Kadcyla 160mg Injection contains Trastuzumab emtansine, a medicine that belongs to a group of medicines called HER2-targeted antibody-drug conjugates. It is used to treat certain types of HER2-positive breast cancer. Kadcyla combines trastuzumab, which targets HER2 on cancer cells, with DM1, a medicine that interferes with cancer cell division.

Kadcyla is given as an intravenous infusion by a healthcare professional. Treatment requires regular monitoring because it can affect the liver, heart, lungs, blood cells and nervous system.

Kadcyla 160mg Injection is used to:

• Treat metastatic breast cancer: It is used in adults with HER2-positive unresectable locally advanced or metastatic breast cancer who have previously received trastuzumab and a taxane.

• Treat early breast cancer: It is used as adjuvant treatment in adults with HER2-positive early breast cancer who have residual disease in the breast and/or lymph nodes after pre-operative systemic treatment that included HER2-targeted therapy. 

Kadcyla contains Trastuzumab emtansine, which combines trastuzumab with DM1. Trastuzumab binds to the HER2 protein found in higher amounts on certain breast cancer cells.

After binding to HER2, Kadcyla is taken into the cancer cell. It is then broken down inside the cell and releases DM1-containing components. DM1 interferes with microtubules, which are needed for cancer cells to divide and grow. This helps destroy HER2-positive cancer cells.

Tell your doctor about all medicines, supplements and herbal products you are taking before starting Kadcyla.

• Strong CYP3A inhibitors: DM1 is mainly metabolised by CYP3A4. Medicines that strongly inhibit CYP3A may increase exposure to DM1, so caution is needed when they are used with Kadcyla.

• Blood-thinning medicines: Tell your doctor if you take anticoagulant or antiplatelet medicines because Kadcyla can increase the risk of bleeding.

• Other medicines: Always inform your doctor about all medicines you take so that potential interactions can be assessed before treatment.

• Store Kadcyla 160mg Injection in a refrigerator at 2°C to 8°C.

• Do not freeze the vial.

• Keep the medicine in its original packaging until it is ready for use.

• After reconstitution, the solution should be used as instructed by the healthcare professional. If not used immediately, follow the specified refrigerated storage period.

• Keep the medicine out of the reach of children. 

The Indian pack states that the 160mg vial is for intravenous use after reconstitution and dilution. It contains 160mg trastuzumab emtansine and is reconstituted with 8 mL sterile water for injection, producing a 20mg/mL solution.

Kadcyla 160mg Injection is given only by a healthcare professional experienced in cancer treatment.

Kadcyla must be reconstituted and diluted before administration and is given as an intravenous infusion. It should not be given as an intravenous push or bolus. The recommended dose is 3.6 mg/kg once every 3 weeks. 

The first infusion is given over approximately 90 minutes. If it is well tolerated, later infusions may be given over 30 minutes. Your doctor will decide how long treatment should continue based on the type of breast cancer, response to treatment and tolerability.

If a planned dose is missed, it should be given as soon as possible rather than waiting for the next scheduled cycle. Your doctor will adjust the treatment schedule while maintaining a 3-week interval between doses.

Common side effects of Kadcyla may include:

• Fatigue

• Nausea

• Constipation

• Vomiting

• Diarrhoea

• Headache

• Muscle or joint pain

• Peripheral neuropathy

• Nosebleeds

• Cough

• Fever

• Low platelet count

• Anaemia

• Increased liver enzymes

• Bleeding 

Serious side effects

Seek medical attention if you develop:

• Severe allergic or infusion-related reactions, including difficulty breathing, wheezing, fever or rapid heartbeat.

• Severe or persistent breathing problems, which may indicate lung inflammation.

• Signs of liver injury, such as yellowing of the skin or eyes or other worsening liver symptoms.

• Unusual or severe bleeding.

• Severe numbness, tingling or weakness.

• Symptoms of heart problems, such as breathlessness or swelling.

• Use Kadcyla only under the supervision of a healthcare professional experienced in cancer treatment.

• Your doctor will confirm that your tumour is HER2-positive before treatment.

• Do not confuse Kadcyla with trastuzumab. They are different medicines and should not be substituted for one another without your doctor's advice.

• Liver function tests and platelet counts should be monitored during treatment.

• Your doctor may check your heart function before and during treatment.

• Tell your doctor if you take anticoagulant or antiplatelet medicines.

• Report new or worsening cough, difficulty breathing, unusual bleeding, numbness or tingling to your doctor.

• Do not change your dose or treatment schedule without medical advice.