What is RYLAZE?

RYLAZE is approved as part of a chemotherapy regimen for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients 1 month or older after an allergic reaction to E. coli asparaginase.

RYLAZE is an Erwinia-derived asparaginase therapy that helps patients with ALL and LBL continue on therapy after an allergic reaction to E. coli-derived asparaginase.

Asparaginase is a naturally occurring enzyme used to break down asparagine in the blood.

Asparagine is an amino acid that circulates throughout the body and is needed by both healthy cells and cancer cells to survive. Unlike healthy cells, cancer cells cannot make asparagine themselves. They must absorb it from the circulating blood to continue growing and spreading.

Asparaginase therapy helps prevent cancer cells from accessing the asparagine they need to survive.

Patients typically receive E. coli-derived asparaginase, but sometimes an allergic reaction may occur. During an allergic reaction to E. coli-derived asparaginase, an immune response in the body is triggered. Just as the body can react to dust, pollen, bee stings, and food allergies, it can also react to medicines like asparaginase.

An allergic reaction to E. coli-derived asparaginase can be a sign that therapy isn’t working as it should. Asparaginase therapy is essential to the treatment of ALL and LBL, but it’s important to stop receiving E. coli-derived asparaginase after developing an allergic reaction.

Being treated again with the E. coli-derived asparaginase that triggered the allergic reaction can cause a similar or even worse reaction.

Switching to an alternate form of asparaginase therapy, that is not derived from E. coli, can help ensure treatment can continue uninterrupted.

RYLAZE is an asparaginase therapy derived from Erwinia chrysanthemi instead of E. coli.

RYLAZE offers a different source of asparaginase which doesn’t come from E. coli. This may help fight ALL and LBL by preventing or limiting missed doses and maintaining the effectiveness of treatment.

The doctor will choose 1 of 2 possible schedules for administering RYLAZE. Those options are either Monday, Wednesday, and Friday, or every 48 hours, over the course of 2 or 3 weeks.

Before administering RYLAZE, the doctor may first administer other medications to decrease the risk of an allergic reaction. The doctor will determine the individualized dose of RYLAZE and monitor for any negative reactions. If an allergic or adverse reaction occurs, alert the healthcare team immediately and treatment with RYLAZE should be paused or stopped.

RYLAZE was studied in a clinical trial of 167 patients (ages 1 to 25 years) with ALL or LBL who experienced an allergic reaction while receiving E. coli-derived asparaginase therapy, along with their chemotherapy regimen.

The FDA approved RYLAZE for treatment of ALL and LBL as part of a multiagent chemotherapy regimen after an allergic reaction to E. coli asparaginase.

Possible side effects with RYLAZE are similar to side effects experienced with other asparaginase therapies.

RYLAZE should not be given to people who have had serious allergic reactions to RYLAZE, or during previous asparaginase treatment have experienced the following: serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding.

RYLAZE may cause serious side effects including allergic reactions, some of which may be life-threatening; swelling of the pancreas, which, if left untreated, may be fatal; blood clots, which may be life-threatening; bleeding, which may be life-threatening, and liver problems.

Some of the most common side effects 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, and low levels of potassium in your blood.

These are not all the possible side effects of RYLAZE.

RYLAZE can harm unborn babies. Inform the doctor of pregnancy, planned pregnancy, or nursing status. 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.

Patients are encouraged to report negative side effects to the FDA or Jazz Pharmaceuticals. Tell the doctor if there are any bothersome side effects that do not go away.

To learn more about ALL, LBL, asparaginase therapy, and allergic reactions, explore RYLAZE.com and the other resources available on the site.