Hersima 440mg Injection consists of Trastuzumab as an active constituent which is indicated for its use in HER 2 breast cancer. In HER 2 positive patients, the breast cancer cells are mostly composed of HER2 proteins that cause rapid development of cancer tumor by serving as a signal to the cancerous. This medication is also used to treat metastatic gastric cancer with increased levels of HER2 proteins.

Her 2 positive breast cancer are most aggressive in nature. The targeted therapy for her 2 positive breast cancer works by selectively targeting the proteins that are responsible for the growth, development, and spread of cancer. Use effective birth control during the treatment and for at least 7 months after the final dose.

Hersima 440mg Injection is not recommended for patients aged under 18, patients who have severe breathing problems or need oxygen treatment. It is necessary to let your physician know if you have any heart problems, breathlessness, or have ever had any other cancer treatment. Make sure you inform your physician of all the medicines, including supplements and herbal medicines, you are taking before you start treatment with this medication.

Hersima 440mg Injection is indicated for its use in the following conditions:

• Advanced and metastatic breast cancer
• Metastatic gastric cancer

Hersima 440mg Injection is a targeted therapy used for treating HER2-positive breast cancer and gastric cancer. It contains trastuzumab, a monoclonal antibody that binds to the HER2 protein, which is overexpressed in certain cancer cells. By blocking HER2 signaling, Hersima 440mg helps slow down or stop the growth of cancer cells. Additionally, it enhances the body's immune response, enabling it to recognize and attack cancerous cells more effectively. This treatment plays a crucial role in reducing tumor progression, improving survival rates, and enhancing the overall quality of life for patients with HER2-positive cancers.

Hersima 440mg Injection (trastuzumab) can interact with other medications, potentially affecting its efficacy or increasing the risk of side effects. Some key interactions include:

• Anthracyclines (e.g., Doxorubicin, Epirubicin) – Combining Hersima with anthracyclines may increase the risk of cardiotoxicity, leading to heart-related complications such as heart failure. Patients receiving both drugs require regular cardiac monitoring.
• Taxanes (e.g., Paclitaxel, Docetaxel) – While often used in combination therapy, taxanes can enhance trastuzumab-related side effects, such as infusion reactions and neuropathy. Careful dose adjustments and monitoring are necessary.
• Immunosuppressants (e.g., Corticosteroids, Cyclosporine) – These may weaken the immune response and interfere with the body's ability to fight infections, increasing the risk of complications during trastuzumab therapy.
• ACE Inhibitors & Beta-Blockers (e.g., Enalapril, Metoprolol) – Used for heart conditions, these medications can mask trastuzumab-induced cardiotoxicity, requiring frequent cardiac assessments for early detection of heart-related issues.
• Live Vaccines (e.g., MMR, Yellow Fever) – Since trastuzumab affects the immune system, live vaccines should be avoided during treatment to prevent potential infections or reduced vaccine efficacy.

Patients undergoing treatment with Hersima 440mg Injection should always inform their healthcare provider about all prescription drugs, over-the-counter medications, and supplements they are taking to minimize interactions and ensure safe and effective therapy.

• Keep Hersima 440mg Injection out of sight and reach of children.
• Store between 2˚C and 8˚C.

Hersima 440mg Injection is administered intravenously under the supervision of a healthcare professional, typically in a hospital or clinical setting. It is given as a slow infusion, with the initial dose infused over 90 minutes and subsequent doses over 30 minutes if well tolerated. Before administration, it must be reconstituted with sterile water and diluted in an appropriate IV solution. It should never be injected rapidly or as a bolus. Patients are closely monitored for infusion-related reactions such as fever, chills, nausea, or allergic responses, and the infusion may be adjusted if necessary. Always follow your doctor's instructions for safe and effective use.

Side effects are unwanted symptoms caused by medicines. Even though all medicines cause side effects, not everyone gets them.

Serious

• Heart Problems
• Allergic reactions
• Kidney problems
• Breathing difficulties

Common

• Fever
• Visual disturbances
• Nose bleeds or runny nose
• Hair loss
• Dizziness
• Nail disorders
• Weight loss
• Loss of appetite
• Bruising
• Dry mouth
• Liver  inflammation
• Muscle pain
• Asthma/ lung disorders

It is suggested to inform your doctor if you have a history of allergic reactions to Hersima 440mg Injection to avoid life-threatening complications. If you have a history of lung disorder or breathing problems inform your doctor beforehand before the treatment commencement. Avoid planning for pregnancy and breastfeeding for a minimum of 7 months after the last dose. Monitor your heart parameters regularly during the treatment with Hersima 440mg Injection as it may impact the functioning of heart.

1. Roche, Electronic Medicines Compendium (EMC), [Revised on Jan 2022] [Accessed on 12th July 2022],  https://www.medicines.org.uk/emc/files/pil.3856.pdf

2. Genentech Inc, [Revised on Feb 2021] [Accessed on 12th July 2022], https://www.gene.com/download/pdf/herceptin_prescribing.pdf

3. Anton Wellstein, Giuseppe Giaccone, Michael B. Atkins, and Edward A. Sausville, Pathway-Targeted Therapies: Monoclonal Antibodies, Protein Kinase Inhibitors, and Various Small Molecules, Goodman & Gilman’s Pharmacological Basis of Therapeutics, 13th Edition, 2018, 1203-1236.