Hycamtin (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 stopping the growth of cancer cells, which are then destroyed. It can also affect the growth of normal cells, leading to other unwanted effects. Some of these effects may be serious and should be reported to your doctor. Effects like hair loss may not be serious but can still be concerning. Some unwanted effects may happen even after you stop taking topotecan.

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

It is very important for your doctor to monitor your progress during regular visits to ensure this medicine is effective. Blood tests are necessary to check for side 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 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 with 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 might be pregnant while using this medicine, tell your doctor immediately.

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

• If possible, avoid people with infections. Contact your doctor immediately if you think you might be getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Contact your doctor immediately 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 cautious when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult your doctor before undergoing any dental work.
• Do not touch your eyes or the inside of your nose unless your hands are clean and you haven't touched anything else in between.
• Be careful not to cut yourself when using sharp objects, such as a safety razor or fingernail or toenail clippers.
• Avoid contact sports or other activities where bruising or injury could happen.

This medicine may lead to a serious bowel issue called typhlitis (neutropenic enterocolitis), which could be life-threatening. Inform your doctor immediately if you experience a fever, abdominal or stomach pain, or a low white blood cell count after using this medicine.

Topotecan may cause diarrhea, and in some cases, it can be severe. Do not take any medication to treat diarrhea without consulting your doctor first. Diarrhea medicines may worsen the diarrhea or prolong it. If you have questions about this or if mild diarrhea continues or worsens, speak with your doctor.

This medicine may make some people feel more tired or weaker than usual. If you experience either of these side effects, do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

Contact your doctor immediately if you have breathing problems, cough, fever, or a fast heartbeat. These could be signs of a serious lung issue.

Do not take other medicines unless you have discussed them 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 and your doctor must consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, please consider the following:

Allergies

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

Pediatric

Appropriate studies have not been conducted on how age affects the effects of topotecan in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown specific problems in older adults that would limit the usefulness of topotecan. However, older patients are more likely to experience diarrhea and age-related kidney issues, which may require caution for patients using topotecan.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other situations, two different medicines may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. It is particularly important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions have been identified based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may adjust some of the other medicines you are taking.

• 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 how often you use one or both of the 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 treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Rolapitant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or eating certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

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

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

• Kidney disease—Use with caution. Effects may be increased due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, 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.