Calaspargase Pegol
Generic Name: calaspargase pegol
Brand Names:
Asparlas
11 DESCRIPTION Calaspargase pegol-mknl contains an asparagine specific enzyme derived from Escherichia coli , as a conjugate of L-asparaginase (L-asparagine amidohydrolase) and monomethoxypolyethylene glycol (mPEG) with a succinimidyl carbonate (SC) linker. The SC linker is a chemically stable carbamate bond between the mPEG moiety and the lysine groups of L-asparaginase. L-asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists of identical 34.5 kDa subunits.
Overview
11 DESCRIPTION Calaspargase pegol-mknl contains an asparagine specific enzyme derived from Escherichia coli , as a conjugate of L-asparaginase (L-asparagine amidohydrolase) and monomethoxypolyethylene glycol (mPEG) with a succinimidyl carbonate (SC) linker. The SC linker is a chemically stable carbamate bond between the mPEG moiety and the lysine groups of L-asparaginase. L-asparaginase is a tetrameric enzyme that is produced endogenously by E. coli and consists of identical 34.5 kDa subunits.
Uses
1 INDICATIONS AND USAGE ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
Dosage
2 DOSAGE AND ADMINISTRATION Recommended Dosage: 2,500 units/m 2 intravenously no more frequently than every 21 days. ( 2.1 ) See Full Prescribing Information for important details regarding dosing modifications and preparation and administration. ( 2.2 , 2.3 , 2.4 ) 2.1 Recommended Dosage The recommended dose of ASPARLAS is 2,500 units/m 2 given intravenously no more frequently than every 21 days. 2.2 Recommended Premedication Premedicate patients with acetaminophen, an H-1 receptor blocker (such as diphenhydramine), and an H-2 receptor blocker (such as famotidine) 30-60 minutes prior to administration of ASPARLAS to decrease the risk and severity of both infusion and hypersensitivity reactions [see Warnings and Precautions (5.1) ] .
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Thrombosis [see Warnings and Precautions (5.3) ] Hemorrhage [see Warnings and Precautions (5.4) ] Hepatotoxicity, including VOD [see Warnings and Precautions (5.5) ] The most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals LLC at 1-800-807-6124 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity : Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions. ( 5.1 ) Pancreatitis : Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose. ( 5.2 ) Thrombosis : Discontinue ASPARLAS for severe or life-threatening thrombosis. ( 5.3 ) Hemorrhage : Discontinue ASPARLAS for severe or life-threatening hemorrhage. Evaluate for etiology and treat. ( 5.4 ) Hepatotoxicity, including hepatic veno-occlusive disease (VOD) : Monitor for toxicity through recovery from cycle. Discontinue ASPARLAS for severe liver toxicity. 4 CONTRAINDICATIONS ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions (5.1) ] History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2) ] History of serious thrombosis during previous L-asparaginase therapy [see Warning...
Pregnancy
8.1 Pregnancy Risk Summary Based on published literature studies with L-asparaginase in pregnant animals, ASPARLAS can cause fetal harm when administered to a pregnant woman. There are no available data on ASPARLAS use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes.
Storage
Store ASPARLAS refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not shake or freeze product. Unopened vials may be stored at room temperature (15°C to 25°C [59°F to 77°F]) for no more than 48 hours.
Frequently Asked Questions
What is Calaspargase Pegol used for?▼
1 INDICATIONS AND USAGE ASPARLAS is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. ( 1.1 ) 1.1 Acute Lymphoblastic Leukemia ASPARLAS is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years.
What are the side effects of Calaspargase Pegol?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Pancreatitis [see Warnings and Precautions (5.2) ] Thrombosis [see Warnings and Precautions (5.3) ] Hemorrhage [see Warnings and Precautions (5.4) ] Hepatotoxicity, including VOD [see Warnings and Precautions (5.5) ] The most common (incidence ≥10%) grade ≥3 adverse reactions were elevated transaminase, bilirubin increased, pancreatitis, and abnormal clotting studies. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Servier Pharmaceuticals LLC at 1-800-807-6124 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Calaspargase Pegol during pregnancy?▼
8.1 Pregnancy Risk Summary Based on published literature studies with L-asparaginase in pregnant animals, ASPARLAS can cause fetal harm when administered to a pregnant woman. There are no available data on ASPARLAS use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes.
What are the important warnings for Calaspargase Pegol?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity : Observe patients for one hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions. ( 5.1 ) Pancreatitis : Discontinue ASPARLAS in patients with pancreatitis. Monitor blood glucose. ( 5.2 ) Thrombosis : Discontinue ASPARLAS for severe or life-threatening thrombosis. ( 5.3 ) Hemorrhage : Discontinue ASPARLAS for severe or life-threatening hemorrhage. Evaluate for etiology and treat. ( 5.4 ) Hepatotoxicity, including hepatic veno-occlusive disease (VOD) : Monitor for toxicity through recovery from cycle. Discontinue ASPARLAS for severe liver toxicity. 4 CONTRAINDICATIONS ASPARLAS is contraindicated in patients with: History of serious hypersensitivity reactions, including anaphylaxis, to pegylated L-asparaginase therapy [see Warnings and Precautions (5.1) ] History of serious pancreatitis during previous L-asparaginase therapy [see Warnings and Precautions (5.2) ] History of serious thrombosis during previous L-asparaginase therapy [see Warning...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.