Pegaspargase

Name: Pegaspargase

Pegaspargase Side Effects

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

Call your doctor at once if you have:

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

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.

  • Cancer
  • Leukemia

Pegaspargase Drug Class

Pegaspargase is part of the drug class:

  • OTHER ANTINEOPLASTIC AGENTS

Pegaspargase Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of this medication, there are no specific foods that you must exclude from your diet.

What is the most important information I should know about pegaspargase?

You should not use pegaspargase if you have ever received asparaginase and it caused pancreatitis, severe bleeding, a blood clot, or a severe allergic reaction.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your pegaspargase injection.

Pegaspargase Pharmacokinetics

Distribution

Extent

Distributes into CSF (reportedly reducing CSF asparagine concentrations to a similar extent as asparaginase (Escherichia coli).1

Not known whether pegaspargase is distributed into milk.1

Elimination

Half-life

Approximately 5.8 days following IM administration in pediatric patients.1

7 days following IV administration in adults.23

1.4–5 and 2.5–8.9 days following IM administration in patients with relapsed ALL previously hypersensitive and non-hypersensitive to asparaginase (Escherichia coli), respectively.1

What are some things I need to know or do while I take Pegaspargase?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
  • Check your blood sugar as you have been told by your doctor.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Unsafe allergic effects may happen. You will be closely watched by your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using pegaspargase while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Pegaspargase?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Onset of Action

Asparagine depletion: IM: Within 4 days

Time to Peak

IM: 3 to 4 days

Reconstitution

IV: Dilute in 100 mL NS or D5W.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F); do not freeze. Do not shake; protect from light. Discard vial if previously frozen, stored at room temperature for >48 hours, excessively shaken/agitated, or if cloudy, discolored, or if precipitate is present. If not used immediately, solutions diluted for infusion in NS or D5W should be protected from light, refrigerated at 2°C to 8°C (36°F to 46°F) and used within 48 hours (including administration time).

Other Comments

Administration advice:
-IM: Single injection site volume administered should be limited to 2 mL. If volume to be administered is greater than 2 mL, multiple injection sites should be used. Use only one dose per vial and discard unused product.
-IV: Pegaspargase should be given over a period of 1 to 2 hours in 100 mL of sodium chloride or dextrose injection 5%, through an infusion that is already running. After the solution is diluted for IV use, the solution should be used immediately.
-Do not administer if drug has been frozen, stored at room temperature 15C to 25C (59F to 77F) for more than 48 hours, shaken or vigorously agitated.

Storage requirements:
-IV: If immediate use is not possible, the diluted solution should be stored at 2C to 8C (36F to 46F). Storage after dilution should not exceed 48 hours from the time of preparation to completion of administration.
-Protect infusion bags from direct sunlight.
-Parenteral drug products should be inspected for particulate matter, cloudiness, or discoloration prior to administration. If any of these are present, discard the vial or container.

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