Herclon® 440 mg Infusion

Herclon contains the active substance trastuzumab, which is a humanised monoclonal antibody. Herclon is used for the treatment of breast and gastric cancer if you have high levels of a protein called HER2 and your chemotherapy is finished. If you have metastatic breast cancer (MBC), Herclon is indicated:

• As monotherapy if you have received at least two chemotherapy regimens for your metastatic disease.
• In combination with paclitaxel or docetaxel if you have not received chemotherapy for your metastatic disease.
• In combination with an aromatase inhibitor if you have hormone-receptor positive metastatic breast cancer.

If you have early breast cancer (EBC), Herclon is indicated:

• Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable); and
• In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
• In combination with adjuvant chemotherapy followed by adjuvant Herclon, for locally advanced breast cancer.

If you have metastatic gastric cancer (MGC), Herclon is indicated:

• In combination with capecitabine or 5-fluorouracil and cisplatin for metastatic cancer of the stomach or gastro-oesophageal junction if you have not received prior anti-cancer treatment for your metastatic disease.

You should not be given Herclon:

• If you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of Herclon.
• If you have breathing problems at rest or if you need oxygen treatment.
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Herclon:

• If you have or have had heart failure, coronary artery disease, heart valve disease (heart murmurs) or high blood pressure. This is because Herclon can cause heart failure.
• If you have ever had chemotherapy with a medicine called doxorubicin or a medicine related to doxorubicin (your doctor can advise you on this). Herclon and doxorubicin-like medicines can damage heart muscle and increase the risk of heart problems when receiving Herclon.
• If you are breathless. Herclon can cause breathing difficulties. This could be more serious if you are already breathless.
• If you have ever had any other treatment for cancer. Your doctor will closely supervise your therapy with Herclon. Treatment with Herclon may affect the heart. Therefore, your heart function will be checked before and during the treatment with Herclon. If you develop any signs of heart failure (that is, inadequate pumping of blood by the heart), you may have to stop Herclon. It may take up to 7 months for Herclon to be removed from the body. Therefore, you should tell your doctor or pharmacist that you have had Herclon if you start any new medicine in the 7 months after stopping treatment.

Use in children and adolescents

Herclon is not recommended for anyone under the age of 18 years.

Other medicines and Herclon

Please tell your doctor or pharmacist that you have had Herclon if you start any medicine in the 6 months after stopping treatment with Herclon. Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).

Pregnancy and Breastfeeding

You must not use Herclon if you are pregnant. Herclon can cause harm to the foetus (unborn baby), in some cases death to the foetus, when taken by a pregnant woman. Before starting treatment, you must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. If you are a woman or a man receiving Herclon, you are advised to use a highly effective form of contraception, including a barrier method, while receiving Herclon and for at least 7 months after your last Herclon dose. Do not breastfeed your baby during Herclon therapy and for 7 months after the last dose of Herclon. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before being given Herclon.

Driving and using machines

It is not known whether Herclon could affect your ability to drive a car or operate machinery. However, if you experience symptoms, such as chills or fever, during an infusion of Herclon, you should not drive or use machines until these symptoms disappear.

Dosage and frequency of administration

Herclon is given as an intravenous infusion (“drip”) directly into your veins. Your doctor will prescribe a dose and treatment regimen that is right for you. The number of infusions you receive will depend on how you respond to the treatment. Your doctor will discuss this with you.

If you stop using Herclon

Do not stop using this medicine without talking to your doctor first. All doses should be taken at the right time every week or every three weeks (depending on your dosing schedule). This helps your medicine work as well as it can. It may take up to 7 months for Herclon to be removed from your body. Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment.

Herclon can cause side effects. Some of these side effects may be serious and may lead to hospitalisation or death. Not all side effects reported for Herclon are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Herclon, please consult your doctor, pharmacist or healthcare professional for advice. Herclon administration can result in severe hypersensitivity reactions (including anaphylaxis), infusion reactions and pulmonary (lung/respiratory) events. These may cause death. In most cases, these symptoms occurred during or within 24 hours of administration of Herclon. During a Herclon infusion, chills, fever and other flu-like symptoms may occur. These are very common. They mainly occur with the first infusion and are temporary. Other infusion-related symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired. These symptoms can be serious and some patients have died (see “Warnings and precautions”). You should tell your doctor immediately if you notice:

• breathlessness (including breathlessness at night)
• cough
• swelling of the lips, face or throat
• fluid retention (swelling) in the legs or arms
• palpitations (heart fluttering or irregular heart beat)

Heart problems can occur and are serious. They include weakening of the heart muscle possibly leading to heart problems, and heart rhythm disturbances. Your doctor will monitor your heart regularly during treatment. Taking Herclon can result in serious and potentially deadly lung problems, including:

• A severe shortness of breath
• Too little oxygen in the body
• Weakening of the heart valve between the heart and the lungs
• Swelling of the lungs
• Fluid in or around the lungs
• Scarring of the lungs

Problems like these may occur after an infusion of Herclon. Some effects mainly occur with the first infusion and during the first few hours after the start of the infusion. Occasionally, symptoms start later than six hours after the infusion begins. Sometimes, symptoms may improve and then get worse later. If either of these happens to you, contact your doctor immediately.

Store out of reach of children. Vials must be stored in a refrigerator (2 °C - 8 °C). Do not use this medicine after the expiry date (EXP) stated on the outer carton and on the vial label. Disposal of unused/expired medicine: The release of pharmaceuticals in the environment should be minimised. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established collection systems, if available in your location.