Treatment may continue following an allergic reaction

While allergic reactions to one form of asparaginase may occur, it does not necessarily mean the end to asparaginase therapy. The FDA has specifically approved ERWINAZE for use after an allergic reaction to other forms of asparaginase. Receiving ERWINAZE may help ensure that the scheduled course of therapy of asparaginase is completed.

How is ERWINAZE different?
ERWINAZE works in a similar way as other asparaginase treatments, but is made from a different asparaginase source, so it may be used in people who have had an allergic reaction to another form of asparaginase. When allergic reactions occur, switching to ERWINAZE may allow continuation of this important type of medicine.

  • In clinical studies, a majority of patients did not have allergic reactions after switching to ERWINAZE
  • In one clinical study, 78% (693/893) of patients were able to complete their prescribed asparaginase treatment course with ERWINAZE

Majority of patients completed therapy

What is ERWINAZE?
ERWINAZE is part of a chemotherapy program to treat patients who have acute lymphoblastic leukemia (ALL), a type of blood cancer that affects the white blood cells that help fight infection. ERWINAZE is used in patients who have had an allergic reaction to a different type of asparaginase treatment.

IMPORTANT SAFETY INFORMATION

Who should not receive ERWINAZE?
ERWINAZE should not be given to people who have had:

  • Serious allergic reactions to ERWINAZE
  • Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during prior L-asparaginase treatment

What are the possible side effects of ERWINAZE?
ERWINAZE may cause serious side effects, including:

  • Allergic reactions (a feeling of tightness in the throat, unusual swelling/redness in the throat and/or tongue, or trouble breathing), some of which may be life-threatening
  • Swelling of the pancreas (stomach pain)
  • Too much sugar in your blood (may be thirsty or need to urinate often)
  • Blood clots (may have headache or pain in leg, arm, or chest), or bleeding

Contact the doctor immediately if any of these side effects occur.

Some of the most common side effects with ERWINAZE include:

  • Allergic reactions
  • Too much sugar in the blood
  • Fever
  • Swelling of the pancreas
  • Local reactions (swelling, rash, etc. where the needle entered the skin)
  • Vomiting
  • Feeling nauseous
  • Blood clots (may have headache or pain in leg, arm, or chest)
  • Liver problems
  • Stomach pain/discomfort
  • Diarrhea

Tell the healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of ERWINAZE. For more information, ask the healthcare provider.

Call the doctor for medical advice about any side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

How is ERWINAZE given?
ERWINAZE is given as an injection (a shot) into a muscle or infusion into a vein.

Please see full Prescribing Information and discuss with the doctor.