Pegaspargase (Oncaspar)
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Pegaspargase (Oncaspar)

Oncaspar®
(pegaspargase) Intravenous -or- Intramuscular Injection

DRUG DESCRIPTION

Oncaspar® (pegaspargase) is a modified version of the enzyme L-asparaginase. To produce Oncaspar® (pegaspargase) , L-asparaginase is modified by covalently conjugating units of monomethoxypolyethylene glycol (PEG), molecular weight of 5,000, to the enzyme, forming the active ingredient PEG-L-asparaginase. The L-asparaginase (L-asparagine amidohydrolase, type EC-2, EC 3.5.1.1) used in the manufacture of Oncaspar® (pegaspargase) is derived from E coli and supplied by Ovation Pharmaceuticals (U.S. License No. 1688) under a shared manufacturing arrangement. Oncaspar® (pegaspargase) activity is expressed in International Units (IU) according to the recommendation of the International Union of Biochemistry. One IU of L-asparaginase is defined as that amount of enzyme required to generate 1 umol of ammonia per minute at pH 7.3 and 37°C.

Oncaspar® (pegaspargase) is supplied as a clear, colorless, preservative-free, isotonic sterile solution in phosphate-buffered saline, pH 7.3. Each milliliter contains Oncaspar® (pegaspargase) 750 IU ± 20% (based on specific activity of at least 85 IU per milligram protein), 1.20 mg monobasic sodium phosphate, USP, 5.58 mg dibasic sodium phosphate, USP, and 8.50 mg sodium chloride, USP, in water for injection, USP.

What are the possible side effects of pegaspargase (Oncaspar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Oncaspar »

What are the precautions when taking pegaspargase (Oncaspar)?

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...

Read All Potential Precautions of Oncaspar »

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

First Line Acute Lymphoblastic Leukemia (ALL)

Oncaspar® (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the first line treatment of patients with ALL.

Acute Lymphoblastic Leukemia and Hypersensitivity to Asparaginase

Oncaspar® (pegaspargase) 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.

DOSAGE AND ADMINISTRATION

Recommended Dose

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

Instructions for Administration

When Oncaspar® (pegaspargase) 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® (pegaspargase) 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.

Preparation and Handling Precautions

Do not administer Oncaspar® (pegaspargase) if drug has been:

  • frozen
  • stored at room temperature (+15°C to +25°C; 59°F to 77°F) for more than 48 hours
  • shaken or vigorously agitated [see HOW SUPPLIED]

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.

HOW SUPPLIED

Dosage Forms And Strengths

3,750 IU/5 mL single-use vial

Dosage Form

NDC 57665-002-02

3,750 IU/5 mL single-use vial individually packaged in a carton

Storage and Handling

Keep refrigerated at +2°C to +8°C (36°F to 46°F).

Use only one dose per vial; do not re-enter the vial. Discard unused portions. Do not save unused drug for later administration.

Do not administer Oncaspar® (pegaspargase) if the drug:

  • has been frozen
  • has been stored at room temperature (+15°C to +25°C: 59°F to 77°F) for more than 48 hours
  • has been shaken or vigorously agitated
  • is cloudy, discolored, and precipitate is present.

Enzon Pharmaceuticals, Inc. Bridgewater NJ 08807.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following serious adverse reactions occur with Oncaspar® treatment [see WARNINGS AND PRECAUTIONS]:

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

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® (pegaspargase) 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® (pegaspargase) , 48 patients (81%) received all 3 planned doses of Oncaspar® (pegaspargase) , 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® (pegaspargase) 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® (pegaspargase) varied by treatment arm, with intermittent doses of Oncaspar® (pegaspargase) 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

  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
1Aspartate aminotransferase, alanine aminotransferase.
2 Prolonged prothrombin time or partial thromboplastin time; or hypofibrinogenemia.

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® (pegaspargase) 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® (pegaspargase) as a single agent or in combination with multi-agent chemotherapy. The toxicity profile of Oncaspar® (pegaspargase) 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® (pegaspargase) were clinical allergic reactions, elevated transaminases, hyperbilirubinemia, and coagulopathies. The most common serious adverse events due to Oncaspar® (pegaspargase) treatment were thrombosis (4%), hyperglycemia requiring insulin therapy (3%), and pancreatitis (1%).

Clinical Allergic Reactions

Clinical allergic reactions include the following: bronchospasm. hypotension, laryngeal edema, local erythema or swelling, systemic rash, and urticaria.

First-Line ALL

Among 58 Oncaspar® (pegaspargase) -treated patients enrolled in Study 1, clinical allergic reactions were reported in 2 patients (3%). One patient experienced a grade 1 allergic reaction and the other grade 3 hives; both occurred during the first delayed intensification phase of the study (see Table 2).

Previously Treated ALL

Among 62 patients with relapsed ALL and prior hypersensitivity reactions to asparaginase, 35 patients (56%) had a history of clinical allergic reactions to native Escherichia (E.) coli L-asparaginase, and 27 patients (44%) had history of clinical allergic reactions to both native E coli and native Erwinia L-asparaginase. Twenty (32%) of these 62 patients experienced clinical allergic reactions to Oncaspar® (pegaspargase) (see Table 2).

Among 112 patients with relapsed ALL with no prior hypersensitivity reactions to asparaginase, 11 patients (10%) experienced clinical allergic reactions to Oncaspar® (pegaspargase) (see Table 2).

TABLE 2: INCIDENCE OF CLINICAL ALLERGIC REACTIONS, OVERALL AND BY SEVERITY GRADE

Patient Status Toxicity Grade, n (%)
1 2 3 4 Total
Previously Hypersensitive Patients (n=62) 7(11) 8(13) 4(6) 1 (2) 20 (32)
Non-Hypersensitive Patients (n=112) 5(4) 4(4) 1 (1) 1 (1) 11 (10)
First Line (n=58) 1 (2) 0 1 (2) 0 2(3)

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity, defined as development of binding and/or neutralizing antibodies to the product.

In Study 1, Oncaspar® (pegaspargase) -treated patients were assessed for evidence of binding antibodies using an enzyme-linked immunosorbent assay (ELISA) method. The incidence of protocol-specified "high-titer" antibody formation was 2% in Induction (n=48), 10% in Delayed Intensification 1 (n=50), and 11% in Delayed Intensification 2 (n=44). There is insufficient information to determine whether the development of antibodies is associated with an increased risk of clinical allergic reactions, altered pharmacokinetics, or loss of anti-leukemic efficacy.

The detection of antibody formation is highly 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. Therefore, comparison of the incidence of antibodies to Oncaspar® (pegaspargase) with the incidence of antibodies to other products may be misleading.

Read the Oncaspar (pegaspargase) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No formal drug interaction studies, between Oncaspar® (pegaspargase) and other drugs, have been performed.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Anaphylaxis and Serious Allergic Reactions

Serious allergic reactions can occur in patients receiving Oncaspar® (pegaspargase) . 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® (pegaspargase) in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue Oncaspar® (pegaspargase) in patients with serious allergic reactions.

Thrombosis

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

Pancreatitis

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

Glucose Intolerance

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

Coagulopathy

Increased prothrombin time, increased partial thromboplastin time. and hypofibrinogenemia can occur in patients receiving Oncaspar® (pegaspargase) . 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

  • No long-term carcinogenicity studies in animals have been performed with Oncaspar® (pegaspargase) .
  • No relevant studies addressing mutagenic potential have been conducted. Oncaspar® (pegaspargase) did not exhibit a mutagenic effect when tested against Salmonella typhimurium strains in the Ames assay.
  • No studies have been performed on impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with Oncaspar® (pegaspargase) . It is also not known whether Oncaspar® (pegaspargase) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Oncaspar® (pegaspargase) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Oncaspar® (pegaspargase) is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Oncaspar® (pegaspargase) , a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

[see Clinical Studies]

Geriatric Use

Clinical studies of Oncaspar® (pegaspargase) did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Three patients received 10,000 IU/m2 of Oncaspar® (pegaspargase) as an intravenous infusion. One patient experienced a slight increase in liver enzymes. A second patient developed a rash 10 minutes after the start of the infusion, which was controlled with the administration of an antihistamine and by slowing down the infusion rate. A third patient did not experience any adverse reactions.

CONTRAINDICATIONS

  • History of serious allergic reactions to Oncaspar® (pegaspargase)
  • History of serious thrombosis with prior L-asparaginase I therapy
  • History of pancreatitis with prior L-asparaginase therapy
  • History of serious hemorrhagic events with prior L-asparaginase therapy

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

The mechanism of action of Oncaspar® (pegaspargase) is thought to be based on selective killing of leukemic cells due to depletion of plasma asparagine. Some leukemic cells are unable to synthesize asparagine due to a lack of asparagine synthetase and are dependent on an exogenous source of asparagine for survival. Depletion of asparagine, which results from treatment with the enzyme L-asparaginase, kills the leukemic cells. Normal cells, however, are less affected by the depletion due to their ability to synthesize asparagine.

Pharmacodynamics

In Study 1, pharmacodynamics were assessed in 57 newly diagnosed pediatric patients with standard-risk ALL who received three IM doses of Oncaspar® (pegaspargase) (2,500 IU/m2), one each during induction and two delayed intensification treatment phases. Pharmacodynamic activity was assessed through serial measurements of asparagine in sera (n=57) and cerebrospinal fluid (CSF) (n=50). The data for asparagine depletion are presented in CLINICAL STUDIES [see Clinical Studies].

Pharmacokinetics

Pharmacokinetic assessments were based on an enzymatic assay measuring asparaginase activity. Serum pharmacokinetics were assessed in 34 newly diagnosed pediatric patients with standard-risk ALL in Study 1 following IM administration of 2,500 IU/m2. The elimination half-life of Oncaspar® (pegaspargase) was approximately 5.8 days during the induction phase. Similar elimination half-lives were observed during Delayed Intensification 1 and Delayed Intensification 2. Concentrations greater than 0.1 IU/mL were observed in over 90% of the samples from patients treated with Oncaspar® (pegaspargase) during induction, Delayed Intensification 1, and Delayed Intensification 2 for approximately 20 days.

In 3 pharmacokinetic studies, 37 patients with relapsed ALL received Oncaspar® (pegaspargase) at 2,500 IU/m2 IM every 2 weeks. The plasma half-life of Oncaspar® (pegaspargase) was 3.2 ±1.8 days in 9 patients who were previously hypersensitive to native E coli L-asparaginase and 5.7 ± 3.2 days in 28 non-hypersensitive patients. The area under the plasma concentration-time curve (AUC) was 9.5 ± 4.0 lU/mL/day in the previously hypersensitive patients and 9.8 ± 6.0 lU/mL/day in the non-hypersensitive patients.

Clinical Studies

First-Line ALL

The safety and effectiveness of Oncaspar® (pegaspargase) was evaluated in an open-label, multicenter, randomized, active-controlled study (Study 1). In this study. 118 pediatric patients aged 1 to 9 years with previously untreated standard-risk ALL were randomized 1:1 to Oncaspar® (pegaspargase) or native E coli L-asparaginase as part of combination therapy. Oncaspar® (pegaspargase) was administered IM at a dose of 2,500 IU/m2 on Day 3 of the 4-week induction phase and on Day 3 of each of two 8-week delayed intensification phases. Native E coli L-asparaginase was administered IM at a dose of 6,000 IU/m2 three times weekly for 9 doses during induction and for 6 doses during each delayed intensification phase.

The primary determination of effectiveness was based on demonstration of similar asparagine depletion (magnitude and duration) in the Oncaspar® (pegaspargase) and native E coli L-asparaginase arms. The protocol-specified goal was achievement of asparagine depletion to a serum concentration of ≤ 1 µM. The proportion of patients with this level of depletion was similar between the 2 study arms during all 3 phases of treatment at the protocol-specified time points.

In all phases of treatment, serum asparagine concentrations decreased within 4 days of the first dose of asparaginase in the treatment phase and remained low for approximately 3 weeks for both Oncaspar® (pegaspargase) and native E coli L-asparaginase arms. Serum asparagine concentrations during the induction phase are shown in Figure 1. The patterns of serum asparagine depletion in the 2 delayed intensification phases are similar to the pattern of serum asparagine depletion in the induction phase.

FIGURE 1: MEAN (± STANDARD ERROR) SERUM ASPARAGINE CONCENTRATIONS DURING STUDY 1 INDUCTION PHASE

Mean (± Standard Error) Serum Asparagine Concentrations During Study 1 Induction Phase - Illustration

Note: Oncaspar® (pegaspargase) (2,500 IU/m2 IM) was administered on Day 3 of the 4-week induction phase. Native E coli L-asparaginase (6,000 IU/m2 IM) was administered 3 times weekly for 9 doses during induction.

CSF asparagine concentrations were determined in 50 patients during the induction phase. CSF asparagine decreased from a mean pretreatment concentration of 3.1 µM to 1.7 µM on Day 4 ± 1 and 1.5 µM 25 ± 1 days after administration of Oncaspar® (pegaspargase) . These findings were similar to those observed in the native E coli L-asparaginase treatment arm.

While the 3-year Event-Free Survival (EFS) for the Oncaspar® (pegaspargase) and native E coli L-asparaginase study arms were similar and in the range of 80%. Study 1 was not designed to evaluate for differences in EFS rates.

ALL Patients Hypersensitive to Asparaginase

The safety and effectiveness of Oncaspar® (pegaspargase) was evaluated in 4 open-label studies enrolling a total of 42 patients with multiply-relapsed, acute leukemia [39 (93%) with ALL] with a history of prior clinical allergic reaction to asparaginase. Hypersensitivity to asparaginase was defined by a history of systemic rash. urticaria, bronchospasm, laryngeal edema, hypotension, or local erythema: urticaria, or swelling, greater than 2 centimeters, for at least 10 minutes following administration of any form of native E coli L-asparaginase. All patients received Oncaspar® (pegaspargase) at a dose of 2,000 or 2,500 IU/m2 administered IM or IV every 14 days. Patients received Oncaspar® (pegaspargase) as a single agent or in combination with multi-agent chemotherapy. The re-induction response rate was 50% (95% confidence interval: 35%, 65%), based upon 36% complete remissions and 14% partial remissions. These results were similar to the overall response rates reported for patients with ALL receiving second-line, native E coli L-asparaginase-containing re-induction chemotherapy. Anti-tumor activity was also observed with single-agent Oncaspar® (pegaspargase) . Three responses (1 complete remission and 2 partial remissions) were observed in 9 adult and pediatric patients with relapsed ALL and hypersensitivity to native E coli L-asparaginase.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Serious Allergic Reactions

Patients should be informed of the possibility of serious allergic reactions. including anaphylaxis, and to immediately report any swellings or difficulty breathing.

Thrombosis

Patients should be advised to immediately report any severe headache. Arm or leg swelling, acute shortness of breath, and chest pain also should be reported immediately.

Pancreatitis

Patients should be advised to immediately report any severe abdominal pain.

Glucose Intolerance

Patients should be advised to report excessive thirst or any increase in the volume or frequency of urination.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Serious Allergic Reactions

Patients should be informed of the possibility of serious allergic reactions. including anaphylaxis, and to immediately report any swellings or difficulty breathing.

Thrombosis

Patients should be advised to immediately report any severe headache. Arm or leg swelling, acute shortness of breath, and chest pain also should be reported immediately.

Pancreatitis

Patients should be advised to immediately report any severe abdominal pain.

Glucose Intolerance

Patients should be advised to report excessive thirst or any increase in the volume or frequency of urination.

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Oncaspar Consumer

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.

PEGASPARGASE - INJECTION

(peg-ASP-are-gace)

COMMON BRAND NAME(S): Oncaspar

USES: This medication is usually used with other anti-cancer (chemotherapy) drugs 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.

Disclaimer

Oncaspar Consumer (continued)

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 your doctor has prescribed this medication because he or she 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, change in the amount of urine.

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, slurred speech, 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Oncaspar (pegaspargase) Side Effects Center for a complete guide to possible side effects »

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 infrequently make your blood sugar level rise, causing or worsening diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly as directed by your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Disclaimer

Oncaspar Consumer (continued)

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 (e.g., "blood thinners" such as warfarin/heparin, anti-platelet drugs including NSAIDs such as ibuprofen).

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Laboratory and/or medical tests (e.g., prothrombin time, complete blood counts, liver function tests, amylase levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish 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 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised October 2011. Copyright(c) 2011 First Databank, Inc.

Oncaspar Patient Information Including Side Effects

Brand Names: Oncaspar

Generic Name: pegaspargase (Pronunciation: peg ah SPAR jase)

What is pegaspargase (Oncaspar)?

Pegaspargase is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Pegaspargase is used to treat acute lymphoblastic leukemia.

Pegaspargase may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pegaspargase (Oncaspar)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • increased thirst or urination; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely to occur, such as:

  • mild skin rash or itching;
  • depression, drowsiness;
  • swelling in your hands, ankles, or feet;
  • nausea, vomiting, loss of appetite, weight loss;
  • stomach cramps; or
  • headache, feeling tired or irritable.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Oncaspar (pegaspargase) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about pegaspargase (Oncaspar)?

Do not receive this medication if you are allergic to pegaspargase, or if you have ever been treated with asparaginase (Elspar) and had a severe allergic reaction or developed a stroke, blood clot, or pancreas problems.

Before receiving pegaspargase, tell your doctor if you are allergic to any drugs, or if you have diabetes or a bleeding disorder such as hemophilia.

While receiving pegaspargase, avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Get emergency medical help if you think you have received too much of this medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of the following side effects during your treatment with pegaspargase:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in one or both legs;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • increased thirst or urination; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Side Effects Centers

Oncaspar Patient Information including How Should I Take

What should I discuss with my health care provider before receiving pegaspargase (Oncaspar)?

Do not receive this medication if you are allergic to pegaspargase, or if you have ever been treated with asparaginase (Elspar) and had:

  • a serious allergic reaction;
  • a stroke or blood clot; or
  • problems with your pancreas.

Before receiving pegaspargase, tell your doctor if you are allergic to any drugs, or if you have:

  • diabetes (pegaspargase can raise blood sugar); or
  • a bleeding or blood clotting disorder such as hemophilia.

If you have any of these conditions, you may not be able to receive pegaspargase, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether pegaspargase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is pegaspargase given (Oncaspar)?

Pegaspargase is given as an injection through an IV needle placed into a vein, or as a shot into a muscle. You will receive this injection in a clinic or hospital setting. The IV medicine must be given slowly, and it can take up to 2 hours to complete.

After receiving this medication, your doctor may want to observe you for at least 1 hour to make sure the medication does not cause harmful side effects.

Before you receive your first treatment with this medication, you may need a skin test to make sure you are not allergic to pegaspargase.

Pegaspargase can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain thyroid tests. Tell any doctor who treats you that you are receiving pegaspargase.

Side Effects Centers

Oncaspar Patient Information including If I Miss a Dose

What happens if I miss a dose (Oncaspar)?

Contact your doctor if you miss an appointment for your pegaspargase injection.

What happens if I overdose (Oncaspar)?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a pegaspargase overdose may include easy bruising or bleeding, unusual weakness, nausea, loss of appetite, and jaundice (yellowing of the skin or eyes).

What should I avoid while receiving pegaspargase (Oncaspar)?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

What other drugs will affect pegaspargase (Oncaspar)?

Before receiving asparaginse, tell your doctor if you are using any of the following drugs:

  • vincristine (Oncovin, Vincasar);
  • prednisone (Deltasone, Meticorten, Orasone, and others); or
  • methotrexate (Folex, Rheumatrex, Trexall).

If you are using any of these drugs, you may not be able to receive pegaspargase, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect pegaspargase. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about pegaspargase written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Side Effects Centers

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