What are the possible Serious Side Effects of Vivitra^TM (Trastuzumab)?

Not all people have serious side effects, but side effects with Vivitra^TM (Trastuzumab) therapy are common. Your doctor will stop treatment if any serious side effects occur.

Vivitra^TM (Trastuzumab) is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:

HEART (CARDIAC) PROBLEMS¹

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems may high in people who received both Vivitra^TM (Trastuzumab) and a certain type of chemotherapy (anthracycline). Your doctor will check for signs of heart problems before, during, and after treatment with Vivitra^TM (Trastuzumab).

INFUSION REACTIONS, including:¹

• Fever and chills.
• Nausea- sensation of vomiting, uneasiness of stomach.
• Vomiting.
• Pain (in some cases at tumor sites).
• Headache.
• Dizziness.
• Shortness of breath.

These signs usually happen within 24 hours after receiving Vivitra^TM (Trastuzumab).

SEVERE LUNG PROBLEMS, including:¹

• Severe shortness of breath.
• Fluid in or around the lungs.
• Weakening of the valve between the heart and the lungs.
• Not enough oxygen in the body.
• Swelling of the lungs.
• Scarring of the lungs.

Your doctor may check for signs of severe lung problems when he or she examines you.

LOW WHITE BLOOD CELL COUNTS¹

Low white blood cell counts can be life threatening. Low white blood cell counts may occur often in patients receiving Vivitra^TM (Trastuzumab) plus chemotherapy than in patients receiving chemotherapy alone.

Your doctor may check for signs of low white blood cell counts when he or she examines you.

Important Precautions while you are on Vivitra^{TM 1} (Trastuzumab)

Be sure to contact your doctor if,

• You are BREAST-FEEDING or PREGNANT. Vivitra^TM (Trastuzumab) may harm a nursing child or an unborn baby.
• Or you are PLANNING TO BECOME PREGNANT. Taking Vivitra^TM (Trastuzumab) could result in death of an unborn baby or birth defects.

If you stop treatment with Vivitra^TM (Trastuzumab), you should keep using birth control for at least 7 months before trying to become pregnant.

Other Important Information¹

Before taking Vivitra^TM (Trastuzumab), you must have a HER2 test to determine if your cancer is HER2-positive. This is because the benefit of treatment with Vivitra^TM (Trastuzumab) has been shown only in patients whose tumors are HER2-postive.

Side Effects Seen Most Often With Vivitra^{TM 1} (Trastuzumab)

• Fever.
• Nausea.
• Vomiting.
• Infusion reactions.
• Diarrhea.
• Infections.
• Increased cough.
• Headache.
• Feeling tired.
• Shortness of breath.
• Rash.
• Low white and red blood cell counts.
• Muscle pain.

You should contact your doctor immediately if you have any of the side effects listed above.

References

1. Vivitra^TM (Trastuzumab) Prescribing Information