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What is RYLAZE?

Key points about how an asparaginase with minimal immunologic crossreactivity to E. coli-derived asparaginase can help patients to complete their intended course of asparaginase treatment.1,2

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.

Asparaginase 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.

Indication

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

IMPORTANT SAFETY INFORMATION

Contraindications

RYLAZE is contraindicated in patients with a history of:

  • Serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
  • Serious pancreatitis during previous asparaginase therapy
  • Serious thrombosis during previous asparaginase therapy
  • Serious hemorrhagic events during previous asparaginase therapy

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions after the use of RYLAZE occurred in 29% of patients in clinical trials, and it was severe in 6% of patients. Anaphylaxis was observed in 2% of patients after intramuscular administration. Discontinuation of RYLAZE due to hypersensitivity reactions occurred in 5% of patients. Hypersensitivity reactions were higher in patients who received intravenous asparaginase erwinia chrysanthemi (recombinant)-rywn. The intravenous route of administration is not approved.

In patients administered RYLAZE intramuscularly in clinical trials, the median number of doses of RYLAZE that patients received prior to the onset of the first hypersensitivity reaction was 12 doses (range: 1-64 doses). The most commonly observed reaction was rash (19%), and 1 patient (1%) experienced a severe rash.

Hypersensitivity reactions observed with L-asparaginase class products include angioedema, urticaria, lip swelling, eye swelling, rash or erythema, blood pressure decreased, bronchospasm, dyspnea, and pruritus.

Premedicate patients prior to administration of RYLAZE as recommended. Because of the risk of serious allergic reactions (e.g., life-threatening anaphylaxis), administer RYLAZE in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, oxygen, intravenous steroids, antihistamines). Discontinue RYLAZE in patients with serious hypersensitivity reactions.

Pancreatitis

Pancreatitis, including elevated amylase or lipase, was reported in 20% of patients in clinical trials of RYLAZE and was severe in 8%. Symptomatic pancreatitis occurred in 7% of patients, and it was severe in 6% of patients. Elevated amylase or lipase without symptomatic pancreatitis was observed in 13% of patients treated with RYLAZE. Hemorrhagic or necrotizing pancreatitis have been reported with L-asparaginase class products.

Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Evaluate patients with symptoms compatible with pancreatitis to establish a diagnosis. Assess serum amylase and lipase levels in patients with any signs or symptoms of pancreatitis. Discontinue RYLAZE in patients with severe or hemorrhagic pancreatitis. In the case of mild pancreatitis, withhold RYLAZE until the signs and symptoms subside and amylase and/or lipase levels return to 1.5 times the ULN. After resolution of mild pancreatitis, treatment with RYLAZE may be resumed.

Thrombosis

Serious thrombotic events, including sagittal sinus thrombosis and pulmonary embolism, have been reported in 1% of patients following treatment with RYLAZE. Discontinue RYLAZE for a thrombotic event, and administer appropriate antithrombotic therapy. Consider resumption of treatment with RYLAZE only if the patient had an uncomplicated thrombosis.

Hemorrhage

Bleeding was reported in 25% of patients treated with RYLAZE, and it was severe in 2%. Most commonly observed reactions were bruising (12%) and nose bleed (9%).

In patients treated with L-asparaginase class products, hemorrhage may be associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.

Hepatotoxicity

Elevated bilirubin and/or transaminases occurred in 75% of patients treated with RYLAZE in clinical trials, and 26% had Grade ≥3 elevations. Elevated bilirubin occurred in 28% of patients treated with RYLAZE in clinical trials, and 2% had Grade ≥3 elevations. Elevated transaminases occurred in 73% of patients treated with RYLAZE in clinical trials, and 25% had Grade ≥3 elevations.

Inform patients of the signs and symptoms of hepatotoxicity. Evaluate bilirubin and transaminases prior to treatment every 2-3 weeks and as indicated clinically during treatment with RYLAZE. In the event of serious liver toxicity, discontinue treatment with RYLAZE and provide supportive care.

Adverse Reactions

The most common adverse reactions (incidence >20%) with RYLAZE are abnormal liver test, nausea, musculoskeletal pain, infection, fatigue, headache, febrile neutropenia, pyrexia, hemorrhage, stomatitis, abdominal pain, decreased appetite, drug hypersensitivity, hyperglycemia, diarrhea, pancreatitis, and hypokalemia.

Use in Specific Populations

Pregnancy and Lactation

RYLAZE can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with RYLAZE and for 3 months after the last dose. Advise women not to breastfeed during treatment with RYLAZE and for 1 week after the last dose.

Please see full Prescribing Information.

References: 1. van der Sluis IM, Vrooman LM, Pieters R, et al. Consensus expert recommendations for identification and management of asparaginase hypersensitivity and silent inactivation. Haematologica. 2016;101(3):279-285. 2. Maese L, Loh ML, Choi MR, et al. Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study. Blood. 2023;141(7):704-712.

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Indication

RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY 
INFORMATION AND INDICATION

Contraindications

RYLAZE is contraindicated in patients with a history of:

  • Serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
  • Serious pancreatitis during previous asparaginase therapy
  • Serious thrombosis during previous asparaginase therapy
  • Serious hemorrhagic events during previous asparaginase therapy