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.

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

• 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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Dosage Modification for Adverse Reactions:
CARDIOMYOPATHY:

• Assess left ventricular ejection fraction (LVEF) prior to initiating therapy and at regular intervals during therapy.
• Withhold dosing for at least 4 weeks for either of the following: Greater than or equal to 16% absolute decrease in LVEF from pretreatment values OR LVEF below institutional limits of normal and 10% or greater absolute decrease in LVEF from pretreatment values.
• Therapy may be resumed if, within 4 to 8 weeks, the LVEF returns to normal limits and the absolute decrease from baseline is 15% or less.
• Permanently discontinue therapy for a persistent (longer than 8 weeks) LVEF decline or for suspension of dosing on more than 3 occasions for cardiomyopathy.

Precautions

US BOXED WARNINGS:
CARDIOMYOPATHY:

• This drug can cause subclinical and clinical cardiac failure. Incidence and severity are highest in patients receiving it with anthracycline-containing chemotherapy regimens.

• Evaluate left ventricular function (LVF) in all patients prior to and during therapy.
• Discontinue therapy in patients receiving adjuvant therapy and withhold this drug in patients with metastatic disease for clinically significant decrease in LVF.

• This drug can cause serious and fatal pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration.

• Discontinue therapy for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
• Monitor patients until symptoms completely resolve.

• If this drug is given during pregnancy it can cause oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

• Advise patients of these risks and the need for effective contraception.

• None

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for subcutaneous administration only.
• No loading dose is required.
• No dose adjustments for body weight or for different concomitant chemotherapy regimens are required.
• The injection site should be alternated between the left and right thigh. New injections should be given at least 2.5 cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender, or hard, or areas where there are moles or scars.
• The dose should be administered subcutaneously over approximately 2 to 5 minutes.
• Other subcutaneous medicinal products should preferably be injected at different sites.

• Store unused vials in the refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light. Do not freeze. Do not shake. When removed from the refrigerator, this drug should be administered within 4 hours and should not be kept above 30C (86F).

• The product is a ready to use solution for injection which does not need to be diluted.
• To avoid needle clogging, attach the hypodermic injection needle to the syringe immediately prior to administration followed by volume adjustment to 5 mL.
• This drug is compatible with polypropylene and polycarbonate syringe material and stainless-steel transfer and injection needles.
• Prepare the dosing syringe in aseptic conditions.
• After the solution is withdrawn from the vial and into the syringe, replace the transfer needle with a syringe closing cap.
• Label the syringe with the peel-off sticker.

• Select patients for therapy based on an approved companion diagnostic for trastuzumab.

Frequently asked questions

• What is Herceptin? Is Herceptin a chemo drug? How does it work?