*Required Field

This field is required.
This field is required.
This field is required.
This field is required.
This field is required.
This field is required.

Privacy Statement

Emily’s story

Watch Emily share her experience with hypersensitivity to E. coli asparaginase and switching to RYLAZE as an adolescent patient.

Emily is quirky. She’s funny. Of course, she’s our sunshine.

She is very mature for her age and she is my heart, my star. 

We were perfect. She was healthy. It was fantastic. In a day, everything changed.

My name is Emily and I live in Phoenix, Arizona. My family is really nice. We all complement each other really well—it's like the Wizard of Oz. The brains, the heart, and the brave. Two years ago, I do remember having these, like, horrible aches and pains. I went to, like, two different doctors and they told me that was just growing pains. 

Fast-forward about a month, she said that she started to feel dizzy, and I noticed that she was starting to get pale. 

We went to her doctor and the doctor’s like, “No, go ahead and take her to emergency.” Wow, like, that's the first time we ever found out that it was something big. 

He told me I had acute lymphoblastic leukemia. 

I didn’t go back to work for two months after that because we were in the hospital. It was insane, just surreal. In the Mexican culture, cancer just seems like such a bad word and I think it’s really important to ask questions. 

I never had a family member go through it so it was all brand new to me, especially being that it was my daughter. There was nights where I didn’t go to sleep and I was just right there with her. 

It was just super comforting to know that they were there with me and that… no, hold on, I thought I’d be the only one that wasn’t going to cry, I was going to brag about it afterwards.

The day that everything came to a screeching halt was a day that I did not expect to go through.

Alex took Emily as normal to her appointment for chemo. 

I remember, like, snippets of it. My whole body feels weird. Not being able to control my arms. My legs like kicking everything. 

I was just terrified. 

I do remember them calling, like, a code blue. 

All the doctors, nurses, staff, everybody came in. 

I don’t remember what happened after that. 

Emily went into shock. She got an allergic reaction to asparaginase. 

It was like a day before she could actually, like, really come to.

Why couldn’t I have it instead of her? Because we don’t want our children to suffer. I would take it a million times as long as she could be okay. 

All I remember is just, like, waking up, seeing my mom there. After my reaction, the doctor said we have a different medication that does the same thing, but it is a longer process. It was an immediate switch to RYLAZE after that. 

Emily took RYLAZE for three months. I'm so thankful that there was an alternative. 

I was on my last treatment and then I got to ring the bell. 

She rang that bell hard, with all her might. She is currently in remission and she is very happy and excited to be where she is right now. 

Once she was in remission, that heaviness that you feel was lifted. I can finally breathe for a little bit, yeah.

This situation has changed us for the best. We are stronger. We are more together as a family.

Emily has such an important role in this world. There is something in store for us that’s going to come from her because she's just truly amazing and she's always been a miracle.

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:

  • History of serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
  • History of serious pancreatitis during previous asparaginase therapy
  • History of serious thrombosis during previous asparaginase therapy
  • History of serious hemorrhagic events during previous asparaginase therapy
  • Severe hepatic impairment

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, including Hepatic Veno-Occlusive Disease

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.

Hepatotoxicity, including severe, life-threatening, and potential fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with asparaginase class products in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer RYLAZE to patients with severe hepatic impairment. Inform patients of the signs and symptoms of hepatotoxicity.

Evaluate bilirubin and transaminases prior to each cycle of RYLAZE and at least weekly during cycles of treatment that include RYLAZE, through four weeks after the last dose of RYLAZE. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after RYLAZE, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, 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.

E. coli=Escherichia coli.

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:

  • History of serious hypersensitivity reactions to Erwinia asparaginase, including anaphylaxis
  • History of serious pancreatitis during previous asparaginase therapy
  • History of serious thrombosis during previous asparaginase therapy
  • History of serious hemorrhagic events during previous asparaginase therapy
  • Severe hepatic impairment