Topotecan, Oral/Injection

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KEY POINTS

• This medicine is given by IV to treat cancer of the cervix, ovaries, small cell lung cancer, or other types of cancer. This medicine is taken by mouth to treat small cell lung cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: topotecan, injection; topotecan, oral; Hycamtin

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a vein) to treat cancer of the cervix, ovaries, or small cell lung cancer when other treatment has failed. It may also be used to treat other types of cancer. This medicine may be taken by mouth to treat small cell lung cancer.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blood disorder or bone marrow disease
• Kidney disease

Also tell your provider if you have recently had any kind of infection or if you are taking radiation therapy or chemotherapy.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not get pregnant during treatment and for at least 1 month after you stop treatment. Talk with your healthcare provider about effective birth control. If you get pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

Males: Use an effective birth control method while you are taking this medicine and for 3 months after stopping it. Tell your healthcare provider right away if your female partner becomes pregnant while you are taking this medicine.

This medicine may affect your ability to have children, whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

How do I use it?

Your healthcare provider will give you the IV infusions of this medicine in a hospital or clinic. Your healthcare provider will explain your treatment plan. Keep all appointments.

If you have the capsules, check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. If you are taking the oral form of this medicine, swallow the capsules whole. Do not chew, crush, break, or open the capsules. Do not touch broken capsules with your bare hands. If you get any of the contents of the capsules on your skin or in your eyes, wash the 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 get the medicine in your eyes.

If you vomit after taking the capsules, do not take another capsule. Call your healthcare provider for instructions.

What if I miss a dose?

For the capsules: If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe diarrhea, fever, cough, sore throat, mouth sores.

What should I watch out for?

You will need to have blood tests frequently to check on how this medicine affects you. Keep all appointments.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may cause nausea, vomiting, and diarrhea. Contact your healthcare provider if these symptoms are severe or do not go away.

This medicine may make your mouth sore. Use a soft bristle brush or mouth swab to brush your teeth.

This medicine may make you drowsy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): High fever; sore throat; burning or pain on urination; severe nausea, vomiting, or diarrhea; severe stomach pain; unusual bruising or bleeding; numbness or tingling in hands or feet; shortness of breath; cough; unusual weakness or extreme tiredness; severe pain, redness, or swelling at the infusion site.

Other: Headache; mild stomach pain, nausea, vomiting, or diarrhea; constipation; hair loss; loss of appetite; muscle or joint pain; white patches or sores inside your mouth or on your lips.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), and erythromycin (E.E.S., Ery-Tab, Erythrocin)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni) and simeprevir (Olysio)
• Atorvastatin (Lipitor)
• Clozapine (Clozaril, FazaClo)
• Conivaptan (Vaprisol)
• Dipyridamole (Persantine)
• Echinacea
• Eliglustat (Cerdelga)
• Eltrombopag (Promacta)
• Filgrastim (Neupogen)
• Heart medicines such as amiodarone (Cordarone, Pacerone), captopril, carvedilol (Coreg), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), felodipine, nicardipine (Cardene), quinidine, ranolazine (Ranexa), reserpine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as cobicistat (Tybost), darunavir (Prezista), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), pimecrolimus (Elidel), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• Lomitapide (Juxtapid)
• Mefloquine
• Natalizumab (Tysabri)
• Other cancer medicines such as abiraterone (Zytiga), carboplatin, cisplatin, crizotinib (Xalkori), dabrafenib (Tafinlar), gefitinib (Iressa), ibrutinib (Imbruvica), imatinib (Gleevec), lapatinib (Tykerb), nilotinib (Tasigna), oxaliplatin (Eloxatin), sunitinib (Sutent), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Pantoprazole (Protonix)
• Phenytoin (Dilantin, Phenytek)
• Progesterone
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Tamoxifen
• Ticagrelor (Brilinta)
• Vaccines

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Keep the capsules in the refrigerator. Do not freeze them. Keep the container tightly closed. Protect from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.