KADCYLA 100 mg powder for concentrate for solution for infusion 100 mg Powder for concentrate for solution for infusion Vial

Product Overview

KADCYLA (trastuzumab emtansine) is a highly specialized, targeted therapy designed for the treatment of HER2-positive breast cancer.

It is an antibody-drug conjugate (ADC) that combines the HER2-targeting capabilities of trastuzumab with the potent chemotherapy drug emtansine.

This innovative approach allows for the selective delivery of chemotherapy directly to cancer cells, minimizing damage to healthy tissues.

For more detailed information, please refer to official product information sources such as , , and .

Benefits of KADCYLA

• Targets HER2-positive cancer cells specifically, reducing systemic toxicity.
• Proven efficacy in improving progression-free and overall survival in eligible patients.
• Offers a unique mechanism of action as an antibody-drug conjugate.
• May be effective in patients who have previously received trastuzumab and a taxane.

How to Use KADCYLA

1. KADCYLA is an intravenous infusion that must be prepared and administered by a qualified healthcare professional.
2. The recommended dose is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle).
3. The initial infusion should be administered over 90 minutes. Subsequent infusions may be given over 30 minutes if the prior infusion was well tolerated.
4. Patients should be monitored closely for infusion-related reactions during and after administration.
5. Dosage adjustments or interruptions may be necessary based on individual patient tolerance and observed adverse reactions.

Caution & Warnings

• Hepatotoxicity: Severe liver injury, including hepatic failure, has been reported. Monitor liver function tests regularly.
• Cardiac Dysfunction: May cause left ventricular dysfunction. Cardiac function should be assessed prior to and during treatment.
• Pulmonary Toxicity: Interstitial lung disease (ILD) and pneumonitis, some fatal, have occurred. Discontinue KADCYLA if ILD is diagnosed.
• Peripheral Neuropathy: Monitor for signs and symptoms of neuropathy; dose modification may be required.
• Thrombocytopenia: Decreased platelet counts are common; monitor complete blood counts prior to each dose.
• Extravasation: Avoid extravasation as it may lead to tissue damage.
• Embryo-Fetal Toxicity: KADCYLA can cause fetal harm when administered to a pregnant woman. Advise women of reproductive potential of the potential risk.
• Hypersensitivity and Infusion-Related Reactions: Monitor patients for signs of hypersensitivity reactions.

Ingredients

• Active Ingredient: Trastuzumab emtansine (T-DM1)
• Excipients: Sucrose, Polysorbate 20, Sodium Succinate, Succinic Acid.

Product Details

• Form: Powder for concentrate for solution for infusion
• Strength: 100 mg per vial
• Manufacturer: Roche
• Drug Type: Prescription Only Medicine (Targeted Oncology Therapy)
• Storage: Store vials in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton to protect from light.