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Hycamtin: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
.25 mg, 1 mg
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Hycamtin

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

HYCAMTIN may cause serious side effects, including:

  • Bone marrow problems. HYCAMTIN can affect your bone marrow and can cause a severe decrease in your white blood cell, red blood cell, and platelet counts. Decreased blood cell counts can make you more likely to develop bleeding, bruising, anemia, or infections which may be life-threatening. Your healthcare provider will do blood tests regularly to check your blood cell counts during treatment with HYCAMTIN. Tell your healthcare provider right away if you have any signs of infection, including:

    • fever (temperature of 100.5°F or greater)
    • chills
    • cough
    • burning or pain on urination

  • Diarrhea. HYCAMTIN can cause severe and life-threatening diarrhea that may need to be treated in a hospital. Tell your healthcare provider right away if you develop:

    • 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?” for more information about side effects.

  1. What is HYCAMTIN?

    HYCAMTIN is a prescription medicine used to treat small cell lung cancer (SCLC) that has come back (relapsed) and:

  2. • the cancer responded to your first chemotherapy, and
  3. • it has been at least 45 days from the last dose of chemotherapy

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

  1. Do not take HYCAMTIN if you are allergic to topotecan or any of the ingreidents in HYCAMTIN. See the end of this leaflet for a complete list of ingredients in HYCAMTIN.

Before taking HYCAMTIN, tell your healthcare provider about all of your medical conditions, including if you:

  • have diarrhea or watery stools
  • have or have had lung problems
  • have kidney problems

  • are pregnant or plan to become pregnant. HYCAMTIN can harm your unborn baby.

    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with HYCAMTIN and for 6 months after the last dose of HYCAMTIN.
    • Males who have female partners who are able to become pregnant, should use effective birth control during treatment with HYCAMTIN and for 3 months after the last dose of HYCAMTIN.
    • Talk to your healthcare provider about birth control methods that may be right for you during treatment with HYCAMTIN.
    • Your healthcare provider will do a pregnancy test before you start taking HYCAMTIN. Tell your healthcare provider right away if you become pregnant, think you might be pregnant, or your female partner becomes pregnant during treatment with HYCAMTIN.
  • are breastfeeding or plan to breastfeed. It is not known if HYCAMTIN passes into your breast milk. Do not breastfeed during treatment with HYCAMTIN and for 1 week after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking HYCAMTIN with certain other medicines can affect how HYCAMTIN works causing side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take HYCAMTIN?

  • Take HYCAMTIN exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how many HYCAMTIN capsules to take and when to take them. Your healthcare provider may change your dose if needed.
  • Your healthcare provider may want you to take both 1 mg and 0.25 mg HYCAMTIN capsules for your prescribed dose. It is important for you to 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 one time 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.

  • Take HYCAMTIN with or without food.

  • Swallow HYCAMTIN whole. Do not open, chew, crush, or divide HYCAMTIN.
  • If any of the HYCAMTIN capsules are broken or leaking, do not touch them with your bare hands. Carefully throw away (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 get HYCAMTIN in your eyes.
  • If you take too much HYCAMTIN, call your healthcare provider right away.
  • If you miss a dose of HYCAMTIN, or if you vomit after taking your HYCAMTIN, take your next dose at the next scheduled time. Do not take another dose on the same day.

What are the possible side effects of HYCAMTIN?

HYCAMTIN may cause serious side effects, including:

  • See “What is the most important information I should know about HYCAMTIN?”
  • 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 most common side effects of HYCAMTIN include:

    • decreased blood cell counts
    • diarrhea
    • hair loss
    • nausea
    • vomiting
    • fatigue

Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking HYCAMTIN if you develop certain serious side effects during treatment with HYCAMTIN.

HYCAMTIN may cause short-term and long-term fertility problems in females. This could affect your ability to become pregnant.

HYCAMTIN may cause lower sperm count problems in men. This could affect your ability to father a child and cause birth defects. Talk to your healthcare provider about family planning options that might be right for you.

These are not all the possible side effects of HYCAMTIN.

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?

  • Store HYCAMTIN in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Keep the bottle of HYCAMTIN in the carton that it comes in to protect it from light.
  • Ask your healthcare provider or pharmacist how to safely throw away any unused or expired HYCAMTIN.

Keep HYCAMTIN and all medicines out of the reach of children.

General information about the safe and effective use of HYCAMTIN

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use HYCAMTIN for a condition for which it was not prescribed. Do not give HYCAMTIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about HYCAMTIN that is written for health professionals.

  1. What are the ingredients in HYCAMTIN?

    Active ingredient: topotecan hydrochloride

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

    Manufactured by:

GlaxoSmithKline Manufacturing S.p.A.

San Polo di Torrile, Parma, Italy for

Sandoz Inc., Princeton, NJ 08540

  1. 731516

    For more information go to www.sandoz.com or call 1-800-525-8747.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 020981 · View the label on DailyMed

Revision date stated in the text: September 2023

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Hycamtin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Topoisomerase Inhibitor
Active ingredient Topotecan hydrochloride
Dosage form Capsule
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) SANDOZ
FDA approval NDA 020981New Drug Application (NDA) Approved October 11, 2007
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
.25 mg – 10 in 1 bottle NDC 66758-101-11
1 mg – 10 in 1 bottle NDC 66758-102-11

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.