WARNING

Ado-trastuzumab emtansine is a targeted cancer therapy used primarily for HER2-positive breast cancer. It combines trastuzumab, an antibody targeting HER2, with a cytotoxic drug (DM1). While it is effective, it does come with a range of potential risks and side effects. Here’s a detailed overview:

• Heart Problems: Ado-trastuzumab emtansine can impact heart function, potentially leading to heart failure or a decrease in left ventricular ejection fraction (a measure of heart function). Patients are monitored for signs of heart issues, especially if they have a history of heart disease.
• Liver Toxicity: Liver function abnormalities are common, including elevated levels of liver enzymes (such as AST and ALT). This can indicate liver inflammation or damage. In severe cases, it can lead to hepatitis or liver dysfunction. Regular liver function tests are necessary to monitor for these issues.
• Hematologic Effects: Ado-trastuzumab emtansine can cause myelosuppression, leading to reduced levels of red blood cells (anemia), white blood cells (neutropenia, which increases infection risk), and platelets (thrombocytopenia, which increases bleeding risk). Low platelet counts increase the risk of bleeding, while low white blood cell counts heighten susceptibility to infections.
• Infusion Reactions: Some patients may experience infusion-related reactions, such as fever, chills, rash, or difficulty breathing. These reactions can range from mild to severe and may require medical intervention.
• Neurological Effects: This includes symptoms like tingling, numbness, or pain in the hands and feet. These side effects can impact daily activities and quality of life.
• Gastrointestinal Issues: These are common side effects and may require antiemetic medications to manage. Some patients may experience gastrointestinal disturbances such as diarrhea.
• Fatigue: Fatigue and weakness are frequent side effects, which can affect a patient’s ability to perform everyday activities
• Hair Loss: Some patients may experience hair loss or thinning.
• Rash: Skin rashes and other dermatological reactions can occur.

Monitoring and managing these risks typically involve regular check-ups and lab tests to detect and address any adverse effects early. It’s essential for patients to discuss their individual risk profile with their healthcare provider to develop a plan for managing potential side effects.

Why is this medication prescribed?

Ado-trastuzumab emtansine is prescribed for the treatment of HER2-positive breast cancer. Specifically, it is used for:

• Metastatic Breast Cancer: For patients with HER2-positive breast cancer that has spread beyond the breast and axillary lymph nodes, especially if the cancer is not responding well to other treatments.
• Adjuvant Therapy: For patients with HER2-positive early breast cancer who have residual disease after receiving standard treatment, including surgery and chemotherapy.

The drug combines trastuzumab, an antibody that targets HER2 (a protein that promotes cancer cell growth), with emtansine, a chemotherapy drug. This combination allows the medication to deliver the chemotherapy directly to the cancer cells, which helps to kill the cells more effectively while sparing normal cells.

How should this medicine be used?

Ado-trastuzumab emtansine is administered as an intravenous infusion. Here’s a general overview of how it is used:

• Dosage and Administration: The dose is typically based on the patient’s weight and is usually given every 3 weeks. The exact dosage will be determined by the healthcare provider. The medication is infused into a vein through an intravenous (IV) line. The infusion usually takes about 30 to 90 minutes.
• Preparation: The drug is prepared by a healthcare professional in a sterile environment to ensure safety and effectiveness.
• Monitoring: During and after the infusion, patients are closely monitored for any adverse reactions or side effects. This is important because ado-trastuzumab emtansine can cause side effects like nausea, fatigue, or infusion reactions.
• Pre-medication: Sometimes, patients may be given pre-medications to help prevent allergic reactions or other side effects.
• Follow-Up: Regular follow-up appointments are necessary to monitor the patient’s response to the treatment and to manage any side effects.

Always follow the specific instructions provided by the healthcare provider or the medication guide for the most accurate and personalized guidance.

Other uses for this medicine

• HER2-Positive Breast Cancer: It is primarily used for patients with HER2-positive breast cancer who have previously received other HER2-targeted therapies.
• Post-Surgical Use: It can be used in cases of metastatic breast cancer or in combination with other treatments.

What special precautions should I follow?

Special Precautions:

1. • Allergic Reactions: Be vigilant for allergic reactions or infusion-related reactions. Symptoms may include fever, chills, rash, or difficulty breathing. Immediate medical attention is required if these occur.
   • Liver Function: Regular liver function tests are essential as the drug can cause liver problems. Report any signs of liver issues such as jaundice, dark urine, or persistent abdominal pain to your healthcare provider.
   • Heart Health: This medication can affect heart function. Patients should be monitored for signs of heart problems, such as shortness of breath, swelling, or irregular heartbeats.
   • Pregnancy and Contraception: Avoid pregnancy during treatment due to potential harm to the fetus. Effective contraception is necessary, and the medication should not be used during pregnancy. If pregnancy occurs, contact your healthcare provider immediately.
   • Breastfeeding: Do not breastfeed while receiving this treatment, as it is unknown whether the drug passes into breast milk and could potentially harm the infant.
   • Drug Interactions: Inform your healthcare provider about all other medications and supplements you are taking to avoid interactions that could affect the effectiveness or safety of the treatment.
   • Bone Marrow Function: Regular blood tests may be required to monitor bone marrow function and detect any potential issues such as low blood cell counts.

Always follow the guidance of your healthcare provider and report any side effects or concerns you may have during your treatment.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with ado-trastuzumab emtansine. However, maintaining a balanced diet and staying hydrated can help manage overall health and side effects. If you experience any side effects that affect your appetite or digestion, discuss these with your healthcare provider, as they may have additional recommendations.

What should I do if I forget a dose?

• If you miss a dose, contact your healthcare provider or treatment center as soon as possible to reschedule the missed dose.
• Do not try to make up for a missed dose by doubling the next one. Your healthcare provider will give you specific instructions on how to proceed.
• Your healthcare provider will guide you on when to resume treatment and any adjustments needed for your treatment schedule.

What side effects can this medication cause?

Ado-trastuzumab emtansine can cause a range of side effects, some of which may be serious. Here are the common and potentially serious side effects:

Common Side Effects:

• Fatigue: Feeling unusually tired or weak.
• Nausea and Vomiting: Feeling sick to the stomach or throwing up.
• Diarrhea: Frequent, loose, or watery bowel movements.
• Muscle and Joint Pain: Aches and pains in muscles and joints.
• Rash: Skin reactions or changes in skin appearance.
• Loss of Appetite: Reduced desire to eat.
• Headache: Pain or discomfort in the head or upper neck.
• Low Blood Counts: This can lead to anemia (low red blood cells), increased risk of infection (low white blood cells), or bleeding (low platelets).

Serious Side Effects:

• Liver Problems: Symptoms may include jaundice (yellowing of the skin or eyes), dark urine, severe abdominal pain, or elevated liver enzymes.
• Heart Issues: This may include symptoms of heart failure such as shortness of breath, swelling in the legs, and irregular heartbeats.
• Infusion Reactions: These can be severe and include symptoms like fever, chills, rash, and difficulty breathing.
• Low Blood Cell Counts: This can lead to anemia, increased risk of infection, or bleeding problems.
• Neuropathy: Numbness, tingling, or pain in the hands and feet.
• Thrombocytopenia: Low platelet counts, which can increase bleeding risk.
• Rash: Skin rashes or other dermatological reactions.

It’s important to contact your healthcare provider if you experience any severe or persistent symptoms, as they may need to adjust your treatment or provide additional support.

What should I know about storage and disposal of this medication?

Storage and Disposal of Ado-trastuzumab emtansine:

Storage:

• Preparation: Ado-trastuzumab emtansine should be prepared and stored by a healthcare professional.
• Temperature: It should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Shelf Life: The medication should be used within a specific time frame after preparation, as determined by your healthcare provider or pharmacy.

Disposal:

• Used Containers: Dispose of any used vials, syringes, or other materials as per your healthcare provider’s instructions. Typically, these should be placed in a designated sharps container.
• Do Not Dispose of in Household Trash: Do not throw away any unused medication in regular trash or flush it down the toilet unless instructed to do so by your healthcare provider or local disposal guidelines.
• Medication Disposal Programs: Check if there are any local medication take-back programs or facilities for proper disposal.

In case of emergency/overdose

Emergency:

• Contact: If you experience severe side effects, allergic reactions, or other urgent health issues, seek immediate medical attention or go to the nearest emergency room.
• Symptoms: Watch for severe symptoms such as difficulty breathing, severe chest pain, or signs of a serious allergic reaction.

Overdose:

• Immediate Action: If you suspect an overdose or have been given too much ado-trastuzumab emtansine, contact your healthcare provider immediately or go to the emergency room.
• Symptoms: Be aware of any unusual or severe symptoms and report them to your healthcare provider.

What other information should I know?

• Regular Monitoring: Regular medical check-ups and tests are necessary to monitor for side effects and effectiveness of the treatment.
• Drug Interactions: Be aware of potential interactions with other medications you are taking. Inform your healthcare provider about all your current medications and supplements.
• Pregnancy and Contraception: As mentioned earlier, effective contraception is required, and pregnancy should be avoided during treatment.
• Support Resources: Consider joining support groups or counseling if needed, as dealing with cancer treatment can be challenging both physically and emotionally.

Always follow your healthcare provider’s guidance for managing treatment and addressing any concerns that arise.