Oncaspar

ONCASPAR- pegaspargase injection, solution

1 INDICATIONS AND USAGE

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 patients with ALL.

1.2 Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase

Oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

The recommended dose of Oncaspar® is 2,500 IU/m2 intramuscularly (IM) or intravenously (IV). Oncaspar® should be administered no more frequently than every 14 days.

2.2 Instructions for Administration

When Oncaspar® is administered IM, the volume at a single injection site should be limited to 2 mL. If the volume to be administered is greater than 2 mL, multiple injection sites should be used.

When administered IV, Oncaspar® should be given over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running.

2.3 Preparation and Handling Precautions

Do not administer Oncaspar® if drug has been:

Parenteral drug products should be inspected visually for particulate matter, cloudiness, or discoloration prior to administration, whenever solution and container permit. If any of these are present, discard the vial.

3 DOSAGE FORMS AND STRENGTHS

3,750 IU/5 mL single-use vial

4 CONTRAINDICATIONS

  • History of serious allergic reactions to Oncaspar®
  • History of serious thrombosis with prior L-asparaginase therapy
  • History of pancreatitis with prior L‑asparaginase therapy
  • History of serious hemorrhagic events with prior L-asparaginase therapy

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylaxis and Serious Allergic Reactions

Serious allergic reactions can occur in patients receiving Oncaspar®. The risk of serious allergic reactions is higher in patients with known hypersensitivity to other forms of L-asparaginase. 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). Discontinue Oncaspar® in patients with serious allergic reactions.

5.2 Thrombosis

Serious thrombotic events, including sagittal sinus thrombosis can occur in patients receiving Oncaspar®. Discontinue Oncaspar® in patients with serious thrombotic events.

5.3 Pancreatitis

Pancreatitis can occur in patients receiving Oncaspar®. Evaluate patients with abdominal pain for evidence of pancreatitis. Discontinue Oncaspar® in patients with pancreatitis.

5.4 Glucose Intolerance

Glucose intolerance can occur in patients receiving Oncaspar®. In some cases, glucose intolerance is irreversible.

5.5 Coagulopathy

Increased prothrombin time, increased partial thromboplastin time, and hypofibrinogenemia can occur in patients receiving Oncaspar®. Monitor coagulation parameters at baseline and periodically during and after treatment. Initiate treatment with fresh-frozen plasma to replace coagulation factors in patients with severe or symptomatic coagulopathy.

6 ADVERSE REACTIONS

The following serious adverse reactions occur with Oncaspar® treatment [see Warnings and Precautions (5)]:

  • Anaphylaxis and serious allergic reactions
  • Serious thrombosis
  • Pancreatitis
  • Glucose intolerance
  • Coagulopathy

The most common adverse reactions with Oncaspar® are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

First-Line ALL

The data presented below are derived from 2 studies in patients with standard-risk ALL who received Oncaspar® as a component of first-line multi-agent chemotherapy. Study 1 was a randomized (1:1), active-controlled study that enrolled 118 patients, with a median age of 4.7 years (1.1-9.9 years), of whom 54% were males and 65% White, 14% Hispanic, 8% Black, 8% Asian, and 6% other. Of the 59 patients in Study 1 who were randomized to Oncaspar® , 48 patients (81%) received all 3 planned doses of Oncaspar® , 6 (10%) received 2 doses, 4 (7%) received 1 dose, and 1 patient (2%) did not receive the assigned treatment. Study 2 is an ongoing, multi-factorial design study in which all patients received Oncaspar® as a component of various multi-agent chemotherapy regimens; interim safety data are available for 2,770 patients. Study participants had a median age of 4 years (1-10 years), and were 55% male, 68% White, 18% Hispanic, 4% Black, 3% Asian, and 7% other. Per protocol, the schedule of Oncaspar® varied by treatment arm, with intermittent doses of Oncaspar® for up to 10 months.

In Study 1, detailed safety information was collected for pre-specified adverse reactions identified as asparaginase-induced adverse reactions and for grade 3 and 4 non-hematologic adverse reactions according to the Children’s Cancer Group (CCG) Toxicity and Complication Criteria. The per-patient incidence, by treatment arm, for these selected adverse reactions occurring at a severity of grade 3 or 4 are presented in Table 1 below:

TABLE 1 STUDY 1: PER-PATIENT INCIDENCE OF SELECTED GRADE 3 AND 4 ADVERSE REACTIONS

1 Aspartate aminotransferase, alanine aminotransferase.

2 Prolonged prothrombin time or partial thromboplastin time; or hypofibrinogenemia.

Oncaspar®
(n=58)
Native
E. coli
L‑Asparaginase
(n=59)
Abnormal Liver Tests 3 (5%) 5 (8%)
Elevated Transaminases1 2 (3%) 4 (7%)
Hyperbilirubinemia 1 (2%) 1 (2%)
Hyperglycemia 3 (5%) 2 (3%)
Central Nervous System
Thrombosis
2 (3%) 2 (3%)
Coagulopathy2 1 (2%) 3 (5%)
Pancreatitis 1 (2%) 1 (2%)
Clinical Allergic Reactions to
Asparaginase
1 (2%) 0

Safety data were collected in Study 2 only for National Cancer Institute Common Toxicity Criteria (NCI CTC) version 2.0, grade 3 and 4 non-hematologic toxicities. In this study, the per-patient incidence for the following adverse reactions occurring during treatment courses in which patients received Oncaspar® were: elevated transaminases, 11%; coagulopathy, 7%; hyperglycemia, 5%; CNS thrombosis/hemorrhage, 2%; pancreatitis, 2%; clinical allergic reaction, 1%; and hyperbilirubinemia, 1%. There were 3 deaths due to pancreatitis.

Previously Treated ALL

Adverse reaction information was obtained from 5 clinical trials that enrolled a total of 174 patients with relapsed ALL who received Oncaspar® as a single agent or in combination with multi-agent chemotherapy. The toxicity profile of Oncaspar® in patients with previously treated relapsed ALL is similar to that reported above with the exception of clinical allergic reactions (see Table 2). The most common adverse reactions of Oncaspar® were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies. The most common serious adverse events due to Oncaspar® treatment were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

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