Kadcyla 100 mg/vial (IV Infusion)

Indications

• Treatment of HER2-positive metastatic breast cancer
• For patients who have received prior treatment with trastuzumab and a taxane

Pharmacology

• Trastuzumab Emtansine contains a HER2-targeted antibody-drug conjugate
• Conjugation of DM1 to trastuzumab increases intracellular delivery of DM1 directly to malignant cells
• MCC linker limits systemic release and increases targeted delivery of DM1
• DM1 binds to tubulin, inhibiting tubulin polymerization and causing apoptotic cell death

Dosage & Administration

• Recommended dose is 3.6 mg/kg given as an intravenous infusion every 3 weeks
• First infusion should be administered over 90 minutes with observation for infusion-related reactions
• Subsequent infusions can be administered over 30 minutes if prior infusions were well tolerated
• Closely monitor the infusion site for possible subcutaneous infiltration during drug administration

Interaction

• In vitro metabolism studies suggest that DM1 is metabolized mainly by CYP3A4 and to a lesser extent by CYP3A5
• Caution should be taken when Kadcyla is co-administered with potent CYP3A inhibitors

Contraindications

• Contraindicated in patients with known hypersensitivity to Trastuzumab Emtansine or any of its excipients

Pregnancy & Lactation

• Not recommended for use in pregnant women
• Potential for harm to the fetus
• Discontinue nursing prior to initiating treatment with trastuzumab emtansine
• Women may begin nursing 7 months after concluding treatment

Precautions & Warnings

• Patients treated with Kadcyla must have confirmed HER2-positive tumor status

Use in Special Populations

• Safety and efficacy in children below 18 years of age have not been established
• Insufficient data to establish the safety and efficacy in patients 75 years of age or older

Therapeutic Class

• Anti neoplastic preparations

Storage Conditions

• Store vials at 2°C-8°C

Related Brands

• Kadcyla 160 mg/vial (IV Infusion) - roche-bangladesh-ltd