Asparaginase (Erwinia chrysanthemi)

Name: Asparaginase (Erwinia chrysanthemi)

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Asparaginase Erwinia chrysanthemi Interactions

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Other drugs may interact with procarbazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Asparaginase Erwinia chrysanthemi Dosage

Asparaginase Erwinia chrysanthemi is injected into a muscle.

Some people develop a life-threatening allergic reaction to asparaginase. You will need to receive this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Call your doctor for instructions if you miss an appointment for your asparaginase Erwinia chrysanthemi injection.

Uses of Asparaginase Erwinia chrysanthemi

Asparaginase Erwinia chrysanthemi is prescription medication used to treat acute lymphocytic leukemia (ALL). ALL is a type of cancer of the white blood cells. It is used in those who have had some types of allergic reactions to medications similar to asparaginase Erwinia chrysanthemi such as (asparaginase [Elspar] or pegaspargase [Oncaspar]).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Asparaginase Erwinia chrysanthemi and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if this medication crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.

Administration

IM Preparation

Visually inspect the powder for foreign particulate matter and discoloration prior to reconstitution; do use vial if present

Reconstitute vial contents by slowly injecting 1 or 2 mL of preservative free sterile sodium chloride (0.9%) injection against the inner vial wall

Do not forcefully inject solution for reconstitution directly onto or into the powder

When reconstituted with 1 mL the resultant concentration is 10,000 IU/mL

When reconstituted with 2 mL the resultant concentration is 5,000 IU/mL

Dissolve contents by gentle mixing or swirling; do not shake or invert vial When reconstituted, solution should be a clear and colorless

Do not use the reconstituted solution if any visible particles or protein aggregates are present

Calculate the dose needed and the volume needed to obtain the calculated dose

Withdraw the volume containing the calculated dose from the vial into a polypropylene syringe within 15 minutes of reconstitution

Administer within 4 hr or discard

IM Administration

Limit volume of single injection site to 2 mL; if volume of dose exceeds 2 mL, use multiple injection sites

If a partial vial is used, do not save or reuse the unused drug for later administration; discard unused portions

IV Preparation

Slowly inject the reconstituted asparaginase into an IV infusion bag containing 100 mL of 0.9%NaCl acclimatized to room temperature

Do not shake or squeeze IV bag

If partial vial is used, do not save or reuse the unused drug for later administration; discard unused portions

IV Administration

Infuse asparaginase in 100 mL of normal saline over 1-2 hr

Do not infuse other drugs through same IV line while administering asparaginase

Storage

Store unused or unopened vials and cartons at 36-46°F (2-8°C) and protect from light

Do not freeze or refrigerate reconstituted solution

Uses for Asparaginase (Erwinia chrysanthemi)

Acute Lymphocytic Leukemia (ALL)

Component of combination chemotherapy for treatment of ALL in patients who are hypersensitive to E. coli-derived asparaginase (native [nonconjugated] asparaginase [Escherichia coli] or pegaspargase; asparaginase [Escherichia coli] no longer commercially available in the US); designated an orphan drug by FDA for this use.1 2 4 6 7 8 9

Actions

  • Inactivates the amino acid asparagine, which is required by tumor cells for protein synthesis.1 8 10

  • Catalyzes deamidation of asparagine to aspartic acid and ammonia, which reduces circulating concentrations of asparagine and leads to leukemic cell death.1 8 10

  • Antigenically distinct from asparaginase (Escherichia coli).6

For the Consumer

Applies to asparaginase erwinia chrysanthemi: injection powder for solution

Along with its needed effects, asparaginase erwinia chrysanthemi 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
  • Cough
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives or welts, itching, or rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • troubled breathing or swallowing
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • bloating
  • blurred vision
  • chills
  • constipation
  • dark 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 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 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:

Less common
  • Diarrhea

For Healthcare Professionals

Applies to asparaginase erwinia chrysanthemi: injectable 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]

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

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