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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
- February 28, 2022
- 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
- February 28, 2022
- Manufacturer
- Teva Pharmaceuticals, Inc.
- Registration number
- ANDA208913
- NDC root
- 0480-4053
- 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 treatment of metastatic non-small cell lung cancer (NSCLC). It is specifically indicated for patients whose tumors have certain mutations in the epidermal growth factor receptor (EGFR), namely exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations can lead to uncontrolled cell growth and cancer progression, and gefitinib works by blocking the activity of the mutated EGFR, thereby inhibiting tumor cell proliferation.
By targeting the EGFR, gefitinib helps to prevent the signals that promote cancer cell growth and survival. It binds more effectively to the mutated forms of EGFR compared to the normal version, making it a tailored treatment option for those with specific genetic profiles in their tumors.
Uses
Gefitinib tablets are used as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) when their tumors have specific 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 gefitinib has not been proven safe or effective 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 food or on an empty stomach, whichever you prefer. It's important to stick to this daily schedule to get the best results from your treatment.
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 tablets, such as skin reactions and diarrhea. It's important to monitor these symptoms, as more serious reactions can occur. For instance, interstitial lung disease (a condition affecting the lungs) may develop, and if you notice worsening respiratory symptoms, you should stop taking the medication. Liver function tests are necessary, as liver damage can occur, requiring you to stop the medication if liver function worsens.
Other serious side effects include gastrointestinal perforation, which is a serious condition that requires immediate discontinuation of the drug, and severe ocular disorders like keratitis (inflammation of the cornea). If you experience significant skin reactions or diarrhea, you may need to withhold the medication. Additionally, gefitinib can harm a developing fetus, so effective contraception is advised if you are of childbearing age. Most side effects are mild to moderate, but it's essential to stay vigilant and consult your healthcare provider if you have concerns.
Warnings and Precautions
You should be aware of several important warnings and precautions when taking gefitinib tablets. If you experience worsening respiratory symptoms, it may indicate interstitial lung disease (ILD), and you should stop taking the medication. If ILD is confirmed, you must discontinue gefitinib. Regular liver function tests are necessary, as hepatotoxicity (liver damage) can occur; if you have significant liver enzyme elevations, you should withhold the medication and stop it if severe liver impairment develops. Additionally, if you experience gastrointestinal perforation, severe diarrhea, or serious eye issues like keratitis, you need to stop taking gefitinib.
It's crucial to understand that gefitinib can cause harm to a developing fetus, so effective contraception is advised if you are of childbearing age. Always consult your doctor if you have any concerns or experience any of these symptoms while on gefitinib.
Overdose
If you suspect an overdose of gefitinib tablets, it’s important to stop taking the medication immediately. While most patients experience mild to moderate side effects, it’s crucial to monitor your condition closely. Supportive care, which means taking steps to help manage any symptoms, should be initiated, and you should be observed until your condition stabilizes.
There are no specific treatments for gefitinib overdose, so your healthcare provider will focus on providing supportive care. If you notice any unusual symptoms or if you feel unwell, seek medical attention right away. Remember, it’s always better to be cautious and get help if you’re unsure about your health.
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. Animal studies have shown that this medication can lead to serious issues, including fetal harm and neonatal death, even at doses lower than what is typically recommended for humans. Therefore, it is crucial to discuss the risks with your healthcare provider, as there is a possibility of miscarriage or major birth defects, although the exact background risk for these outcomes in the general population is not fully known.
Research indicates that gefitinib can cross the placenta, which means it can affect your developing baby. In studies with pregnant rats, exposure to gefitinib resulted in fewer live births and higher rates of neonatal mortality. Similar effects were observed in rabbits, where the medication led to reduced fetal weight. Given these findings, it is essential to weigh the potential risks and benefits of using gefitinib during pregnancy with your doctor.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to be aware of the potential risks associated with gefitinib, a medication used to treat certain types of cancer. While it is not known if gefitinib passes into human breast milk, studies in animals have shown that it can be present in rat milk at levels significantly higher than in the mother's blood. This raises concerns about the possibility of serious side effects in nursing infants.
Due to these risks, it is recommended that you discontinue breastfeeding while undergoing treatment with gefitinib. Always consult with your healthcare provider for personalized advice and to discuss any concerns you may have 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 pediatric patients (children and adolescents). If you are considering this treatment for your child, it is important to discuss it thoroughly with their healthcare provider to understand the potential risks and benefits.
Geriatric Use
In clinical trials involving 823 patients, a significant portion—45%—were aged 65 and older, with 11% being 75 years and older. The good news is that no overall safety differences were found between older adults and younger patients, meaning that the medication is generally safe for use in this age group. However, it's important to note that there isn't enough information to determine if the medication works differently for older adults compared to younger individuals.
As you consider treatment options, keep in mind that while the safety profile appears consistent across age groups, individual responses can vary. Always consult with a healthcare provider to discuss any specific concerns or to tailor the treatment to meet the unique needs of older adults.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to monitor your liver health regularly. You should have periodic liver function tests (these tests check how well your liver is working). If your tests show a Grade 2 or higher elevation in ALT or AST (enzymes that indicate liver health), you will need to stop taking gefitinib tablets until your liver function improves. In cases of severe liver impairment, you should discontinue the medication altogether. Always consult your healthcare provider for guidance tailored to your specific situation.
Drug Interactions
It's important to talk to your healthcare provider about any medications you are taking, especially if you are prescribed gefitinib tablets. If you are using strong CYP3A4 inducers (medications that can increase the activity of certain enzymes in your body), your doctor may need to adjust your gefitinib dose to 500 mg daily. Conversely, if you are taking CYP3A4 inhibitors (medications that can decrease enzyme activity), your doctor will want to monitor you closely for any side effects.
Additionally, if you are on proton pump inhibitors (medications that reduce stomach acid), it's best to avoid using them with gefitinib if possible. If you are taking warfarin (a blood thinner), your healthcare provider will need to keep an eye on your blood clotting levels, as changes may occur. Always ensure you discuss all your medications and any lab tests with your healthcare provider to ensure your safety and the effectiveness of your treatment.
Storage and Handling
To ensure the safety and effectiveness of your product, store it at a temperature between 20° to 25°C (68° to 77°F), which is considered a controlled room temperature. This helps maintain its quality. When you need to dispense the product, make sure to use a tight, light-resistant container that has a child-resistant closure. This is important for preventing accidental exposure, especially to children.
Always handle the product with care, keeping it in its designated container when not in use. Following these guidelines will help you use the product safely and effectively.
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 unborn child. Women who can become pregnant should use effective contraception during treatment and for at least two weeks after finishing the medication.
Additionally, some serious skin conditions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, have been reported in patients taking gefitinib tablets. If you notice any unusual skin reactions, contact your healthcare provider immediately.
FAQ
What is Gefitinib?
Gefitinib is a kinase inhibitor used for the treatment of metastatic non-small cell lung cancer (NSCLC) with specific epidermal growth factor receptor (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 be used during pregnancy?
Gefitinib can cause fetal harm; pregnant women should be advised of the potential risks and use effective contraception during treatment.
Is it safe to breastfeed while taking Gefitinib?
It is not known if Gefitinib is excreted in human milk, so women are advised to discontinue breastfeeding during treatment.
What should I do if I experience severe side effects?
You should discontinue Gefitinib and contact your doctor if you experience gastrointestinal perforation or persistent ulcerative keratitis.
How should Gefitinib be stored?
Store Gefitinib at 20° to 25°C (68° to 77°F) in a tight, light-resistant container with a child-resistant closure.
Are there any contraindications for Gefitinib?
There are no specific contraindications listed for Gefitinib.
What laboratory tests are recommended while taking Gefitinib?
Periodic liver function testing is recommended to monitor for hepatotoxicity.
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 4-Quinazolinamine N-(3-chloro-4-fluorophenyl)-7-methoxy-6-3-(4-morpholinyl) propoxy. Its molecular formula is C22H24ClFN4O3, and it has a relative molecular mass of 446.9 daltons. Gefitinib appears as a white-colored powder and is classified as a free base. The molecule exhibits pKa values of 5.4 and 7.2, demonstrating sparing solubility at pH 1, while being practically insoluble above pH 7. The solubility of gefitinib decreases sharply between pH 4 and pH 6. In non-aqueous solvents, gefitinib is freely soluble in glacial acetic acid and dimethyl sulfoxide, soluble in pyridine, sparingly soluble in tetrahydrofuran, and slightly soluble in methanol, ethanol (99.5%), ethyl acetate, propan-2-ol, and acetonitrile.
Gefitinib is formulated as light brown to brown film-coated tablets, each containing 250 mg of gefitinib for oral administration. The inactive ingredients in the tablet core include croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The tablet coating consists of polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow 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 possess 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 actions based on clinical findings.
Interstitial Lung Disease (ILD) Interstitial lung disease has been reported in patients taking gefitinib. In cases of worsening respiratory symptoms, it is imperative to withhold gefitinib tablets. Should ILD be confirmed, discontinuation of gefitinib is required.
Hepatotoxicity Periodic liver function tests must be conducted to monitor liver health. If there are elevations in ALT and/or AST of 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 For patients experiencing Grade 3 or higher diarrhea, it is necessary to withhold gefitinib tablets until the condition is resolved.
Ocular Disorders Patients should be monitored for signs and symptoms of severe or worsening ocular disorders, including keratitis. If such symptoms arise, gefitinib tablets should be withheld. Persistent ulcerative keratitis necessitates discontinuation of the medication.
Bullous and Exfoliative Skin Disorders In cases of Grade 3 or higher skin reactions or exfoliative conditions, gefitinib tablets should be withheld to prevent further complications.
Embryo-fetal Toxicity Gefitinib has the potential to cause fetal harm. Healthcare professionals must advise patients of this risk and recommend the use of effective contraception during treatment.
Laboratory Monitoring Regular liver function testing is essential to ensure patient safety while on gefitinib therapy.
Side Effects
Adverse reactions associated with gefitinib tablets have been observed in clinical trials and postmarketing experiences. The adverse reactions can be categorized into common and serious reactions.
Common adverse reactions reported include skin reactions and diarrhea. These events were generally mild to moderate in severity and consistent with the known safety profile of gefitinib tablets.
Serious adverse reactions include interstitial lung disease (ILD), which has been documented in patients taking gefitinib tablets. In cases of worsening respiratory symptoms, it is recommended to withhold gefitinib tablets, and discontinuation is advised if ILD is confirmed. Hepatotoxicity is another serious concern; periodic liver function testing should be conducted, with withholding of gefitinib tablets for Grade 2 or higher elevations in ALT and/or AST, and discontinuation for severe hepatic impairment.
Gastrointestinal perforation is a critical adverse reaction that necessitates immediate discontinuation of gefitinib tablets. Diarrhea, while common, can also be serious; withholding of gefitinib tablets is recommended for Grade 3 or higher diarrhea. Ocular disorders, including keratitis, require withholding of gefitinib tablets for any signs or symptoms of severe or worsening conditions, with discontinuation advised for persistent ulcerative keratitis. Additionally, bullous and exfoliative skin disorders warrant withholding of gefitinib tablets for Grade 3 or higher skin reactions or exfoliative conditions.
It is important to note that gefitinib tablets 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.
Overall, while adverse events associated with gefitinib tablets were primarily mild to moderate, careful monitoring and management of serious reactions are essential for patient safety.
Drug Interactions
Concomitant use of gefitinib tablets with strong CYP3A4 inducers necessitates an increase in the gefitinib dosage to 500 mg daily to maintain therapeutic efficacy.
When gefitinib is used alongside CYP3A4 inhibitors, careful monitoring for adverse reactions is advised due to the potential for increased gefitinib exposure and associated toxicity.
The use of gefitinib tablets with proton pump inhibitors should be avoided if possible, as these medications can significantly alter gastric pH and potentially affect the absorption and efficacy of gefitinib.
In patients receiving warfarin, it is essential to monitor prothrombin time or INR closely, as gefitinib may increase the risk of hemorrhage, necessitating adjustments in anticoagulant therapy based on the patient's clinical status.
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 should be exercised 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, while 93 patients (11%) were 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. Given the lack of specific efficacy data for geriatric patients, healthcare providers should exercise caution when prescribing this medication to elderly patients. Monitoring for any adverse effects and adjusting dosages as necessary may be prudent in this population.
Pregnancy
Gefitinib tablets can cause fetal harm when administered to pregnant patients, as indicated by its mechanism of action and animal data. In reproductive studies conducted in animals, oral administration of gefitinib from organogenesis through weaning resulted in fetotoxicity and neonatal death at doses below the recommended human dose. Therefore, healthcare professionals should advise pregnant women of the potential hazards to a fetus and the risk of pregnancy loss associated with gefitinib.
The background risk of major birth defects and miscarriage in the indicated population is unknown; however, in the U.S. general population, the background risk for major birth defects is estimated to be between 2% and 4%, while the risk of miscarriage is approximately 15% to 20% of clinically recognized pregnancies.
Pharmacokinetic studies in rats have demonstrated that gefitinib crosses the placenta following an oral dose of 5 mg/kg. When pregnant rats were treated with this dose from the beginning of organogenesis to the end of weaning, there was a notable reduction in the number of offspring born alive. This effect was exacerbated at a higher dose of 20 mg/kg, which was associated with increased neonatal mortality shortly after birth. Additionally, in rabbits, administration of 20 mg/kg/day resulted in reduced fetal weight.
Given these findings, healthcare providers should exercise caution when prescribing gefitinib to women of childbearing potential and consider the potential risks to the fetus.
Lactation
It is not known whether gefitinib is excreted in human milk. However, animal studies have shown that gefitinib and its metabolites are present in rat milk at concentrations higher than those in maternal plasma. Specifically, levels of gefitinib and its metabolites were found to be 11- to 19-fold higher in milk than in blood following oral exposure of lactating rats to a dose of 5 mg/kg. Due to the potential for serious adverse reactions in nursing infants from gefitinib, it is advised that lactating mothers discontinue breastfeeding during treatment with gefitinib tablets.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.
Hepatic Impairment
Patients with hepatic impairment should undergo periodic liver function testing to monitor for hepatotoxicity. If alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations reach Grade 2 or higher, gefitinib tablets should be withheld. In cases of severe hepatic impairment, discontinuation of gefitinib is recommended. Regular monitoring and appropriate management of liver function are essential to ensure patient safety and treatment efficacy.
Overdosage
In clinical observations involving twenty-three patients treated weekly with doses ranging from 1,500 mg to 3,500 mg of gefitinib tablets, it was noted that exposure to the drug did not increase proportionally with escalating doses. The adverse events reported in these cases were predominantly mild to moderate in severity and aligned with the established safety profile of gefitinib tablets.
In the event of a suspected overdose, it is recommended to immediately interrupt the administration of gefitinib tablets. Supportive care should be instituted, and patients should be closely monitored until clinical stabilization is achieved. It is important to note that there are no specific measures or treatments indicated for managing gefitinib tablets overdosing. Therefore, healthcare professionals should focus on supportive management and observation during the recovery process.
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 reduced from 375 mg/m²/day starting at week 22. This study revealed the development of hepatocellular adenomas in female mice. Similarly, a two-year carcinogenicity study in rats at a dose of 60 mg/m²/day, approximately 0.4 times the recommended daily clinical dose on a mg/m² basis, resulted in the occurrence of hepatocellular adenomas and hemangiomas/hemangiosarcomas of the mesenteric lymph nodes in female rats. The clinical significance of these findings remains uncertain.
In a dedicated fertility study involving 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 decrease in corpora lutea, and reductions 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 that may also result in death, have been documented. Symptoms indicative of liver issues include jaundice (yellowing of the skin or eyes), dark or tea-colored urine, light-colored stools, decreased appetite, and pain in the right side of the abdomen.
Cases of perforation in the wall of the stomach or intestines have been reported, necessitating immediate medical attention for severe abdominal pain.
Diarrhea is a common adverse event associated with gefitinib tablets, with some instances being severe. Patients are advised to inform their healthcare provider if they experience severe or persistent diarrhea.
Ocular issues have been reported, including watery eyes, sensitivity to light, blurred vision, eye pain, redness, or changes in vision.
Skin reactions such as redness, rash, itching, and acne are frequently observed. Severe skin reactions, including peeling or blistering, require prompt medical attention.
Additionally, gefitinib tablets may lead to fertility problems in females, and patients are encouraged to discuss family planning with their healthcare provider.
Patients are advised 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 regular 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 event of severe or persistent diarrhea, patients are advised to contact their healthcare provider promptly.
Ocular disorders, including keratitis, may occur; therefore, 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. If a patient becomes pregnant during treatment, they should inform their healthcare provider right away.
Women who are breastfeeding should be advised to discontinue breastfeeding during treatment with gefitinib tablets, as it is not known if the medication passes into breast milk. Patients should discuss alternative feeding options with their healthcare provider during this time.
Before initiating treatment with gefitinib tablets, patients should inform their healthcare provider about all their medical conditions, particularly any lung or breathing problems, history of liver issues, vision or eye problems, and any plans for pregnancy.
Patients taking an effective method of birth control during treatment and for at least two weeks after the last dose of gefitinib tablets should be emphasized, along with the importance of avoiding pregnancy during this period.
Patients should also disclose all medications they are taking, including prescription and over-the-counter medicines, vitamins, or herbal supplements. If they are using a proton pump inhibitor (PPI), H blocker, or antacid, they should consult their healthcare provider regarding the optimal timing for taking these medications during treatment with gefitinib tablets.
Lastly, patients on the blood thinner warfarin should be informed that their healthcare provider will need to conduct regular blood tests to monitor clotting times during treatment with gefitinib tablets.
Storage and Handling
The product is supplied in a tight, light-resistant container equipped with a child-resistant closure. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.
Additional Clinical Information
Clinicians are advised to obtain periodic liver function tests 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 that bullous conditions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, have been reported in patients treated with gefitinib tablets.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Gefitinib as submitted by Teva Pharmaceuticals, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.