What is an allergic reaction?

Allergic reaction

Allergic reactions trigger an immune response throughout the body

An immune response is when the body’s immune system (the part of the body that fights infection and illness) recognizes something as foreign or harmful and attacks it in an attempt to destroy it. Just as the body sometimes reacts to dust, pollen, bee stings, and certain foods such as peanuts, it can also react to medicines meant to treat illness.

Allergic reactions can occur as a result of asparaginase therapy

  • Allergic reactions usually happen after repeated administration of asparaginase because the immune system starts to react more quickly to the therapy than it did after the first treatment
  • Most allergic reactions occur quickly, but some can occur up to 6 hours after treatment
  • Being treated again with the same asparaginase triggering the allergic reaction can cause a similar or even worse reaction
  • An allergic reaction can be a sign that the asparaginase therapy isn’t working as it should

Up to 3 out of 10

Percentage of patients who may experience an allergic reaction after E. coli-derived asparaginase therapy

patients may experience an allergic reaction after E. coli-derived asparaginase therapy

The antibodies the body creates during an allergic reaction will recognize the asparaginase as foreign and attack it again.

Experiencing an allergic reaction may signal that the asparaginase therapy is not successfully eliminating the cancer cells’ asparagine supply. Depleting cancer cells’ asparagine supply helps kill off the cancer cells, which is the goal of asparaginase therapy. 

How asparaginase causes allergic reactions

1
Cells creating antibodies

Cells in the body may create antibodies after asparaginase enters the body.

2
Antibodies circulating in blood

Those antibodies may circulate throughout the blood and can also bind to immune cells.

3
Antibodies attaching to asparaginase

Upon reexposure to asparaginase, the antibodies may attach to asparaginase, blocking its ability to break down asparagine. Eventually, the asparaginase gets removed from the body before it can work properly.

4
Antibodies releasing mediators

When antibodies attach to asparaginase, the immune cells recruited by the antibodies can release additional chemicals called mediators, which can cause symptoms of an allergic reaction. 

Cell

Cell

Asparaginase

Asparaginase

Antibody

Antibody

Mediators

Mediators

Switching to another form of asparaginase therapy that is not derived from E. coli can help ensure treatment continues uninterrupted.

An allergic reaction can affect the body in different ways

Signs and symptoms of an allergic reaction may include one or more of the following:

Mouth

Mouth: Swelling of lips, itchy throat, tongue

Lungs

Respiratory: Shortness of breath, wheezing, coughing, chest pain and/or tightness

Stomach

Stomach: Vomiting, diarrhea, cramps

Allergic reaction signs and symptoms
Head

General: Headache, nasal congestion, watery eyes, sweating, feeling of impending doom, loss of consciousness

Heart

Heart: Drop in blood pressure, dizziness, faintness

Arm

Skin: Itching, redness, swelling, hives

After an allergic reaction to asparaginase derived from E. coli, the doctor may recommend switching to a different kind of asparaginase. This change allows most patients to finish treatment uninterrupted.

An asparaginase therapy such as RYLAZE, which is derived from Erwinia chrysanthemi, has the same effect on asparagine as an asparaginase therapy derived from E. coli

Work with the healthcare team to understand what that means. The asparaginase therapy derived from Erwinia chrysanthemi is administered differently than the asparaginase therapy causing the allergic reaction. RYLAZE is short-acting. As such, RYLAZE is given more frequently to help ensure patients can maintain effective levels of asparaginase in their blood.

It is important to pay attention to any side effects and inform the healthcare team right away if something seems different or worse than what was expected.

What is RYLAZE?

RYLAZE is a prescription medicine, given by intramuscular injection, that is part of a chemotherapy regimen used to treat adults and children 1 month or older who have acute lymphoblastic leukemia (ALL), a type of blood cancer that affects the white blood cells that help fight infection, and lymphoblastic lymphoma (LBL), a type of non-Hodgkin lymphoma that also affects white blood cells. RYLAZE is used in patients who have had an allergic reaction to E. coli asparaginase.

IMPORTANT SAFETY INFORMATION

RYLAZE should not be given to people who have:

  • History of serious allergic reactions to RYLAZE
  • History of serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
  • Severe damage to the liver

RYLAZE may cause serious side effects, including:

  • Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, rash, or trouble breathing), some of which may be life-threatening
  • Swelling of the pancreas (stomach pain), which, if left untreated, may be fatal
  • Blood clots (may be experienced as headache, arm or leg swelling, shortness of breath, or chest pain), which may be life-threatening
  • Bleeding, which may be life-threatening
  • Liver problems (may result in abnormal laboratory values) or, in severe cases, hepatic veno-occlusive disease (reduced blood flow in the liver)

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

Some of the most common side effects with RYLAZE include:

  • Liver problems
  • Nausea and vomiting
  • Bone and muscle pain
  • Infection
  • Tiredness
  • Headache
  • Fever with low white blood cell count
  • Fever
  • Bleeding
  • Mouth swelling (sometimes with sores)
  • Pain in the abdomen
  • Decreased appetite
  • Allergic reactions
  • High blood sugar levels
  • Diarrhea
  • Swelling of the pancreas
  • Low levels of potassium in your blood

RYLAZE 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 hormonal contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week 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 RYLAZE. 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 (1-800-332-1088).

Please see full Prescribing Information and discuss with your doctor.

What is RYLAZE?

RYLAZE is a prescription medicine, given by intramuscular injection, that is part of a chemotherapy regimen used to treat adults and children 1 month or older who have acute lymphoblastic leukemia (ALL), a type of blood cancer that affects the white blood cells that help fight infection, and lymphoblastic lymphoma (LBL), a type of non-Hodgkin lymphoma that also affects white blood cells. RYLAZE is used in patients who have had an allergic reaction to E. coli asparaginase.

IMPORTANT SAFETY INFORMATION & APPROVED USE

RYLAZE should not be given to people who have:

  • History of serious allergic reactions to RYLAZE
  • History of serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
  • Severe damage to the liver

RYLAZE may cause serious side effects, including:

  • Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, rash, or trouble breathing), some of which may be life-threatening
  • Swelling of the pancreas (stomach pain), which, if left untreated, may be fatal
  • Blood clots (may be experienced as headache, arm or leg swelling, shortness of breath, or chest pain), which may be life-threatening
  • Bleeding, which may be life-threatening
  • Liver problems (may result in abnormal laboratory values) or, in severe cases, hepatic veno-occlusive disease (reduced blood flow in the liver)