pegaspargase


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pegaspargase

 [peg-as´pahr-jās]
l-asparaginase derived from Escherichia coli and covalently linked to polyethylene glycol; used as an antineoplastic in the treatment of acute lymphoblastic leukemia, administered intramuscularly or intravenously.

pegaspargase (PEG-L-asparaginase)

Oncaspar

Pharmacologic class: Enzyme

Therapeutic class: Antineoplastic

Pregnancy risk category C

Action

Stimulates production of effector proteins, such as serum neopterin and 2', 5' oligodenylate synthetase; raises body temperature and reversibly lowers white blood cell and platelet counts

Availability

Injection: 750 international units/ml, 5-ml vial in phosphate-buffered saline solution

Indications and dosages

Acute lymphoblastic leukemia

Adults and children with body surface area (BSA) greater than 0.6 m2: 2,500 international units/m2 I.M. or I.V. q 14 days

Adults and children with BSA less than 0.6 m2: 82.5 international units/m2 I.M. or I.V. q 14 days

Contraindications

• Hypersensitivity or previous serious allergic reaction (such as generalized urticaria, bronchospasm, laryngeal edema, hypotension) to drug

• Pancreatitis or history of pancreatitis

• Previous hemorrhagic events related to L-asparaginase therapy

Precautions

Use cautiously in:

• renal or hepatic disease, CNS disorders

• concurrent use of hepatotoxic agents, anticoagulants, aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

• pregnant or breastfeeding patients.

Administration

Follow facility protocol for handling, preparing, and disposing of chemotherapeutic drugs.

Avoid inhaling vapors and contact with skin or mucous membranes.

Keep resuscitation equipment, epinephrine, oxygen, steroids, and anti-histamines readily available.

• Know that I.M. route is preferred because it's less likely to cause hepato-toxicity, coagulopathy, and GI or renal disorders. For single I.M. injection, don't exceed volume of 2 ml.

• For I.V. use, dilute in 100 ml of normal saline solution or dextrose 5% in water. Infuse over 1 to 2 hours.

Don't freeze; freezing inactivates drug.

Adverse reactions

CNS: dizziness, headache, confusion, hallucinations, emotional lability, drowsiness, neuritis, Parkinson-like syndrome, malaise, coma, seizures

CV: hypertension, hypotension, chest pain, peripheral edema, tachycardia, endocarditis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, anorexia, pancreatitis GU: glycosuria, polyuria, urinary frequency, hematuria

Hematologic: hemolytic anemia, leukopenia, pancytopenia, thrombocy-topenia, disseminated intravascular coagulation

Hepatic: jaundice, fatty liver deposits, hepatotoxicity, hepatomegaly

Metabolic: hypoproteinemia, hyperuricemia, hyperammonemia, hyponatremia, hyperglycemia, hypoglycemia Respiratory: dyspnea, cough, bronchospasm

Skin: rash, urticaria, pruritus, night sweats, alopecia

Other: increased appetite and thirst, weight loss, chills, fever, injection site reaction, facial or lip edema, hypersensitivity reactions including anaphylaxis, septic shock

Interactions

Drug-drug. Aspirin, dipyridamole, heparin, NSAIDs, warfarin: increased risk of bleeding or thrombosis

Methotrexate: decreased methotrexate action

Drug-diagnostic tests. Amylase, blood urea nitrogen, creatinine, lipase, uric acid: increased levels

Glucose: increased or decreased level

Liver function tests: abnormal results

Lymphoblasts: decreased count

Plasma proteins: altered levels

Patient monitoring

Watch for anaphylaxis and other hypersensitivity reactions, especially during first hour of therapy.

• Monitor CBC (including platelet count); fibrinogen; prothrombin and partial thromboplastin times; International Normalized Ratio; and serum amylase, lipase, and uric acid levels.

Assess neurologic status. Stay alert for decreased level of consciousness and evidence of impending seizure.

• Check for signs and symptoms of bleeding, infection, and hyperglycemia.

• Monitor heart rate, blood pressure, respiratory rate, temperature, and fluid intake and output.

Patient teaching

Teach patient to recognize and immediately report signs and symptoms of hypersensitivity reactions, bleeding, infection, and other adverse reactions.

• Tell patient drug is likely to cause reversible hair loss.

• Stress importance of undergoing follow-up laboratory tests.

• Advise patient to avoid situations that increase risk for infection.

• Instruct patient to consult pre-scriber before taking other prescription drugs or over-the-counter preparations.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

References in periodicals archive ?
Pharmacokinetics-based integration of multiple doses of intravenous pegaspargase in a pediatric regimen for adults with newly diagnosed acute lymphoblastic leukemia.
Xbrane is also accelerating development of Xcimzane (certoizumab pegol [Cimzia] biosimilar) and Xoncane (pegaspargase [Oncaspar] biosimilar) and aims to develop two additional biosimilars on biologics with patent expiration 2026-2028.
Peter Gale et al., "Efficacy of pegaspargase, etoposide, methotrexate and dexamethasone in newly diagnosed advanced-stage extra-nodal natural killer/T-cell lymphoma with the analysis of the prognosis of whole blood EBV-DNA," Blood Cancer Journal, vol.
Graham, "Pegaspargase: a review of clinical studies," Advanced Drug Delivery Reviews, vol.
An observational retrospective study on the use of gemcitabine in pretreated/refractory ENKTL has been recently completed, but the results are not yet available so far [51]; in addition two randomized controlled multicenter clinical trials are now evaluating the efficacy of the DDGP (gemcitabine, pegaspargase, cisplatin, and dexamethasone) regimen for patients with ENKTL [52, 53].
Avenues of ongoing research include an anti-interferon-gamma monoclonal antibody and the study of pegaspargase together with liposomal Doxorubicin, etoposide, and high-dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis [15].
Oncology revenues were $53 million from the acquisition of ONCASPAR (pegaspargase) leukemia portfolio from Sigma-Tau.
(NYSE: BXLT) has completed the USD 900m acquisition of the OnCaspar (pegaspargase) portfolio from Italian drugmaker Sigma-Tau Finanziaria S.p.A., the company said on Thursday.
For these reasons, the comparison of the incidence of antibodies to denileukin diftitox with the incidence of antibodies to other products may be misleading' Oncaspar The detection of antibody formation is highly (pegaspargase) dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications and underlying disease.
Examples of these are the enzymes asparaginase and pegaspargase; ribonucleotide reductase inhibitor hydroxyurea; retinoids bexarotene, isotretinoin and tretinoin.
According to the contract, Servier will acquire oncology treatment Oncaspar (pegaspargase), as well as ex-US rights of Onivyde (irinotecan pegylated liposomal formulation).
The European Commission has granted marketing authorisation to Shire plc (LON: SHP) for its lyophilised ONCASPAR (pegaspargase), the company confirmed on Wednesday.