"When we found out Leighton was allergic to her [E. coli-derived] asparaginase therapy, it was the first time in treatment that we hit a fork in the road."
- Leighton’s Father (Actual Patient Family)

How RYLAZE can help

May prevent missed doses

RYLAZE offers a different source of asparaginase, which doesn't come from E. coli. This may help fight acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) by preventing or limiting missed doses and maintaining the effectiveness of treatment. Patients who miss asparaginase doses are at greater risk of negative outcomes such as relapse, so it’s important for asparaginase therapy to continue after an allergic reaction. Switching to RYLAZE can help asparaginase therapy finish uninterrupted.

Talk with the healthcare team about treatment with RYLAZE.

Why was RYLAZE developed?

RYLAZE was developed by medical scientists for patients who experienced an allergic reaction from asparaginase therapy derived from E. coli.

Without an alternative type of asparaginase therapy, many patients went without this essential part of treatment.

RYLAZE was derived from Erwinia chrysanthemi to give patients another option after experiencing an allergic reaction from E. coli-derived asparaginase.

How RYLAZE was studied

RYLAZE was studied in a clinical trial of 167 patients (ages 1-25) receiving an injection into the muscle. Data from these patients were used to predict asparaginase levels for 2,000 virtual patients. All patients had ALL or LBL and experienced an allergic reaction while receiving asparaginase therapy derived from E. coli, along with their chemotherapy regimen.

RYLAZE study results

The Food and Drug Administration (FDA) approved RYLAZE as part of a multi-agent chemotherapy regimen for the treatment of ALL and LBL based on the results of the study.

The study showed that RYLAZE maintained effective asparaginase levels in the body and met safety requirements specified by the FDA.

Approximately 9 out of every 10

virtual patients achieved and maintained asparaginase levels considered to be effective for treatment.

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 had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment

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

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.