Gefitinib Tablets 250mg Technical Specification:
Product Name: | Gefitinib Tablets 250mg |
Brand Name: | Gefitinib |
Strength: | 100mg, 250mg |
Dosage Form: | Film-coated Tablet |
Packing: | 10s, 30s |
Route of Administration: | For Oral Use only. |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Anti-Cancer |
Indication: | Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes. |
Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Gefitinib Tablets 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.
THERAPEUTIC INDICATIONS:
Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86° F).
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Why Taj Pharmaceuticals ?
Taj Pharma stands as a beacon of hope in the fight against cancer with our Gefitinib Tablets. We are dedicated to improving the lives of patients battling cancer by offering a reliable and effective treatment option. Our commitment to quality and innovation is unwavering, ensuring that you receive the best care possible. When you choose Taj Pharma for Gefitinib Tablets, you choose a company with a rich history of pharmaceutical excellence. With years of experience, we have developed a deep understanding of cancer therapies, and our products reflect this expertise. Our Gefitinib Tablets are formulated to meet the highest industry standards, giving patients and healthcare professionals the confidence they need in the battle against cancer. At Taj Pharma, we prioritize your well-being. Our rigorous quality control measures guarantee that every tablet is safe and effective, providing you with a powerful tool in the fight against cancer. We understand the importance of reliability when it comes to cancer treatment, and that’s why our Gefitinib Tablets have earned the trust of medical practitioners and patients alike. Make an informed choice for your cancer treatment journey. Choose Taj Pharma’s Gefitinib Tablets and experience the difference in quality, innovation, and care. Together, we can make strides toward a brighter and healthier future.
What are Gefitinib Tablets and their use?
Gefitinib Tablets are a medication used in the treatment of certain types of cancer, particularly non-small cell lung cancer (NSCLC). Gefitinib is the active ingredient in these tablets, and it belongs to a class of drugs called epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors.
The primary use of Gefitinib Tablets is to target and inhibit the EGFR protein, which plays a crucial role in the growth and spread of cancer cells in some cases of NSCLC. NSCLC is one of the most common forms of lung cancer, and it can be further categorized based on specific genetic mutations in the EGFR gene. Gefitinib is particularly effective in treating NSCLC when it is associated with certain EGFR mutations.
Used:
- EGFR Mutation Detection: Before prescribing Gefitinib, a patient’s tumor tissue is usually tested for EGFR mutations. This is important because the drug tends to be most effective in patients with specific EGFR mutations, such as exon 19 deletions or L858R mutations.
- FirstLine Treatment: For patients with advanced or metastatic NSCLC and specific EGFR mutations, Gefitinib may be prescribed as a first-line treatment. It can be used as an initial therapy to help control the growth of cancer cells.
- Maintenance Therapy: In some cases, Gefitinib can be used as a maintenance therapy after a patient has responded well to initial chemotherapy. This means patients continue taking Gefitinib to help prolong the period of disease control.
- SecondLine Treatment: For patients who have progressed on other EGFRtargeted therapies or have developed resistance to previous treatments, Gefitinib may still be considered as a second-line treatment option.
- Symptom Management: Gefitinib can help alleviate symptoms associated with advanced lung cancer, such as difficulty breathing, pain, and coughing, which can improve a patient’s overall quality of life.
It’s essential to note that the use of Gefitinib Tablets is specific to patients with EGFRmutated NSCLC, and it may not be effective for other types of cancer or nonmutated NSCLC. The decision to use Gefitinib as part of a cancer treatment regimen should be made by an oncologist or healthcare provider after careful consideration of the patient’s individual circumstances and the results of EGFR mutation testing. Additionally, like all medications, Gefitinib may have potential side effects, and patients should be monitored closely during treatment.
how do Gefitinib Tablets work?
Gefitinib Tablets work by targeting a specific protein called epidermal growth factor receptor (EGFR) in cancer cells. To understand how Gefitinib functions, let’s break down the process:
- EGFR and Cancer: In many cases of non-small cell lung cancer (NSCLC) and some other cancers, there is an overexpression of the EGFR protein or mutations in the EGFR gene. This overexpression or mutation can lead to uncontrolled cell growth and division, a hallmark of cancer.
- EGFR Signaling: EGFR is a receptor on the surface of cancer cells that plays a critical role in transmitting signals for cell growth and proliferation. When a growth factor (such as epidermal growth factor or EGF) binds to EGFR, it activates a cascade of signals inside the cell that promote cell division and survival.
- Inhibition by Gefitinib: Gefitinib is classified as a tyrosine kinase inhibitor. It works by blocking the activity of the EGFR tyrosine kinase, which is the part of the EGFR protein responsible for transmitting signals inside the cell. By inhibiting this kinase activity, Gefitinib disrupts the downstream signaling pathways that drive cancer cell growth and division.
- Apoptosis Induction: In addition to inhibiting cell growth signals, Gefitinib can also promote apoptosis (cell death) in cancer cells. This is another way in which it can reduce the size and progression of tumors.
- Tumor Shrinkage: When Gefitinib is effective, it can lead to the shrinkage of cancerous tumors and a reduction in cancer symptoms. This is particularly observed in patients with NSCLC who have specific EGFR mutations, such as exon 19 deletions or L858R mutations.
- Resistance and Alternatives: It’s important to note that while Gefitinib can be highly effective initially, some patients may develop resistance to the drug over time. In such cases, alternative treatments or newer EGFR inhibitors may be considered.
Benefits of Gefitinib Tablets:
- Effective Treatment: Gefitinib can be highly effective in treating certain types of cancer, particularly non-small cell lung cancer (NSCLC) with specific EGFR mutations. It is often used when standard chemotherapy has not been successful.
- Tumor Shrinkage: One of the primary benefits is the potential for tumor shrinkage. In many cases, patients experience a reduction in the size of cancerous tumors, which can lead to symptom relief and improved quality of life.
- Symptom Improvement: Gefitinib can help alleviate cancer-related symptoms such as coughing, difficulty breathing, and pain, making it easier for patients to manage their condition.
- Prolonged Disease Control: It can be used as a maintenance therapy to help prolong the period of disease control after a patient has responded well to initial treatment.
Potential Side Effects of Gefitinib Tablets:
- Skin Rash: One of the most common side effects of Gefitinib is a skin rash, which can range from mild to severe. It can be itchy and bothersome for some patients.
- Diarrhea: Gefitinib can cause diarrhea, which can also range from mild to severe. It’s important to stay hydrated and report severe or persistent diarrhea to your healthcare provider.
- Liver Problems: Some patients may experience liver problems, including elevated liver enzymes. Regular liver function tests are often performed during treatment.
- Gastrointestinal Issues: Other gastrointestinal side effects can include nausea, vomiting, abdominal pain, and loss of appetite.
- Interstitial Lung Disease (ILD): In rare cases, Gefitinib has been associated with ILD, a potentially serious lung condition. Patients may experience symptoms such as difficulty breathing, cough, or fever, and these should be reported immediately.
- Eye Irritation: Gefitinib can cause eye irritation and changes in vision in some patients.
- Fatigue: Fatigue is a common side effect of cancer treatments, including Gefitinib.
- Changes in Nails and Hair: Some patients may experience changes in their nails (e.g., brittle or discolored) and hair (e.g., thinning or loss).
frequently asked questions about Gefitinib Tablets?
- What is Gefitinib, and what is it used for?
Gefitinib is a medication used in the treatment of certain types of cancer, particularly non-small cell lung cancer (NSCLC) with specific EGFR mutations.
- How does Gefitinib work?
Gefitinib works by inhibiting the activity of the EGFR protein, which is often overactive in some cancer cells. This inhibition disrupts the signaling pathways that promote cancer cell growth and division.
- Who is a suitable candidate for Gefitinib treatment?
Patients with NSCLC who have specific EGFR mutations, such as exon 19 deletions or L858R mutations, are suitable candidates for Gefitinib treatment.
- How is Gefitinib administered?
Gefitinib is typically taken orally in the form of tablets, and the dosing regimen is determined by a healthcare provider.
- What are the potential side effects of Gefitinib Tablets?
Common side effects may include skin rash, diarrhea, liver problems, gastrointestinal issues, and fatigue. Rare but serious side effects like interstitial lung disease (ILD) can also occur.
- How long should I take Gefitinib?
The duration of Gefitinib treatment varies based on individual patient response and the advice of your healthcare provider. Some patients may take it for an extended period, especially if it continues to be effective.
- Can Gefitinib cure cancer?
Gefitinib is not typically considered a curative treatment for cancer. It is often used to control the growth of cancer cells and manage the disease, potentially leading to tumor shrinkage and symptom relief.
- What should I do if I miss a dose of Gefitinib?
If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule.
- Can I take other medications while on Gefitinib?
It’s important to inform your healthcare provider about all medications, supplements, and herbal products you are taking to ensure there are no interactions with Gefitinib.
- Are there any foods or substances I should avoid while on Gefitinib?
Certain foods or substances (e.g., grapefruit) may interact with Gefitinib, so it’s essential to follow your healthcare provider’s advice regarding dietary restrictions.
- How often will I need to see my doctor during Gefitinib treatment?
Regular checkups and monitoring are crucial during treatment to assess its effectiveness and manage potential side effects. Your doctor will determine the frequency of these visits.
- What should I do if I experience side effects?
If you experience any side effects while taking Gefitinib, it’s essential to promptly report them to your healthcare provider. They can provide guidance on managing side effects.
- Can I continue my daily activities while on Gefitinib?
In general, most patients can continue their daily activities while taking Gefitinib. However, it’s crucial to discuss any specific concerns or limitations with your doctor.
As Gefitinib Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Gefitinib Tablets product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Gefitinib Tablets Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Gefitinib Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
Gefitinib Tablets 100mg
Gefitinib Tablets 250mg
Gefitinib Tablets 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Gefitinib Tablets 100mg
Each film-coated tablet contains:
Gefitinib…………………………100 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron. Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.
Each film-coated tablet contains:
Gefitinib…………………………100 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron. Gefitinib Tablets 250mg
Each film-coated tablet contains:
Gefitinib…………………………250 mg
Excipients……………………….q.s.
Colours: Titanium Dioxide USP, Red Oxide of Iron, Yellow Oxide of Iron.
THERAPEUTIC INDICATIONS:
Gefitinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal epidermal growth factor (EGFR) genes.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a cancer specialist only.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59° to 86° F).
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.