Erwinaze Side Effects
Generic name: asparaginase erwinia chrysanthemi
Medically reviewed by Drugs.com. Last updated on Aug 23, 2024.
Note: This document provides detailed information about Erwinaze Side Effects associated with asparaginase erwinia chrysanthemi. Some dosage forms listed on this page may not apply specifically to the brand name Erwinaze.
Applies to asparaginase erwinia chrysanthemi: injection powder for solution.
Other dosage forms:
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child have chills, fever, lightheadedness, dizziness, or fainting, fast, pounding heartbeat, swelling of the face, tongue, and throat, or trouble breathing after you receive the medicine.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).
Erwinase® can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor right away if you or your child start having increased thirst or hunger, increased urination, pale skin, nausea, sweating, or faintness. These may be signs that you are having problems with the amount of blood sugar in your body.
Tell your doctor right away if you or your child develop confusion, headache, nausea and vomiting, numbness or tingling in the arms or legs, or chest pain after receiving this medicine. These may be symptoms of a serious bleeding or blood clotting problem.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Erwinaze
Along with its needed effects, asparaginase erwinia chrysanthemi (the active ingredient contained in Erwinaze) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking asparaginase erwinia chrysanthemi:
More common side effects
- agitation
- back pain
- black, tarry stools
- bleeding gums
- bloating
- blood in the urine or stools
- blurred vision
- chest pain
- chills
- coma
- confusion
- constipation
- cough or hoarseness
- difficulty in walking
- dizziness
- drooping eyelids
- drowsiness
- dry mouth
- lightheadedness
- fainting
- fast heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- hallucinations
- headache
- increased hunger
- increased menstrual flow or vaginal bleeding
- increased thirst
- increased urination
- indigestion
- irritability
- jaw pain
- lower back or side pain
- mood or mental changes
- nosebleeds
- numbness or tingling in the fingers and toes
- pain in the fingers and toes
- pain in the testicles
- pains in the chest, groin, or legs, especially calves of the legs
- pains in stomach, side, or abdomen, possibly radiating to the back
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- rapid, shallow breathing
- seizures
- severe headaches of sudden onset
- sleepiness or unusual drowsiness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stiff neck
- stomach pain
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- sweating
- swollen glands
- trouble breathing
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- yellow eyes or skin
Less common side effects
- chest tightness
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- hives, itching, skin rash
- increase in frequency of seizures
- loss of appetite
- loss of consciousness
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Incidence not known
- diarrhea
- nervousness
- pounding in the ears
- slow or fast heartbeat
- unpleasant breath odor
- vomiting of blood
Other side effects of Erwinaze
Some side effects of asparaginase erwinia chrysanthemi may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For healthcare professionals
Applies to asparaginase erwinia chrysanthemi: injectable powder for injection, intramuscular solution.
General adverse events
The most frequent nonhematological serious adverse reactions (in greater than 5% of patients) were febrile neutropenia, infection, drug hypersensitivity, pyrexia, nausea, dehydration, stomatitis, acute kidney injury, pancreatitis, diarrhea, and viral infection.[Ref]
Hypersensitivity
- Very common (15% or more): Hypersensitivity reactions including rash, infusion related reaction, lip swelling, periorbital edema, throat irritation, urticaria, dry skin, eczema, erythema, hand dermatitis, rash maculo-papular, rash papular (21% to 24%)
- Very rare (less than 0.01%): Anaphylaxis[Ref]
Gastrointestinal
- Very common (15% or more): Stomatitis (24% to 27%), nausea (45% to 47%), abdominal pain (21% to 25%), diarrhea (18% to 25%), pancreatitis (12% to 22%)[Ref]
Nervous system
- Very common (15% or more): Headache (22% to 36%), peripheral neuropathy including peripheral motor neuropathy, neuropathy peripheral, peripheral sensory neuropathy (6% to 15%)[Ref]
Dermatologic
- Common (1% to 10%): Rash (19%)
- Frequency not reported: Toxic epidermal necrosis[Ref]
Hepatic
- Very common (15% or more): Abnormal liver tests (70% to 75%)
- Frequency not reported: Hepatomegaly, cholestatic jaundice[Ref]
Hematologic
- Very common (15% or more): Febrile neutropenia (27% to 30%), hemorrhage including contusion, epistaxis, catheter site hemorrhage, petechiae, hematochezia, menorrhagia, mouth hemorrhage, increased tendency to bruise, rectal hemorrhage (24 to 27%)
- Frequency not reported: clotting factor decreased, antithrombin III decreased, protein C decreased, protein S decreased, fibrinogen decreased[Ref]
Cardiovascular
- Very common (reported as 15% or more): Tachycardia (16 to 18%)[Ref]
Metabolic
- Very common (15% or more): Hyperglycemia (12% to 21%), hypokalemia (9% to 22%, dehydration (12% to 15%), decreased appetite (21% to 27%)
- Rare (0.01% to 0.1%): Diabetic ketoacidosis
- Very rare (less than 0.01%): Hyperammonemia[Ref]
Other
Infections:
- Very common (15% or more): Including sepsis, upper respiratory tract infection, enterocolitis infectious, skin infection, bacteremia, paronychia, pneumonia, otitis externa, soft tissue infection, abdominal infection, conjunctivitis, device related infection, folliculitis, lymph gland infection, necrotizing fasciitis, perirectal abscess, peritonsillar abscess, sinusitis, subcutaneous abscess, wound infection (27% to 36%)[Ref]
Musculoskeletal
- Very common (15% or more): Musculoskeletal pain, including arthralgia, back pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, pain in extremity (35% to 45%)[Ref]
Psychiatric
- Very common (15% or more): Insomnia (4% to 15%)[Ref]
Respiratory
- Very common (15% or more): Cough (15%)[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. "Product Information. Erwinaze (asparaginase Erwinia chrysanthemi)." EUSA Pharma
3. (2022) "Product Information. Rylaze (asparaginase Erwinia chrysanthemi)." Jazz Pharmaceuticals
More about Erwinaze (asparaginase erwinia chrysanthemi)
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- Dosage information
- During pregnancy
- FDA approval history
- Drug class: miscellaneous antineoplastics
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Patient resources
Other brands
Professional resources
- Erwinase prescribing information
- Erwinaze (FDA)
- Asparaginase (Erwinia chrysanthemi) (Recombinant) (AHFS Monograph)
Other brands
Related treatment guides
Further information
Erwinaze side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.