Herceptin 150 mg VIAL (Refrigerator)

Trastuzumab 150 mg powder concentrate, solution for infusion

What Trastuzumab is used for:

• Trastuzumab is a medication that is used to treat the following indications: 
• Early breast cancer, with high HER2 levels. 
• Metastatic breast cancer (breast cancer that has spread beyond the original tumor) with high HER2 levels.
• Trastuzumab may be given in combination with the chemotherapy medicine known as paclitaxel or docetaxel as primary therapy for metastatic breast cancer or it may be given alone if other medicines did not succeed in giving good results.
• Trastuzumab is also given in combination with medications that belong to a class known as aromatase inhibitors in patients who have high HER2 levels and hormone receptor-positive metastatic breast cancer (cancer that is sensitive to the availability of female sex hormones). 
• Metastatic gastric cancer (stomach cancer that has spread beyond the original tumor) with high HER2 levels, when it is given with other cancer medicines called capecitabine or 5-flououracil and cisplatin.

Do not take Trastuzumab: 

• If you are allergic to Trastuzumab, to murine (mouse) proteins or any of the ingredients in this medicine.
• If you suffer from severe breathing problems at rest that are caused by your cancer or if you require oxygen therapy.

Warnings and Precautions:

• Talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness. 
• Your doctor should monitor your heart for any problems regularly.
• Taking Trastuzumab on its own or with a cancer medicine that belongs to a class known as taxanes may affect the heart, especially if you have previously used an anthracycline (another type of medicine used to treat cancer).
• The effects on the heart may be moderate to severe and can lead to death.
• Therefore, your doctor should check your heart function before, during (every three months) and after (up to two to five years) therapy with Trastuzumab.
• If you experience any signs of heart failure (inability of your heart muscle to pump blood properly), your doctor may need to check your heart function more frequently (every six to eight weeks) and may also start you on a treatment for your heart failure or may decide to completely stop giving you Trastuzumab. 
• Talk to your healthcare provider before you are given Trastuzumab if you have a history of heart diseases like heart failure, heart valve disease (heart murmurs), coronary artery disease, high blood pressure, or if you currently take or have previously taken medications used to treat high blood pressure or a medicine known as doxorubicin or epirubicin (medicines used to treat cancer).
• The use of doxorubicin or epirubicin (or other anthracyclines) can cause damage to your heart muscle and put you at higher risk of developing heart problems when being treated with Trastuzumab. 
• Talk to your healthcare provider before you are given Trastuzumab if you suffer from difficulty breathing, especially if you are also taking a taxane.
• Trastuzumab can lead to breathing problems, particularly during the start of therapy with this medicine.
• These breathing difficulties can be very serious if you already feel breathless.
• Very rarely, patients who already had severe breathing difficulties prior to starting their therapy with Trastuzumab have died when Trastuzumab was started. 
• Talk to your healthcare provider before you are given Trastuzumab if you have ever taken any other cancer therapy.
• If you will be receiving Trastuzumab with any other cancer medicines, like docetaxel, paclitaxel, an aromatase inhibitor, 5-fluorouracil, capecitabine or cisplatin, make sure that you read the patient information leaflets for these medicines as well. 
• The use of this medicine is not recommended for patients under the age of 18 years. 

Possible side effects:

• Possible side effects include allergic reactions, heart failure (breathlessness, cough, fluid retention in the legs or arms and palpitations), tumor lysis syndrome (metabolic complications that may happen after cancer treatment causing signs like, nausea, vomiting, weakness, decreased urination, numbness, tingling, diarrhea, fatigue, muscle twitches or cramps, irregular heart rhythm, kidney failure and the need for dialysis, seizure and sometimes death).
• Very common side effects during Trastuzumab infusion include chills, fever and flu like symptoms.
• Other very common side effects of Trastuzumab include heartburn, diarrhea, fatigue, runny nose, skin rash, chest pain, constipation, joint pain, infections, low counts of red blood cells and white blood cells sometimes with fever, abdominal pain, conjunctivitis (type of eye inflammation), watery eyes, muscle pain, nose bleeds, nail disorders, headache, hair loss, numbness or tingling of the fingers and toes, difficulty sleeping, tremor, dizziness, weight loss, loss of appetite, nausea, taste changes, vomiting, bruising, hot flush, low platelet count, swelling, redness, or sores in your mouth or throat, pain, swelling, redness or tingling of hands or feet, difficulty breathing and cough. Common side effects include allergic reactions, dry mouth and skin, throat infections, dry eyes, drowsiness, sweating, neck pain, bladder and skin infections, weakness, anxiety, leg cramps, itchiness, muscle tension, infection of lungs, liver inflammation, pain in the arms or legs, lung problems, depression, breast inflammation, itchy rash, asthma, back ache, hemorrhoids, kidney problems, bone pain and acne. 

Other medicines and Trastuzumab: 

• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including vitamins, prescription medicines, over-the-counter medicines and herbal supplements.
• Keep a list of the medications that you take.
• This medication can take up to 7 months for it to completely exit your body, therefore it is very important that you tell your healthcare providers that you are taking or have taken this medicine during your treatment and for 7 months after your last dose of Trastuzumab.

How to take Trastuzumab:

• Prior to starting this medicine, your doctor will check the amount of HER2 present in your tumor and will start Trastuzumab only if you have a large amount of HER2.
• The dose that you will be receiving depends on your weight. 
• This medicine should only be given by your doctor or nurse. 
• Your doctor will determine the dose and full treatment regimen that you need to receive, which will be specific for you depending on your case.
• There are two different formulations of Trastuzumab; one is an intravenous infusion (infusion into a vein) and the other is a subcutaneous injection (injection under the skin).
• Therefore, it is crucial that you verify the product labels to make sure that the right formulation is being given as prescribed. 
• Trastuzumab intravenous formulation must be administered as an intravenous infusion only and is not intended for subcutaneous use.
• Your doctor may take into consideration changing your Trastuzumab intravenous treatment to Trastuzumab subcutaneous treatment or the other way around depending on your case and what suits you. 
• Trastuzumab intravenous formulation is given as an intravenous infusion (drip) directly into your veins.
• You will be receiving your first dose of Trastuzumab for 90 minutes with the supervision of a health professional to monitor for the development of any side effects.
• Your following doses may be given for 30 minutes if you tolerate your first dose well. Your doctor will determine the number of infusions needed depending on your response to the medication.  
• Make sure that you verify the vial labels before receiving your dose in order to avoid possible medication errors and to ensure that the medicine being prepared and that will be given to you is Trastuzumab and not Trastuzumab emtansine. 
• You will be receiving your medicine every 3 weeks if you are being treated for early/metastatic breast cancer or metastatic gastric cancer. Your doctor may also recommend that you receive Trastuzumab once a week if you have metastatic breast cancer. 
• Trastuzumab may take up to 7 months to completely exit your body. Therefore, your doctor may keep on monitoring your heart functions, even after finishing your therapy with this medicine.

How to store Trastuzumab: 

• Store medication in its original container in the refrigerator at 2° to 8°C until time of use. Do not freeze the reconstituted medication. 
• Protect medication from direct sunlight. 
• Do not use the medication beyond the expiry date mentioned on the carton and the vial label. 
• Keep the medication out of the sight and reach of children and pets. 
• Infusion solutions must be used right after dilution. 
• Do not use the solution if you notice any particulate matter or discoloration in it. 
• Do not discard the medicine in wastewater or household waste.