Hycamtin Capsules

DRUG DESCRIPTION

Topotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.

The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4?­ethyl-4,9-dihydroxy-1H-pyrano[3',4':6,7] indolizino [1,2-b]quinoline-3,14-(4H,12H)-dione monohydrochloride. It has the molecular formula C23H23N3O5•HCl and a molecular weight of 457.9. It is soluble in water and melts with decomposition at 213° to 218°C

Topotecan hydrochloride has the following structural formula:

HYCAMTIN® (topotecan) Structural Formula Illustration

HYCAMTIN capsules contain topotecan hydrochloride, the content of which is expressed as topotecan free base. The major excipients are hydrogenated vegetable oil, glyceryl monostearate, gelatin, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide.

What are the possible side effects of topotecan (Hycamtin)?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • diarrhea with fever and stomach cramps;
  • pain or burning when you urinate;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • white patches or sores inside your mouth or on your lips; or
  • skin...

Read All Potential Side Effects and See Pictures of Hycamtin Capsules »


Hycamtin Capsules Patient Information Including Side Effects

Brand Names: Hycamtin

Generic Name: topotecan (Pronunciation: TOE poe TEE kan)

  • What is topotecan (Hycamtin Capsules)?
  • What are the possible side effects of topotecan (Hycamtin Capsules)?
  • What is the most important information I should know about topotecan (Hycamtin Capsules)?
  • What should I discuss with my healthcare provider before using topotecan (Hycamtin Capsules)?
  • How should I use topotecan (Hycamtin Capsules)?
  • What happens if I miss a dose (Hycamtin Capsules)?
  • What happens if I overdose (Hycamtin Capsules)?
  • What should I avoid while using topotecan (Hycamtin Capsules)?
  • What other drugs will affect topotecan (Hycamtin Capsules)?
  • Where can I get more information?

What is topotecan (Hycamtin Capsules)?

Topotecan is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

Topotecan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of topotecan (Hycamtin Capsules)?

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

Call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • diarrhea with fever and stomach cramps;
  • pain or burning when you urinate;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • white patches or sores inside your mouth or on your lips; or
  • skin changes or severe irritation where the needle is placed.

Less serious side effects may include:

  • bruising or swelling where the medicine was injected;
  • tired feeling;
  • headache, body pain, joint or muscle pain;
  • mild skin rash;
  • nausea, diarrhea, vomiting; or
  • temporary hair loss.

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.

What is the most important information I should know about topotecan (Hycamtin Capsules)?

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Topotecan can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with topotecan, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Call your doctor at once if you have fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, severe diarrhea with fever or stomach pain, unusual weakness, white patches or sores inside your mouth or on your lips, or other signs of infection.

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