Herceptin SC: Uses, Side Effects and Dosage

Serious warnings and precautions box

What HERCEPTIN SC is used for:

• HERCEPTIN SC is a cancer medicine that must be prescribed by a doctor.
• Patients whose breast cancer tumour cells produce large amounts of the HER2 protein can use HERCEPTIN SC.
• HERCEPTIN SC is used for certain patients with early breast cancer following surgery and after
• Medication Errors

There is a risk of medication errors between HERCEPTIN (trastuzumab) and trastuzumab emtansine or trastuzumab deruxtecan. Verify with the healthcare provider that the recommended HERCEPTIN (trastuzumab) dose and NOT trastuzumab emtansine or trastuzumab deruxtecan dose is used.

• Cardiotoxicity (harm to the heart)

HERCEPTIN can result in the development of heart problems including heart failure. The appearance of heart failure can be delayed and can occur after treatment with HERCEPTIN is completed. In early breast cancer, the incidence of cardiac dysfunction was higher in patients who received HERCEPTIN plus chemotherapy versus chemotherapy alone, with higher risk when HERCEPTIN was administered together with a taxane following an anthracycline and cyclophosphamide. In patients with breast cancer that has spread to other parts or organs of the body, the incidence and severity of cardiac dysfunction was particularly high in patients who received HERCEPTIN at the same time as anthracyclines and cyclophosphamide.

You should have your heart function evaluated by your doctor before and during treatment with HERCEPTIN.

• Toxicity to Fetus (Unborn Baby)

HERCEPTIN can cause harm to the fetus (unborn baby), in some cases death of the fetus, when taken by a pregnant woman. Women who could become pregnant need to use effective birth control methods during HERCEPTIN treatment and for at least 7 months after treatment with HERCEPTIN. Nursing mothers treated with HERCEPTIN should discontinue nursing or discontinue HERCEPTIN.

• chemotherapy OR following surgery and with taxane chemotherapy as well as for patients to whom breast cancer has spread to other parts or organs of the body.
• HERCEPTIN SC is used to slow down the growth of specific breast cancer cells that produce large amounts of HER2 protein. It is used only for patients whose tumours are growing more rapidly than normal because of a genetic problem in the cells. This occurs in about 25 to 30% of breast cancer tumours.

How HERCEPTIN SC works:

• Our bodies have a natural defence system against cancer cells. When cancer cells appear, our bodies respond by making special proteins called antibodies. The antibodies attach to other proteins on the growing tumour cells. Researchers studied this to learn how to create antibodies that help with cancer treatment.
• Antibodies are now made that can target tumours to try to control the growth of cancer.
• HERCEPTIN SC belongs to a family of medicines called monoclonal antibodies. It is an antibody that targets the HER2 gene to stop its activity. It attaches to the HER2 receptor on the cancer cell. When it is in place, it works to stop the growth of the cancer cells and may destroy them.

The ingredients in HERCEPTIN SC are:

Medicinal ingredient(s): trastuzumab

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 20, Recombinant human hyaluronidase PH20 (rHuPH20), α,α-trehalose dehydrate, Water for injection.

HERCEPTIN SC comes in the following dosage form(s):

HERCEPTIN SC is a solution that is given as an injection under the skin (subcutaneous injection). Each single dose vial of HERCEPTIN SC contains 600 mg trastuzumab.

Do not use HERCEPTIN SC if:

• you are allergic to trastuzumab, Chinese Hamster Ovary (CHO) cell proteins, or any component of this product (see “The ingredients in HERCEPTIN SC are”).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take HERCEPTIN SC. Talk about any health conditions or problems you may have, including if you:

• have ever had a bad reaction to HERCEPTIN or any of the inactive ingredients;
• are allergic to hyaluronidase (an enzyme that is part of the formulation that helps to increase the absorption of injected active substance);
• are allergic to other medicines, food and dyes;
• are taking any other medicines, including those not prescribed by your doctor;
• have any other illness or diseases, such as heart problems, heart disease, breathing problems or lung disease; the risk of heart problems may be increased in geriatric patients in both early breast cancer and breast cancer that has spread to other parts or organs of the body; the risk of lung disease may increase if you have taken chemotherapy drugs which are toxic for the lungs;
• have already been treated with chemotherapy drugs (especially anthracyclines such as doxorubicin, epirubicin or related drugs such as mitoxantrone) or radiation therapy;
• are pregnant, plan to become pregnant or are breast-feeding a child. Please note that a reduction in the amount of [amniotic] fluid that surrounds the developing fetus within the amniotic sac has been observed in pregnant women receiving HERCEPTIN;
• have difficulty breathing at rest.

Other warnings you should know about:

• HERCEPTIN SC has a minor influence on the ability to drive and use machines. Dizziness and sleepiness may occur during treatment with HERCEPTIN SC. If you experience unwanted effects related to the HERCEPTIN SC administration (such as itching, wheezing, dizziness, racing heart) you should not drive or operate machinery until symptoms resolve completely.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Formal drug interaction studies with HERCEPTIN have not been done in humans. Important interactions with other medications were not seen during clinical trials with HERCEPTIN.

How to take HERCEPTIN SC:

Your doctor has prescribed HERCEPTIN SC after carefully studying your condition. Other people may not benefit from taking this medicine, even though their problems may seem similar to yours.

Verify with the healthcare provider that the correct formulation is being given as prescribed. HERCEPTIN SC fixed dose formulation is not for intravenous (IV) use and should be given as a subcutaneous (SC) injection only.

HERCEPTIN SC will be given to you by a health care professional who is experienced with the use of this treatment.

Your doctor may consider switching your HERCEPTIN treatment to HERCEPTIN SC treatment (and vice versa) if considered appropriate for you.

Also verify with the healthcare provider that the recommended HERCEPTIN (trastuzumab) dose and NOT trastuzumab emtansine or trastuzumab deruxtecan dose is used.

Usual dose:

The recommended dose is 600 mg. HERCEPTIN SC is given as a subcutaneous injection (under the skin) over 2 to 5 minutes every three weeks.

The injection site should be alternated between the left and right thigh. New injections should be given at least 2.5 cm away from an old site. No injection should be given into areas where the skin is red, bruised, tender or hard.

If other medicines for subcutaneous use are used during the treatment course with HERCEPTIN SC, a different injection site should be used.

Overdose:

It is unlikely that you will receive too much HERCEPTIN SC as you will be closely monitored by Healthcare Professionals during your administration. However, if you suspect you received too much HERCEPTIN SC contact your doctor and poison control centre immediately.

If you think you, or a person you are caring for, have taken too much HERCEPTIN SC, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

For information on the risk of trastuzumab emtansine or trastuzumab deruxtecan overdose due to medication errors, see their respective Product Monographs.

Missed dose:

If you miss a dose of HERCEPTIN SC, contact your doctor immediately. Your doctor will advise you on when your next administration of HERCEPTIN SC will be.

Possible side effects from using HERCEPTIN SC:

These are not all the possible side effects you may have when taking HERCEPTIN SC. If you experience any side effects not listed here, tell your healthcare professional.

Some unwanted effects happen during the first administration or shortly after it is completed. The effects usually do not last long but may need treatment.

These unwanted effects related to the administration may include:

• Itching
• Wheezing
• Dizziness
• Racing heart

Giving certain medications before the next administration of HERCEPTIN may prevent these unwanted effects.

In clinical studies, the most common unwanted effects were fever and chills, nausea, vomiting, diarrhea, pain, and headache. The symptoms can easily be treated. Giving certain medications before HERCEPTIN can prevent some unwanted effects.

Less common unwanted effects are:

• Shortness of breath and water retention, which are symptoms of heart problems. These are caused by an effect on the heart muscle that reduces the strength of the pumping action of the heart. This unwanted effect is more common in women who have previously had anthracycline chemotherapy (e.g. doxorubicin, epirubicin). Heart failure as a result of HERCEPTIN treatment can vary in severity and may require treatment with heart medications and/or HERCEPTIN treatment may need to be stopped.
• Shortness of breath, fatigue, or a racing heart, which are symptoms of anemia. This is caused by a temporary decrease in the number of red blood cells.
• A temporary decrease in the number of white blood cells may increase your risk of infection and diarrhea.

Difficulty breathing, fatigue and weight loss are commonly seen with lung disease.

Call your doctor immediately if you notice any of the following:

• Shortness of breath;
• Increased cough;
• Swelling of the legs as a result of water retention;
• Diarrhea – if you have an extra four bowel movements each day or any diarrhea at night;

• Symptoms of infection that include:

  • fever: a temperature of 38°C or greater
  • sore throat
  • cough
  • any redness or swelling
  • pain when you pass urine

• Symptoms of an allergic reaction include:

  • closing of the throat
  • swelling of lips and tongue
  • hives
  • rash
  • dizziness
  • fast heartbeat

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• The hospital pharmacy will store HERCEPTIN SC in a refrigerator.
• Keep out of reach and sight of children.

If you want more information about HERCEPTIN SC:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (www.rochecanada.com); or by calling 1-888-762-4388.

Date of Authorization: 2025-05-02

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HERCEPTIN^® is a registered trademark of Genentech Inc., used under license

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