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HERZUMA 440 mg Powder for concentrate for solution for infusion 50ml Vial
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10331014283
HERZUMA 440 mg is a biosimilar to Herceptin (trastuzumab) used for HER2-positive breast and metastatic gastric cancers. It is an intravenous infusion that targets HER2 proteins to inhibit cancer cell growth. Administered by healthcare professionals, it offers improved survival and response rates.
HERZUMA 440 mg Powder for concentrate for solution for infusion 50ml Vial
HERZUMA (trastuzumab-pkrb) is a biosimilar to Herceptin (trastuzumab), indicated for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
It is a targeted therapy designed to specifically bind to the HER2 protein found on the surface of some cancer cells, helping to inhibit their growth and survival.
Product Details
- Brand: HERZUMA
- Strength: 440 mg
- Form: Powder for concentrate for solution for infusion
- Manufacturer: Celltrion Healthcare
- Active Ingredient: Trastuzumab-pkrb
- Package Size: 1 Vial
Benefits of Use
HERZUMA offers significant therapeutic benefits for patients with HER2-positive cancers:
- Targeted action against HER2-positive cancer cells.
- Improved disease-free survival and overall survival in early breast cancer.
- Enhanced response rates when used in combination with chemotherapy for metastatic breast and gastric cancers.
- Provides a cost-effective biosimilar option for trastuzumab therapy.
How to Use
HERZUMA is administered by a healthcare professional in a clinical setting.
- HERZUMA 440 mg vial contains sterile, white to pale yellow, lyophilized powder.
- The powder is reconstituted with 20 mL of sterile water for injection to yield a multiple-dose solution containing 21 mg/mL trastuzumab-pkrb.
- The reconstituted solution is then diluted further into an infusion bag containing 0.9% Sodium Chloride Injection, USP.
- The solution is administered as an intravenous infusion over a period determined by your physician, usually 30 to 90 minutes, depending on the dose and patient tolerance.
- Do not administer as an intravenous push or bolus.
Caution & Warnings
- Cardiotoxicity: HERZUMA can cause ventricular dysfunction and congestive heart failure. Assess cardiac function prior to and during treatment.
- Infusion Reactions: Serious and fatal infusion reactions have been observed. Monitor patients during and after infusion for fever, chills, nausea, vomiting, pain, headache, dizziness, dyspnea, hypotension, rash, and asthenia.
- Pulmonary Toxicity: Severe pulmonary toxicity, including fatal acute respiratory distress syndrome, interstitial pneumonitis, and lung fibrosis, has been reported.
- Embryo-fetal Toxicity: HERZUMA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus.
- Excipients: Contains trehalose and polysorbate 20.
Ingredients
Each vial contains 440 mg of Trastuzumab-pkrb as the active ingredient. Excipients include L-Histidine Hydrochloride Monohydrate, L-Histidine, Trehalose Dihydrate, and Polysorbate 20.
| Gtin | 352-334-20 |
|---|---|
| Recommended Sale Price | 4003.1 |
| Is Wasfaty Product | No |
| Brand | Not Defined |
| Ingredient Name | Trastuzumab |
| SFDA Reg. No | 352-334-20 |
| IBC | 352-334-20 |
| Drug Type | Prescription |
| Scientific Name | Trastuzumab-pkrb |
| Strength | 440 |
| Strength Unit | mg |
| Form | Powder for concentrate for solution for infusion |
| Admin Route | Intravenous |
| Size | 50 |
| Size Unit | ml |
| Package Types | Vial |
| Package Size | 1 |
| shelfLife | 36 months |
| Storage conditions | Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vial in the outer carton to protect from light. |
| Refrigerator Storage | Yes |
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