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Ositag 80mg Tablet 10pcs
Ositag is prescribed for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have specific epidermal growth factor receptor (EGFR) mutations, such as exon 19 deletions or exon 21 L858R mutations. These mutations must be identified using an FDA-approved test. Additionally, it is used for patients with metastatic NSCLC with the EGFR T790M mutation who have experienced disease progression after treatment with EGFR tyrosine kinase inhibitors (TKIs).
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✅ Description:
Osimertinib is a kinase inhibitor targeting specific mutant forms of EGFR (T790M, L858R, and exon 19 deletion), with minimal activity against normal EGFR. In both cell cultures and animal models, it has shown potent anti-tumor activity against NSCLC cell lines with EGFR mutations. Two active metabolites (AZ7550 and AZ5104) have been identified, contributing to its overall effectiveness. AZ5104, in particular, demonstrates greater potency against certain mutations and wild-type EGFR.
The drug exhibits dose-proportional pharmacokinetics between 20 and 240 mg. After oral administration, it accumulates over 15 days, achieving steady-state levels. It has a half-life of approximately 48 hours, with most of the drug being eliminated through feces (68%) and, to a lesser extent, urine (14%).
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✔️ Quick Tips for Patients
- Take the medication at the same time daily for best results.
- Stay hydrated to manage diarrhea, a common side effect.
- Report unusual symptoms like severe rash, difficulty breathing, or extreme fatigue.
- Regular blood tests are necessary to monitor for side effects.
- Avoid pregnancy or breastfeeding while on this medication.
✔️ Dosage & Administration
The recommended dose is 80 mg once daily, taken with or without food. If a dose is missed, skip it and take the next dose as scheduled. Do not double the dose.
For patients who have difficulty swallowing:
- Disperse the tablet in 60 ml of non-carbonated water.
- Stir gently (the tablet will break into pieces but won’t fully dissolve).
- Drink immediately. Rinse the glass with 120–240 ml of water to ensure all medication is consumed.
For nasogastric tube administration, follow the same dispersal method, using 15 ml of water for dispersion and an additional 15 ml to rinse. The solution must be consumed or administered within 30 minutes of preparation.
✔️ Common side effects include
- Digestive system: Diarrhea, loss of appetite, stomatitis (mouth inflammation).
- Skin: Rash, dry skin, nail toxicity.
- General: Fatigue, decreased appetite.
✔️ Rare but serious side effects:
- Lung: Interstitial lung disease (pneumonitis).
- Heart: QTc prolongation, cardiomyopathy.
✔️ Special Population
- Pediatric: Not established.
- Geriatric: Older adults may experience more severe side effects.
- Renal impairment: No dose adjustment is needed for mild to severe renal impairment.
- Hepatic impairment: No dose adjustment is required for mild to moderate liver issues, but data is lacking for severe cases.
✔️ Drug Interactions
- Strong CYP3A inhibitors (e.g., itraconazole, ritonavir): These can increase Ositag levels in the blood. If no alternative exists, patients should be closely monitored for side effects.
- Strong CYP3A inducers (e.g., phenytoin, rifampicin): These can reduce Ositag levels and should be avoided.
- Other drugs metabolized by CYP3A or BCRP: Caution is advised as Ositag may alter their plasma concentrations.
✔️ Precautions & Warnings
- Interstitial Lung Disease (ILD): Monitor for symptoms like shortness of breath, cough, or fever. Severe cases may require discontinuation.
- QTc Prolongation: Monitor heart rhythms and electrolytes in at-risk patients.
- Pregnancy & Fertility: Ositag can harm a developing fetus. Women should use contraception during treatment and for 6 weeks afterward. Men should use contraception for 4 months after the final dose.
- Breastfeeding: Not recommended due to the potential risk to the infant.
✔️ Storage
Store below 30°C, away from light and moisture. Safely dispose of expired or unused medicine. Keep out of reach of children.
⚠️Disclaimer:
At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.
