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Gefitinib
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- Active ingredient
- Gefitinib 250 mg
- Other brand names
- Drug class
- Kinase Inhibitor
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2023
- Label revision date
- March 10, 2026
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Gefitinib 250 mg
- Other brand names
- Drug class
- Kinase Inhibitor
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2023
- Label revision date
- March 10, 2026
- Manufacturer
- Natco Pharma USA LLC
- Registration number
- ANDA212827
- NDC root
- 69339-168
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Gefitinib is a medication classified as a kinase inhibitor, primarily used for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have specific mutations in the epidermal growth factor receptor (EGFR). These mutations, specifically exon 19 deletions or the exon 21 (L858R) substitution, are associated with tumor growth and resistance to cell death.
By targeting and inhibiting the activity of the mutated EGFR, gefitinib helps to block the signals that promote cancer cell proliferation and survival. This action can slow down or stop the growth of the cancer, making it a crucial option for patients with these specific genetic markers.
Uses
Gefitinib tablets are used as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC). This is specifically for those whose tumors have certain genetic changes known as epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations can be identified through an FDA-approved test.
It's important to note that the safety and effectiveness of gefitinib have not been established for patients whose tumors have different types of EGFR mutations. If you have questions about your specific condition or treatment options, be sure to discuss them with your healthcare provider.
Dosage and Administration
When you take this medication, the recommended dose is 250 mg, which you should take once a day. You can take it with or without food, so you can choose what works best for you. Just make sure to take it at the same time each day to help you remember.
What to Avoid
It's important to be aware of certain factors when considering this medication. There are no specific contraindications, meaning there are no known conditions or situations that would prevent you from using it. However, always consult with your healthcare provider to ensure it's safe for you, especially if you have any underlying health issues or are taking other medications.
Additionally, be mindful that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Abuse refers to using the medication in a way not prescribed, while dependence (a condition where your body becomes reliant on a substance) can develop with prolonged use. Always follow your healthcare provider's instructions and never share your medication with others.
Side Effects
You may experience some common side effects while taking gefitinib, such as skin reactions and diarrhea. However, there are also serious side effects to be aware of. Interstitial lung disease (ILD), which affects your lungs, can occur, and you should stop taking gefitinib if you notice worsening respiratory symptoms. Liver problems (hepatotoxicity) may arise, so regular liver function tests are necessary, and treatment should be paused or stopped based on the severity of liver issues.
Other serious concerns include gastrointestinal perforation, which requires immediate discontinuation of the medication, and severe ocular disorders, including keratitis, which may also necessitate stopping treatment. If you experience Grade 3 or higher diarrhea or skin reactions, you should withhold the medication. Additionally, gefitinib can harm a developing fetus, so effective contraception is advised if you are of childbearing age.
Warnings and Precautions
You should be aware of several important warnings and precautions when taking gefitinib tablets. If you experience worsening respiratory symptoms, it’s crucial to withhold the medication and consult your doctor, as interstitial lung disease (ILD) has been reported in some patients. Additionally, regular liver function tests are necessary, and if you have significant liver enzyme elevations or severe liver impairment, you should stop taking gefitinib and seek medical advice.
Be cautious of gastrointestinal issues; if you develop a gastrointestinal perforation, you must discontinue gefitinib immediately. Severe diarrhea (Grade 3 or higher) also requires you to withhold the medication. If you notice any severe eye problems, such as keratitis, stop taking gefitinib and contact your healthcare provider. Skin reactions, particularly severe ones or exfoliative conditions, should also prompt you to withhold the medication. Lastly, if you are pregnant or could become pregnant, be aware that gefitinib can harm a developing fetus, so effective contraception is essential.
Overdose
If you suspect an overdose of gefitinib tablets, it’s important to stop taking the medication immediately. You should focus on supportive care, which means providing comfort and monitoring your condition until you feel stable again. Unfortunately, there are no specific treatments available for gefitinib overdose, so observation is key.
While signs of overdose can vary, it’s crucial to be aware of any unusual symptoms you may experience. If you notice anything concerning or if your condition worsens, seek medical help right away. Always prioritize your health and safety by consulting a healthcare professional if you have any doubts or questions.
Pregnancy Use
If you are pregnant or planning to become pregnant, it’s important to be aware that gefitinib tablets can potentially harm your fetus. Studies in animals have shown that taking gefitinib during pregnancy can lead to serious issues, including fetal death and reduced survival rates of newborns, even at doses lower than what is typically recommended for humans.
You should discuss the risks with your healthcare provider, as there is a possibility of miscarriage and major birth defects, although the exact background risk for those taking gefitinib is not well established. In animal studies, gefitinib was found to cross the placenta, and higher doses resulted in significant negative effects on fetal development. Always consult your doctor before starting or continuing any medication during pregnancy.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to be aware that gefitinib tablets can potentially harm a developing fetus if taken during pregnancy. Therefore, if you are of reproductive age, you should use effective contraception while on gefitinib and for at least two weeks after finishing the treatment. Additionally, gefitinib may reduce fertility in women who are capable of becoming pregnant, which is something to consider when planning for the future. Always consult with your healthcare provider for personalized advice and guidance regarding your treatment and breastfeeding.
Pediatric Use
Currently, the safety and effectiveness of gefitinib tablets for children have not been established. This means that there is not enough information to confirm whether this medication is safe or works well for kids. If you are considering this treatment for your child, it’s important to discuss it thoroughly with your healthcare provider to understand the potential risks and benefits.
Geriatric Use
In clinical trials involving 823 patients, nearly half (45%) were aged 65 and older, with 11% being 75 years or older. The good news is that no significant safety concerns were found for older adults compared to younger patients. However, there isn't enough information to determine if the treatment works differently for older adults versus younger ones.
As you consider treatment options, it's important to keep in mind that while older adults generally experienced similar safety outcomes, individual responses can vary. Always consult with your healthcare provider to discuss any specific concerns or adjustments that may be necessary for older patients.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.
Hepatic Impairment
If you have liver problems, it's important to monitor your liver health regularly. This means you should have periodic liver function tests, which check how well your liver is working. If your tests show a moderate increase in liver enzymes (specifically ALT or AST), you may need to temporarily stop taking gefitinib tablets. In cases of severe liver impairment, you should discontinue the medication altogether.
Always keep your healthcare provider informed about your liver condition, as they will guide you on the best course of action based on your test results and overall health.
Drug Interactions
It's important to talk to your healthcare provider about any medications you are taking, especially if you are using gefitinib tablets. If you are on a strong CYP3A4 inducer (a type of medication that can increase the activity of certain enzymes in your body), your doctor may need to increase your gefitinib dose to 500 mg daily. Conversely, if you are taking a CYP3A4 inhibitor (a medication that can decrease enzyme activity), your doctor will want to monitor you closely for any side effects.
Additionally, if you are using medications that affect stomach acid, like proton pump inhibitors, it's best to avoid taking them with gefitinib if possible. If you are on warfarin (a blood thinner), your healthcare provider will need to keep an eye on your blood tests to ensure your levels remain stable. Always keep your doctor informed about all the medications and supplements you are using to ensure your safety and the effectiveness of your treatment.
Storage and Handling
To ensure the best performance of your product, store it at a controlled room temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain the product's effectiveness and safety.
When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.
Additional Information
It's important to have regular liver function tests while you are taking gefitinib tablets to monitor your liver health. If you are pregnant or planning to become pregnant, be aware that there may be risks to your fetus, so it's crucial to discuss this with your healthcare provider. Additionally, if you are a woman who can become pregnant, you should use effective contraception during your treatment and for at least two weeks after finishing the medication.
There have been reports of serious skin conditions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, associated with gefitinib treatment. If you notice any unusual skin reactions, contact your doctor immediately.
FAQ
What is Gefitinib?
Gefitinib is a kinase inhibitor used for the treatment of metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
What is the recommended dosage of Gefitinib?
The recommended dose of Gefitinib is 250 mg taken orally once daily, with or without food.
What are the common side effects of Gefitinib?
Common side effects include skin reactions and diarrhea.
What serious adverse reactions can occur with Gefitinib?
Serious adverse reactions include interstitial lung disease (ILD), hepatotoxicity, gastrointestinal perforation, and severe ocular disorders.
Can Gefitinib cause fetal harm?
Yes, Gefitinib can cause fetal harm; it is advised to use effective contraception during treatment and for at least two weeks after.
What should I do if I experience worsening respiratory symptoms while taking Gefitinib?
You should withhold Gefitinib and consult your healthcare provider if you experience worsening respiratory symptoms.
Are there any contraindications for using Gefitinib?
There are no specific contraindications mentioned for Gefitinib.
How should Gefitinib be stored?
Gefitinib should be stored at a controlled room temperature of 20°C-25°C (68°F-77°F).
Is there any special monitoring required while taking Gefitinib?
Yes, periodic liver function testing is recommended while taking Gefitinib.
What should I do if I am pregnant or planning to become pregnant?
If you are pregnant or planning to become pregnant, you should inform your healthcare provider due to the potential risk to a fetus.
Packaging Info
The table below lists all NDC Code configurations of Gefitinib, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 250 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Gefitinib, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Gefitinib is a kinase inhibitor with the chemical name N-(3ʹ-Chloro-4ʹ-fluorophenyl)-7-methoxy-6-{3-(4-morpholinyl)proproxy}-4-quinazolinamine. Its molecular formula is C22H24ClFN4O3, and it has a relative molecular mass of 446.9 daltons. Gefitinib appears as a white to off-white crystalline powder and is classified as a free base. The molecule exhibits pKa1 of 6.5 and pKa2 of 6.9. It is soluble at pH 1 but becomes insoluble above pH 7. Gefitinib is freely soluble in dimethylformamide and acetic acid, and slightly soluble in methanol.
Gefitinib is available in the form of brown film-coated tablets, each containing 250 mg of gefitinib for oral administration. The inactive ingredients in the tablet core include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, and magnesium stearate. The tablet coating consists of polyvinyl alcohol, polyethylene glycol/PEG, talc, titanium dioxide, yellow iron oxide, and red iron oxide.
Uses and Indications
Gefitinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as confirmed by an FDA-approved test.
Limitations of Use: The safety and efficacy of gefitinib tablets have not been established in patients whose tumors harbor EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.
Dosage and Administration
The recommended dose for the medication is 250 mg, administered orally once daily. It may be taken with or without food, allowing for flexibility in patient adherence. Healthcare professionals should ensure that patients are informed about the dosing schedule and the option to take the medication in conjunction with meals if preferred.
Contraindications
There are no contraindications associated with the use of this product.
Warnings and Precautions
Patients receiving gefitinib tablets should be closely monitored for several serious adverse effects, necessitating specific precautions and interventions.
Interstitial Lung Disease (ILD) The occurrence of interstitial lung disease has been reported in patients taking gefitinib tablets. In cases where respiratory symptoms worsen, it is imperative to withhold gefitinib treatment. Should ILD be confirmed, discontinuation of gefitinib tablets is required.
Hepatotoxicity Regular monitoring of liver function is essential. Periodic liver function tests should be conducted to assess ALT and AST levels. If elevations reach Grade 2 or higher, gefitinib tablets should be withheld. In instances of severe hepatic impairment, discontinuation of gefitinib is warranted.
Gastrointestinal Perforation In the event of gastrointestinal perforation, gefitinib tablets must be discontinued immediately.
Diarrhea Patients experiencing Grade 3 or higher diarrhea should have gefitinib tablets withheld until symptoms improve.
Ocular Disorders Signs and symptoms of severe or worsening ocular disorders, including keratitis, necessitate withholding gefitinib tablets. If persistent ulcerative keratitis occurs, discontinuation of the medication is required.
Bullous and Exfoliative Skin Disorders For patients presenting with Grade 3 or higher skin reactions or exfoliative conditions, gefitinib tablets should be withheld.
Embryo-fetal Toxicity Gefitinib has the potential to cause fetal harm. Healthcare professionals should counsel patients regarding the risks to a fetus and the importance of using effective contraception during treatment.
Side Effects
Patients receiving gefitinib tablets may experience a range of adverse reactions, which can be categorized into common and serious reactions.
Common adverse reactions observed in clinical trials include skin reactions and diarrhea. These reactions are generally manageable but should be monitored closely.
Serious adverse reactions associated with gefitinib tablets include interstitial lung disease (ILD), hepatotoxicity, gastrointestinal perforation, severe diarrhea, ocular disorders (including keratitis), and bullous and exfoliative skin disorders. ILD has been reported in patients taking gefitinib; therefore, it is recommended to withhold the medication for any worsening respiratory symptoms and to discontinue treatment if ILD is confirmed. Hepatotoxicity necessitates periodic liver function testing, with the recommendation to withhold gefitinib for Grade 2 or higher elevations in ALT and/or AST, and to discontinue in cases of severe hepatic impairment.
In the event of gastrointestinal perforation, gefitinib tablets should be discontinued immediately. For diarrhea, treatment should be withheld for Grade 3 or higher severity. Ocular disorders, including keratitis, require withholding of gefitinib for any signs or symptoms of severe or worsening conditions, with discontinuation advised for persistent ulcerative keratitis. Additionally, for bullous and exfoliative skin disorders, treatment should be withheld for Grade 3 or higher skin reactions or exfoliative conditions.
It is important to note that gefitinib can cause embryo-fetal toxicity, posing a risk of fetal harm. Patients should be advised of this potential risk and the necessity of using effective contraception during treatment.
Drug Interactions
Concomitant use of gefitinib tablets with drugs that affect the cytochrome P450 3A4 (CYP3A4) enzyme may necessitate dosage adjustments and careful monitoring.
CYP3A4 Inducers When gefitinib is administered alongside a strong CYP3A4 inducer, it is recommended to increase the gefitinib dosage to 500 mg daily to maintain therapeutic efficacy.
CYP3A4 Inhibitors In cases where gefitinib is used concurrently with a CYP3A4 inhibitor, healthcare professionals should closely monitor patients for any adverse reactions, as the inhibitor may increase gefitinib plasma concentrations.
Drugs Affecting Gastric pH The use of proton pump inhibitors (PPIs) in conjunction with gefitinib tablets should be avoided if possible, as these medications can alter gastric pH and potentially affect the absorption and effectiveness of gefitinib.
Anticoagulants For patients taking warfarin, it is essential to monitor prothrombin time or International Normalized Ratio (INR) closely, as gefitinib may increase the risk of hemorrhage. Adjustments to warfarin dosage may be necessary based on these monitoring results.
Packaging & NDC
The table below lists all NDC Code configurations of Gefitinib, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 250 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
The safety and effectiveness of gefitinib tablets in pediatric patients have not been established. Therefore, caution is advised when considering the use of this medication in children and adolescents. Further studies are needed to determine appropriate dosing and potential outcomes in this population.
Geriatric Use
In clinical trials involving 823 patients, 374 patients (45%) were aged 65 years and older, with 93 patients (11%) aged 75 years and older. The data indicate that there were no overall differences in safety profiles between elderly patients (65 years and older) and those younger than 65 years.
However, there is insufficient information to evaluate potential differences in efficacy between older and younger patients. Therefore, healthcare providers should exercise caution when prescribing to geriatric patients, considering the lack of specific efficacy data and the need for careful monitoring of this population.
Pregnancy
Based on its mechanism of action and animal data, gefitinib tablets 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. Pregnant women should be advised of the potential hazard to a fetus or the potential risk for loss of the pregnancy.
The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the background risk in the U.S. general population of major birth defects is estimated to be 2 - 4%, and the risk of miscarriage is approximately 15 - 20% of clinically recognized pregnancies. A single dose study in rats demonstrated that gefitinib crosses the placenta after an oral dose of 5 mg/kg (30 mg/m², about 0.2 times the recommended human dose on a mg/m² basis). When pregnant rats were treated with 5 mg/kg from the beginning of organogenesis to the end of weaning, there was a reduction in the number of offspring born alive. This effect was more pronounced at 20 mg/kg (approximately the human clinical dose on a mg/m² basis) and was associated with high neonatal mortality soon after parturition. Additionally, in rabbits, a dose of 20 mg/kg/day (240 mg/m², about twice the recommended dose in humans on a mg/m² basis) resulted in reduced fetal weight.
Healthcare professionals should carefully consider the potential risks when prescribing gefitinib to women of childbearing potential and advise appropriate contraceptive measures during treatment.
Lactation
Gefitinib tablets can cause fetal harm when administered to a pregnant woman. Therefore, lactating mothers should be advised to use effective contraception during treatment with gefitinib tablets and for at least two weeks following the completion of therapy.
There is no specific data available regarding the excretion of gefitinib in human breast milk or its effects on breastfed infants. Given the potential risks associated with gefitinib, healthcare professionals should carefully consider the benefits and risks of continuing breastfeeding during treatment. Additionally, gefitinib may result in reduced fertility in females of reproductive potential, which should be taken into account when counseling lactating mothers.
Renal Impairment
There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.
Hepatic Impairment
Patients with hepatic impairment should undergo periodic liver function testing to monitor for hepatotoxicity. In cases where alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations reach Grade 2 or higher, gefitinib tablets should be withheld. Additionally, the use of gefitinib is contraindicated in patients with severe hepatic impairment, necessitating discontinuation of the medication in such instances. Regular monitoring and appropriate management are essential to ensure patient safety and therapeutic efficacy.
Overdosage
In the event of a suspected overdose of gefitinib tablets, it is imperative to immediately interrupt the administration of the medication. Supportive care should be instituted promptly, and the patient must be closely observed until clinical stabilization is achieved.
Currently, there are no specific measures or treatments recommended for managing an overdose of gefitinib tablets. Healthcare professionals should focus on supportive care and monitoring the patient for any potential symptoms that may arise during this period.
Nonclinical Toxicology
Gefitinib has undergone extensive evaluation for genotoxicity through a series of in vitro assays, including bacterial mutation, mouse lymphoma, and human lymphocyte tests, as well as an in vivo rat micronucleus test. The results from these studies indicate that gefitinib does not induce genetic damage under the tested conditions.
In a two-year carcinogenicity study conducted in mice, gefitinib was administered at a dose of 270 mg/m²/day, which is approximately twice the recommended daily dose of 250 mg on a mg/m² basis, with the dose being reduced from 375 mg/m²/day starting from week 22. This study revealed the development of hepatocellular adenomas in female mice.
Similarly, a two-year carcinogenicity study in rats involved the administration of gefitinib at a dose of 60 mg/m²/day, approximately 0.4 times the recommended daily clinical dose on a mg/m² basis. This study found hepatocellular adenomas and hemangiomas/hemagiosarcomas of the mesenteric lymph nodes in female rats. The clinical significance of these findings remains uncertain.
In a dedicated fertility study in rats, doses of gefitinib at or above 120 mg/m², which is approximately equivalent to the recommended human dose on a mg/m² basis, were associated with an increased incidence of irregular estrous cycles, a reduction in corpora lutea, and decreases in both uterine implants and live embryos per litter.
Postmarketing Experience
Postmarketing experience with gefitinib tablets has identified several serious side effects reported voluntarily or through surveillance programs.
Lung or breathing problems have been noted, including inflammation of the lung, which may lead to fatal outcomes. Symptoms resembling those of lung cancer, such as trouble breathing, shortness of breath, cough, or fever, have been reported.
Liver problems, including inflammation of the liver, have also been associated with gefitinib tablets, potentially resulting in death. Symptoms indicative of liver issues include jaundice (yellowing of the skin or eyes), dark or tea-colored urine, light-colored stools, decreased appetite, and abdominal pain on the right side.
Cases of perforation in the wall of the stomach or intestines have been documented, with severe abdominal pain being a critical symptom warranting immediate medical attention.
Diarrhea is a common adverse event associated with gefitinib tablets, with instances of severe diarrhea reported. Patients are advised to inform their healthcare provider if they experience severe or persistent diarrhea.
Ocular issues have been reported, including symptoms such as watery eyes, sensitivity to light, blurred vision, eye pain, redness, or changes in vision.
Skin reactions, including redness, rash, itching, and acne, are frequently observed. Severe skin reactions, such as peeling or blistering, require prompt medical intervention.
Additionally, gefitinib tablets may lead to fertility problems in females, and patients planning to become pregnant should consult their healthcare provider.
Healthcare professionals and patients are encouraged to report any side effects to the FDA at 1-800-FDA-1088.
Patient Counseling
Patients should be advised to read the FDA-approved patient labeling (Patient Information) thoroughly. It is important for patients to be aware of the potential risk of interstitial lung disease; they should immediately contact their healthcare provider if they experience new onset or worsening pulmonary symptoms, such as dyspnea, cough, or fever.
Patients must be informed about the risk of hepatotoxicity associated with gefitinib tablets. They will need to undergo lab tests to monitor liver function and should report any new symptoms that may indicate hepatic toxicity to their healthcare provider.
Additionally, patients should be made aware that gefitinib tablets can increase the risk of gastrointestinal perforation. They should seek immediate medical attention if they experience severe abdominal pain. In the case of severe or persistent diarrhea, patients are advised to contact their healthcare provider promptly.
Ocular disorders, including keratitis, are another concern. Patients should be instructed to contact their healthcare provider immediately if they develop any eye symptoms, such as lacrimation, light sensitivity, blurred vision, eye pain, red eye, or changes in vision.
Patients should also be informed about the risk of bullous and exfoliative skin disorders associated with gefitinib tablets. They should seek immediate medical attention for any severe skin reactions.
For pregnant women, it is crucial to discuss the potential risk to a fetus or the possibility of pregnancy loss. Females of reproductive potential should be advised to use effective contraception during treatment with gefitinib tablets and for at least two weeks following the completion of therapy. They should also be instructed to inform their healthcare provider immediately if they become pregnant during treatment.
Women are advised to discontinue breastfeeding during treatment with gefitinib tablets. Before starting treatment, patients should inform their healthcare provider about all medical conditions, including any lung or breathing problems, history of liver issues, vision or eye problems, and any plans for pregnancy.
Females capable of becoming pregnant should be reminded to use an effective method of birth control during treatment and for at least two weeks after the last dose of gefitinib tablets, and they should avoid becoming pregnant during this time.
Patients should also disclose all medications they are taking, including prescription and over-the-counter medicines, vitamins, or herbal supplements. If they are taking a proton pump inhibitor (PPI), H2 blocker, or antacid, they should discuss with their healthcare provider the best timing for taking these medications during treatment with gefitinib tablets.
Lastly, patients taking the blood thinner warfarin should be informed that their healthcare provider will need to perform regular blood tests to monitor how quickly their blood clots during treatment with gefitinib tablets.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent contamination and degradation. Special handling needs should be observed to avoid exposure to extreme temperatures or conditions that may compromise the integrity of the product.
Additional Clinical Information
Clinicians are advised to obtain periodic liver function testing for patients undergoing treatment with gefitinib tablets. It is important to counsel pregnant women about the potential risks to a fetus associated with this medication. Additionally, females of reproductive potential should be instructed to use effective contraception during treatment and for at least two weeks after completing therapy.
Postmarketing experience has revealed reports of bullous conditions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, in patients treated with gefitinib tablets.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Gefitinib as submitted by Natco Pharma USA LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.