"The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Zykadia is an anaplastic lymphoma kinase (ALK)"...
- Patient Information:
Details with Side Effects
What is the most important information I should know about HYCAMTIN capsules?
HYCAMTIN capsules can cause serious side effects, including:
Decreased blood counts. HYCAMTIN capsules affects your bone marrow and can cause a severe decrease in your blood cell counts (bone marrow suppression) including 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)
- burning or pain on urination
Tell your healthcare provider about any abnormal bleeding or bruising.
Diarrhea. HYCAMTIN capsules can cause severe and life-threatening diarrhea that may need to be treated in 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?” for more information about side effects.
What are HYCAMTIN capsules?
HYCAMTIN capsules is a prescription used to treat small cell lung cancer that has come back (relapsed).
HYCAMTIN capsules may be right for you if:
- your cancer responded to your first chemotherapy, and
- it has been 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 if:
- you are allergic to topotecan. See the end of this leaflet for a complete list of ingredients in HYCAMTIN capsules.
What should I tell my healthcare provider before taking HYCAMTIN capsules?
Before you take HYCAMTIN capsules, tell your healthcare provider if you:
- have kidney problems
- are pregnant or plan to become pregnant. HYCAMTIN
capsules can harm your unborn baby. You should not become pregnant while you
are taking HYCAMTIN capsules.
- Females who can become pregnant should use effective birth control (contraception) during treatment with HYCAMTIN and for 1 month after treatment.
- If you are a male and your female sexual partner is able to become pregnant, you should use effective birth control during treatment with HYCAMTIN and for 3 months after treatment.
- Talk to your healthcare provider about birth control options to prevent pregnancy while you are taking HYCAMTIN.
- Tell your healthcare provider right away if you or your female partner becomes pregnant while taking HYCAMTIN.
- are breastfeeding or plan to breastfeed. It is not known if HYCAMTIN passes into your breast milk. You and your healthcare provider should decide if you will take HYCAMTIN or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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 capsules?
- Take HYCAMTIN capsules 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 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 0.25mg 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 capsules.
- Swallow HYCAMTIN capsules whole. Do not open, chew, or crush HYCAMTIN capsules.
- Take HYCAMTIN with or without food.
- 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 vomit after taking your HYCAMTIN, just take the next scheduled dose. Do not take another dose on the same day.
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 most common side effects of HYCAMTIN include:
- hair loss
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.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of HYCAMTIN capsules. For more information, ask your healthcare provider 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°F to 46°F (2°C to 8°C).
- Keep the bottle of HYCAMTIN capsules 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 capsules and all medicines out of the reach of children.
General information about HYCAMTIN capsules
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.
For more information go to www.gsk.com or call 1-888-825-5249.
What are the ingredients in HYCAMTIN capsules?
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.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/7/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Hycamtin Capsules Information
- Hycamtin Capsules Drug Interactions Center: topotecan oral
- Hycamtin Capsules Side Effects Center
- Hycamtin Capsules in detail including Side Effects and Drug Images
- Hycamtin Capsules FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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