Ujvira 100mg Injection is used for:

• HER2-positive metastatic breast cancer after prior trastuzumab and taxane treatment

• HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy

Ujvira contains trastuzumab emtansine, an antibody-drug conjugate.

The trastuzumab component binds to HER2 receptors on cancer cells, allowing the medicine to be taken into the cell. Inside the cancer cell, DM1 is released and disrupts microtubules, preventing cell division and leading to cancer cell death.

Tell your doctor about all prescription medicines, over-the-counter medicines, vitamins and herbal supplements you take.

• Medicines that strongly inhibit CYP3A4 may increase exposure to DM1 and raise the risk of side effects.

• Medicines that strongly induce CYP3A4 may reduce the effectiveness of the treatment.

• Other medicines that affect liver function should be used with caution.

Your doctor will review your medicines before starting treatment.

• Store Ujvira 100mg Injection in a refrigerator at 2°C to 8°C.

• Do not freeze.

• Keep the vial in its original carton to protect it from light.

• Keep out of the sight and reach of children.

Ujvira 100mg Injection should only be administered by a trained healthcare professional.

It is given as an intravenous infusion. The first infusion is usually given over 90 minutes, and if well tolerated, subsequent infusions may be given over 30 minutes.

The dose is based on body weight and is usually repeated every 3 weeks, unless your doctor recommends a different schedule.

Common side effects may include:

• Fatigue

• Nausea

• Headache

• Muscle or joint pain

• Nosebleeds

• Constipation

• Reduced appetite

• Increased liver enzymes

• Low platelet count

Serious side effects

Seek medical attention immediately if you develop:

• Heart problems

• Severe allergic or infusion-related reactions

• Serious liver injury

• Lung problems

• Significant bleeding due to low platelet counts

• Attend all scheduled heart function tests during treatment.

• Liver function tests and blood counts should be monitored regularly.

• Report unusual bruising or bleeding promptly.

• Tell your doctor if you develop new cough or breathing difficulty.

• Use effective contraception during treatment and for 7 months after the last dose.

• Inform your healthcare team about all medicines and supplements you take.