Topotecan capsules

Generic Name: topotecan (TOE-poe-TEE-kan)
Brand Name: Hycamtin

Topotecan capsules may cause severe and sometimes fatal bone marrow suppression and blood problems. These blood problems may increase the risk of developing a severe infection. Topotecan capsules should not be used in patients who have low platelet levels or very low white blood cell levels. Contact your doctor at once if you have symptoms of an infection (eg, fever, chills, persistent sore throat, painful urination), unusual bruising or bleeding, or unusual fatigue. Frequent blood tests will be performed to monitor for side effects. Be sure to keep all doctor and lab appointments.


Topotecan capsules is used for:

Treating small cell lung cancer in certain patients.

Topotecan capsules is an antineoplastic. It works by killing certain cancer cells.

Do NOT use topotecan capsules if:

  • you are allergic to any ingredient in topotecan capsules
  • you are taking amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, dronedarone, eltrombopag, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir, quercetin, quinidine, ranolazine, ritonavir, ticagrelor, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

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Before using topotecan capsules:

Some medical conditions may interact with topotecan capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney problems, bone marrow problems (eg, low platelet levels, low white blood cell counts), or blood problems
  • if you have a history of kidney problems, bone marrow problems, or blood problems
  • if you have a history of lung problems (eg, interstitial lung disease [ILD], pulmonary fibrosis, lung cancer) or if your chest area has been exposed to radiation
  • if you have recently received a live vaccine

Some MEDICINES MAY INTERACT with topotecan capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that may harm the lungs (eg, certain antiarrhythmics, certain antibiotics, amphotericin B, certain cancer drugs) because the risk of serious lung problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the lungs.
  • Carboplatin, cisplatin, granulocyte colony-stimulating factor (G-CSF), or other antineoplastic medicines because the risk or duration of severe bone marrow or blood problems may be increased
  • P-glycoprotein inhibitors (eg, cyclosporine, elacridar, ketoconazole, ritonavir, saquinavir) because they may increase the risk of topotecan capsules's side effects
  • Hydantoins (eg, phenytoin) because they may decrease topotecan capsules's effectiveness
  • Live vaccines (eg, measles, mumps) because the risk of their side effects may be increased by topotecan capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if topotecan capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use topotecan capsules:

Use topotecan capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with topotecan capsules. Talk to your pharmacist if you have questions about this information.
  • Take topotecan capsules by mouth with or without food.
  • Swallow topotecan capsules whole. Do not break, crush, or chew before swallowing.
  • Take topotecan capsules with a full glass of water (8 oz [240 mL]).
  • If you vomit after you take a dose, do not repeat the dose.
  • If you miss a dose of topotecan capsules, skip the missed dose and go back to your regular dosing schedule. Let your doctor know that you missed a dose.

Ask your health care provider any questions you may have about how to use topotecan capsules.

Important safety information:

  • Topotecan capsules may cause tiredness or weakness during treatment and for several days after treatment. These effects may be worse if you take it with alcohol or certain medicines. Use topotecan capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Topotecan capsules may lower the ability of your body to fight infection. Serious and sometimes fatal infections have happened with topotecan capsules. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Topotecan capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding, or if you have dark, tarry, or bloody stools.
  • Some patients taking topotecan capsules have developed severe and sometimes fatal lung problems. The risk may be greater if you have a history of certain lung problems or if your chest area has been exposed to radiation. it may also be greater if you take certain other medicines. Tell your doctor right away if you develop a cough, fever, shortness of breath, blue or unusually pale skin or nails, or chest pain.
  • Diarrhea can happen with topotecan capsules. Sometimes, diarrhea has been severe or deadly. It has also led to the need to go to the hospital. Discuss any questions or concerns with your doctor.
  • If nausea, vomiting, diarrhea, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking topotecan capsules. Talk with your doctor before you receive any vaccine.
  • Do not touch broken or leaking capsules. If you get topotecan capsules on your skin, wash it off right away with soap and water. Contact your doctor if you experience a skin reaction. Talk with your doctor about how to dispose of broken or leaking capsules.
  • Do not get topotecan capsules in your eyes. If you get it in your eyes, rinse with cool water for 15 minutes and contact your doctor.
  • If you may become pregnant, you must use an effective form of birth control while you take topotecan capsules and for at least 1 month after your last dose. If you have questions about effective birth control, talk with your doctor.
  • Topotecan capsules may cause fertility problems. This may affect being able to have children. Discuss any questions or concerns with your doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 3 months after treatment ends. Use an effective form of birth control.
  • If you are a man and have unprotected sex with a female who is or could get pregnant, or your female partner gets pregnant, call your doctor right away.
  • Topotecan capsules may affect sperm in men. This may affect being able to father a child. Discuss any questions or concerns with your doctor.
  • Lab tests, including complete blood cell counts, may be performed while you use topotecan capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use topotecan capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: Topotecan capsules may cause harm to the fetus. Avoid becoming pregnant while you are taking it and for at least 1 month after your last dose. If you think you may be pregnant, contact your doctor right away. It is not known if topotecan capsules is found in breast milk. Do not breast-feed while taking topotecan capsules.

Possible side effects of topotecan capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; fatigue; hair loss; loss of appetite; nausea; stomach pain; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue or unusually pale skin or nails; chest pain; fever, chills, or persistent sore throat; painful or burning urination; severe or persistent cough; severe or persistent diarrhea, stomach pain, or cramps; severe or persistent tiredness or weakness; shortness of breath; swelling or soreness of the mouth or tongue; unusual or unexplained bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of topotecan capsules:

Store topotecan capsules in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C) in the original container. Do not freeze. Store away from heat, moisture, and light. Keep topotecan capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about topotecan capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Topotecan capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take topotecan capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about topotecan capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to topotecan capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using topotecan capsules.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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