Topotecan (oral/injection)

Topotecan is used to treat ovarian cancer, small cell lung cancer, and certain types of cervical cancer.

Topotecan is usually given after other treatments have failed.

Topotecan may also be used for reasons that are not included in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Topotecan capsules are taken by mouth, with or without food. You may need to take two different colored capsules at the same time. Make sure you know the difference between the capsules, as one contains 4 times as much topotecan as the other, even if they are the same size.

If you vomit after taking a topotecan capsule, do not take another dose that same day.

Do not use a broken or opened capsule. The medicine from a broken capsule can be dangerous if it gets in your eyes or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water for at least 15 minutes. Then call your doctor.

Store topotecan capsules in the refrigerator and protect them from light.

Topotecan injection is given as an infusion into a vein. A healthcare provider will give you this injection. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when topotecan is injected.

Topotecan can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your doctor will determine how long to treat you with topotecan.

Topotecan can impact your immune system. This means you may be more likely to get infections, including serious or life-threatening ones. Contact your doctor if you notice unusual bruising or bleeding, or if you have symptoms of an infection such as fever, chills, cough, diarrhea, stomach cramps, or pain or burning when you urinate.

You should not use topotecan if you are allergic to it.

Tell your doctor if you have ever had:

• severe diarrhea;
• kidney disease;
• lung problems; or
• a chest X-ray or radiation treatment of your chest area.

Topotecan can harm an unborn baby or cause birth defects if the mother or the father is using topotecan.

• If you are a woman, do not use topotecan if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using topotecan.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because topotecan may harm the baby if a pregnancy does occur.

You should not breastfeed while using topotecan, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Topotecan may cause serious side effects. Call your doctor right away if you have:

• new or worsening cough, fever, trouble breathing;
• diarrhea with fever and stomach cramps;
• pain or burning when you urinate;
• signs of pneumonia--fever, chills, cough with mucus, chest pain, feeling short of breath; or
• low blood cell counts--fever, chills, flu-like symptoms, mouth sores, skin sores, pale skin, cold hands and feet, bruising or bleeding, feeling light-headed.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of topotecan may include:

• low blood cell counts;
• trouble breathing, pneumonia;
• nausea, diarrhea, vomiting, stomach pain;
• loss of appetite;
• hair loss; or
• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Ovarian Cancer:

1.5 mg/m(2) IV over 30 minutes once a day for 5 consecutive days, starting on day 1 of a 21 day courseComments:-In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed.-The median time to response was 9 to 12 weeks.-Recommended dosage should generally not exceed 4 mg.Use: Metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.

Usual Adult Dose for Cervical Cancer:

0.75 mg/m(2) IV over 30 minutes on days 1, 2, and 3 of each 21 day cycleComments:-Administer cisplatin 50 mg/m(2) IV on day 1 of each 21 day cycle.-Consult cisplatin manufacturer product information for administration and hydration guidelines, and for dose adjustments.-Recommended dosage should generally not exceed 4 mg.Use: In combination with cisplatin, treatment of stage IVB, recurrent or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

Usual Adult Dose for Small Cell Lung Cancer:

IV formulation: 1.5 mg/m(2) IV over 30 minutes once a day for 5 consecutive days, starting on day 1 of a 21 day courseOral capsules: 2.3 mg/m(2) orally once a day for 5 consecutive days, starting on day 1 of a 21 day course (round dose to nearest 0.25 mg)Duration of therapy: Until disease progressionComments:-In the absence of tumor progression, a minimum of 4 courses is recommended because tumor response may be delayed.-The median time to response was 5 to 7 weeks.-Recommended IV dosage should generally not exceed 4 mg.-Do not prescribe a replacement oral capsule dose for emesis.Uses: IV formulation: Small cell lung cancer sensitive disease after failure of first-line chemotherapy. Sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 to 90 days after chemotherapy.Capsule formulation: Treatment of relapsed small cell lung cancer in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if you miss an appointment for your topotecan injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include skin rash or other irritation, nausea, vomiting, diarrhea, or mouth sores.

Avoid driving or doing activities that could be dangerous until you know how topotecan will affect you. Your reactions could be impaired.

Avoid close contact with people who are sick or have infections. Tell your doctor right away if you notice signs of infection.

You should not receive a "colony stimulating factor" medicine within 24 hours after your last topotecan injection. This includes:

• filgrastim (Neupogen, Granix, Zarxio);
• pegfilgrastim (Neulasta); or
• sargramostim (Leukine).

Other drugs may affect topotecan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.