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Fasturtec 7.5 mg Powder and solvent for solution for infusion Vial
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SKU
10331014326
Fasturtec 7.5 mg is a specialized intravenous medication designed to rapidly reduce high uric acid levels in the blood. It is primarily used in cancer patients to prevent and treat acute hyperuricemia, particularly in cases of Tumor Lysis Syndrome associated with chemotherapy. This prescription-only drug helps prevent severe kidney complications by converting uric acid into an easily excretable substance.
Product Description
Fasturtec 7.5 mg Powder and solvent for solution for infusion is a specialized medication designed for the rapid and effective management of hyperuricemia.It is particularly indicated for the prevention and treatment of acute hyperuricemia, a condition characterized by abnormally high levels of uric acid in the blood, often associated with malignancies and chemotherapy-induced Tumor Lysis Syndrome (TLS).
As an advanced enzyme therapy, Fasturtec (Rasburicase) works by converting uric acid into allantoin, a more water-soluble compound that is easier for the kidneys to excrete, thereby reducing the risk of kidney complications like acute renal failure.
This prescription-only medication is administered intravenously under close medical supervision, ensuring precise dosage and patient monitoring.
Benefits of Use
- Rapid and effective reduction of plasma uric acid levels.
- Prevents and treats hyperuricemia in patients undergoing chemotherapy for malignancies, especially those at risk of or with established Tumor Lysis Syndrome.
- Reduces the risk of acute renal failure due to uric acid nephropathy.
- Helps to avoid complications associated with high uric acid levels during cancer treatment.
How to Use
- Fasturtec is for intravenous administration only and must be prepared by a healthcare professional.
- The lyophilized powder must be reconstituted with the provided solvent.
- The reconstituted solution should then be further diluted in 0.9% sodium chloride for infusion.
- Administer the diluted solution as a daily infusion over 30 minutes.
- Dosage is determined by a physician based on the patient's body weight (mg/kg/day).
- Treatment typically lasts for 5-7 days or as clinically indicated to normalize plasma uric acid levels.
- This medication is administered in a hospital setting under strict medical supervision.
Caution & Warnings
- Hypersensitivity Reactions: Severe allergic reactions, including anaphylaxis, can occur. Patients must be closely monitored during and after administration.
- Hemolytic Anemia: Cases of hemolytic anemia have been reported, particularly in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. G6PD screening is recommended prior to treatment.
- Methemoglobinemia: Cases of methemoglobinemia have been reported. Monitor for cyanosis or other symptoms indicative of methemoglobinemia.
- Antibody Formation: Patients may develop antibodies to rasburicase, which can lead to a loss of efficacy and/or increased risk of hypersensitivity reactions.
- Pregnancy and Lactation: Use with caution and only if clearly needed, as insufficient data are available regarding its safety during pregnancy and breastfeeding.
- Pediatric Use: Safety and efficacy have been established in pediatric patients with hyperuricemia related to malignancy.
Ingredients
- Active Ingredient: Rasburicase
- Excipients: Mannitol, Disodium phosphate dodecahydrate, Tromethamine, Hydrochloric acid (for pH adjustment), Water for injection (solvent).
Product Details
- Formulation: Powder and solvent for solution for infusion.
- Strength: 7.5 mg Rasburicase per vial.
- Packaging: Typically includes one vial containing lyophilized powder and a separate vial or ampoule of solvent for reconstitution.
- Storage: Store the unopened product in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.
- Manufacturer: Sanofi
| Gtin | 1301221588 |
|---|---|
| Recommended Sale Price | 1632.9 |
| Is Wasfaty Product | No |
| Brand | Not Defined |
| Ingredient Name | RASBURICASE |
| SFDA Reg. No | 1301221588 |
| IBC | 1301221588 |
| Drug Type | Prescription |
| Scientific Name | Rasburicase |
| Strength | 7.5 |
| Strength Unit | mg |
| Form | Powder and solvent for solution for infusion |
| Admin Route | Intravenous (IV) |
| Size | 1 |
| Size Unit | Vial |
| Package Types | Vial(s) |
| Package Size | 1 |
| Storage conditions | Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light. |
| Refrigerator Storage | Yes |
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