Laparen 250 mg (Tablet)

Indications

• Treatment of advanced or metastatic breast cancer
• Combination therapy for HER2-positive tumor overexpression
• Treatment after prior therapy including Anthracycline, Taxane, and Trastuzumab
• Limitations of use for patients with disease progression on Trastuzumab prior to treatment

Pharmacology

• Kinase inhibitor of EGFR and HER2 receptors
• Inhibition of ErbB-driven tumor cell growth
• Additive effect with specific chemotherapeutic agents
• Absorption following oral administration
• Serum concentrations and peak plasma levels
• High plasma protein binding
• Extensive metabolism by CYP enzymes
• Predominantly hepatic elimination

Dosage & Administration

• Recommended daily dose for different breast cancer indications
• Administration with specific duration and cycle
• Dosing in combination with different chemotherapeutic agents
• Considerations for missed doses and dose adjustments
• No established safety and effectiveness in pediatric patients

Interaction

• Inhibition of drug-metabolizing enzymes and transport systems
• Effects on CYP3A4, CYP2C8, and P-glycoprotein (P-gp)
• Interactions with Midazolam, Paclitaxel, and Digoxin
• Impact of cytochrome P450 3A4 inhibitors and inducers
• Effect of acid-reducing agents on solubility

Contraindications

• Contraindicated in severe hypersensitivity reactions

Side Effects

• Common adverse reactions during treatment
• Adverse reactions based on specific combination therapies

Pregnancy & Lactation

• Potential fetal harm based on animal studies
• Absence of human data on drug-associated risks
• Advisory against breastfeeding during treatment

Precautions & Warnings

• Risk of decreased left ventricular ejection fraction
• Monitoring for hepatoxicity and liver function tests
• Management and intervention for Laparen-induced diarrhea
• Association with interstitial lung disease and pneumonitis
• Risk of QT prolongation and severe cutaneous reactions

Use in Special Populations

• Dose modification guidelines for cardiac events
• Dose adjustments based on hepatic impairment
• Management of diarrhea and concomitant drug interactions
• Discontinuation or interruption of dosing based on toxicities

Overdose Effects

• Absence of known antidote for Laparen overdoses
• Reported asymptomatic and symptomatic overdose cases
• General supportive measures for managing overdose

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Below 30°C in a dry place
• Keep out of the reach of children

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