Pegaspargase Side Effects

Some side effects of pegaspargase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pegaspargase: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking pegaspargase: 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.

For Healthcare Professionals

Applies to pegaspargase: injectable solution

Hepatic

Hepatic side effects have been reported frequently. These have included chemical hepatotoxicities. Increased SGPT has been reported frequently. Bilirubinemia and increased SGOT have been reported occasionally.

Hematologic

Hematologic side effects have been reported the most frequently. These have included coagulopathies. Thrombosis (4%), leukopenia, pancytopenia, thrombocytopenia, decreased fibrinogen, increased thromboplastin, hyperuricemia, hypoproteinemia, and hemolytic anemia have been reported occasionally.

Gastrointestinal

Gastrointestinal side effects reported frequently have included nausea and vomiting. Clinical pancreatitis, anorexia, diarrhea, jaundice, and lip edema have also been reported occasionally.

Endocrine

Endocrine side effects have included hyperglycemia requiring insulin therapy (3%) and hypoglycemia.

Dermatologic

Dermatologic side effects have included rash, erythema, and urticaria.

Respiratory

Respiratory side effects have included dyspnea, cough, upper respiratory infections, and bronchospasm.

Cardiovascular

Cardiovascular side effects have included edema. Hypotension, disseminated intravascular coagulation, peripheral edema, and tachycardia, chest pain, and endocarditis have been reported occasionally.

General

General side effects reported frequently have included fever and malaise. Chills, night sweats, pain (general), pain in the extremities, and abdominal pain have also been reported.

Local

Local side effects have included injection site pain and injection site reaction.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia.

Nervous system

Nervous system side effects have included convulsions, headaches, and paresthesia.

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