Topotecan treats certain types of cancer. Topotecan may cause drowsiness during and for several days after treatment. Do not drive and do not operate machinery until you know how it affects you.
Topotecan is a prescription medication used to treat small cell lung cancer, ovarian cancer, and cervical cancer. Topotecan belongs to a group of drugs called topoisomerase I inhibitors, which kill cancer cells.
This medication comes in capsule form and in an injectable form. The capsules are taken by mouth, once daily for 5 days, every 3 weeks. The injectable form is given directly into a vein (IV) usually once daily (for 30 minutes) for 3 to 5 days every 21 days (for a certain number of cycles).
Common side effects include nausea, diarrhea, and hair loss.
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Topotecan Cautionary Labels
Uses of Topotecan
Topotecan is a prescription medication used to treat small cell lung cancer, ovarian cancer, and cervical cancer.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Topotecan Brand Names
Topotecan may be found in some form under the following brand names:
Topotecan Drug Class
Topotecan is part of the drug class:
Side Effects of Topotecan
Topotecan can cause serious side effects. See "Precautions" section.
Common side effects include:
- loss of appetite
- hair loss
- low white blood cells
- low blood platelets
Tell your healthcare provider if you have any side effect that bothers you or does not go away. Your healthcare provider may change your dose of topotecan to a dose that is better for you or may stop your treatment with topotecan for a while. This can help reduce the side effects and may keep them from getting worse. Let your healthcare provider know if this helps or does not help your side effects.
These are not all of the possible side effects of topotecan. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- cyclosporine (Gengraf, Neoral, and Sandimmune)
- ketoconazole (Nizoral)
- ritonavir (Norvir)
- saquinavir (Fortovase, Invirase)
This is not a complete list of topotecan drug interactions. Ask your doctor or pharmacist for more information.
Topotecan capsules can cause serious side effects:
Lung problems that can cause death. Tell your healthcare provider right away if you have new or worse symptoms of coughing, fever, shortness of breath, or problems breathing.
Decreased blood counts. Taking topotecan affects your bone marrow and can cause a severe decrease in your blood cell counts (bone marrow suppression) - neutrophils (a type of white blood cell important in fighting bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and control of bleeding).
- You should have blood tests regularly to check your blood counts. A decrease in neutrophils (neutropenia) may affect how your body fights infection.
- Your healthcare provider will tell you if your blood counts are too low before you begin treatment with topotecan.
- Your dose of topotecan may need to be changed or stopped until your blood counts recover enough after each cycle of treatment.
- Call your healthcare provider right away if you get any of the following signs of infection:
- fever (temperature of 100.5°F or greater)
- burning or pain on urination
- Tell your healthcare provider about any abnormal bleeding or bruising.
Diarrhea. Diarrhea may occur from taking topotecan capsules, and may be serious enough that you must be treated in the hospital. Tell your healthcare provider right away if you have:
- diarrhea with fever
- diarrhea 3 or more times a day
- diarrhea with stomach-area pain or cramps
Do not take topotecan capsules if:
- you are allergic to anything in topotecan capsules.
- the results of your last blood test show blood counts that are too low. Your healthcare provider will tell you.
Topotecan may make you feel drowsy or sleepy both during and for several days after treatment. If you feel tired or weak, do not drive and do not use heavy tools or operate machinery.
Topotecan Food Interactions
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of topotecan there are no specific foods that you must exclude from your diet when receiving topotecan.
Before you take topotecan, tell your healthcare provider if you:
- are allergic to topotecan or any other medication
- are pregnant or breastfeeding
- have an infection
- have kidney disease
- have a history of interstitial lung disease or pulmonary fibrosis
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Topotecan and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Topotecan and Lactation
Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if topotecan passes into human breast milk or if it can harm your baby. You and your healthcare provider should decide if you will take topotecan or breast feed. You should not do both.
Topotecan comes in both injectable and oral capsule form.
- Take topotecan capsules exactly as your doctor prescribes them.
- Your healthcare provider may want you to take both 1 mg and 0.25 mg capsules together to make up your complete dose. You must be able to tell the difference between the capsules. The 1 mg capsule is a pink color and the 0.25 mg capsule is a white to yellowish-white color.
- Take topotecan capsules once a day for 5 days in a row. This treatment will normally be repeated every 3 weeks (a treatment cycle). Your healthcare provider will decide how long you will take topotecan capsules.
- Swallow topotecan capsules whole with water. Do not open, chew, or crush topotecan capsules. topotecan capsules may be taken with or without food.
- If any of the topotecan capsules are broken or leaking, do not touch them with your bare hands. Carefully dispose of the capsules, and then wash your hands well with soap and water.
- If you get any of the contents of topotecan capsules on your skin or in your eyes, do the following:
- Wash the area of skin well with soap and water right away,
- Wash your eyes right away with gently flowing water for at least 15 minutes.
- Call your healthcare provider if you get a skin reaction or if you get the medicine in your eyes.
- If you take too much topotecan, contact your healthcare provider right away.
- If you forget to take topotecan at any time, do not double the dose to make up for a forgotten dose. Wait and take the next scheduled dose. Let your healthcare provider know that you missed a dose.
- If you vomit after taking your topotecan, do not take another dose on the same day. Let your healthcare provider know right away that you have vomited.
Injectable (IV) Form
This medication is given directly into a vein (IV) usually once daily (for 30 minutes) for 3 to 5 days every 21 days (for a certain number of cycles).
Burning or stinging at the site of injection may be a sign that the medication is leaking outside the vein, often a mild, but sometime serious situation. Tell your healthcare provider right away if this happens to you.
Topotecan Dosing - Oral Capsules for the treatment of relapsed small cell lung cancer
Recommended Dosing: The recommended dose of topotecan capsules is 2.3 mg/m2/day once daily for 5 consecutive days repeated every 21 days. Round the calculated oral daily dose to the nearest 0.25 mg, and prescribe the minimum number of 1 mg and 0.25 mg capsules. The same number of capsules should be prescribed for each of the 5 dosing days.
Dose Modification Guidelines - Oral Capsules
Patients should not be treated with subsequent courses of topotecan until neutrophils recover to >1,000 cells/mm3, platelets recover to >100,000 cells/mm3, and hemoglobin levels recover to ≥9.0 g/dL (with transfusion if necessary).
For patients who experience severe neutropenia (neutrophils <500 cells/mm3 associated with fever or infection or lasting for 7 days or more) or neutropenia (neutrophils 500 to 1,000 cells/mm3 lasting beyond day 21 of the treatment course), the topotecan capsules dose should be reduced by 0.4 mg/m2/day for subsequent courses. Doses should be similarly reduced if the platelet count falls below 25,000 cells/mm3.
For patients who experience Grade 3 or 4 diarrhea, the topotecan capsules dose should be reduced by 0.4 mg/m2/day for subsequent courses. Patients with Grade 2 diarrhea may need to follow the same dose modification guidelines.
Recommended Dosage: The recommended dose of topotecan is 1.5 mg/m2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on day 1 of a 21-day course. In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed. The median time to response in 3 ovarian clinical trials was 9 to 12 weeks, and median time to response in 4 small cell lung cancer trials was 5 to 7 weeks.
Dosage Modification Guidelines: In the event of severe neutropenia (defined as <500 cells/mm3) during any course, reduce the dose by 0.25 mg/m2 (to 1.25 mg/m2) for subsequent courses. Alternatively, in the event of severe neutropenia, administer G-CSF (granulocyte-colony stimulating factor) following the subsequent course (before resorting to dose reduction) starting from day 6 of the course (24 hours after completion of topotecan administration).
In the event the platelet count falls below 25,000 cells/mm3, reduce doses by 0.25 mg/m2 (to 1.25 mg/m2) for subsequent courses.
Cervical Cancer - Injectable
Recommended Dosage: The recommended dose of topotecan is 0.75 mg/m2 by intravenous infusion over 30 minutes daily on days 1, 2, and 3; followed by cisplatin 50 mg/m2 by intravenous infusion on day 1 repeated every 21 days (a 21-day course).
Dosage Modification Guidelines: Dosage adjustments for subsequent courses of topotecan in combination with cisplatin are specific for each drug. See manufacturer’s prescribing information for cisplatin administration and hydration guidelines and for cisplatin dosage adjustment in the event of hematologic toxicity.
- In the event of severe febrile neutropenia (defined as <1,000 cells/mm3 with temperature of 38.0°C or 100.4°F), reduce the dose of topotecan to 0.60 mg/m2 for subsequent courses.
- Alternatively, in the event of severe febrile neutropenia, administer G-CSF following the subsequent course (before resorting to dose reduction) starting from day 4 of the course (24 hours after completion of administration of topotecan).
- If febrile neutropenia occurs despite the use of G-CSF, reduce the dose of topotecan to 0.45 mg/m2 for subsequent courses.
- In the event the platelet count falls below 25,000 cells/mm3, reduce doses to 0.60 mg/m2 for subsequent courses.
Dosage Adjustment in Specific Populations - Injectable
Renal Impairment: No dosage adjustment of topotecan appears to be required for patients with mild renal impairment (Clcr 40 to 60 mL/min). Dosage adjustment of topotecan to 0.75 mg/m2 is recommended for patients with moderate renal impairment (20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for topotecan.
Topotecan in combination with cisplatin for the treatment of cervical cancer should only be initiated in patients with serum creatinine ≤1.5 mg/dL. In the clinical trial, cisplatin was discontinued for a serum creatinine >1.5 mg/dL. Insufficient data are available regarding continuing monotherapy with topotecan after cisplatin discontinuation in patients with cervical cancer.
If you take too much oral topptecan, call your local Poison Control Center or seek emergency medical attention right away.
- Store topotecan capsules in a refrigerator between 36° to 46°F (2° and 8°C).
- Keep the bottle of topotecan capsules in the carton that it comes in to protect it from light.
- Dispose of topotecan capsules that are out of date or no longer needed.
- Keep topotecan capsules and all other medicines out of the reach of children.
Topotecan FDA Warning
WARNING: Bone Marrow Suppression
Topotecan should be administered only to patients with baseline neutrophil counts of ≥1,500 cells/mm3 and a platelet count ≥100,000 cells/mm3. In order to assess the occurrence of bone marrow suppression, blood cell counts should be monitored.