Hyaluronidase is a genetically designed protein. Trastuzumab is a cancer medicine.

Hyaluronidase and trastuzumab is a combination medicine used to treat certain types of breast cancer.

Hyaluronidase and trastuzumab may also be used for purposes not listed in this medication guide.

hyaluronidase and trastuzumab 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 caregiver right away if you feel dizzy, nauseated, feverish, chilled, short of breath, or if you have diarrhea, a rash, chest pain, swelling in your face, or trouble breathing.

hyaluronidase and trastuzumab is injected under the skin, usually once every 3 weeks.

A healthcare provider will give you this injection.

Hyaluronidase and trastuzumab is usually given for 1 year, or until your body no longer responds to the medicine.

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.

Hyaluronidase and trastuzumab can have long lasting effects on your body. You may need frequent medical tests while using this medicine and for at least 2 years after your last dose.

Usual Adult Dose for Breast Cancer:

10,000 units/600 mg (10,000 units hyaluronidase/600 mg trastuzumab) subcutaneously over 2 to 5 minutes every 3 weeks

Duration of therapy:
-Treat adjuvant breast cancer for 52 weeks or until disease recurrence, whichever occurs first; extending therapy beyond one year is not recommended.
-Treat metastatic breast cancer until progression of disease.

Comments:
-If a dose is missed, it should be given as soon as possible, and the next dose should be given 3 weeks later.

Uses:
-For adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel OR as with docetaxel and carboplatin OR as a single agent following multi-modality anthracycline based therapy
-For metastatic breast cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer OR as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

This medicine 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)

Tell your doctor if you have ever had:

• heart problems;

• high blood pressure; or

• if you have recently had an infection.

Do not use hyaluronidase and trastuzumab 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.

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 hyaluronidase and trastuzumab on the baby.

It may not be safe to breast-feed 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 hyaluronidase and trastuzumab injection.

Since hyaluronidase and trastuzumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, feverish, chilled, short of breath, or if you have diarrhea, a rash, chest pain, swelling in your face, or trouble breathing.

Hyaluronidase and trastuzumab may cause serious side effects. Call your doctor at once if you have:

• new or worsening cough, wheezing, shortness of breath or rapid breathing;

• swelling in your face or lower legs, rapid weight gain;

• fast or pounding heartbeats, fluttering in your chest;

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

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

• fluid build-up in the lungs--pain when you breathe, feeling short of breath while lying down, gasping for breath, cough with foamy mucus; or

• low blood cell counts--fever, sore throat, tiredness, skin sores, pale skin, cold hands and feet, feeling light-headed.

Common side effects of hyaluronidase and trastuzumab may include:

• nausea, vomiting, diarrhea;

• fever, chills, tiredness;

• cough, breathing problems;

• swelling;

• hair loss;

• flushing (sudden warmth, redness, or tingly feeling);

• headache, muscle or joint pain;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• sleep problems (insomnia);

• rash; or

• pain, burning, itching, swelling, warmth redness, bruising, bleeding, skin changes, or a hard lump where the medicine was injected.

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 affect hyaluronidase and 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.

Hyaluronidase and 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 trastuzumab, tell any doctor who treats you that you have used hyaluronidase and trastuzumab.