Please wait while the formulary information is being retrieved.
Drug overview for GEFITINIB (gefitinib):
Generic name: GEFITINIB (ge-FI-ti-nib)
Drug class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Therapeutic class: Antineoplastics
Gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: GEFITINIB (ge-FI-ti-nib)
Drug class: Antineoplastic - Protein-Tyrosine Kinase Inhibitors
Therapeutic class: Antineoplastics
Gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
GEFITINIB 250 MG TABLET
The following indications for GEFITINIB (gefitinib) have been approved by the FDA:
Indications:
Metastatic non-small cell lung cancer with EGFR exon 19 deletion
Metastatic non-small cell lung cancer with EGFR exon 21 L858R substitution mutation
Professional Synonyms:
None.
Indications:
Metastatic non-small cell lung cancer with EGFR exon 19 deletion
Metastatic non-small cell lung cancer with EGFR exon 21 L858R substitution mutation
Professional Synonyms:
None.
The following dosing information is available for GEFITINIB (gefitinib):
For the first-line treatment of metastatic NSCLC in patients whose tumors harbor EGFR del19 or L858R substitution mutations, the recommended dosage of gefitinib in adults is 250 mg once daily. Therapy should be continued until disease progression or unacceptable toxicity occurs. In the principal efficacy study (IPASS), gefitinib therapy was continued for a median duration of 8 months.
If gefitinib is used concomitantly with a potent inducer of CYP3A4, the dosage should be increased to 500 mg once daily in the absence of severe adverse drug reactions. If concomitant use of the CYP3A4 inducer is discontinued, the usual gefitinib dosage (250 mg once daily) may be resumed 7 days following discontinuance of the CYP3A4 inducer.
If gefitinib is used concomitantly with a potent inducer of CYP3A4, the dosage should be increased to 500 mg once daily in the absence of severe adverse drug reactions. If concomitant use of the CYP3A4 inducer is discontinued, the usual gefitinib dosage (250 mg once daily) may be resumed 7 days following discontinuance of the CYP3A4 inducer.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for GEFITINIB (gefitinib):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for GEFITINIB (gefitinib):
Drug contraindication overview.
*The manufacturer states there are no known contraindications to the use of gefitinib.
*The manufacturer states there are no known contraindications to the use of gefitinib.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Interstitial pneumonitis |
| Pregnancy |
| Pulmonary fibrosis |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
The following adverse reaction information is available for GEFITINIB (gefitinib):
Adverse reaction overview.
Adverse effects reported in >=20%of patients receiving gefitinib include skin reactions/rash (e.g., acne, maculopapular rash, erythema, generalized rash, papular rash, pruritic rash, macular rash, dry skin) and diarrhea.
Adverse effects reported in >=20%of patients receiving gefitinib include skin reactions/rash (e.g., acne, maculopapular rash, erythema, generalized rash, papular rash, pruritic rash, macular rash, dry skin) and diarrhea.
There are 32 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dehydration Dyspnea Hemorrhage Hyperbilirubinemia Increased alanine transaminase Increased aspartate transaminase Peripheral edema Toxic amblyopia |
| Rare/Very Rare |
|---|
|
Acute pancreatitis Acute respiratory failure Alveolitis Angioedema Corneal erosion Corneal ulcer Cutaneous vasculitis Cystitis Epistaxis Erythema multiforme Gastrointestinal perforation Hematuria Hemorrhagic cystitis Interstitial lung disease Interstitial pneumonitis Keratitis Ocular inflammation Ocular pain Pancreatitis Pulmonary fibrosis Pulmonary thromboembolism Stevens-johnson syndrome Toxic epidermal necrolysis Urticaria |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acne vulgaris Anorexia Diarrhea Dry skin General weakness Nausea Pruritus of skin Skin rash Vomiting Weight loss |
Alopecia Aphthous stomatitis Bullous dermatitis Conjunctivitis Dry eye Fever Nail disorders Xerostomia |
| Rare/Very Rare |
|---|
|
Palmar-plantar erythrodysesthesia |
The following precautions are available for GEFITINIB (gefitinib):
Safety and efficacy of gefitinib have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Gefitinib may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Gefitinib and its metabolites are distributed into milk in rats. It is not known whether gefitinib is distributed into human milk. Because of the potential risk in nursing infants, advise women not to breast-feed while receiving gefitinib.
Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.
Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Gefitinib | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Not recommended,potential sev add eff in infant |
In 2 controlled clinical studies, 45% of patients were 65 years of age or older and 11% were >=75 years of age. No overall differences in safety were observed between geriatric and younger adults. The manufacturer states that insufficient data are available to determine differences in efficacy between geriatric patients and younger adults.
The following prioritized warning is available for GEFITINIB (gefitinib):
WARNING: Gefitinib has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including stomach/abdominal pain, unusual tiredness, dark urine, yellowing eyes/skin. Gefitinib has also rarely caused very serious (possibly fatal) tears in the wall of the stomach or intestines. Get medical help right away if you develop stomach/abdominal pain, black/bloody stools, or vomit that looks like coffee grounds.
WARNING: Gefitinib has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including stomach/abdominal pain, unusual tiredness, dark urine, yellowing eyes/skin. Gefitinib has also rarely caused very serious (possibly fatal) tears in the wall of the stomach or intestines. Get medical help right away if you develop stomach/abdominal pain, black/bloody stools, or vomit that looks like coffee grounds.
The following icd codes are available for GEFITINIB (gefitinib)'s list of indications:
No ICD codes found for this drug.
No ICD codes found for this drug.
Formulary Reference Tool