Rylaze
- Generic Name: asparaginase erwinia chrysanthemi (recombinant) - rywn) injection
- Brand Name: Rylaze
Rylaze (Asparaginase Erwinia Chrysanthemi (Recombinant) - rywn) Injection) side effects drug center
Rylaze Side Effects Center
What Is Rylaze?
Rylaze (asparaginase Erwinia chrysanthemi (recombinant) rywn) is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen 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.
What Are Side Effects of Rylaze?
Side effects of Rylaze include:
- abnormal liver test,
- nausea,
- musculoskeletal pain,
- fatigue,
- infection,
- headache,
- fever,
- drug hypersensitivity,
- febrile neutropenia,
- decreased appetite,
- sores or inflammation in the mouth,
- bleeding,
- high blood sugar (hyperglycemia),
- abdominal pain,
- fast heart rate,
- diarrhea,
- constipation,
- dehydration,
- numbness and tingling of extremities,
- cough, and
- insomnia.
Dosage for Rylaze
When replacing a long-acting asparaginase product, the recommended dosage of Rylaze is 25 mg/m2 administered intramuscularly every 48 hours.
Rylaze In Children
The safety and effectiveness of Rylaze in the treatment of ALL and LBL have been established in pediatric patients 1 month to 17 years who have developed hypersensitivity to a long-acting E. coli derived asparaginase.
The safety and effectiveness of Rylaze have not been established in pediatric patients younger than 1 month of age.
What Drugs, Substances, or Supplements Interact with Rylaze?
Rylaze may interact with other medicines.
Tell your doctor all medications and supplements you use.
Rylaze During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Rylaze; it may harm a fetus. Pregnancy testing is recommended in females of reproductive potential prior to initiating Rylaze. Females of reproductive potential are advised to use effective non-hormonal contraceptive methods during treatment with Rylaze and for 3 months after the last dose. It is unknown if Rylaze passes into breast milk. Because of the potential for adverse reactions in the breastfed child, breastfeeding is not recommended during treatment with Rylaze and for 1 week after the last dose.
Additional Information
Our Rylaze (asparaginase Erwinia chrysanthemi (recombinant) rywn) Injection, for Intramuscular Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Rylaze Professional Information
SIDE EFFECTS
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Pancreatic Toxicity [see WARNINGS AND PRECAUTIONS]
- Thrombosis [see WARNINGS AND PRECAUTIONS]
- Hemorrhage [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of RYLAZE described in the WARNINGS AND PRECAUTIONS reflect exposure to RYLAZE at various dosages, including dosage other than the recommended, used in combination with chemotherapy in 102 patients in JZP458-201 [see Clinical Studies]. These patients received a median of 3 courses of RYLAZE (range: 1-14 courses); 38% of patients received at least four courses.
The safety of RYLAZE described below was evaluated in a cohort of 33 patients from JZP458-201 who received RYLAZE 25 mg/m² intramuscularly on Monday, Wednesday, and Friday for 6 doses as a replacement for a single dose of pegaspargase as a component of multi-agent chemotherapy [see Clinical Studies]. The patients had a median age of 11 years (range: 1 to 24 years); the majority of patients were male (51%) and white (73%). The patients received a median of 4 courses of RYLAZE (range: 1-14 cycles); 48% of patients received at least four courses.
A fatal adverse reaction (infection) occurred in 1 patient treated with the RYLAZE 25 mg/m² dosage. Serious adverse reactions occurred in 55% of patients who received the RYLAZE 25 mg/m² dosage.
The most frequent serious adverse reactions (in ≥ 5% of patients) were febrile neutropenia, dehydration, pyrexia, stomatitis, diarrhea, drug hypersensitivity, infection, nausea, and viral infection. Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received the RYLAZE 25 mg/m² dosage. Adverse reactions resulting in permanent discontinuation included hypersensitivity (6%) and infection (3%).
All patients treated with the RYLAZE 25 mg/m² dosage as a component of multi-agent chemotherapy developed neutropenia, anemia, or thrombocytopenia. The most common nonhematological adverse reactions in patients were abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycemia. Table 2 shows the common adverse reactions occurring in at least 15% of the patients.
Table 2: Adverse Reactions (≥ 15% incidence) in Patients Receiving RYLAZE 25 mg/m² as a Component of Multi-Agent Chemotherapy in Study JZP458-201
| Adverse Reaction | RYLAZE 25 mg/m² Dosagea N=33 |
|
| All Grades (%) | Grades 3-4 (%) | |
| Abnormal liver test* | 70 | 12 |
| Nausea* | 46 | 9 |
| Musculoskeletal pain* | 39 | 6 |
| Fatigue* | 36 | 3 |
| Infection*b | 30 | 12 |
| Headache | 30 | 0 |
| Pyrexia | 27 | 6 |
| Drug hypersensitivity* | 24 | 6 |
| Febrile neutropenia | 24 | 24 |
| Decreased appetite | 21 | 6 |
| Stomatitis | 21 | 9 |
| Bleeding* | 21 | 0 |
| Hyperglycemia | 21 | 3 |
| Abdominal pain* | 18 | 0 |
| Tachycardia* | 18 | 0 |
| Diarrhea* | 18 | 6 |
| Constipation | 15 | 0 |
| Dehydration | 15 | 9 |
| Neuropathy peripheral* | 15 | 0 |
| Cough | 15 | 0 |
| Insomnia | 15 | 0 |
| *Includes grouped terms Grading is based on Common Terminology Criteria for Adverse Events version 5.0 a RYLAZE was administered as a component of multi-agent chemotherapy regimens. b Does not include the following fatal adverse reactions: infection (N=1). Safety data for patients treated on a Monday, Wednesday and Friday schedule. |
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Clinically relevant adverse reactions in <15% of patients who received RYLAZE in combination with chemotherapy included:
Gastrointestinal disorders: Abdominal discomfort, abdominal distension, pancreatitis
General disorders and administration site conditions: Infusion site reaction, pain
Infections and infestations: Viral infection, bacterial infection, fungal infection
Investigations: Blood fibrinogen decreased, activated partial thromboplastin time prolonged
Metabolism and nutrition disorders: Acidosis
Musculoskeletal and connective tissue disorders: bone pain, muscular weakness, muscle spasms
Nervous system disorders: paresthesia
Psychiatric disorders: Agitation, anxiety, irritability
Renal and urinary disorders: Acute kidney injury
Skin and subcutaneous disorders: Pruritus
Vascular disorders: Hypotension
Immunogenicity
The incidence of ADA and subsequent effects on pharmacokinetics, pharmacodynamics, safety, or effectiveness have not been established.
DRUG INTERACTIONS
No Information provided
Read the entire FDA prescribing information for Rylaze (Asparaginase Erwinia Chrysanthemi (Recombinant) - rywn) Injection)
&Copy; Rylaze Patient Information is supplied by Cerner Multum, Inc. and Rylaze Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.