Pegaspargase Drug Information

 

Pegaspargase is a converted version of the enzyme known as asparaginase. The active substance is specifically a covalent conjugate of E. coli or Escherichia coli extracted asparaginase with mPEG using a succinimidyl-succinate linker. One ml of solution typically contains 750 units (U) of pegaspargase; one unit is defined as the quantity of enzyme needed to liberate 1 µmol ammonia per minute at pH 7.3 and 37 °C. A single vial of 5 ml solution contains 3,750 U.

U.S. FDA-Approved Indications: Acute lymphoblastic leukemia (ALL):

• The pegaspargase injection is used as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL. 
• Pegaspargase is used as a component of a multi-agent chemotherapeutic regimen to treat pediatric and adults with ALL and hypersensitivity to native forms of L-asparaginase.

Pegaspargase is supplied as Oncaspar and is a conjugate of mPEG and L-asparagine amidohydrolase, an asparagine-specific enzyme. L-asparaginase is a kind of an enzyme that catalyzes the conversion of the amino acid L-asparagine into ammonia and aspartic acid. The pharmacological effect of pegaspargase is thought to be dependent on the selective destruction of leukemic cells because of the depletion of plasma L-asparagine. Leukemic cells with low expression of asparagine synthetase have a lower ability to synthesize L-asparagine and therefore depend on an exogenous source of L-asparagine for survival. 

Dosage and Administration 

Pegaspargase (Oncaspar) comes as a 3,750 International Units/5 mL (750 International Units/mL) solution in a single-dose vial for intramuscular or intravenous use. For tiny volumes, the recommended route of administration is Intramuscular.

Acute lymphoblastic leukemia: Pegaspargase (oncaspar 3750) is administered intramuscularly or intravenously no more frequently than every two weeks (14 days) and the recommended dosage is as follows: 

• For individuals aged 21 years and younger: 2,500 International Units/m2 
• For individuals aged over 21 years: 2,000 International Units/m2

Adverse Reactions

The most commonly reported adverse reactions with the use of Pegaspargase are allergic reactions (including anaphylaxis), pancreatitis, central nervous system (CNS) thrombosis, hyperbilirubinemia, elevated transaminases, coagulopathy, and hyperglycemia. 

Hyperlipidemia ( hypertriglyceridemia and hypercholesterolemia) has been reported in patients exposed to Pegaspargase.

Warnings and Precautions

Anaphylaxis and Severe Allergic Reactions: Anaphylaxis and serious allergic reactions can emerge in patients receiving Pegaspargase. The probability of serious allergic reactions is higher in patients with known hypersensitivity to other forms of L-asparaginase. Assess patients for 60 minutes after the administration of Pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, intravenous steroids, epinephrine, oxygen, antihistamines). Discontinue Pegaspargase in patients with severe allergic reactions.

Thrombosis: Severe thrombotic events, including sagittal sinus thrombosis can emerge in patients receiving Pegaspargase. Discontinue pegaspargase 3750 in patients with severe thrombotic events.

Pancreatitis: Pancreatitis can emerge in patients receiving Pegaspargase. Assess patients with abdominal pain for evidence of pancreatitis. Discontinue Pegaspargase uses in patients with pancreatitis.

Glucose Intolerance: Glucose intolerance can emerge in patients receiving Pegaspargase. In some cases, glucose intolerance is irreversible. Serum glucose needs to be monitored.

Coagulopathy: Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can emerge in patients receiving Pegaspargase. Monitor coagulation parameters periodically during and after treatment. Start treatment with fresh-frozen plasma in order to replace the coagulation factors in patients with severe or symptomatic coagulopathy.

Abnormal Liver Function Hepatotoxicity: Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), bilirubin (direct and indirect), alkaline phosphatase, and depression of serum albumin, and plasma fibrinogen can emerge. Appropriate monitoring needs to be performed. 

Contraindications

Pegaspargase (oncaspar injection) is contraindicated in patients:

• with previously anaphylactic or severe hypersensitivity reactions to the active substance or to any of other excipients;
• with severe thrombosis during previous therapy with asparaginase;
• with known pancreatitis including pancreatitis related to previous therapy with asparaginase;
• with known severe haemorrhagic events during previous therapy with asparaginase;
• with known severe hepatic impairment.

Interactions with Other Medicines

Protein Effects: Reduction in serum proteins caused by Pegaspargase can increase the toxicity of protein-bound medicinal products. 

By blocking protein synthesis and cell division, Oncaspar can disturb the function of other substances which require cell division for their effect, e.g., methotrexate. Cytarabine and methotrexate can interfere differently; prior to use of these substances can increase the action of this drug synergistically. However, if these substances are given subsequently, the effect of Pegaspargase can be weakened antagonistically.

Use with Vincristine: Promptly preceding or concomitant treatment with vincristine can be responsible for increasing the toxicity of Pegaspargase and increasing the probability of anaphylactic reactions. Thus, vincristine should be administered in a timely manner prior to the use of Pegaspargase to minimize toxicity. 

Metabolism effects: Pegaspargase can interfere with the metabolism of other medications, especially in the liver.

Coagulation effects: The use of Pegaspargase can lead to varying levels of coagulation factors. This could increase the probability of bleeding or thrombosis. Caution is required when anticoagulants such as heparin, coumarin, dipyridamole, acetylsalicylic acid, or nonsteroidal anti-inflammatory medicines are given concomitantly. 

Oral contraceptive effects: An indirect interaction cannot be ruled out b/w Pegaspargase and oral contraceptives because of the pegaspargase hepatotoxicity that may impair the hepatic clearance of oral contraceptives. Therefore, the combination of Pegaspargase and oral contraceptives is avoided. A method other than oral contraception needs to be used in females of childbearing potential. 

Use of live vaccines: Simultaneous vaccination of live vaccines with Pegaspargase increases the probability of severe infections attributable to the patient’s underlying disease and the typically combined chemotherapy. Vaccination with live vaccines needs to be given, at the earliest, three months after the termination of the entire antileukemic treatment.

Price, Presentation, and Storage Conditions

The pegaspargase price in India is reasonably authentic. Prices typically may fluctuate depending on a wide range of brands. This medicinal product is available in 5 mL glass vials with a rubber stopper and an aluminum seal with a flip-off cap. The medicine Pegaspargase must be stored under refrigerated conditions (2°C to 8°C). Do not freeze. If you are looking to buy Pegaspargase online at the lowest prices, then The Indian Pharma can be your one-stop solution. The Indian Pharma is certified by WHO-GDP & ISO and it is a leading Supplier, Exporter, Retailer, and Wholesaler of Generic & Branded Prescription medicines. Kindly reach out to us at TOLL-FREE: 1800-889-1064 or send your Quote at info@theindianpharma.com to find pegaspargase injection price in the most affordable range.  

Note: The information provided in this article is intended for just general knowledge only and is not a substitute for professional medical advice or treatment for specific medical conditions. Do not use this information in order to diagnose or treat a health complication or disease without consulting with a qualified health specialist. Please consult your health specialist with any concerns you may have regarding your condition.