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 your throat, unusual swelling/redness in your 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 your 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
- Swelling of the pancreas
- Local reactions (swelling, rash, etc. where the needle entered the skin)
- Feeling nauseous
- Blood clots (may have headache or pain in leg, arm, or chest)
- Liver problems
- Stomach pain/discomfort
ERWINAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving ERWINAZE and for 3 months after the final dose.
Tell your 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 your healthcare provider.
Call your 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.
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.
What should your doctor or healthcare provider be told?
The doctor or healthcare provider should be informed about any:
- Allergic reaction to ERWINAZE or any asparaginase treatment
- Stomach pain, blood clots, or stroke during any asparaginase treatment
- Current pregnancy or plans to become pregnant
- Current breastfeeding or plans to breastfeed
Please see full Prescribing Information and discuss with your doctor.