (TOE poe TEE kan) is a chemotherapy drug. It is used to treat small cell lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• low blood counts, like low white cell, platelet, or red cell counts

• an unusual or allergic reaction to topotecan, gelatin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. You can take it with or without food. Do not cut, crush, or chew this medicine. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• amiodarone

• azithromycin

• captopril

• carvedilol

• certain medications for fungal infections like ketoconazole and itraconazole

• clarithromycin

• conivaptan

• cyclosporine

• diltiazem

• dronedarone

• eltrombopag

• erythromycin

• felodipine

• grapefruit juice

• lopinavir

• quercetin

• quinidine

• ranolazine

• ritonavir

• ticagrelor

• verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing difficulties

• diarrhea

• dizziness

• fever or chills, sore throat

• mouth sores or pain

• pain, tingling, numbness in the hands or feet

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• hair loss

• headache

• loss of appetite

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Keep this medicine in the original container. Protect from light. Throw away any unused medicine after the expiration date.

Topotecan Hydrochloride Solution for injection

What is this medicine?

TOPOTECAN (TOE poe TEE kan) is a chemotherapy drug. It is used to treat lung cancer, ovarian cancer, and cervical cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood disorders

• dehydration

• diarrhea

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• low blood counts, like low white cell, platelet, or red cell counts

• recent or ongoing radiation therapy

• an unusual or allergic reaction to topotecan, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for infusion into a vein. It is usually given by a health care professional in a hospital or clinic setting.

In rare cases, you might get this medicine at home. You will be taught how to give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• amiodarone

• antiviral medicines for HIV or AIDS

• cisplatin

• clarithromycin

• cyclosporine

• diltiazem

• erythromycin

• grapefruit or grapefruit juice

• medicines for fungal infections like ketoconazole and itraconazole

• mefloquine

• mifepristone, RU-486

• nicardipine

• phenytoin

• propafenone

• quinidine

• tacrolimus

• tamoxifen

• testosterone

• vaccines

• verapamil

Talk to your prescriber or health care professional before taking any of these medicines:

• aspirin

• acetaminophen

• ibuprofen

• naproxen

• ketoprofen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing difficulties

• diarrhea

• dizziness

• fever or chills, sore throat

• mouth sores or pain

• pain, tingling, numbness in the hands or feet

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• hair loss

• headache

• loss of appetite

• nausea, vomiting

• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This drug is usually given in a hospital or clinic and will not be stored at home.

In rare cases, this medicine may be given at home. If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.