Pegaspargase

Pegaspargase is a prescription medication used to treat the symptoms of Acute Lymphoblastic Leukemia.

• Pegaspargase is available under the following different brand names: Oncaspar, PEG L Asparaginase

Common side effects of Pegaspargase include:

• Nausea,
• Vomiting,
• Weakness,
• Loss of appetite,
• Diarrhea, and
• Pain, swelling, and redness at the injection site

Serious side effects of Pegaspargase include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Easy bruising,
• Unusual bleeding,
• Purple or red spots under the skin,
• Fever,
• Mouth sores,
• Skin sores,
• Sore throat,
• Cough,
• Trouble breathing,
• Loss of appetite,
• Upper stomach pain (that may spread to the back),
• Nausea,
• Vomiting,
• Fast heart rate,
• Dark urine,
• Yellowing of the skin or eyes (jaundice),
• Increased thirst,
• Increased urination,
• Dry mouth,
• Fruity breath odor,
• Sudden numbness or weakness,
• Problems with vision or speech, and
• Swelling or redness in an arm or leg

Rare side effects of Pegaspargase include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 750 units/mL (5-mL single-dose vial)

Acute Lymphoblastic Leukemia

Adult dosage

• 2,000 international units/m2 Intramuscular or Intravenous no more frequently than every 14 days 

Pediatric dosage

• First-line treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) OR
• Treatment for adult and pediatric patients with ALL and with hypersensitivity to native forms of L-asparaginase
• Below 21 years: 2,500 international units/m2 Intramuscular or Intravenous no more frequently than every 14 days
• Above 21 years: 2,000 international units/m2 Intramuscular or Intravenous no more frequently than every 14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pegaspargase has severe interactions with no other drugs.
• Pegaspargase has serious interactions with no other drugs.
• Pegaspargase has moderate interactions with at least 41 other drugs.
• Pegaspargase has minor interactions with the following drugs:
  • aspirin rectal
  • choline magnesium trisalicylate
  • ketorolac intranasal
  • taurine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Serious hypersensitivity reactions, including anaphylaxis, to pegaspargase or any of the excipients
• Severe hepatic impairment
• Related to prior L-asparaginase therapy
• History of serious thrombosis
• History of pancreatitis, including pancreatitis
• History of serious hemorrhagic events

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pegaspargase?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pegaspargase?”

Cautions

• Serious thrombotic events, including sagittal sinus thrombosis, can occur; discontinue therapy in patients with serious thrombotic events
• Pancreatitis, including hemorrhagic or necrotizing pancreatitis, reported; consult on signs and symptoms of pancreatitis; assess serum amylase and/or lipase levels to confirm early signs of pancreatic inflammation; discontinue treatment in patients where pancreatitis is suspected; if pancreatitis is confirmed, do not resume therapy
• Glucose intolerance may occur; in some cases, glucose intolerance is irreversible; monitor serum glucose
• Increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia reported; evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, fibrinogen; discontinue drug for severe or life-threatening hemorrhage
• Hepatotoxicity and abnormal liver function, including elevated AST/AST, bilirubin (direct and indirect), reduced serum albumin, and plasma fibrinogen may occur; evaluate bilirubin and AST/ALT at least weekly during treatment cycles, including through at least 6 weeks after the last dose; in the event of serious liver toxicity, discontinue treatment and provide supportive care
• Anaphylaxis and serious hypersensitivity reactions
• Anaphylaxis and serious hypersensitivity reaction may occur
• Risk of serious hypersensitivity reaction is higher in patients 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
• Premedicate patients 30-60 minutes before administration of the drug; observe patients for 1 hour after administration in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (for example, epinephrine, oxygen, intravenous steroids, antihistamines); discontinue treatment in patients with serious hypersensitivity reactions
• Drug interaction overview
  • Glucocorticoids
    • Pegaspargase may increase the risk of glucocorticoid-induced toxicities, including osteonecrosis, through a potential increase in exposure to dexamethasone

Pregnancy and Lactation

• 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
• Verify pregnancy in females of reproductive potential before initiating
• Contraception
  • Females of reproductive potential: Use effective nonhormonal contraceptive methods during treatment and for at least 3 months after the last dose
  • Since there is a potential for an indirect interaction between therapy and oral contraceptives, concomitant use of drugs and oral contraceptives is not recommended
• Lactation
  • There are no data on the presence of the drug in human milk, its effects on breastfed children, or milk production
  • Advise lactating women not to breastfeed while receiving the drug and for 1 month after the last dose