IRESSA- gefitinib tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GEFITINIB (UNII: S65743JHBS) (GEFITINIB - UNII:S65743JHBS)

Available from:

AstraZeneca Pharmaceuticals LP

INN (International Name):

GEFITINIB

Composition:

GEFITINIB 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14)] . Limitation of Use: Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies (14)] . None. Risk Summary Based on its mechanism of action and animal data, IRESSA can cause fetal harm when administered to a pregnant woman. In animal reproductive studies, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose (see Animal Data ). Advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy. The background risk of major birth defect

Product summary:

IRESSA® (gefitinib) is available as 250 mg tablets. IRESSA 250 mg tablets are round, biconvex, brown film-coated, debossed with "IRESSA 250" on one side and plain on the other side. IRESSA® (gefitinib) tablets are supplied as: Bottles of 30 Tablets (NDC 0310-0482-30) Store at controlled room temperature 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature ].

Authorization status:

New Drug Application

Patient Information leaflet

AstraZeneca Pharmaceuticals LP
----------
Patient Information
IRESSA (eye-RES-sah)
(gefitinib) tablets
What is IRESSA?
IRESSA is a prescription medicine used to treat people with non-small
cell lung cancer (NSCLC) that has
spread to other parts of the body and:
•
that have certain types of abnormal epidermal growth factor receptor
(EGFR) genes, and
•
who have not had previous treatment for cancer
Your healthcare provider will perform a test to make sure that IRESSA
is right for you.
It is not known if IRESSA is safe and effective in people with NSCLC
that have other types of EGFR
genes.
It is not known if IRESSA is safe and effective in children.
Before taking IRESSA, tell your healthcare provider about all of your
medical conditions, including if
you:
•
have lung or breathing problems
•
ever had liver problems
•
have vision or eye problems
•
are pregnant or plan to become pregnant. IRESSA can harm your unborn
baby.
•
Females who are able to become pregnant should use an effective method
of birth control
during treatment with IRESSA and for at least 2 weeks after the last
dose of IRESSA. You
should avoid becoming pregnant during treatment with IRESSA.
•
Tell your healthcare provider right away if you become pregnant during
treatment with
IRESSA.
•
are breastfeeding or plan to breastfeed. It is not known if IRESSA
passes into your breast milk. Do
not breastfeed during treatment with IRESSA. 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, or herbal supplements.
If you take a proton pump inhibitor (PPI), H2 blocker, or an antacid
medicine, talk to your healthcare
provider about the best time to take it during treatment with IRESSA.
If you take a blood thinner called warfarin, your healthcare provider
should do blood tests regularly to
check how fast your blood clots, during treatment with IRESSA.
How should I take IRESSA?
•
Take

Summary of Product characteristics

IRESSA- GEFITINIB TABLET, COATED
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRESSA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IRESSA.
IRESSA (GEFITINIB) TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
IRESSA is a tyrosine kinase inhibitor indicated for the first-line
treatment of patients with metastatic non-
small cell lung cancer (NSCLC) whose tumors have epidermal growth
factor receptor (EGFR) exon 19
deletions or exon 21 (L858R) substitution mutations as detected by an
FDA-approved test. (1)
Limitation of Use: Safety and efficacy of IRESSA have not been
established in patients whose tumors have
EGFR mutations other than exon 19 deletions or exon 21 (L858R)
substitution mutations. (1)
DOSAGE AND ADMINISTRATION
Recommended dose is 250 mg orally, once daily with or without food.
(2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most commonly reported adverse drug reactions (ADRs), reported in
more than 20% of the patients
and greater than placebo were skin reactions and diarrhea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA
AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
•
•
•
•
USE IN SPECIFIC POPULATIONS
Lactation: Discontinue breast-feeding. (8.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2023
®
Interstitial lung disease (ILD): ILD occurred in patients taking
IRESSA. Withhold IRESSA for worsening of
respiratory symptoms. Discontinue IRESSA if ILD is confirmed. (2.4,
5.1)
Hepatotoxicity: Obtain periodic liver function testing. Withhold
IRESSA for Grade 2 or higher for ALT
and/or AST elevations. Discontinue for severe hepatic impairment.
(2.4, 5.2)
Gastrointestinal perforation: Discontinue IRESSA for gastrointestinal
perforation. (2.4, 5.3)
Diarrhea: Wit