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HYCAMTIN®
(hi-CAM-tin)
(topotecan) Capsules

Read the Patient Information that comes with HYCAMTIN capsules before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about taking HYCAMTIN capsules?

HYCAMTIN capsules can cause serious side effects:

Decreased blood counts. Taking HYCAMTIN affects your bone marrow and can cause a severe decrease in your blood cell counts (bone marrow suppression) - neutrophils (a type of white blood cell important in fighting bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and control of bleeding).

• You should have blood tests regularly to check your blood counts. A decrease in neutrophils (neutropenia) may affect how your body fights infection.
• Your healthcare provider will tell you if your blood counts are too low before you begin treatment with HYCAMTIN.
• Your dose of HYCAMTIN may need to be changed or stopped until your blood counts recover enough after each cycle of treatment.
• Call your healthcare provider right away if you get any of the following signs of infection:
• fever (temperature of 100.5°F or greater)
  • chills
  • cough
  • burning or pain on urination
• Tell your healthcare provider about any abnormal bleeding or bruising.

Diarrhea. Diarrhea may occur from taking HYCAMTIN capsules, and may be serious enough that you must be treated in the hospital. Tell your healthcare provider right away if you have:

• diarrhea with fever
• diarrhea 3 or more times a day
• diarrhea with stomach-area pain or cramps

See “What are the possible side effects of HYCAMTIN capsules?”

What are HYCAMTIN capsules?

HYCAMTIN capsules are prescription medicines you take by mouth. HYCAMTIN capsules are used to treat a certain type of lung cancer called small cell lung cancer.

HYCAMTIN capsules may be right for you if:

• your cancer responded to your first chemotherapy
• your cancer came back at least 45 days after you finished your last dose of chemotherapy

It is not known if HYCAMTIN is safe and effective in children.

Who should not take HYCAMTIN capsules?

Do not take HYCAMTIN capsules if:

• you are allergic to anything in HYCAMTIN capsules. See the end of this leaflet for a complete list of ingredients in HYCAMTIN capsules.
• the results of your last blood test show blood counts that are too low. Your healthcare provider will tell you.

What else should I tell my healthcare provider before taking HYCAMTIN capsules?

Before you take HYCAMTIN capsules, tell your healthcare provider if you:

• are pregnant or may become pregnant. HYCAMTIN capsules may harm your unborn baby. You should not become pregnant while you are taking HYCAMTIN capsules.
• are breastfeeding or plan to breastfeed. It is not known if HYCAMTIN passes into your breast milk or if it can harm your baby. You and your healthcare provider should decide if you will take HYCAMTIN or breast feed. You should not do both.
• Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. HYCAMTIN capsules and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you are taking: cyclosporine (SANDIMMUNE®, GENGRAF®, NEORAL®), ketoconazole (NIZORAL®, EXTINA®), ritonavir (NORVIR®, KALETRA®), saquinavir (INVIRASE®).
• Know your medicines. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take HYCAMTIN capsules?

• Take HYCAMTIN capsules exactly as your doctor prescribes them.
• Your healthcare provider may want you to take both 1 mg and 0.25 mg capsules together to make up your complete dose. You must be able to tell the difference between the capsules. The 1 mg capsule is a pink color and the 0.25 mg capsule is a white to yellowish-white color.
• Take HYCAMTIN capsules once a day for 5 days in a row. This treatment will normally be repeated every 3 weeks (a treatment cycle). Your healthcare provider will decide how long you will take HYCAMTIN capsules.
• Swallow HYCAMTIN capsules whole with water. Do not open, chew, or crush HYCAMTIN capsules. HYCAMTIN capsules may be taken with or without food.
• If any of the HYCAMTIN capsules are broken or leaking, do not touch them with your bare hands. Carefully dispose of the capsules, and then wash your hands well with soap and water.
• If you get any of the contents of HYCAMTIN capsules on your skin or in your eyes, do the following:
  • Wash the area of 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 if you get the medicine in your eyes.
• If you take too much HYCAMTIN, contact your healthcare provider right away.
• If you forget to take HYCAMTIN at any time, do not double the dose to make up for a forgotten dose. Wait and take the next scheduled dose. Let your healthcare provider know that you missed a dose.
• If you vomit after taking your HYCAMTIN, do not take another dose on the same day. Let your healthcare provider know right away that you have vomited.

What should I avoid while taking HYCAMTIN capsules?

HYCAMTIN may make you feel drowsy or sleepy both during and for several days after treatment. If you feel tired or weak, do not drive and do not use heavy tools or operate machinery.

What are the possible side effects of HYCAMTIN capsules?

HYCAMTIN can cause serious side effects including:

• See “What is the most important information I should know about HYCAMTIN capsules?”
• Lung problems that can cause death. Tell your healthcare provider right away if you have new or worse symptoms of coughing, fever, shortness of breath, or problems breathing. Your healthcare provider may tell you to stop taking HYCAMTIN capsules.

The following side effects have been reported in patients taking HYCAMTIN capsules:

• stomach problems such as nausea (feeling sick) and vomiting
• tiredness
• hair loss
• weakness

Tell your healthcare provider if you have any side effect that bothers you or does not go away. Your healthcare provider may change your dose of HYCAMTIN to a dose that is better for you or may stop your treatment with HYCAMTIN for a while. This can help reduce the side effects and may keep them from getting worse. Let your healthcare provider know if this helps or does not help your side effects.

These are not all of the possible side effects of HYCAMTIN capsules. For more information, ask your doctor or pharmacist.

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

How should I store HYCAMTIN capsules?

• Store HYCAMTIN capsules in a refrigerator between 36° to 46°F (2° and 8°C).
• Keep the bottle of HYCAMTIN capsules in the carton that it comes in to protect it from light.
• Dispose of HYCAMTIN capsules that are out of date or no longer needed.
• Keep HYCAMTIN capsules and all other medicines out of the reach of children.

What are the ingredients in HYCAMTIN capsules?

Active Ingredient: Topotecan

Inactive Ingredients: Hydrogenated vegetable oil, glyceryl monostearate, gelatin, and titanium dioxide. The 1 mg capsules also contain red iron oxide. The capsules are imprinted with edible black ink.

(capsules shown larger than actual size)

General information about HYCAMTIN capsules

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Only your doctor knows what treatment is best for you. Do not use HYCAMTIN capsules for a condition for which it was not prescribed by your healthcare provider. Do not give HYCAMTIN capsules to other people, even if they have the same condition that you have. It may harm them.

This leaflet summarizes the most important information about HYCAMTIN capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about HYCAMTIN capsules that is written for health professionals. For more information you can call toll-free 1-888-825-5249 or visit www.gsk.com.

This patient information leaflet has been approved by the US Food and Drug Administration.

Last reviewed on RxList: 10/28/2011
This monograph has been modified to include the generic and brand name in many instances.