Oncaspar
(Pegaspargase)Dosage & Administration
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Oncaspar Prescribing Information
Warnings and Precautions (Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ONCASPAR in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy [see Adverse Reactions (6)]. Do not administer ONCASPAR to patients with severe hepatic impairment[see Contraindications (4)] .Evaluate bilirubin and transaminases prior to each dose of ONCASPAR and at least weekly, during cycles of treatment that include ONCASPAR, through 6 weeks after the last dose of ONCASPAR. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ONCASPAR, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ONCASPAR and provide supportive care [see Dosage and Administration (2.3)] . | 3/2024 |
ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of pediatric and adult patients with:
- First-line acute lymphoblastic leukemia ()
1.1 First Line Acute Lymphoblastic Leukemia (ALL)ONCASPAR®is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with ALL.
- Acute lymphoblastic leukemia and hypersensitivity to asparaginase ()
1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to AsparaginaseONCASPAR is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL and hypersensitivity to native forms of L-asparaginase.
- Administered intramuscularly or intravenously no more frequently than every 14 days. ()
2.1 Recommended DosagePatients 21 Years of Age or YoungerThe recommended dose of ONCASPAR for patients up to and including 21 years of age is 2,500 International Units/m2intramuscularly or intravenously no more frequently than every 14 days.
Patients More Than 21 Years of AgeThe recommended dose of ONCASPAR for adult patients more than 21 years of age is 2,000 International Units/m2intramuscularly or intravenously no more frequently than every 14 days.
- Patients ages 21 years and younger: 2,500 International Units/m2. ()
2.1 Recommended DosagePatients 21 Years of Age or YoungerThe recommended dose of ONCASPAR for patients up to and including 21 years of age is 2,500 International Units/m2intramuscularly or intravenously no more frequently than every 14 days.
Patients More Than 21 Years of AgeThe recommended dose of ONCASPAR for adult patients more than 21 years of age is 2,000 International Units/m2intramuscularly or intravenously no more frequently than every 14 days.
- Patients ages over 21 years: 2,000 International Units/m2. ()
2.1 Recommended DosagePatients 21 Years of Age or YoungerThe recommended dose of ONCASPAR for patients up to and including 21 years of age is 2,500 International Units/m2intramuscularly or intravenously no more frequently than every 14 days.
Patients More Than 21 Years of AgeThe recommended dose of ONCASPAR for adult patients more than 21 years of age is 2,000 International Units/m2intramuscularly or intravenously no more frequently than every 14 days.
- For intramuscular administration, limit the volume at a single injection site to 2 mL; if greater than 2 mL, use multiple injection sites. ()
2.3 Recommended Monitoring and Dosage Modifications for Adverse ReactionsMonitor patients at least weekly, with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1.
Table 1. Dosage Modifications Adverse Reaction SeverityGrade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening. Action Infusion Reaction/Hypersensitivity Reaction [see Warnings and Precautions (5.1)]Grade 1 - Reduce the infusion rate by 50%
Grade 2 - Interrupt the infusion of ONCASPAR
- Treat the symptoms
- When symptoms resolve, resume the infusion and reduce the infusion rate by 50%
Grade 3 to 4 - Discontinue ONCASPAR permanently
Thrombosis [see Warnings and Precautions (5.2)]Uncomplicated deep vein thrombosis - Hold ONCASPAR
- Treat with appropriate antithrombotic therapy
- Upon resolution of symptoms consider resuming ONCASPAR, while continuing antithrombotic therapy
Severe or life-threatening thrombosis - Discontinue ONCASPAR permanently
- Treat with appropriate antithrombotic therapy
Pancreatitis [see Warnings and Precautions (5.3)]Grades 3 to 4 - Hold ONCASPAR for elevations in lipase or amylase >3 × ULN until enzyme levels stabilize or are declining
- Discontinue ONCASPAR permanently if clinical pancreatitis is confirmed
Hemorrhage [see Warnings and Precautions (5.5)]Grade 3 to 4 - Hold ONCASPAR
- Evaluate for coagulopathy and consider clotting factor replacement as needed
- Resume ONCASPAR with the next scheduled dose if bleeding is controlled
Hepatotoxicity [see Warnings and Precautions (5.6)]Total bilirubin more than 3 times to no more than 10 times the ULN - Hold ONCASPAR until total bilirubin is ≤1.5 times the ULN
Total bilirubin more than 10 times the ULN - Discontinue ONCASPAR and do not make up for missed doses
- For intravenous administration, give over a period of 1 to 2 hours in 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP through an infusion that is already running. ()
2.3 Recommended Monitoring and Dosage Modifications for Adverse ReactionsMonitor patients at least weekly, with bilirubin, transaminases, glucose and clinical examinations until recovery from the cycle of therapy. If an adverse reaction should occur, modify treatment according to Table 1.
Table 1. Dosage Modifications Adverse Reaction SeverityGrade 1 is mild, grade 2 is moderate, grade 3 is severe, and grade 4 is life-threatening. Action Infusion Reaction/Hypersensitivity Reaction [see Warnings and Precautions (5.1)]Grade 1 - Reduce the infusion rate by 50%
Grade 2 - Interrupt the infusion of ONCASPAR
- Treat the symptoms
- When symptoms resolve, resume the infusion and reduce the infusion rate by 50%
Grade 3 to 4 - Discontinue ONCASPAR permanently
Thrombosis [see Warnings and Precautions (5.2)]Uncomplicated deep vein thrombosis - Hold ONCASPAR
- Treat with appropriate antithrombotic therapy
- Upon resolution of symptoms consider resuming ONCASPAR, while continuing antithrombotic therapy
Severe or life-threatening thrombosis - Discontinue ONCASPAR permanently
- Treat with appropriate antithrombotic therapy
Pancreatitis [see Warnings and Precautions (5.3)]Grades 3 to 4 - Hold ONCASPAR for elevations in lipase or amylase >3 × ULN until enzyme levels stabilize or are declining
- Discontinue ONCASPAR permanently if clinical pancreatitis is confirmed
Hemorrhage [see Warnings and Precautions (5.5)]Grade 3 to 4 - Hold ONCASPAR
- Evaluate for coagulopathy and consider clotting factor replacement as needed
- Resume ONCASPAR with the next scheduled dose if bleeding is controlled
Hepatotoxicity [see Warnings and Precautions (5.6)]Total bilirubin more than 3 times to no more than 10 times the ULN - Hold ONCASPAR until total bilirubin is ≤1.5 times the ULN
Total bilirubin more than 10 times the ULN - Discontinue ONCASPAR and do not make up for missed doses
- Do not administer ONCASPAR if drug has been frozen, stored at room temperature for more than 48 hours, or shaken or vigorously agitated. ()
16 HOW SUPPLIED/STORAGE AND HANDLINGONCASPAR (pegaspargase) injection is supplied as a sterile, clear, colorless, preservative-free solution in Type I single-dose vial containing 3,750 International Units of pegaspargase per 5 mL (750 International Units per mL) solution (NDC 72694-954-01).
Store ONCASPAR 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.
Injection: 3,750 International Units/5 mL (750 International Units/mL) clear, colorless solution in a single-dose vial.
There are no data on the presence of pegaspargase in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ONCASPAR and for 1 month after the last dose.
ONCASPAR is contraindicated in patients with a:
- History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see.]
5.1 Anaphylaxis and Serious Hypersensitivity ReactionsAnaphylaxis and serious hypersensitivity reactions can occur in patients receiving ONCASPAR. The risk of serious hypersensitivity reactions is higher in patients with known hypersensitivity to (
E.) coliderived L-asparaginase formulations. Other hypersensitivity reactions can include angioedema, lip swelling, eye swelling, erythema, blood pressure decreased, bronchospasm, dyspnea, pruritus, and rash[see Adverse Reactions (6.1)].Premedicate patients 30-60 minutes prior to administration of ONCASPAR.
[see Dosage and Administration (2.2)]. Observe patients for 1 hour after administration of ONCASPAR in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines)[see Dosage and Administration (2.4)]. Discontinue ONCASPAR in patients with serious hypersensitivity reactions. - History of serious thrombosis with prior L-asparaginase therapy [see.]
5.2 ThrombosisSerious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving ONCASPAR
[see Adverse Reactions (6.1)]. Discontinue ONCASPAR in patients with serious thrombotic events[see Dosage and Administration (2.3)]. - History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy [see.]
5.3 PancreatitisPancreatitis can occur in patients receiving ONCASPAR. Hemorrhagic or necrotizing pancreatitis with fatal outcomes have been reported
[see Adverse Reactions (6.1)]. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to confirm early signs of pancreatic inflammation. Discontinue ONCASPAR in patients where pancreatitis is suspected. If pancreatitis is confirmed, do not resume ONCASPAR[see Dosage and Administration (2.3)]. - History of serious hemorrhagic events with prior L-asparaginase therapy [see.]
5.5 HemorrhageIncreased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving ONCASPAR
[see Adverse Reactions (6.1)]. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy. Discontinue ONCASPAR for severe or life-threatening hemorrhage[see Dosage and Administration (2.3)]. - Severe hepatic impairment [see.]
5.6 Hepatotoxicity, Including Hepatic Veno-Occlusive DiseaseHepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ONCASPAR in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy[see Adverse Reactions (6)].Do not administer ONCASPAR to patients with severe hepatic impairment[see Contraindications (4)].Evaluate bilirubin and transaminases prior to each dose of ONCASPAR and at least weekly, during cycles of treatment that include ONCASPAR, through 6 weeks after the last dose of ONCASPAR. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ONCASPAR, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ONCASPAR and provide supportive care[see Dosage and Administration (2.3)].