Hycamtin

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Topotecan decreases bone marrow function. This effect may lead to a low number of blood cells such as red cells, white cells, and platelets. A low number of blood cells can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.

Your doctor will order frequent blood tests to monitor your bone marrow function while you are taking this medication. Keep all medical and lab appointments.

Read the Patient Information Leaflet if available from your pharmacist before you start taking topotecan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily for 5 days. Each 5-day treatment period is called a cycle. You will usually repeat this cycle every 21 days. The dosage is based on your body size, medical condition, lab tests, and response to treatment.

Swallow the capsules whole. Do not open, crush, or chew the capsules. If the capsule contents touch your skin, wash the skin right away and completely with soap and water. If the contents get into your eyes, mouth, or nose, flush right away with water for at least 15 minutes. Consult your doctor if you have redness/burning/swelling on the area of skin the contents touched or if the contents get into your eyes.

If you vomit after taking a dose, do not take another dose at that time. Take your next dose on your usual dosing schedule.

All people should wash their hands carefully after handling this drug. Women who are pregnant or who may become pregnant should not handle this medication.

See also Warning section.

Nausea, vomiting, diarrhea, tiredness, loss of appetite, weakness, and fever may occur. If these effects last or get worse, tell your doctor or pharmacist promptly. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects.

Diarrhea can also be severe and may require treatment in a hospital. Tell your doctor right away if you have any diarrhea with fever, diarrhea with stomach pain, or diarrhea 3 or more times a day.

Temporary hair loss may occur. However, normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: lung problems (such as cough, shortness of breath).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using topotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

This drug may make you feel weak or tired. Alcohol or marijuana (cannabis) can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Topotecan can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using topotecan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially diarrhea and decreased bone marrow function.

This medication can affect fertility in both males and females. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using topotecan. Topotecan may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of topotecan from your body, which may affect how topotecan works. Examples include azole antifungals (such as ketoconazole), cyclosporine, macrolide antibiotics (such as erythromycin), ritonavir, among others.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).