Osicent
Generic Name
osicent-80-mg-tablet
Manufacturer
PharmaCorp International
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| osicent 80 mg tablet | ৳ 500.00 | ৳ 5,000.00 |
Description
Overview of the medicine
Osicent 80 mg Tablet is a targeted therapy used in the treatment of certain types of cancer, specifically non-small cell lung cancer (NSCLC) with specific EGFR mutations. It works by selectively inhibiting epidermal growth factor receptor (EGFR) tyrosine kinase activity.
Uses & Indications
Dosage
Adults
80 mg orally once daily, with or without food.
Elderly
No specific dose adjustment required based on age.
Renal_impairment
No dose adjustment required for mild to moderate renal impairment. Severe renal impairment data limited, use with caution.
How to Take
Take Osicent 80 mg Tablet orally once daily, at approximately the same time each day. Swallow the tablet whole with water. Do not crush, chew, or split the tablet.
Mechanism of Action
Osicent is an irreversible, potent, and selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It targets both EGFR-sensitizing mutations and the EGFR T790M resistance mutation, which are commonly found in NSCLC. By inhibiting EGFR phosphorylation, it blocks downstream signaling pathways that promote cell proliferation and survival in cancer cells.
Pharmacokinetics
Onset
Clinical effects typically observed within weeks of treatment initiation.
Excretion
Mainly via feces (68%), with a smaller portion via urine (14%).
Half life
Approximately 48 hours.
Absorption
Well absorbed orally, peak plasma concentration reached within 6-8 hours.
Metabolism
Primarily metabolized by CYP3A4 and flavin-containing monooxygenase (FMO) enzymes, with active metabolites.
Side Effects
Contraindications
- Hypersensitivity to osicent or any excipients
- Co-administration with St. John's wort
Drug Interactions
QTc-prolonging agents
Increased risk of QTc prolongation, monitor ECG.
Strong CYP3A4 Inducers (e.g., Rifampicin, Phenytoin)
May decrease osicent plasma concentrations, reducing efficacy. Avoid co-administration or adjust dose.
Strong CYP3A4 Inhibitors (e.g., Itraconazole, Clarithromycin)
May increase osicent plasma concentrations, increasing toxicity. Monitor closely, consider dose reduction.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Treatment of overdose should consist of general supportive measures. In case of suspected overdose, interrupt Osicent therapy and monitor the patient's condition closely.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose. It is not known whether osicent is excreted in human milk; avoid breastfeeding during treatment and for 6 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to osicent or any excipients
- Co-administration with St. John's wort
Drug Interactions
QTc-prolonging agents
Increased risk of QTc prolongation, monitor ECG.
Strong CYP3A4 Inducers (e.g., Rifampicin, Phenytoin)
May decrease osicent plasma concentrations, reducing efficacy. Avoid co-administration or adjust dose.
Strong CYP3A4 Inhibitors (e.g., Itraconazole, Clarithromycin)
May increase osicent plasma concentrations, increasing toxicity. Monitor closely, consider dose reduction.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Treatment of overdose should consist of general supportive measures. In case of suspected overdose, interrupt Osicent therapy and monitor the patient's condition closely.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose. It is not known whether osicent is excreted in human milk; avoid breastfeeding during treatment and for 6 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Under patent protection (until 2035)
Clinical Trials
Numerous phase I, II, and III clinical trials (e.g., FLAURA, AURA3) have demonstrated the efficacy and safety of osicent in various settings of NSCLC. Studies showed superior progression-free survival compared to standard chemotherapy or earlier generation TKIs.
Lab Monitoring
- Complete Blood Count (CBC) at baseline and periodically
- Liver function tests (LFTs) at baseline and periodically
- Renal function tests at baseline and periodically
- Electrolytes (e.g., potassium, magnesium) before and during treatment
- ECG at baseline and periodically for QTc prolongation
Doctor Notes
- Confirm EGFR mutation status before starting treatment.
- Monitor for ILD symptoms; discontinue if suspected.
- Regularly assess cardiac function (ECG, ECHO) due to potential QTc prolongation and cardiomyopathy.
- Counsel patients on adherence and side effect management, especially skin and gastrointestinal issues.
Patient Guidelines
- Inform your doctor about all medications and supplements you are taking.
- Report any new or worsening symptoms immediately.
- Do not stop taking the medicine without consulting your doctor.
- Avoid prolonged sun exposure and use sunscreen.
- Perform regular skin checks for rashes or skin changes.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is less than 12 hours before the next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Osicent may cause fatigue or visual disturbances. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Maintain good hydration.
- Practice good skin care and moisturize regularly.
- Avoid irritants that can worsen skin or nail conditions.
- Eat a balanced diet.
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