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USP DI Vol. II - GEFITINIB (Systemic)

GEFITINIB (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Iressa

? Not commercially available in Canada.


Category

  • Antineoplastic

Description

Gefitinib ((ge-FI-tye-nib)) belongs to the group of medicines called antineoplastics.It is used to treat non-small cell lung cancer after the failure of otherchemotherapy treatment.

Before you begin treatment with gefitinib, you and your doctor should talkabout the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

    Oral
  • Tablets (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For gefitinib, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to gefitinib. Also tell your doctor and pharmacist ifyou are allergic to any other substances such as food, preservatives, or dyes.

Pregnancy?Gefitinib has been shown to cause miscarriagesand death of the fetus in animals. However, this medicine may be needed inserious diseases or other situations that threaten the mother's life. Be sureyou have discussed this with your doctor.

It is best to use some kind of birth control while you are receiving gefitinib.Tell your doctor right away if you think you have become pregnant while receivinggefitinib.

Breast-feeding?It is not known whether gefitinib passes intothe breast milk. However, gefitinib is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of gefitinibin children with use in other age groups.

Older adults?This medicine has been tested in elderly patientsand has not been shown to cause different side effects or problems in olderpeople than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinggefitinib, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

  • CYP3A4 inducers such as
  • Phenytoin (e.g., Dilantin), or
  • Rifampin (e.g., Rifadin)?May decreases the effectiveness ofgefitinib.
  • Histamine H2-receptor antagonist (medicinefor ulcers), such as
  • Cimetidine (e.g., Tagamet), or
  • Ranitidine (e.g., Zantac )?May decrease the effectiveness ofgefitinib.
  • Itraconazole (e.g., Sporanox) or
  • Ketoconazole (e.g., Nizoral)?Higher blood levels of gefitinibmay occur, increasing the chance of serious side effects.
  • Metoprolol (e.g., Toprol-XL, Lopressor)?Higher blood levelsof metoprolol may occur.
  • Vinorelbine (e.g., Navelbine)?Use with gefitinib may increasethe side effects of vinorelbine.
  • Warfarin (e.g., Coumadin)?Bleeding may occur.

Other medical problems?The presence of other medicalproblems may affect the use of gefitinib. Make sure you tell your doctor ifyou have any other medical problems, especially:

  • Idiopathic pulmonary fibrosis?Condition may worsen while receivinggefitinib therapy
  • Kidney disease or
  • Liver disease?The chance of serious side effects is greatlyincreased.

Proper Use of This Medicine

Dosing?The dose of gefitinib will be different for different patients. Follow your doctor's orders or the directions on thelabel. The following information includes only the average doses ofgefitinib. If your dose is different, do not change it unless your doctor tells you to do so.

  • For oral dosage form:
    • For lung cancer, non-small cell:
      • Adults?250 milligrams (mg) daily.
      • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.


Precautions While Using This Medicine

It isvery important that your doctor check your progress at regular visitsto make sure that this medicine is working properly and to check for unwantedeffects.

It is very important to check with your doctor if youhave diarrhea, nausea or anorexia.

It is very important to check with your doctor if youhave problems breathing.

It is very important to check withyour doctor if you have any new eye problems.


Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Check with your doctorimmediately if any of the following side effects occur:

      Less common

        bloating or swelling of face, arms, hands, lower legs, or feet; burning, dry or itching eyes; change in vision; difficult or labored breathing; eye discharge or excessive tearing; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; shortness of breath; tightness in chest; tingling of hands or feet; unusual weight gain or loss; wheezing

      Incidence unknown

        abnormal eyelash growth; blistering,peeling, loosening of skin; bloating of stomach; blood in urine; bloody nose; chills; constipation; cough; darkened urine; diarrhea; fainting or loss of consciousness; fast heartbeat; fast or irregular breathing; fever; indigestion; joint or muscle pain; large, hive-likeswelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of appetite; nausea; pains in stomach, side, or abdomen, possibly radiatingto the back; redness, tenderness, itching, or burningof skin; seeing floating spots before the eyes; severe stinging of the eye; skin rash; sore throat; sores, ulcers,or white spots in mouth or on lips; unusual tirednessor weakness; vomiting; yellow eyes or skin

      Symptoms of Overdose

      Get emergency help immediately if any of the followingsymptoms of overdose occur

        Diarrhea; skin rash

    Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

      More Common

        blemishes on the skin, pimples; lackor loss of strength; dry skin

      Less common

        irritation or soreness of mouth; blistersunder the skin, large, hard skin blisters

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.


Developed: 12/3/2003
Revised: 07/14/2005