Hycamtin

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 »

What are the precautions when taking topotecan hydrochloride (Hycamtin)?

Before using topotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (neutropenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (e.g., low platelet/white blood cell/red blood cell levels), kidney disease, liver disease.

This drug may make you weak or tired. Do not drive, use machinery, or do any activity that requires...

Read All Potential Precautions of Hycamtin »


Hycamtin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Weakness, tiredness, headache, cough, nausea, vomiting, diarrhea, constipation, abdominal pain, loss of appetite, and mouth sores may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pain/redness/bruising at injection site, numbness/tingling of the arms/legs, yellowing eyes/skin, dark urine, lung problems (such as cough, shortness of breath).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using topotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (neutropenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (e.g., low platelet/white blood cell/red blood cell levels), kidney disease, liver disease.

This drug may make you weak or tired. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Wash your hands well to prevent the spread of infections.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Hycamtin Patient Information Including Side Effects

Brand Names: Hycamtin

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

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

What is topotecan (Hycamtin)?

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)?

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)?

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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