pegaspargase (Rx)

Brand and Other Names:Oncaspar, PEG L Asparaginase
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 750 units (5 mL)

Acute Lymphoblastic Leukemia

For use in patients with hypersensitivity to native forms of L-asparaginase

First line agent as part of multiagent chemotherapeutic regimen

2500 international units/m² IM (preferred) or IV q14Days  

Monitor CBC, serum amylase

Dosage Forms & Strengths

powder for injection

  • 750 units

Acute Lymphoblastic Leukemia

2500 units/m² IM (preferred) or IV q14Days  

Off-label Dosing

  • BSA ≤ 0.6 m²: 82.5 units/kg IM or IV q14Days as part of multiagent chemotherapeutic regimen
  • BSA >0.6 m²: 2500 units/m² IM (preferred) or IV q14Days as part of multiagent chemotherapeutic regimen

Monitor

CBC, serum amylase

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Interactions

Interaction Checker

and pegaspargase

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (42)

                • antithrombin alfa

                  pegaspargase increases effects of antithrombin alfa by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • antithrombin III

                  pegaspargase increases effects of antithrombin III by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • argatroban

                  pegaspargase increases effects of argatroban by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • aspirin

                  pegaspargase increases effects of aspirin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • aspirin/citric acid/sodium bicarbonate

                  pegaspargase increases effects of aspirin/citric acid/sodium bicarbonate by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • bivalirudin

                  pegaspargase increases effects of bivalirudin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • celecoxib

                  pegaspargase increases effects of celecoxib by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • cholera vaccine

                  pegaspargase decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

                • dabigatran

                  pegaspargase increases effects of dabigatran by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • dalteparin

                  pegaspargase increases effects of dalteparin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • diclofenac

                  pegaspargase increases effects of diclofenac by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • diflunisal

                  pegaspargase increases effects of diflunisal by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • enoxaparin

                  pegaspargase increases effects of enoxaparin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • etodolac

                  pegaspargase increases effects of etodolac by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • fenoprofen

                  pegaspargase increases effects of fenoprofen by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • flurbiprofen

                  pegaspargase increases effects of flurbiprofen by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • fondaparinux

                  pegaspargase increases effects of fondaparinux by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • heparin

                  pegaspargase increases effects of heparin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • ibuprofen

                  pegaspargase increases effects of ibuprofen by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • ibuprofen IV

                  pegaspargase increases effects of ibuprofen IV by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • indomethacin

                  pegaspargase increases effects of indomethacin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • ketoprofen

                  pegaspargase increases effects of ketoprofen by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Increased risk of bleeding events.

                • ketorolac

                  pegaspargase increases effects of ketorolac by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • meclofenamate

                  pegaspargase increases effects of meclofenamate by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • mefenamic acid

                  pegaspargase increases effects of mefenamic acid by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • meloxicam

                  pegaspargase increases effects of meloxicam by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • methotrexate

                  pegaspargase decreases effects of methotrexate by pharmacodynamic antagonism. Use Caution/Monitor. It is recommended to give pegaspargase at least 10-14 days prior to methotrexate or shortly after methotrexate administration.

                • nabumetone

                  pegaspargase increases effects of nabumetone by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • naproxen

                  pegaspargase increases effects of naproxen by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • ofatumumab SC

                  ofatumumab SC, pegaspargase. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

                • oxaprozin

                  pegaspargase increases effects of oxaprozin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • pegloticase

                  pegloticase will decrease the level or effect of pegaspargase by Other (see comment). Use Caution/Monitor. According to the manufacturer, potential for anti-PEG antibody development that may bind to other pegylated drugs; clinical significance unknown

                • pegvaliase

                  pegvaliase, pegaspargase. Other (see comment). Use Caution/Monitor. Comment: The majority of patients treated with pegvaliase develop anti-polyethylene glycol (PEG) IgM and IgG antibodies. Risk of coadministration with different PEGylated products is unknown. There is a case report of anaphylaxis following a medroxyprogesterone acetate injectable suspension that contained PEG 3350. Carefully read all drug labels, including OTC drugs to check contents for PEG. Note: Unable to include an exhaustive product list for this interaction.

                • piroxicam

                  pegaspargase increases effects of piroxicam by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • protamine

                  pegaspargase increases effects of protamine by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • salicylates (non-asa)

                  pegaspargase increases effects of salicylates (non-asa) by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • salsalate

                  pegaspargase increases effects of salsalate by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • siponimod

                  siponimod and pegaspargase both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

                • sulfasalazine

                  pegaspargase increases effects of sulfasalazine by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • sulindac

                  pegaspargase increases effects of sulindac by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • tolmetin

                  pegaspargase increases effects of tolmetin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                • warfarin

                  pegaspargase increases effects of warfarin by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

                Minor (4)

                • aspirin rectal

                  pegaspargase increases effects of aspirin rectal by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of bleeding events.

                • choline magnesium trisalicylate

                  pegaspargase increases effects of choline magnesium trisalicylate by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of bleeding events.

                • ketorolac intranasal

                  pegaspargase increases effects of ketorolac intranasal by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of bleeding events.

                • taurine

                  pegaspargase decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown. Taurine was found to reduce platelet aggregation and may increase the risk of bleeding.

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                Adverse Effects

                1-10%

                >5%

                • Edema
                • Fever, malaise
                • Nausea, vomiting
                • Coagulopathy
                • Rash
                • ALT increased
                • Dyspnea
                • Erythema
                • Urticaria
                • Swelling
                • Chills

                1-5%

                • Anaphylaxis
                • Hypotension
                • Peripheral edema
                • Tachycardia
                • Thrombosis
                • CNS toxicity
                • Chills
                • Headache
                • Pain
                • Seizure
                • Erythema, rash, urticaria
                • Hyperglycemia, hyperuricemia, hypoglycemia, hypoproteinemia, hyperlipidemia
                • Bleeding tendency
                • LFT abnormalities, AST increased, jaundice, hyperbilirubinemia
                • Dyspnea
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                Warnings

                Contraindications

                Hypersensitivity

                History of (with prior L-asparaginase treatment): pancreatitis, including pancreatitis related to prior L-asparaginase therapy; hemorrhagic events; serious thrombosis

                Cautions

                No more than 2 mL should be administered at any one injection site

                Anaphylaxis or serious allergic reactions may occur, 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 monitor patient for 1 hr after administration; discontinue with serious allergic reactions

                Glucose intolerance reported (irreversible in some cases); monitor serum glucose

                Hepatotoxicity and abnormal liver function, including elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin (direct and indirect), and depression of serum albumin, and plasma fibrinogen may occur; monitor; evaluate bilirubin and transaminases at least weekly during cycles of treatment that include drug through at least 6 weeks after last dose; in event of serious liver toxicity, discontinue treatment with therapy and provide supportive care

                Discontinue if pancreatitis occurs; evaluate patients with abdominal pain for pancreatitis; hemorrhagic or necrotizing pancreatitis with fatal outcomes have been reported; assess serum amylase and/or lipase levels to confirm early signs of pancreatic inflammation; discontinue therapy in patients where pancreatitis suspected; if pancreatitis confirmed, do not resume therapy

                Serious thrombotic events, including sagittal sinus thrombosis reported; discontinue if this occurs

                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 therapy for severe or life-threatening hemorrhage

                Increased prothrombin time, increased PTT and hypofibrinogenemia may occur; monitor for coagulopathy

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                Pregnancy & Lactation

                Pregnancy

                There are no available data on the use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage or adverse maternal or fetal outcomes; published literature studies in pregnant animals suggest asparagine depletion may cause harm to animal offspring; advise patients of potential risk to a fetus

                Patients with reproductive potential

                • Based on studies in pregnant animals, drug can cause fetal harm when administered to a pregnant woman
                • Conduct pregnancy testing in females of reproductive potential prior to starting treatment
                • Advise females of reproductive potential to avoid becoming pregnant while receiving therapy
                • Females should use effective contraceptive methods, including a barrier method, during treatment and for at least 3 months after last dose; since there is a potential for an indirect interaction between therapy and oral contraceptives, concomitant use of drug and oral contraceptives is not recommended; another, non-hormonal contraception should be used in women of childbearing potential

                Lactation

                There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; because many drugs are excreted in human milk and because of potential for adverse reactions in a breastfed child, advise lactating women not to breastfeed while receiving drug and for 3 months after last dose

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Modified version of L-asparaginase depletes asparagine, the aminoacid required for protein synthesis, and in turn kills leukemic cells

                Pharmacokinetics

                Half-Life: 5-5.6 days

                Onset: Asparagine depleted within 4 days (IM)

                Duration: 21 days (IM); 2-4 weeks (IV in asparaginase naive adults)

                Vd: 1.5 L/m² (IM in children); 2.4 L/m² (IV in adults)

                Metabolism: Systemically

                Peak plasma time: 3-4 days (IM)

                Excretion: Urine (trace amounts)

                IV/IM Administration

                No need for test dose

                IM: must only be given as a deep intramuscular injection into a large muscle; limit the volume of a single injection site to 2 mL; if the volume to be administered is >2 mL, use multiple injection sites

                IV given as a 1- to 2- hr infusion; do not give IV push

                Administration

                • Have parenteral epinephrine, diphenhydramine, and hydrocortisone available at the bedside
                • Have a freely running IV in place
                • Have a physician readily accessible
                • Monitor the patients closely for 30-60 min
                • Do not filter solution
                • Have available appropriate agents for maintenance of an adequate airway and treatment of a hypersensitivity reaction (antihistamine, epinephrine, oxygen, IV corticosteroids)
                • Be prepared to treat anaphylaxis at each administration
                • Administer through an infusion that is already running

                IV/IM Preparation

                Reconstitution: Avoid excessive agitation; do not shake

                Standard IM dilution: Do not exceed 2 mL volume per injection site

                Standard IV dilution: Dose/100 mL NS or D5W

                Storage

                Refrigerate

                Do not use if cloudy or if precipitate is present

                Do not freeze

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Oncaspar injection
                -
                750 unit/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                pegaspargase injection

                PEGASPARGASE - INJECTION

                (peg-ASP-are-gace)

                COMMON BRAND NAME(S): Oncaspar

                USES: This medication is usually used to treat acute lymphocytic leukemia (ALL), especially in patients who are allergic to L-asparaginase. It works by starving tumor cells of a certain amino acid (asparagine), causing the tumor cells to die.

                HOW TO USE: This medication is given by injection into a vein or a muscle by a health care professional. Dosage is based on your body size and response to treatment.

                SIDE EFFECTS: Nausea, vomiting, weakness, loss of appetite, diarrhea, or pain/swelling/redness at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, signs of an infection (e.g., fever), increased thirst/urination, easy bruising/bleeding, dark urine, yellowing eyes/skin, pain/redness/swelling/numbness/tingling of the arms or legs.Get medical help right away if any of these rare but very serious side effects occur: sudden shortness of breath, chest pain, severe headache, seizures, trouble speaking, confusion, vision changes, weakness on one side of the body.A very serious allergic reaction to this drug can occur. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using pegaspargase, tell your doctor or pharmacist if you are allergic to it; or to L-asparaginase; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of a serious reaction to L-asparaginase (e.g., bleeding, blood clots, pancreatitis), diabetes, clotting/bleeding disorders, liver disease, pancreatitis.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Wash your hands well to prevent the spread of infections.To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. If you have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pegaspargase. Pegaspargase may harm a pregnant woman and her unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for at least 3 months after stopping treatment. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (for example, "blood thinners" such as warfarin/heparin, anti-platelet drugs including NSAIDs such as ibuprofen).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Lab and/or medical tests (such as prothrombin time, complete blood counts, liver function tests, amylase levels, blood sugar) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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