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Other brands with the same active ingredient
These brands contain the same active ingredient (Gefitinib). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Seberb 250 mg Tablet is indicated for:
Pharmacology
Gefitinib reversibly inhibits the kinase activity of wild-type EGFR and certain of its activating mutations, preventing autophosphorylation of tyrosine residues linked to the receptor. This blocks further downstream signalling and stops EGFR-dependent cell proliferation. Gefitinib binds more strongly to EGFR carrying an exon 19 deletion or the exon 21 point mutation L858R than it does to wild-type EGFR. It also inhibits IGF and PDGF-mediated signalling at clinically relevant concentrations, though its effects on other tyrosine kinase receptors have not been fully characterized.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Recommended dose: 250 mg Gefitinib taken by mouth once daily, with or without food, continued until disease progression or unacceptable toxicity. A missed dose should not be taken within 12 hours of the next dose.
Administration to patients who have difficulty swallowing solids: Drop the Gefitinib tablet into 4 to 8 ounces of water and stir for approximately 15 minutes. The liquid should be drunk immediately or administered through a naso-gastric tube. Rinse the container with another 4 to 8 ounces of water, and drink this immediately or administer it through the naso-gastric tube.
Side Effects
The most common side effects of this tablet are interstitial lung disease, liver toxicity (hepatotoxicity), gastrointestinal perforation, severe or persistent diarrhea, ocular (eye) disorders including keratitis, and bullous and exfoliative skin disorders.
Cautions & Contraindications
Warnings & Precautions
Interstitial lung disease (ILD): ILD or ILD-like adverse drug reactions (for example lung infiltration, pneumonitis, acute respiratory distress syndrome, or pulmonary fibrosis) occurred in 1.3% of the 2462 patients who received Genib across clinical trials. Genib should be withheld and the patient promptly investigated for ILD whenever respiratory symptoms such as dyspnea, cough and fever get worse. It should be permanently discontinued if ILD is confirmed. Hepatotoxicity: Among patients receiving Genib across clinical trials, 11.4% had increased alanine aminotransferase (ALT), 7.9% had increased aspartate aminotransferase (AST), and 2.7% had increased bilirubin. Liver function tests should be carried out periodically. Genib should be withheld in patients with worsening liver function and discontinued in patients with severe hepatic impairment. Gastrointestinal perforation: Gastrointestinal perforation occurred in three (0.1%) of the 2462 Genib-treated patients across clinical trials. It should be permanently discontinued in patients who develop gastrointestinal perforation. Severe or persistent diarrhea: Grade 3 or 4 diarrhea occurred in 3% of the 2462 Genib-treated patients across clinical trials. It should be withheld for severe or persistent (up to 14 days) diarrhea. Ocular disorders including keratitis: Ocular disorders, namely keratitis (0.1%), corneal erosion and aberrant eyelash growth (0.2%), and conjunctivitis, blepharitis and dry eye (6.7%), occurred in the 2462 Genib-treated patients across clinical trials. It should be interrupted or discontinued for severe or worsening ocular disorders. Bullous and exfoliative skin disorders: Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme have been reported with Genib treatment. Erythema multiforme and dermatitis bullous have been reported in two patients (0.08%) across NSCLC trials. Genib treatment should be interrupted or discontinued if the patient develops severe bullous, blistering or exfoliating conditions.
Contraindications
Gefitinib must not be used in patients with a known hypersensitivity (allergy) to Gefitinib or to any of the other ingredients in this medicine.
Pregnancy & Breastfeeding
There are no adequate, well-controlled studies of Gefitinib in pregnant women. If a woman uses Gefitinib during pregnancy, or becomes pregnant while taking it, she should be told about the possible harm to the unborn baby and the chance that the pregnancy could be lost. It is not known whether Gefitinib passes into breast milk. Because it could cause serious side effects in a nursing baby, mothers should be advised to stop breastfeeding while they are on Gefitinib.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Children: the safety and effectiveness of Gefitinib in children have not been established.
Severe kidney problems: no clinical studies were done with Gefitinib in patients who have severe renal impairment.
Liver problems: if Gefitinib is given to patients with moderate or severe hepatic impairment, their adverse reactions should be monitored.
Storage
Keep Gefitinib at a temperature between 20 and 25°C. Choose a cool, dry place and keep it away from sunlight. Always keep it out of the reach of children.
Drug Interactions
Common questions about Seberb 250 mg Tablet 250 mg
What is Seberb 250 mg Tablet 250 mg Tablet?
Seberb 250 mg Tablet 250 mg Tablet is a medicine that contains Gefitinib. It is made by Genvio Pharma Ltd. It belongs to the Targeted Cancer Therapy group of medicines.
What is Seberb 250 mg Tablet used for?
Seberb 250 mg Tablet is used for: Cancer.
What are the side effects of Seberb 250 mg Tablet?
The most common side effects of this tablet are interstitial lung disease, liver toxicity (hepatotoxicity), gastrointestinal perforation, severe or persistent diarrhea, ocular (eye) disorders including keratitis, and bullous and exfoliative skin disorders.
Can I take Seberb 250 mg Tablet during pregnancy or while breastfeeding?
There are no adequate, well-controlled studies of Gefitinib in pregnant women. If a woman uses Gefitinib during pregnancy, or becomes pregnant while taking it, she should be told about the possible harm to the unborn baby and the chance that the pregnancy could be lost. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Seberb 250 mg Tablet?
Keep Gefitinib at a temperature between 20 and 25°C. Choose a cool, dry place and keep it away from sunlight.
Can I take other medicines with Seberb 250 mg Tablet?
Some medicines can interact with Gefitinib, for example: Rifampicin, Itraconazole, Ketoconazole, Phenytoin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Seberb 250 mg Tablet?
Seberb 250 mg Tablet is a prescription (Rx) medicine. Take it as your doctor advises.