Oncaspar
(pegaspargase)Dosage & Administration
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Oncaspar Prescribing Information
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
ONCASPAR 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.
Recommended Dosage
Patients 21 Years of Age or Younger
The recommended dose of ONCASPAR for patients up to and including 21 years of age is 2,500 International Units/m2 intramuscularly or intravenously no more frequently than every 14 days.
Patients More Than 21 Years of Age
The recommended dose of ONCASPAR for adult patients more than 21 years of age is 2,000 International Units/m2 intramuscularly or intravenously no more frequently than every 14 days.
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 ONCASPAR to decrease the risk and severity of both infusion and hypersensitivity reactions [see Warnings and Precautions (5.1)].
Recommended Monitoring and Dosage Modifications for Adverse Reactions
Monitor 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.
| Adverse Reaction | Severity * | Action |
|---|---|---|
| ||
| Infusion Reaction/Hypersensitivity Reaction [see Warnings and Precautions (5.1)] | Grade 1 |
|
| Grade 2 |
| |
| Grade 3 to 4 |
| |
| Thrombosis [see Warnings and Precautions (5.2)] | Uncomplicated deep vein thrombosis |
|
| Severe or life-threatening thrombosis |
| |
| Pancreatitis [see Warnings and Precautions (5.3)] | Grades 3 to 4 |
|
| Hemorrhage [see Warnings and Precautions (5.5)] | Grade 3 to 4 |
|
| Hepatotoxicity [see Warnings and Precautions (5.6)] | Total bilirubin more than 3 times to no more than 10 times the ULN |
|
| Total bilirubin more than 10 times the ULN |
| |
Preparation and Administration
Administer ONCASPAR in a healthcare setting with appropriate medical support and resuscitation equipment to manage hypersensitivity reactions, should they occur [see Warnings and Precautions (5.1)].
ONCASPAR is a clear and colorless solution. Visually inspect parenteral drug products for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial.
When ONCASPAR is administered intramuscularly:
- Limit the volume at a single injection site to 2 mL.
- If the volume to be administered is greater than 2 mL, use multiple injection sites.
When ONCASPAR is administered intravenously:
- Dilute ONCASPAR with 100 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, using aseptic technique.
- After dilution, administer immediately into a running infusion of either 0.9% Sodium Chloride, USP or 5% Dextrose Injection, USP, respectively.
- Administer over a period of 1-2 hours.
- Do not infuse other drugs through the same intravenous line during administration of ONCASPAR.
- The diluted solution should be used immediately. If immediate use is not possible, the diluted solution should be stored refrigerated at 2°C to 8°C (36°F to 46°F) for up to 48 hours. Protect infusion bags from direct sunlight.
ONCASPAR does not contain a preservative. Use only one dose per vial; discard unused product.
Injection: 3,750 International Units/5 mL (750 International Units/mL) clear, colorless solution in a single-dose vial.
Pregnancy
Risk summary
Based on published literature studies with L-asparaginase in pregnant animals, ONCASPAR can cause fetal harm when administered to a pregnant woman. There are no available data on ONCASPAR use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published literature studies in pregnant animals suggest asparagine depletion may cause harm to the animal offspring (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.
Data
Animal Data
Animal reproduction studies have not been conducted with ONCASPAR to evaluate its effect on reproduction and fetal development. Published literature studies in which pregnant rabbits were administered L-asparaginase or pregnant rats were deprived of dietary asparagine suggested harm to the animal offspring.
Lactation
Risk summary
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.
Females and Males of Reproductive Potential
ONCASPAR can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
Pregnancy
Pregnancy testing is recommended in females of reproductive potential prior to initiating ONCASPAR.
Contraception
Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with ONCASPAR and for 3 months after the last dose.
Pediatric Use
The safety and effectiveness of ONCASPAR in the treatment of ALL have been established in pediatric patients. Use of ONCASPAR in these age groups is supported by evidence of efficacy as first-line treatment from one adequate and well-controlled trial, and evidence of efficacy for treatment of patients with hypersensitivity to asparaginase from four adequate and well-controlled trials [see Clinical Studies (14.1)], and safety data from 7 total trials. The pediatric patients treated with ONCASPAR 2,500 International Units/m2 on these trials included 26 infants (1 month to <2 years old), 165 children (2 years to <12 years old), and 39 adolescents (12 to 17 years old).
Geriatric Use
Clinical studies of ONCASPAR did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.
ONCASPAR is contraindicated in patients with a:
- History of serious hypersensitivity reactions, including anaphylaxis, to ONCASPAR or to any of the excipients [see Warnings and Precautions (5.1)].
- History of serious thrombosis with prior L-asparaginase therapy [see Warnings and Precautions (5.2)].
- History of pancreatitis, including pancreatitis related to prior L-asparaginase therapy [see Warnings and Precautions (5.3)].
- History of serious hemorrhagic events with prior L-asparaginase therapy [see Warnings and Precautions (5.5)].
- Severe hepatic impairment [see Warnings and Precautions (5.6)].
Anaphylaxis and Serious Hypersensitivity Reactions
Anaphylaxis 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.) coli derived 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.
Thrombosis
Serious 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)].
Pancreatitis
Pancreatitis 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)].
Glucose Intolerance
Glucose intolerance can occur in patients receiving ONCASPAR [see Adverse Reactions (6.1)]. In some cases, glucose intolerance is irreversible. Monitor serum glucose [see Dosage and Administration (2.3)].
Hemorrhage
Increased 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)].
Hepatotoxicity, Including Hepatic Veno-Occlusive Disease
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)].