Asparaginase (Erwinia chrysanthemi)

Asparaginase may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• ongoing pain that begins in the stomach area, but may spread to the back
• extreme thirst
• frequent urination
• extreme hunger
• weakness
• blurred vision
• headache
• arm or leg swelling
• shortness of breath
• chest pain
• unusual bleeding
• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• dark colored urine
• loss of appetite
• lack of energy
• seizure

Asparaginase Erwinia chrysanthemi may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• any bleeding that will not stop;
• fever;
• seizure (convulsions);
• sudden numbness or weakness, especially on one side of the body;
• sudden severe headache, confusion, problems with vision, speech, or balance;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs; or
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Common side effects may include:

• mild nausea;
• diarrhea; or
• mild stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Instruct patients on the risk of allergic reactions, including anaphylaxis. Describe the symptoms of allergic reactions, including anaphylaxis, and instruct the patient to seek medical advice immediately if they experience such symptoms.
• Instruct patients on the risk of pancreatitis and to seek medical advice immediately if they experience abdominal pain.
• Instruct patients on the risk of hyperglycemia and glucose intolerance. Advise patients to seek medical advice if they experience excessive thirst or any increase in the volume or frequency of urination.
• Instruct patients on the risk of thrombosis and hemorrhage and to seek medical advice immediately if they experience headache, arm or leg swelling, shortness of breath, and chest pain.

Common side effects include the following:

• serious hypersensitivity reactions, such as anaphylaxis
• inflammation of the pancreas
• liver dysfunction
• blood clots
• bleeding
• nausea
• vomiting
• elevated blood sugar levels

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no well-done studies of asparaginase Erwinia chrysanthemi in pregnant women. Animal studies have not been done with asparaginase Erwinia chrysanthemi. It is not known whether asparaginase Erwinia chrysanthemi, can cause fetal (unborn baby) harm when taken if pregnant. Asparaginase Erwinia chrysanthemi should be given to a pregnant woman only if clearly needed.

Asparaginase Erwinia chrysanthemi comes as a powder to be added to fluid and injected into a muscle (IM) or into the vein (IV) by a doctor or nurse in a medical facility. It is usually given 3 times a week.

You should not receive asparaginase Erwinia chrysanthemi if you are allergic to it, or if you have received asparaginase (Elspar) in the past and it caused you to have:

• serious pancreas problems;

• a blood clots; or

• serious bleeding problems.

To make sure you can safely use asparaginase Erwinia chrysanthemi, tell your doctor if you have any of these other conditions:

• diabetes;

• a bleeding or blood clotting disorder such as hemophilia;

• a history of blood clots; or

• a history of pancreas problems.

It is not known whether asparaginase Erwinia chrysanthemi will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using asparaginase Erwinia chrysanthemi.

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

Your doctor or pharmacist can provide more information about asparaginase Erwinia chrysanthemi.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• Leukemia

Commonly reported side effects of asparaginase erwinia chrysanthemi include: anaphylaxis. Other side effects include: pancreatitis and severe hypersensitivity. See below for a comprehensive list of adverse effects.

To substitute for a dose of pegaspargase:
25,000 International Units/m2 intramuscularly three times a week (Monday/Wednesday/Friday) for six doses for each planned dose of pegaspargase.

To substitute for a dose of native E. coli asparaginase:
25,000 International Units/m2 administered intramuscularly for each scheduled dose of native E. coli asparaginase within a treatment regimen.

Comments:
-Limit the volume of reconstitution at a single injection site to 2 mL; if reconstituted dose to be administered is greater than 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.

Use:
-Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

Data not available