Topotecan (Oral)

Topotecan is used to treat small cell lung cancer that has come back or worsened. It is part of a group of medicines called antineoplastics or cancer medicines.

Topotecan works by interfering with the growth of cancer cells, which are eventually destroyed. The growth of normal cells may also be affected by this medicine, leading to other unwanted effects. Some of these effects may be serious and should be reported to your doctor. Some effects, like hair loss, may not be serious but can still be concerning. Some unwanted effects may happen even after treatment with topotecan has stopped.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Topotecan can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious bowel problem called typhlitis (neutropenic enterocolitis), which could be life-threatening. Tell your doctor right away if you have a fever, abdominal or stomach pain, or a low count of white blood cells after using this medicine.

Topotecan may cause diarrhea, and in some cases, it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause some people to become more tired or weaker than they are normally. If either of these side effects occurs, do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have breathing problems, cough, fever, or fast heartbeat. These could be symptoms of a serious lung problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it may provide. This is a decision you will make together with your doctor. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been conducted to determine how age affects the effects of topotecan in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not found any age-related issues that would limit the usefulness of topotecan in older adults. However, older patients are more likely to experience diarrhea and age-related kidney issues, which may require caution when taking topotecan.

Breast Feeding

There are no adequate studies involving women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the possible risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be taken together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may need to be taken. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while you are on this medicine. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to use this medication for you or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Adenovirus Vaccine
• Amiodarone
• Bacillus of Calmette and Guerin Vaccine, Live
• Capmatinib
• Carvedilol
• Cholera Vaccine, Live
• Clarithromycin
• Cobicistat
• Conivaptan
• Cyclosporine
• Darolutamide
• Dengue Tetravalent Vaccine, Live
• Dronedarone
• Eltrombopag
• Enasidenib
• Encorafenib
• Flibanserin
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lapatinib
• Leflunomide
• Leniolisib
• Midostaurin
• Momelotinib
• Poliovirus Vaccine, Live
• Quinidine
• Ranolazine
• Ritonavir
• Smallpox Vaccine
• Tafamidis
• Telaprevir
• Teriflunomide
• Typhoid Vaccine, Live
• Velpatasvir
• Vemurafenib
• Venetoclax
• Verapamil
• Voxilaprevir
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Rolapitant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Blood or bone marrow problems or
• Lung problems (e.g., interstitial lung disease, lung cancer, pulmonary fibrosis)—Use with caution. This condition may worsen.

• Infection—May reduce your body's ability to fight infections.

• Kidney disease—Use with caution. The effects may be stronger due to slower elimination of the medicine from the body.

Along with its needed effects, Topotecan (Oral) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain
• chills
• cough
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Cracked lips
• diarrhea
• difficulty in swallowing
• dizziness
• fast heartbeat
• heartburn
• hives, itching, skin rash
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe abdominal pain, cramping, or burning
• tightness in the chest
• trouble breathing
• vomiting of material that looks like coffee grounds, severe and continuing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• hair loss or thinning of the hair
• lack or loss of strength
• loss of appetite
• vomiting
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Hycamtin

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Topoisomerase I Inhibitor

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all of the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the capsule whole with water. Do not open, crush, break, or chew it.

You may take this medicine with or without food.

Be careful not to handle broken or leaking capsules. If you get the contents from the capsule on your skin, wash the area with soap and water and call your doctor right away. If the medicine gets into your eyes, rinse them immediately with gently flowing water for at least 15 minutes and call your doctor right away.

Topotecan often causes nausea and vomiting. It is very important that you continue to use the medicine even if it makes you feel ill. Ask your doctor for ways to lessen these effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):For small cell lung cancer: Adults—Dose is based on body size and must be determined by your doctor. The dose is 2.3 milligrams per square meter of body surface area once a day for 5 days in a row. Your dose will be repeated every 21 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking a dose of this medicine, take your next dose at the next scheduled time. Do not take another dose on the same day.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton. Protect from light.