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Rasburicase | CAS No: 134774-45-1 | GMP-certified suppliers
A medication that rapidly reduces elevated plasma uric acid levels in hyperuricemia associated with chemotherapy-induced tumor lysis, aiding in the management of hematologic malignancies.
Therapeutic categories
Primary indications
- For treatment of hyperuricemia, reduces elevated plasma uric acid levels (from chemotherapy)
Product Snapshot
- Rasburicase is an injectable enzyme formulation supplied as a lyophilized powder for intravenous use
- It is indicated for the management of hyperuricemia associated with malignancy and chemotherapy
- The product is approved and marketed in the US, Canada, and the EU
Clinical Overview
The accumulation of uric acid and other purine metabolites during chemotherapy-induced tumor lysis can lead to toxic plasma concentrations, contributing to renal dysfunction and other complications. Rasburicase addresses this by enzymatically catalyzing the oxidation of uric acid into allantoin, a highly soluble and inactive metabolite that is more readily excreted by the kidneys. This mechanism provides a biochemical means of reducing uric acid levels and mitigating the metabolic effects associated with rapid tumor cell breakdown.
Pharmacodynamically, rasburicase acts rapidly following intravenous administration. While specific pharmacokinetic parameters such as absorption and distribution are consistent with enzyme preparations intended for parenteral use, metabolism predominantly involves conversion of uric acid rather than modification of the enzyme itself. Elimination is largely through renal excretion of allantoin. Safety concerns include potential hypersensitivity reactions and the theoretical risk of methemoglobinemia, due to the enzyme's oxidative activity. Monitoring for allergic events and adverse hematologic effects is recommended during clinical use.
Rasburicase is categorized within enzymatic agents used as detoxifying substances in antineoplastic treatment, with additional recognition as an antigout preparation and methemoglobinemia-associated agent. Its recombinant origin classifies it among recombinant protein therapeutics. Notable brand names include Elitek, widely used in oncology treatment centers for acute management of tumor lysis syndrome.
From a sourcing and quality control perspective, procurement of rasburicase APIs requires stringent characterization to ensure enzymatic activity, recombinant protein integrity, and absence of contaminants. Compliance with global regulatory standards for biologics, including validation of genetic constructs and purification processes, is essential to maintain consistent clinical efficacy and safety profiles.
Identification & chemistry
| Generic name | Rasburicase |
|---|---|
| Molecule type | Biotech |
| CAS | 134774-45-1 |
| UNII | 08GY9K1EUO |
| DrugBank ID | DB00049 |
Pharmacology
| Summary | Rasburicase enzymatically converts uric acid into allantoin, a more soluble and inactive metabolite, facilitating its excretion. It is used to reduce elevated plasma uric acid levels associated with tumor lysis syndrome in hematologic malignancies. The primary pharmacodynamic effect involves lowering toxic uric acid concentrations to mitigate chemotherapy-induced metabolic complications. |
|---|---|
| Mechanism of action | Rasburicase catalyzes enzymatic oxidation of uric acid into an inactive and soluble metabolite (allantoin). |
| Pharmacodynamics | Drugs used to treat lympohoid leukemia, non-Hodgkin's lymphoma and acute myelogenous leukemia often lead to the accumulation of toxic plasma levels of purine metabolites (i.e. uric acid). The injection of rasburicase reduces levels of uric acid and mitigates the toxic effects of chemotherapy induced tumor lysis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Uric acid | Humans | metabolizer |
ADME / PK
| Half-life | 18 hours |
|---|---|
| Volume of distribution | * 110 to 127 mL/kg [pediatric patients] * 75.8 to 138 mL/kg [adult patients] |
Formulation & handling
- Rasburicase is a biotech product formulated exclusively for intravenous injection, not suitable for oral use.
- As a recombinant urate oxidase enzyme, it requires handling as a biologic with potential sensitivity to temperature and moisture.
- Lyophilized powder formulations must be reconstituted prior to use and protected from light to maintain stability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is in the mature phase of its lifecycle, with key patents in Canada having expired in 2015 and 2016. Products containing this API are currently marketed in the US, Canada, and the EU. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Rasburicase is manufactured and supplied by originator companies with branded products available primarily in the US, Canada, and EU markets. Multiple brand samples indicate established presence in these regions. The listed patents expired in 2015 and 2016, indicating that generic competition is likely present or imminent in the market. |
|---|
Rasburicase is a type of Uric acid lowering agents
Uric acid lowering agents are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) specifically designed to target and reduce elevated levels of uric acid in the body. Uric acid is a byproduct of purine metabolism and is typically excreted through the kidneys. However, when uric acid levels become excessively high, it can lead to a condition known as hyperuricemia, which is associated with gout and other related disorders.
Uric acid lowering agents work by inhibiting the production of uric acid or enhancing its excretion from the body. One commonly used class of drugs in this category is xanthine oxidase inhibitors (XOIs), which inhibit the enzyme xanthine oxidase responsible for converting purines to uric acid. By reducing the activity of xanthine oxidase, XOIs effectively lower uric acid levels.
Another class of drugs used as uric acid lowering agents are uricosurics. Uricosurics work by blocking the reabsorption of uric acid in the kidneys, thereby increasing its elimination through urine. This mechanism helps to lower the concentration of uric acid in the bloodstream.
Uric acid lowering agents play a crucial role in the management of hyperuricemia and related conditions such as gout. By effectively reducing uric acid levels, these pharmaceutical APIs alleviate symptoms associated with elevated uric acid, such as joint pain and inflammation.
It is important to note that the use of uric acid lowering agents should be done under the guidance and supervision of a healthcare professional. Individual patient factors and medical history should be considered when determining the appropriate medication and dosage.
Rasburicase (Uric acid lowering agents), classified under Genitourinary Agents
Genitourinary agents are a category of pharmaceutical active ingredients (APIs) that are specifically designed to target and treat disorders related to the genitourinary system. The genitourinary system encompasses the organs and structures involved in the production, storage, and elimination of urine, as well as the reproductive organs.
These APIs play a crucial role in the treatment of various genitourinary conditions, including urinary tract infections (UTIs), erectile dysfunction, urinary incontinence, benign prostatic hyperplasia (BPH), and other related disorders. They exert their therapeutic effects by interacting with specific receptors or enzymes in the genitourinary system, regulating physiological processes, and restoring normal function.
Some commonly used genitourinary agents include alpha-blockers, which relax the smooth muscles in the prostate and bladder neck, improving urine flow in patients with BPH. Additionally, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are widely prescribed for erectile dysfunction, as they enhance blood flow to the penile tissues, facilitating erection.
These APIs are typically formulated into various dosage forms, such as tablets, capsules, creams, gels, or injections, allowing for convenient administration to patients. The development and production of genitourinary agents involve stringent quality control measures and compliance with regulatory guidelines to ensure safety, efficacy, and consistent product performance.
In summary, genitourinary agents form a crucial category of pharmaceutical APIs used to treat a range of disorders affecting the genitourinary system. Their targeted mechanisms of action and diverse dosage forms make them valuable tools in improving genitourinary health and enhancing patients' quality of life.
Rasburicase API manufacturers & distributors
Compare qualified Rasburicase API suppliers worldwide. We currently have 1 companies offering Rasburicase API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Sanofi | Producer | France | France | CoA, GMP | 93 products |
When sending a request, specify which Rasburicase API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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