Herceptin is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Herceptin is used to treat certain types of breast cancer or stomach cancer. Other cancer medicines are sometimes used in combination with Herceptin.

Herceptin is sometimes used when the cancer has spread to other parts of the body (metastatic).

Do not use Herceptin if you are pregnant. It could harm the unborn baby. Avoid becoming pregnant for at least 7 months after your last dose of trastuzumab. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Herceptin can cause heart failure, especially if you have heart disease or if you are also receiving certain other cancer medicines.

Some side effects may occur during the injection. Tell your caregivers if you feel dizzy, nauseated, light-headed, weak, short of breath, or if you have a headache, fever, or chills.

Before taking this medicine

You should not be treated with Herceptin if you are allergic to trastuzumab.

To make sure Herceptin is safe for you, tell your doctor if you have ever had:

• heart disease;

• congestive heart failure;

• a heart attack; or

• any allergies or breathing problems.

Trastuzumab can cause heart failure, especially if you have heart disease or if you are also receiving certain other cancer medicines (such as daunorubicin, doxorubicin, epirubicin, or idarubicin).

You may need to have a negative pregnancy test before starting this treatment.

Do not use Herceptin if you are pregnant. This medicine can cause injury or death to the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose. Tell your doctor if you become pregnant during treatment.

If you become pregnant while using this medicine or within 7 months after you stop, your name may be listed on a pregnancy registry to track the effects of trastuzumab on the baby.

It may not be safe to breastfeed while using this medicine and for up to 7 months after your last dose. Ask your doctor about any risk.

Herceptin is given as an infusion into a vein. A healthcare provider will give you this injection.

Herceptin is usually given once every week or every 1 to 3 weeks. Follow your doctor's dosing instructions very carefully.

Your doctor will perform a medical test to make sure trastuzumab is the right medicine to treat your cancer.

This medicine must be given slowly, and the infusion can take up to 90 minutes to complete.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Your heart function may need to be checked before and during treatment with trastuzumab. You may also need heart function testing every 6 months for 2 years after your last dose of this medicine.

Herceptin is usually given for 52 weeks, or until your body no longer responds to the medication.

Usual Adult Dose of Herceptin for Breast Cancer:

For use in the treatment of metastatic breast cancer:
Administer trastuzumab, alone or in combination with paclitaxel.
Initial dose: 4 mg/kg IV infusion over 90 minutes
Subsequent therapy: 2 mg/kg IV infusion over 30 minutes once weekly until disease progression

Usual Adult Dose of Herceptin for Breast Cancer -- Adjuvant:

Administer according to one of the following doses and schedules:

1) Initiate trastuzumab during and following paclitaxel, docetaxel, or docetaxel/carboplatin:
Initial dose: 4 mg/kg IV infusion over 90 minutes then 2 mg/kg IV infusion over 30 minutes weekly during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin).
Subsequent therapy: one week after the last weekly dose of trastuzumab, give trastuzumab as 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks for a total of 52 weeks of therapy.
or
2) Initiate trastuzumab as a single agent within 3 weeks following completion of all chemotherapy.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks for a total of 17 doses (52 weeks of therapy)

Usual Adult Dose of Herceptin for Esophageal Carcinoma:

For use in the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma:
Administer trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks until disease progression

Usual Adult Dose of Herceptin for Gastric Cancer:

For use in the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma:
Administer trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil.
Initial dose: 8 mg/kg IV infusion over 90 minutes
Subsequent therapy: 6 mg/kg IV infusion over 30 to 90 minutes every 3 weeks until disease progression

You should not be treated with Herceptin if you are allergic to trastuzumab.

To make sure Herceptin is safe for you, tell your doctor if you have ever had:

• heart disease;

• congestive heart failure;

• a heart attack; or

• any allergies or breathing problems.

Trastuzumab can cause heart failure, especially if you have heart disease or if you are also receiving certain other cancer medicines (such as daunorubicin, doxorubicin, epirubicin, or idarubicin).

You may need to have a negative pregnancy test before starting this treatment.

Do not use Herceptin if you are pregnant. This medicine can cause injury or death to the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 7 months after your last dose. Tell your doctor if you become pregnant during treatment.

If you become pregnant while using this medicine or within 7 months after you stop, your name may be listed on a pregnancy registry to track the effects of trastuzumab on the baby.

It may not be safe to breastfeed while using this medicine and for up to 7 months after your last dose. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your trastuzumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Herceptin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection, or in the days afterward. Tell your caregiver right away if you feel dizzy, nauseated, itchy, light-headed, weak, short of breath, or if you have a headache, fever, chills, or chest pain.

Call your doctor at once if you have:

• new or worsening cough;

• a light-headed feeling, like you might pass out;

• severe headache, blurred vision, pounding in your neck or ears;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• heart problems - pounding heartbeats, dizziness, swelling in your lower legs, rapid weight gain, feeling short of breath;

• low blood cell counts - fever, chills, tiredness, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed; or

• signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Herceptin side effects may include:

• heart problems;

• nausea, diarrhea, weight loss;

• headache;

• trouble sleeping, feeling tired;

• low blood cell counts;

• rash;

• fever, chills, cough, or other signs of infection;

• mouth sores;

• altered sense of taste; or

• cold symptoms such as stuffy nose, sinus pain, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with trastuzumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Trastuzumab can have long lasting effects on your heart, especially if you receive other cancer medicines. For at least 7 months after your last dose of Herceptin, tell any doctor who treats you that you have used this medicine.