HER-2N 200 mg (Tablet)

Indications

• Treatment of HR-positive, HER2-negative advanced breast cancer
• Combination therapy with aromatase inhibitor or fulvestrant

Pharmacology

• Inhibitor of cyclin-dependent kinase 4 and 6
• Regulation of cell cycle progression
• Reduced cell proliferation
• Tumor growth inhibition

Dosage & Administration

• Oral administration with or without food
• Recommended starting dose of 600 mg once daily for 21 days followed by 7 days off
• Dose interruption, reduction, and discontinuation may be required based on safety and tolerability

Interaction

• Avoid concomitant use with strong CYP3A inhibitors
• Avoid concomitant use with strong CYP3A inducers
• Dose adjustment may be needed for sensitive CYP3A substrates
• Avoid concomitant use with drugs known to prolong QT interval

Side Effects

• Common adverse reactions including leukocytes and platelets decrease, nausea, fatigue, diarrhea, alopecia, rash, back pain
• Laboratory abnormalities include increased aspartate aminotransferase and creatinine

Pregnancy & Lactation

• Potential fetal harm when administered to pregnant women
• No data on presence in human milk or effects on breastfed infants

Precautions & Warnings

• Monitoring for pulmonary symptoms indicative of ILD/pneumonitis
• Severe cutaneous adverse reactions
• QT interval prolongation
• Hepatobiliary toxicity
• Neutropenia
• Embryo-fetal toxicity

Therapeutic Class

• Targeted Cancer Therapy

Storage Conditions

• Keep below 30°C temperature
• Away from light & moisture
• Keep out of the reach of children

Related Brands

• Kisqali 200 mg (Tablet) - novartis-bangladesh-ltd