AryoTrust (Trastuzumab) for Treatment of Breast cancer and Gastric cancer

AryoTrust contains the active ingredient Trastuzumab (a monoclonal antibody). Trastuzumab attach to specific proteins or antigens and is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2). HER2 is found on the surface of some cancer cells where it stimulates their growth. AryoTrust binds to HER2 and stops the growth of such cells, causing them to die.

• You have early breast cancer, with high levels of a protein called HER2.

• You have metastatic breast cancer with high levels of HER2. AryoTrust may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as the first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful. AryoTrust is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone receptor-positive metastatic breast cancer.

• You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-flououracil and cisplatin.

• You are allergic to Trastuzumab, murine (mouse) proteins, or to any of the other ingredients of this medicine.

• You have severe breathing problems at rest due to your cancer or if you need oxygen treatment.

• If you are under the age of 18 years.

• Heart problems: AryoTrust when used alone or with a taxane may affect the heart, especially if you have ever used an anthracycline. The effects may be moderate to severe and could cause death. Therefore, your heart function will be checked before, every three months and after for up to two to five years) treatment with AryoTrust. If you develop any signs of heart failure, your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop AryoTrust treatment.

• You have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine, or are currently taking any high blood pressure medicine.

• You have ever had or are currently using a medicine called doxorubicin or epirubicin. These medicines or any other anthracyclines can damage the heart muscle and increase the risk of heart problems with AryoTrust.

• You suffer from breathlessness, especially if you are currently using a taxane. AryoTrust may cause breathing difficulties, especially when it is first given. This could be more serious if you are already breathless. Very rarely, patients with severe breathing difficulties before treatment have died when they were given AryoTrust.

• You have ever had any other treatment for cancer. If you receive AryoTrust with any other medicine to treat cancer, such as an aromatase inhibitor, capecitabine, paclitaxel, docetaxel, 5-fluorouracil, or cisplatin.

• If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. You should use effective contraception during treatment with AryoTrust and for at least 7 months after treatment has ended.

• Do not breastfeed your baby during AryoTrust therapy and for 7 months after the last dose of AryoTrust as AryoTrust may pass to your baby through your breast milk.

• Tell your doctor if have recently taken, you are taking, or may take any other medicines. It may take up to 7 months for AryoTrust to be removed from the body. Therefore you should tell your doctor, that you have had AryoTrust if you start any new medicine in the 7 months after stopping treatment.

AryoTrust may affect your ability to drive a car or operate machines. If you experience symptoms, such as chills or fever during treatment, you should not drive or use machines until these symptoms disappear.

Before starting the treatment your doctor will determine the amount of HER2 in your tumour. Only patients with a large amount of HER2 will be treated with AryoTrust. AryoTrust should only be given by a doctor or nurse. Your doctor will prescribe a dose and treatment regimen that is right for you. The dose of AryoTrust depends on your body weight.

AryoTrust intravenous formulation is given as an intravenous infusion directly into your veins. The first dose is given over 90 minutes and you will be observed by a doctor while it is being given in case you have any side effects. If the first dose is tolerated the next doses may be given over 30 minutes. The number of infusions you receive will depend on how well you respond to the treatment.

In order to prevent medication errors, it is important to check the vial labels to ensure that the medicine is prepared and given is AryoTrust (Trastuzumab) and not Trastuzumab emtansine.

AryoTrust is given every 3 weeks. AryoTrust may also be given once a week for metastatic breast cancer.

AryoTrust is available in 150 mg powder and 440 mg powder.

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 AryoTrust to be removed from your body. Therefore your doctor may decide to continue to check your heart functions, even after you finish treatment. If you have any further questions on the use of this medicine, ask your doctor.

• Infusion-related reactions: During AryoTrust infusion, chills, fever, and other flu-like symptoms may occur. These are very common. 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 heartbeat), swelling of the face and lips, rash and feeling tired. Some of these symptoms can be serious and some patients have died.

• These effects mainly occur with the first intravenous infusion and during the first few hours after the start of the infusion. They are temporary. You will be observed by a doctor during the infusion and for at least six hours after the start of the first infusion and for two hours after the start of other infusions. If you develop a reaction, they may stop or slow down the infusion and may give you treatment to counteract the side effects. The infusion may be continued after the symptoms improve. Usually, the symptoms start later than six hours after the infusion begins. If this happens to you, contact your doctor right away. Sometimes, symptoms may improve and then get worse later. Other side effects can occur at any time during treatment with AryoTrust, not just related to an infusion.

• Heart problems: can sometimes occur during treatment and occasionally after treatment has stopped and can be serious. They include weakening of the heart muscle possibly leading to heart failure, inflammation (swollen, red, hot, and in pain) of the lining around the heart, and heart rhythm disturbances. This can lead to symptoms such as:
  • Breathlessness (including breathlessness at night),
  • Cough,
  • Fluid retention (swelling) in the legs or arms,
  • Palpitations (heart fluttering or irregular heartbeat).
  • Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms

• Infections, diarrhea, constipation, heartburn (dyspepsia), weakness

• Skin rashes, chest pain, abdominal pain, joint pain

• Low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever

• Muscle pain, conjunctivitis, watery eyes, nose bleeds, runny nose, hair loss, tremor, hot flush, dizziness

• Nail disorders, weight loss, loss of appetite, inability to sleep (insomnia), altered taste

• Low platelet count, bruising, numbness or tingling of the fingers and toes

• Redness, swelling, or sores in your mouth and/or throat

• Pain, swelling, redness, or tingling of hands and/or feet

• Breathlessness, headache, cough, vomiting, and nausea

• Bladder and skin infections, shingles

• Allergic reactions, throat infections

• Inflammation of the breast, inflammation of the liver

• Kidney disorders

• Pain in the arms and/or legs, Itchy rash

• Increased muscle tone or tension (hypertonia)

• Hemorrhoids, itchiness

• Sleepiness (somnolence)

• Dry mouth and skin

• Dry eyes, sweating

• Feeling weak and unwell

• Anxiety, depression

• Abnormal thinking, asthma

• Infection of lungs, lung disorders

• Back pain, neck pain, Bone pain

• Leg cramps

• Acne

• Bumpy rash

• Deafness

• Blood infection

• Jaundice

• Weakness

• Inflammation or scarring of the lungs

• Anaphylactic reactions

• Abnormal or impaired blood clotting

• Swelling of the brain, swelling or bleeding at the back of the eye

• High potassium levels

• Shock

• Swelling of the lining of the heart

• Slow heart rate

• Abnormal heart rhythm

• Respiratory distress

• Respiratory failure

• Acute accumulation of fluid in the lungs

• Acute narrowing of the airways

• Abnormally low oxygen levels in the blood

• Difficulty in breathing when lying flat

• Liver damage/failure

• Swelling of the face, lips, and throat

• Abnormally low levels of fluid around baby in the womb

• Kidney failure

• Failure of the lungs of the baby to develop in the womb

• Abnormal development of the kidneys of the baby in the womb

Some of the side-effects you experience may be due to your underlying cancer. If you receive AryoTrust in combination with chemotherapy, some of them may also be due to the chemotherapy.

• AryoTrust will be stored by the health professionals at the hospital.

• Keep this medicine out of reach of children.

• The unopened vial should be stored in a refrigerator (2 – 8°C).

• Do not freeze the reconstituted solution.

The active ingredient is Trastuzumab

The inactive ingredient(s) are L-histidine hydrochloride, L-histidine, α,α-trehalose dihydrate, polysorbate 20