Ontruzant 150 mg Powder for concentrate for solution for infusion Vial

Product Description

Ontruzant 150 mg Powder for concentrate for solution for infusion is a targeted biological medicine used in the treatment of specific types of cancer.
It is a biosimilar to Herceptin (trastuzumab), a monoclonal antibody designed to selectively target and block the activity of the Human Epidermal growth factor Receptor 2 (HER2) protein, which can be overexpressed in some cancer cells.
This mechanism helps to inhibit the growth and spread of these cancer cells.

For more detailed information, please refer to reputable pharmaceutical resources such as official drug prescribing information and regulatory agency websites like EMA or FDA.
While general product information might be found on e-commerce platforms like Nahdi Online, , or for certain products, specialized oncology treatments typically require consultation with healthcare professionals.

Benefits of Use

• Targets HER2-positive cancer cells, offering a specific treatment approach.
• Used in the treatment of early and metastatic HER2-positive breast cancer.
• Also indicated for metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
• As a biosimilar, it provides an alternative treatment option with demonstrated similarity in efficacy, safety, and quality to the reference product.

How to Use

1. Ontruzant is provided as a powder and must be reconstituted and then diluted by a trained healthcare professional.
2. It is administered as an intravenous (IV) infusion into a vein.
3. The dosing regimen and duration of treatment will be determined by your doctor based on your specific condition, weight, and response to treatment.
4. Infusions typically occur every one or three weeks, depending on the treatment protocol.
5. Patients will be closely monitored during and after the infusion for any potential reactions.

Caution & Warnings

• Ontruzant should only be administered under the supervision of a physician experienced in the administration of anticancer agents.
• Infusion-related reactions: Patients may experience reactions during or shortly after infusion, including fever, chills, nausea, vomiting, pain, headache, dizziness, rash, and weakness. Severe reactions, though rare, can occur.
• Cardiac dysfunction: Regular monitoring of cardiac function (e.g., LVEF) is essential before and during treatment, especially in patients with pre-existing cardiac issues.
• Pulmonary toxicity: Lung problems, including shortness of breath, cough, and fluid in the lungs, can occur.
• Embryo-fetal toxicity: Ontruzant can cause fetal harm when administered to a pregnant woman. Effective contraception should be used during treatment and for 7 months following the last dose.
• Lactation: It is unknown whether trastuzumab is excreted in human milk. Breastfeeding is not recommended during treatment and for 7 months after the last dose.
• Hypersensitivity reactions: Severe allergic reactions are possible.
• Not interchangeable with other trastuzumab products without consulting a healthcare professional.

Ingredients

• Active Ingredient: Trastuzumab (150 mg per vial)
• Excipients: L-Histidine, L-Histidine hydrochloride monohydrate, alpha,alpha-Trehalose dihydrate, Polysorbate 20.

Product Details

• Form: Powder for concentrate for solution for infusion
• Strength: 150 mg
• Package Type: Single-use vial
• Manufacturer: Samsung Bioepis
• IBC: 1910234365