Asparaginase erwinia chrysanthemi Side Effects

Not all side effects for asparaginase erwinia chrysanthemi may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to asparaginase erwinia chrysanthemi: intramuscular powder for solution

In addition to its needed effects, some unwanted effects may be caused by asparaginase erwinia chrysanthemi. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking asparaginase erwinia chrysanthemi, check with your doctor or nurse immediately:

More common
  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives or welts
  • hoarseness
  • irritation
  • itching
  • joint pain, stiffness, or swelling
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • redness of the skin
  • shortness of breath
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • unusual tiredness or weakness
  • wheezing
Less common
  • Abdominal or stomach pain
  • bloating
  • blurred vision
  • chills
  • constipation
  • darkened urine
  • dry mouth
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • loss of appetite
  • nausea
  • pains in the chest, groin, or legs, especially calves of the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • seizures
  • severe headaches of sudden onset
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • sweating
  • unexplained weight loss
  • vomiting
  • yellow eyes or skin
Rare
  • Blood in the urine or stools
  • bruising
  • confusion
  • coughing or vomiting blood
  • headache
  • numbness or tingling in the face, arms, or legs
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • red streaks on the skin
  • swelling, tenderness, or pain at the injection site
  • trouble speaking, thinking, or walking

Some of the side effects that can occur with asparaginase erwinia chrysanthemi may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Diarrhea

For Healthcare Professionals

Applies to asparaginase erwinia chrysanthemi: intramuscular powder for injection

General

Most common adverse reactions were systemic hypersensitivity, hyperglycemia, abnormal transaminases, fever, pancreatitis, local reactions, vomiting, nausea, thrombosis, hyperbilirubinemia, abdominal pain/discomfort, and diarrhea.[Ref]

Hypersensitivity

Very common (10% or more): Systemic hypersensitivity (14%)
Very rare (less than 0.01%): Anaphylaxis[Ref]

Gastrointestinal

Common (1% to 10%): Pancreatitis, vomiting, nausea, abdominal pain/discomfort, diarrhea, serum amylases increased, serum lipase increased[Ref]

Nervous system

Common (1% to 10%): Lethargy, somnolence, confusion, dizziness, neurotoxicity, convulsions, headache
Rare (less than 0.1%): Dysphasia, dysphagia, CNS depression, coma[Ref]

Dermatologic

Common (1% to 10%): Rash, urticarial, pruritus, erythema, facial edema[Ref]

Hepatic

Common (1% to 10%): Transaminases abnormal, hyperbilirubinemia, alkaline phosphatase increased, cholesterol increased
Rare (less than 0.1%): Hepatic failure
Frequency not reported: Hepatomegaly, cholestatic jaundice[Ref]

Hematologic

Common (1% to 10%): Hypofibrinogenemia, asymptomatic coagulopathy
Very rare (less than 0.01%): Neutropenia, febrile neutropenia, thrombocytopenia
Frequency not reported: clotting factor decreased, antithrombin III decreased, protein C decreased, protein S decreased, fibrinogen decreased[Ref]

Cardiovascular

Common (1% to 10%): Thrombosis, pallor
Very rare (less than 0.01%): Hemorrhage
Frequency not reported: Hypertension[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia
Uncommon (0.1% to 1%): Hyperlipidemia
Rare (0.01% to 0.1%): Diabetic ketoacidosis
Very rare (less than 0.01%): Hyperammonemia[Ref]

Local

Common (1% to 10%): Local reactions[Ref]

Other

Common (1% to 10%): Fever[Ref]

Musculoskeletal

Very rare (less than 0.01%): Myalgia, reactive arthritis
Frequency not reported: Extremity pain[Ref]

Immunologic

Very rare (less than 0.01%): Life-threatening sepsis[Ref]

References

1. "Product Information. Erwinaze (asparaginase Erwinia chrysanthemi)." EUSA Pharma, Newtown, PA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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