Rising Pharmaceuticals launches Edetate calcium disodium injection in the US

Rising Pharmaceuticals, Inc., a prominent provider of generic and specialty-branded pharmaceuticals in the United States, has announced the immediate availability of its FDA-approved Edetate calcium disodium injection. This product is crucial for reducing blood lead levels and depot stores of lead in cases of both acute and chronic lead poisoning, as well as lead encephalopathy, for both pediatric and adult patients.

David Picard, Executive Vice President for Institutional Markets at Rising, noted the importance of this development, stating that the availability of Edetate calcium disodium injection offers healthcare providers a vital treatment option for patients affected by lead exposure. He emphasized that this continued availability underscores Rising's commitment to addressing product supply shortages, thereby ensuring that necessary treatments remain accessible to healthcare providers and their patients.

Edetate calcium disodium injection comes in a 5 mL single-dose vial, each containing 200 mg of edetate calcium disodium per mL, totaling 1000 mg per vial. These vials are supplied in boxes containing five units, ensuring ample supply for medical facilities.

Rising Pharmaceuticals has built a strong reputation as a leader in the generic and specialty-branded pharmaceuticals sector. The company focuses on various aspects of the product lifecycle, including development, regulatory compliance, and commercialization, while partnering with strategic Contract Manufacturing Organizations (CMO) and Contract Development Organizations (CDO) for the manufacturing process. With a substantial portfolio of over 182 commercialized generic medicines and more than 620 active Stock Keeping Units (SKUs), Rising Pharmaceuticals supplies nearly 9 billion doses of generic medicine annually to the U.S. market.

Edetate calcium disodium injection is used intravenously or intramuscularly and must be administered with caution due to its potential toxic effects. Lead encephalopathy is more common in pediatric patients than adults and can lead to high mortality rates if not managed properly. For patients with lead encephalopathy and cerebral edema, the intramuscular route is preferred to avoid rapid increases in intracranial pressure that can be fatal. Intravenous administration should be done cautiously, avoiding rapid infusion.

This sterile, injectable chelating agent is effective due to its ability to form stable chelates with metals such as lead, zinc, cadmium, manganese, iron, and mercury. While the drug significantly increases the excretion of zinc, it does not increase calcium excretion. Notably, edetate calcium disodium is poorly absorbed from the gastrointestinal tract and primarily excreted through the kidneys, with a half-life ranging from 20 to 60 minutes.

The primary source of lead chelated by edetate calcium disodium is from bone, although it also reduces kidney lead levels post-therapy. However, animal studies have shown that while urinary lead output increases and blood lead concentration decreases following a single dose, brain lead levels may actually increase due to lead redistribution.

Edetate calcium disodium injection is contraindicated for patients with anuria, active renal disease, or hepatitis. It must be used with caution in individuals with pre-existing mild renal disease and those undergoing therapy should have their urine flow monitored continuously to prevent nephrotoxicity. Furthermore, it is crucial to monitor cardiac rhythm irregularities and ECG changes during intravenous therapy.

In terms of administration, the recommended dose for asymptomatic adults and pediatric patients with blood lead levels of 20 mcg/dl is 1000 mg/m2/day, given either intravenously or intramuscularly. For adults with lead nephropathy, a specific dosing regimen is suggested based on serum creatinine levels. The therapy typically spans over a period of five days, followed by a 2 to 4-day break to allow for lead redistribution and to avoid severe depletion of essential metals like zinc.

Edetate calcium disodium injection is available for intravenous infusion or intramuscular injection, with specific protocols depending on the patient's condition and route of administration. Proper storage conditions are essential to maintain the product's efficacy.

Rising Pharmaceuticals continues to play a crucial role in providing essential medications to the market, ensuring healthcare providers have the necessary tools to treat lead poisoning effectively.