- Potentially induce anaphylaxis and other severe hypersensitivity events. As soon as a patient develops clinical signs of a severe hypersensitivity response, it should be stopped promptly and permanently.
- This medication can result in severe hemolysis in people with G-6-PD deficiency.
- Any patient experiencing hemolysis should have this treated promptly and permanently. Screening should be done before beginning Rasburicase in individuals more likely to have G-6-PD deficiency (such as those of African or Mediterranean heritage).
- The usage of Rasburicase and methemoglobinemia have been linked. Any patient who develops methemoglobinemia should have this treated right away and permanently.
- Blood samples kept at room temperature experience enzymatic uric acid breakdown due to Rasburicase, which results in artificially low uric acid levels. Plasma samples must be tested within four hours after sample collection to ensure reliable readings. Blood must be drawn into prechilled tubes containing heparin anticoagulant, immediately submerged, and kept in an ice water bath.
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
India, the United States, Canada, countries within the European Union, Australia, Japan and South Korea.
Rasburicase is an anti-hyperuricemic agent belonging to the pharmacological class of recombinant urate oxidase enzymes.
The FDA approves Rasburicase to treat hyperuricemia (elevated uric acid levels) associated with tumour lysis syndrome (TLS) in patients with hematologic malignancies undergoing chemotherapy expected to result in tumour lysis and at risk of TLS.
Rasburicase is quickly absorbed, extensively distributed, and mostly removed by enzymatic destruction after undergoing metabolic breakdown via peptide hydrolysis in plasma.
The most common side effects of Rasburicase include nausea, headache, vomiting, and rash.
Rasburicase is available as tablets and powder for injection.
The molecule is available in India, the United States, Canada, countries within the European Union, Australia, Japan and South Korea.
Rasburicase is an anti-hyperuricemic agent belonging to the pharmacological class of recombinant urate oxidase enzymes.
A soluble metabolite called allantoin is produced when the enzyme rasturicase converts uric acid. A recombinant strain of the fungus Aspergillus flavus, which has undergone genetic modification, produces this enzyme found in mammals, which saves humans. When chemotherapy treats malignancies, raburicase is administered to prevent hyperuricaemia.
Rasburicase typically exhibits onset within 4 hours of the initial administration.
Rasburicase is available as a powder for injection.
Powder for injection: To be administered parenterally, as applicable.
As the physician prescribes, take the medication once daily, with or without meals.
Rasburicase is indicated for first-line treatment of plasma uric acid levels in adult and pediatric patients undergoing anticancer therapy anticipated to cause tumour lysis and the consequent rise of plasma uric acid. These patients have solid tumour malignancies, lymphomas, and leukaemia.
Limitation of use: Rasburicase is indicated only for a single therapy session.
Parenterally: Administer Rasburicase over a 30-minute infusion period without bolus administration. Avoid filtering during the infusion, and if a separate line is unavailable, flush the IV line with at least 15 mL of normal saline before and after Rasburicase infusion. Initiate chemotherapy 4-24 hours after the first dose. Discontinue Rasburicase if signs of hypersensitivity, hemolysis, or methemoglobinemia occur. Monitor plasma uric acid levels continually to assess the treatment's effectiveness.
The dosage and duration of treatment should be as per the treating physician's clinical judgment.
Rasburicase is available as a powder for injection.
Dose Adjustment in Adult Patients:
Hyperuricemia Caused by Tumor Lysis
0.2 mg per kg IV infused over 30 min Daily for up to 5 days.
It is advised to provide up to one course or to dose for up to five days.
There are no specific dietary requirements when taking Rasburicase. When taking Rasburicase, avoid smoking and alcohol. Maintain a well -balanced diet that includes fruits and vegetables that are rich in nutrients and low-fat proteins like lean meats, fish and poultry. Stay hydrated and maintain a balanced diet. Avoid smoking and alcohol consumption.
The dietary restriction should be individualized as per patient requirements.
- In patients who have shown a hypersensitive or idiosyncratic reaction to Rasburicase.
- G6PD deficiency
- History of methemoglobinemia or hemolysis in response to Rasburicase.
- Anaphylaxis: Rasburicase may cause severe allergic responses, including anaphylaxis. Anaphylaxis can occur at any point during therapy, including at the first dosage, with clinical trials reporting <1% of patients experiencing it. If there are clinical signs of a significant hypersensitivity response, stop using Rasburicase immediately.
- Hemolysis: Rasburicase should not be administered to individuals with G6PD deficiency because of the possibility of hemolysis. In less than 1% of cases, severe hemolytic responses may require stopping Rasburicase immediately and permanently. Before starting therapy, high-risk patients should be screened, and appropriate monitoring and support measures should be provided.
- Methemoglobinemia: In clinical trials, less than 1% of patients taking Rasburicase had methemoglobinemia, which resulted in severe hypoxemia, necessitating the need for medical support measures. It's unclear if those deficient in antioxidant enzymes such as cytochrome b5 reductase are more vulnerable. If methemoglobinemia is discovered, Rasburicase must be stopped immediately and permanently. Adequate monitoring and supportive measures, such as transfusion assistance or the injection of methylene blue, must also be taken.
Alcohol Warning
Breast Feeding Warning
Pregnancy Warning
Food Warning
- Common Adverse Effects: Vomiting, fever, nausea, headache, abdominal pain, constipation, diarrhea, mucositis, and rash.
- Less Common Adverse Effects: Neutropenia, respiratory distress, hyperphosphatemia, sepsis, and neutropenic fever.
- Rare Adverse Effects: Severe allergic reactions such as anaphylaxis, hemolysis, methemoglobinemia, and developing a severe rash.
- Pregnancy
- Nursing Mothers
- Pediatric Use
- Absorption: After administering Rasburicase at a daily dose of 0.20 mg/kg, a steady state is reached in two to three days. There is minimal accumulation (<1.3 fold) between day 1 and day 5 of dosage.
- Distribution: The mean distribution volume, similar to physiological vascular volume, varies from 110–127 ml/kg in pediatric patients and 75.8–138 ml/kg in adult patients.
- Metabolism: Rasburicase is not anticipated to bind to proteins as a protein. Protein-specific metabolic pathways, such as peptide hydrolysis, are used in the breakdown process. It is unlikely that it will interact with other drugs.
- Elimination: Rasburicase has a clearance rate of approximately 3.5 ml/h/kg. The terminal half-life typically lasts between 15.7 and 22.5 hours for both pediatric and adult patients. Children and adolescents have higher clearance (about 35%) than adults, resulting in less systemic exposure. One thought to be a minor mechanism for the clearance of Rasburicase is renal elimination.
- Majumdar S, Sharma N, Sengar M, Thorat J, Nayak L, Bonda A, Bagal B, Rajendra A, Sethi A, Jain H. A phase II study to evaluate the efficacy of low-dose rasburicase (1.5mg) in adolescent and adult acute leukemia and high-grade lymphomas with tumor lysis syndrome. Leuk Lymphoma. 2023 Mar;64(3):628-638. doi: 10.1080/10428194.2023.2167491. Epub 2023 Mar 8. PMID: 36891578.
- McDonnell AM, Lenz KL, Frei-Lahr DA, Hayslip J, Hall PD. Single-dose rasburicase 6 mg in the management of tumor lysis syndrome in adults. Pharmacotherapy. 2006 Jun;26(6):806-12. doi: 10.1592/phco.26.6.806. PMID: 16716134.
- Digumarti R, Sinha S, Nirni SS, Patil SG, Pedapenki RM. Efficacy of rasburicase (recombinant urate oxidase) in the prevention and treatment of malignancy-associated hyperuricemia: an Indian experience. Indian J Cancer. 2014 Apr-Jun;51(2):180-3. doi: 10.4103/0019-509X.138299. PMID: 25104205.
- Galardy PJ, Hochberg J, Perkins SL, Harrison L, Goldman S, Cairo MS. Rasburicase in the prevention of laboratory/clinical tumour lysis syndrome in children with advanced mature B-NHL: a Children's Oncology Group Report. Br J Haematol. 2013 Nov;163(3):365-72. doi: 10.1111/bjh.12542. Epub 2013 Sep 6. PMID: 24032600; PMCID: PMC3835461.
- https://www.ncbi.nlm.nih.gov/books/NBK548485/
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103946s5083lbl.pdf
- https://ec.europa.eu/health/documents/community-register/2017/20170524138057/anx_138057_en.pdf
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm
